This page shows what was measured, who it was measured in, and what that does not settle.
What Glimepiride does in the body
Type 2 diabetes — the sulfonylurea with the largest outcome trial behind it
Cells in the pancreas that make insulin stay quiet because potassium leaks out through an open channel. Rising blood sugar closes that channel and the cell releases insulin. Glimepiride closes it chemically instead, so insulin is released whether or not blood sugar is high. It works within two to three hours, is broken down by a liver enzyme into one product that still works and a second that does not, and it needs surviving beta cells to act on at all.
What happened in people
A hazard ratio of 0.98 (95.47% CI 0.84 to 1.14) for three-point MACE, linagliptin against glimepiride, over a median 6.3 years in 6,033 patients
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes (NCT01243424) · a recorded source, not a stored snapshot
The only sulfonylurea with a dedicated cardiovascular outcome trial, and the sulfonylurea most guidelines name when one is used at all
Where it acts
Pancreatic islet beta cell plasma membrane
Kind of result
The kind of result is not recorded
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 125 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Blood sugar
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
△Only a number moved16 registered test measure.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Blood sugar
hba1c from baseline to week 26; hba1c after 24 weeks; time to hba1c 8; hba1c change from baseline at week 12; hba1c; treatment difference in hba1c; glycemic measure hba1c; hba1c change from baseline
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
△ Only a number moved
16 registered test measure.
— Not recorded
Harms were not a registered measure for this goal.
… Waiting for a reviewer
Who was studied is listed further down the page.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Time to first cardiovascular death, non-fatal myocardial infarction or non-fatal stroke, linagliptin against glimepiride, non-inferiority margin 1.3
✓ The study showed what it set out to show
Who was studied
CAROLINA (NCT01243424)
How many people
6033
Study design
Randomised, double-blind, active-controlled non-inferiority cardiovascular outcome trial, median 6.3 years
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
P < 0.001 for non-inferiority; hazard ratio 0.98 (95.47% CI 0.84 to 1.14). Superiority not met (P = 0.76)
Repeated elsewhere
Unreplicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. There was no placebo arm, so the trial cannot establish that either drug is cardiovascularly neutral in absolute terms. At least one hypoglycaemic adverse event occurred in 37.7% of the glimepiride arm against 10.6% on linagliptin.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, once daily, in 1 mg, 2 mg and 4 mg strengths
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes (NCT01243424) · a recorded source, not a stored snapshot
Confirmed glycated haemoglobin of 7.0% or higher, comparing insulin glargine, glimepiride, liraglutide and sitagliptin added to metformin
✗ The study did not show it
Who was studied
GRADE — glycaemic outcomes (NCT01794143)
How many people
5047
Study design
Randomised comparative-effectiveness trial of four second-line agents, mean 5.0 years
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
P < 0.001 for the global test across arms; 26.5, 26.1, 30.4 and 38.1 events per 100 participant-years for glargine, liraglutide, glimepiride and sitagliptin
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. Severe hypoglycaemia was significantly more frequent on glimepiride (2.2%) than on glargine (1.3%), liraglutide (1.0%) or sitagliptin (0.7%) — more than on insulin.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, once daily, in 1 mg, 2 mg and 4 mg strengths
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes (NCT01243424) · a recorded source, not a stored snapshot
Albuminuria, renal impairment, peripheral neuropathy, MACE, heart-failure hospitalisation, any cardiovascular disease and death across the four arms
✗ The study did not show it
Who was studied
GRADE — microvascular and cardiovascular outcomes (NCT01794143)
How many people
5047
Study design
Prespecified secondary outcomes of the same randomised trial, mean 5.0 years
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
No material differences on microvascular outcomes or death; hazard ratios against the combined other three arms for any cardiovascular disease were 1.1 (95% CI 0.9 to 1.4) for glimepiride and 0.7 (95% CI 0.6 to 0.9) for liraglutide
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. The authors state the confidence limits are not adjusted for multiple comparisons, which applies to the liraglutide signal as much as to the rest.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, once daily, in 1 mg, 2 mg and 4 mg strengths
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes (NCT01243424) · a recorded source, not a stored snapshot
P < 0.001 for the 1 mg arm; adjusted mean differences from placebo of -1.2 (95% CI -1.5 to -0.8), -1.8 (95% CI -2.1 to -1.4) and -1.8 (95% CI -2.2 to -1.5) percentage points at 1, 4 and 8 mg
Repeated elsewhere
Unreplicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Patients were withdrawn from existing sulfonylurea therapy before randomisation, so the placebo arm deteriorated by 1.5 percentage points and supplies most of the between-group difference. Weight differed from placebo by 3.2 kg at 8 mg, and only 66% of the placebo arm completed against 92% on the higher doses.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, once daily, in 1 mg, 2 mg and 4 mg strengths
Interval reported. 95% CI -1
Written into the record, not signed off as a reviewed claim.
CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes (NCT01243424) · a recorded source, not a stored snapshot
RNAWiki holds 4 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
□Living longer, or avoiding a major eventNo evidence recorded. Death, a heart attack, a stroke, a hospital stay.0 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.24 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Where a source records it acting
Pancreas: Primarily lowers blood glucose by stimulating the release of insulin from pancreatic beta cells
US prescribing information · 0003458f-352a-46fa-9d99-230daa76ae29 · read 2026-08-27
Start
Glimepiride
What a person takes: Oral tablet, once daily, in 1 mg, 2 mg and 4 mg strengths.
The measurement behind this step
A conventional immediate-release tablet of a practically water-insoluble sulfonylurea. Absorption is complete enough that food changes exposure by less than a tenth, and pharmacokinetics are linear across the marketed dose range with no accumulation. The drug is fully metabolised — nothing is excreted unchanged — through CYP2C9 to an active M1 metabolite and then to inactive M2.
Getting in
Absorbed and at peak within two to three hours
Blood levels peak two to three hours after a dose, and that is also when blood sugar hits its lowest point. Taking it with food shifts things only slightly.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Peak plasma concentration occurs 2 to 3 hours post-dose, and time to minimum blood glucose in healthy subjects is the same 2 to 3 hours. Food reduces mean peak concentration by 8% and exposure by 9%. Clearance is linear from 1 mg to 8 mg and there is no accumulation on repeated dosing. Protein binding exceeds 99.5%.
CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes (NCT01243424) · a recorded source, not a stored snapshot
It binds the receptor sitting on the beta-cell potassium channel
On the surface of insulin-producing cells is a gate that lets potassium out, with a control protein attached. Glimepiride binds that control protein.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
The label states the mechanism directly: sulfonylureas bind the sulfonylurea receptor in the pancreatic beta-cell plasma membrane, leading to closure of the ATP-sensitive potassium channel. The receptor is SUR1, an ABC-transporter-family protein encoded by ABCC8, assembled four-to-four with the Kir6.2 pore encoded by KCNJ11.
CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes (NCT01243424) · a recorded source, not a stored snapshot
With potassium no longer leaking out, positive charge accumulates inside. That voltage change is exactly what the cell normally waits for glucose to produce.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Channel closure removes the resting potassium conductance and depolarises the membrane toward the threshold for voltage-gated L-type calcium channels. Physiologically the trigger is a rising ATP-to-ADP ratio from glucose metabolism; here it is pharmacological and glucose-independent.
CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes (NCT01243424) · a recorded source, not a stored snapshot
Calcium channels open, calcium floods the cell, and the packets of insulin already sitting at the membrane fuse with it and release their contents into the blood.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Rising cytosolic calcium triggers SNARE-mediated exocytosis of docked insulin granules. Because the drug supplies the depolarisation, secretion proceeds at normal and low glucose as well as high — the mechanistic origin of sulfonylurea hypoglycaemia.
CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes (NCT01243424) · a recorded source, not a stored snapshot
The liver makes one product that still works and one that does not
A liver enzyme converts the drug into a first breakdown product that retains roughly a third of the activity, then a second enzyme converts that into an inactive one.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Metabolism is complete and oxidative. Cytochrome P450 2C9 converts glimepiride to the cyclohexyl hydroxymethyl derivative M1, which in animals possesses about one third of the pharmacological activity of the parent; cytosolic enzymes then convert M1 to the carboxyl derivative M2, which is inactive. CYP2C9 activity therefore shifts the active exposure, not just the clearance rate.
CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes (NCT01243424) · a recorded source, not a stored snapshot
HbA1c falls, weight rises, and the effect wears off over years
Average blood sugar comes down and stays down for a while. Weight goes up. Over five years the control slips faster than on insulin or a GLP-1 drug, because the drug depends on beta cells that are still being lost.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
In the registration trial the 8 mg arm differed from placebo by -1.8 HbA1c percentage points and +3.2 kg. In GRADE, the rate of losing HbA1c control below 7.0% was 30.4 per 100 participant-years on glimepiride against 26.5 on insulin glargine and 26.1 on liraglutide, with severe hypoglycaemia at 2.2% against 1.3% and 1.0%.
CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes (NCT01243424) · a recorded source, not a stored snapshot
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
hba1c from baseline to week 26
hba1c after 24 weeks
time to hba1c 8
glycosylated haemoglobin a1c at week 52
glycosylated haemoglobin a1c at week 104
glycosylated haemoglobin a1c at week 156
hba1c change from baseline at week 12
hba1c
treatment difference in hba1c
glycosylated haemoglobin value 7
and 14 more.
Meaningful
Things that change how a life goes, not only a number.
No registered study measured anything of this kind.
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (16)
primary major macrovascular events
a1c at month 6
carotid intima media thickness
nominal change from baseline in atheroma volume
glycosylated a1c at week 26
glycosylated a1c at week 104
treatment failure
time to treatment failure
long term glycemic control
pancreatic beta cell function
cell function parameter
catecholamines
acetylcholine mediated forearm blood flow
bioequivalence
homeostatic model assessment beta cell
who experienced one or more episodes of hypoglycemia
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Adults with type 2 diabetes, usually added to metformin. It costs under four cents a tablet and is one of the most-dispensed diabetes drugs in the world.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The pharmacokinetics, efficacy and safety of glimepiride have been evaluated in pediatric patients with type 2 diabetes as described below.”
US prescribing information · 489dc098-0ac7-4f8e-b258-326229539c7c · read 2026-08-30
On older people, the label states: “In clinical trials of glimepiride, 1053 of 3491 patients (30%) were >65 years of age.”
US prescribing information · 489dc098-0ac7-4f8e-b258-326229539c7c · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Available data from a small number of published studies and postmarketing experience with glimepiride use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes.”
US prescribing information · 489dc098-0ac7-4f8e-b258-326229539c7c · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Breastfed infants of lactating women using glimepiride should be monitored for symptoms of hypoglycemia (see Clinical Considerations) .”
US prescribing information · 489dc098-0ac7-4f8e-b258-326229539c7c · read 2026-08-30
On people with reduced kidney function, the label states: “The pharmacokinetics of glimepiride was evaluated in the multiple-dose titration study and the results were consistent with those observed in patients enrolled in a single-dose study.”
US prescribing information · 489dc098-0ac7-4f8e-b258-326229539c7c · read 2026-08-30
Where the result stopped carrying
Glimepiride was the least durable of the three effective arms in GRADE, and the only one whose severe hypoglycaemia rate exceeded insulin glargine
CAROLINA met non-inferiority but not superiority (p=0.76), so no cardiovascular advantage was demonstrated in either direction
The 1970 UGDP class warning survives on the label, in modern format as "Potential Increased Risk of Cardiovascular Mortality with Sulfonylureas", unresolved by the largest trial ever run in this class
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral tablet, once daily, in 1 mg, 2 mg and 4 mg strengths
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
A conventional immediate-release tablet of a practically water-insoluble sulfonylurea. Absorption is complete enough that food changes exposure by less than a tenth, and pharmacokinetics are linear across the marketed dose range with no accumulation. The drug is fully metabolised — nothing is excreted unchanged — through CYP2C9 to an active M1 metabolite and then to inactive M2.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
The recorded stepping schedule
What follows is the schedule printed on the label, recorded as it is written there. It is a record of what was done, not a recommendation.
US prescribing information · 0003458f-352a-46fa-9d99-230daa76ae29 · read 2026-08-27
Starting dose: 1 or 2 mg once daily — Label-stated recommended starting dose, administered with breakfast or first meal of the day
US prescribing information · 0003458f-352a-46fa-9d99-230daa76ae29 · read 2026-08-27
No more frequently than every 1 to 2 weeks: Increase in 1 or 2 mg increments based on glycemic response — Label-stated uptitration
US prescribing information · 0003458f-352a-46fa-9d99-230daa76ae29 · read 2026-08-27
Maximum: 8 mg once daily — Label-stated maximum recommended dose
US prescribing information · 0003458f-352a-46fa-9d99-230daa76ae29 · read 2026-08-27
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
Hypoglycaemia is the defining risk and can be severe: the label warns that impaired concentration and reaction may present a risk while driving or operating machinery, and that severe hypoglycaemia can cause unconsciousness, convulsions, temporary or permanent brain impairment, or death. Older patients and those with renal impairment are at higher risk. Weight gain is expected — 3.2 kg against placebo at the highest dose in the registration trial. Postmarketing hypersensitivity reports include anaphylaxis, angioedema and Stevens-Johnson syndrome. Haemolytic anaemia can occur in glucose-6-phosphate dehydrogenase deficiency, and the label suggests a non-sulfonylurea alternative in that setting. The label carries both a warning on potential increased cardiovascular mortality with sulfonylureas and a statement that no macrovascular benefit has been conclusively established for any antidiabetic drug.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes (NCT01243424) · a recorded source, not a stored snapshot
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Glimepiride appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2301 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
hypoglycaemia — 1161 reaction mentions
hypoglycaemic coma — 157 reaction mentions
acute kidney injury — 142 reaction mentions
blood glucose increased — 141 reaction mentions
diabetes mellitus inadequate control — 133 reaction mentions
lactic acidosis — 132 reaction mentions
loss of consciousness — 124 reaction mentions
drug interaction — 120 reaction mentions
renal impairment — 106 reaction mentions
hyperhidrosis — 85 reaction mentions
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral tablet, once daily, in 1 mg, 2 mg and 4 mg strengths
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Absorption is complete enough that food changes exposure by less than a tenth, and pharmacokinetics are linear across the marketed dose range with no accumulation. The drug is fully metabolised — nothing is excreted unchanged — through CYP2C9 to an active M1 metabolite and then to inactive M2.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
124 products list this as an active ingredient in the United States drug directory. 116 of them contain it and nothing else.
FDA National Drug Code directory · 11532-3043 · read 2026-08-29
They are sold as powder and tablet, taken oral.
FDA National Drug Code directory · 11532-3043 · read 2026-08-29
The regulator's established pharmacologic class for it is sulfonylurea compounds [cs] and sulfonylurea [epc].
FDA National Drug Code directory · 11532-3043 · read 2026-08-29
75 published labels name it as an active ingredient. 73 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 489dc098-0ac7-4f8e-b258-326229539c7c · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 489dc098-0ac7-4f8e-b258-326229539c7c · read 2026-08-29
Glimepiride is tablets (scored) at 1 mg, 2 mg, 4 mg, recorded as prescription product; fda label in effect 2024-11-13 in the United States.
US prescribing information · 0003458f-352a-46fa-9d99-230daa76ae29 · read 2026-08-27
Recorded price in US: 0.02389–0.05144 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 54 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Glimepiride studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That CAROLINA established the cardiovascular safety of sulfonylureas — the trial had no placebo arm and its conclusion is a statement about linagliptin
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That glimepiride reduces macrovascular events — its label states no clinical study has conclusively established macrovascular risk reduction for this or any antidiabetic drug
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the -1.8 percentage-point registration effect is what a person starting the drug should expect — the placebo arm had been withdrawn from an active sulfonylurea and deteriorated by 1.5 points
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That SUR1 selectivity translates into a clinical cardiovascular advantage over older sulfonylureas — that is a mechanistic argument, and no trial has compared glimepiride against glyburide or glipizide for cardiovascular outcomes
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Glimepiride are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
CAROLINA is the only large cardiovascular outcome trial of a sulfonylurea
In plain words
Six thousand people with early type 2 diabetes and raised cardiovascular risk were randomly given glimepiride or a newer tablet, and followed for more than six years with heart attacks, strokes and cardiovascular deaths counted and adjudicated. The two arms came out the same.
What was measured
Hazard ratio for adjudicated three-point MACE over a median 6.3 years, linagliptin against glimepiride, in 6,033 treated patients
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
CAROLINA (NCT01243424) randomised 6,042 adults at 607 sites in 43 countries — 6,033 treated and analysed — with type 2 diabetes, HbA1c 6.5% to 8.5% and elevated cardiovascular risk, to linagliptin 5 mg daily (n=3,023) or glimepiride 1 to 4 mg daily (n=3,010), double-blind, on top of usual care. Mean age was 64.0 years, mean HbA1c 7.2%, median diabetes duration 6.3 years, 42% had macrovascular disease and 59% were on metformin monotherapy. Over a median 6.3 years the primary composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke occurred in 356 of 3,023 (11.8%) on linagliptin and 362 of 3,010 (12.0%) on glimepiride: hazard ratio 0.98 (95.47% CI 0.84 to 1.14), meeting the prespecified non-inferiority margin of 1.3 (p<0.001) but not superiority (p=0.76). Adjudicated acute pancreatitis occurred in 0.5% of each arm.
Written into the record, not signed off as a reviewed claim
CAROLINA did not show glimepiride is cardiovascularly safe — it had no placebo arm
In plain words
The trial is widely described as clearing sulfonylureas of the cardiovascular suspicion they have carried since 1970. It compared glimepiride against another active drug, not against nothing. Two treatments coming out equal does not establish that either one is harmless.
What was measured
That CAROLINA proves sulfonylureas are cardiovascularly safe — the trial had no placebo arm, and its stated conclusion is about the comparator, not about glimepiride
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
CAROLINA was designed as an active-controlled non-inferiority trial of linagliptin against glimepiride, with the stated objective of establishing that the upper bound of the two-sided 95.47% confidence interval for the hazard ratio of linagliptin relative to glimepiride was below 1.3. There was no placebo group and no untreated group. The conclusion the authors state is that linagliptin resulted in a non-inferior risk of a composite cardiovascular outcome — a statement about linagliptin. Reading the same result backwards as evidence that glimepiride does not increase cardiovascular risk requires assuming linagliptin itself is cardiovascularly neutral, which rests on separate placebo-controlled trials of linagliptin, and it exports a conclusion the trial was not designed to license. The label continues to carry both a warning on potential increased risk of cardiovascular mortality with sulfonylureas and the statement that no clinical study has established conclusive evidence of macrovascular risk reduction with glimepiride or any other antidiabetic drug.
Written into the record, not signed off as a reviewed claim
Over a third of the glimepiride arm had a hypoglycaemic event across six years
In plain words
In the same trial, 1,132 of the 3,010 people on glimepiride had at least one episode of low blood sugar. On the comparator it was 320 of 3,023. That is more than three times as many people affected.
What was measured
Proportion of participants with at least one hypoglycaemic adverse event over 6.3 years, and proportion with severe hypoglycaemia over 5 years by treatment arm
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
At least one hypoglycaemic adverse event occurred in 320 of 3,023 participants (10.6%) in the linagliptin group and 1,132 of 3,010 (37.7%) in the glimepiride group, hazard ratio 0.23 (95% CI 0.21 to 0.26) for linagliptin against glimepiride. Overall adverse events were similar — 93.4% against 94.9% — so the difference is specific to hypoglycaemia rather than a general tolerability gap. In GRADE, run in a different population over five years, severe hypoglycaemia requiring assistance occurred in 2.2% of the glimepiride arm against 1.3% on insulin glargine, 1.0% on liraglutide and 0.7% on sitagliptin: rare in absolute terms, and significantly more frequent on glimepiride than on any of the three comparators, insulin included.
Written into the record, not signed off as a reviewed claim
In GRADE it held blood sugar down less durably than glargine or liraglutide
In plain words
The largest trial ever run of what to add after metformin gave 5,047 people one of four drugs and followed them for five years. Glimepiride lost control of blood sugar more often than insulin glargine or liraglutide, and less often than sitagliptin.
What was measured
Cumulative incidence per 100 participant-years of a confirmed HbA1c of 7.0% or higher, by randomised second-line agent, over a mean 5.0 years
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
GRADE (NCT01794143) randomised 5,047 participants with type 2 diabetes of less than ten years duration, on metformin, with HbA1c 6.8% to 8.5%, to insulin glargine U-100, glimepiride, liraglutide or sitagliptin, and followed them a mean of 5.0 years. The primary metabolic outcome was a confirmed HbA1c of 7.0% or higher. Cumulative incidence differed significantly across the four groups (p<0.001 for the global test): 26.5 per 100 participant-years on glargine, 26.1 on liraglutide, 30.4 on glimepiride and 38.1 on sitagliptin. Differences on the secondary outcome of confirmed HbA1c above 7.5% paralleled the primary. There were no material differences across prespecified subgroups by sex, age or race and ethnicity, though among participants with higher baseline HbA1c glargine, liraglutide and glimepiride all appeared to do better than sitagliptin. The cohort was 19.8% Black and 18.6% Hispanic or Latinx.
Written into the record, not signed off as a reviewed claim
GRADE found no difference between the four drugs on complications or death
In plain words
The same trial also counted kidney damage, nerve damage, heart attacks, heart failure and deaths. Across five years, the four drugs were indistinguishable on all of them. The only signal was a modest one favouring liraglutide on any cardiovascular disease.
What was measured
Event rates per 100 participant-years for microvascular outcomes, MACE, heart-failure hospitalisation and death, and unadjusted hazard ratios for any cardiovascular disease by arm
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Over a mean 5.0 years in 5,047 participants, GRADE found no material differences between glargine, glimepiride, liraglutide and sitagliptin in the development of hypertension or dyslipidaemia, or in microvascular outcomes: overall rates per 100 participant-years were 2.6 for moderately increased albuminuria, 1.1 for severely increased albuminuria, 2.9 for renal impairment and 16.7 for diabetic peripheral neuropathy. The groups did not differ on MACE (overall rate 1.0), hospitalisation for heart failure (0.4), cardiovascular death (0.3) or all deaths (0.6). Rates of any cardiovascular disease were 1.9, 1.9, 1.4 and 2.0 in the glargine, glimepiride, liraglutide and sitagliptin groups. Comparing each treatment against the combined other three, hazard ratios for any cardiovascular disease were 1.1 (95% CI 0.9 to 1.3) for glargine, 1.1 (95% CI 0.9 to 1.4) for glimepiride, 0.7 (95% CI 0.6 to 0.9) for liraglutide and 1.2 (95% CI 1.0 to 1.5) for sitagliptin. The authors state these confidence limits are not adjusted for multiple comparisons.
Written into the record, not signed off as a reviewed claim
The registration trial measured a 1.8-point HbA1c effect and 3.2 kg of weight with it
In plain words
The 14-week trial that got the drug approved took 304 people off their existing sulfonylurea, then gave them placebo or glimepiride. The placebo group got 1.5 percentage points worse. The 8 mg group got 0.4 points better, and gained about three kilograms more than the placebo group lost.
What was measured
Adjusted mean change in HbA1c and body weight from baseline at 14 weeks by dose, with differences from placebo and 95% confidence intervals
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
A 14-week multicentre randomised double-blind placebo-controlled trial enrolled 304 patients with type 2 diabetes already on sulfonylurea therapy, withdrew it, ran a three-week placebo washout, then randomised to placebo (n=74) or glimepiride 1 mg (n=78), 4 mg (n=76) or 8 mg (n=76). Baseline HbA1c was 7.9% to 8.0% across arms. Adjusted mean change from baseline was +1.5 percentage points on placebo, +0.3 on 1 mg, -0.3 on 4 mg and -0.4 on 8 mg; differences from placebo were -1.2 (95% CI -1.5 to -0.8, p<0.001), -1.8 (95% CI -2.1 to -1.4) and -1.8 (95% CI -2.2 to -1.5). Weight fell 2.3 kg on placebo and rose 1.0 kg on 8 mg, a difference from placebo of 3.2 kg (95% CI 2.5 to 4.0). Completion was 66% on placebo against 92% on 4 mg or 8 mg. The design matters to the number: much of the apparent effect size is deterioration in a placebo arm withdrawn from an active drug, not improvement on glimepiride, and the entire between-group HbA1c difference is bought with a 3.2 kg weight difference.
Source
FDA prescribing information for glimepiride tablets, section 14.1 Monotherapy, Table 3
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
How many documents were read
73 documents were read for this substance.
RNAWiki source record
73 of them state the same proteinBinding, and they agree.
RNAWiki source record
73 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
6KY687524K
CAS registry number
93479-97-1
PubChem compound
3476
RxNorm concept
25789
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✗ Not passed
Safety mode resolved
No register row and no identity class settled the question.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
22 approved applications cover products containing this substance. The earliest was NDA020496, approved 19951130 to SANOFI AVENTIS US.
This order is fixed in code and does not count clicks or time on the page.
What is not here
4 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A sulfonylurea that closes the beta-cell ATP-sensitive potassium channel to force insulin release, lowering HbA1c by 1.8 percentage points against placebo in its 304-patient registration trial while adding 3.2 kg of weight — and the only drug of its class with a dedicated cardiovascular outcome trial, in which 37.7% of the 3,010 patients taking it had at least one hypoglycaemic event over 6.3 years against 10.6% on the comparator.
Recorded evidence blocks (14)
Q1
What did Glimepiride's largest trial (1499650 people) and its longest (13 years) measure?
1499650 people in Glimepiride's largest registered study, 13 years in its longest registered window, measuring Changes of Cellular senescence markers. ClinicalTrials.gov · 2026-09-01
80 phase3, 59 phase4, 17 na, 16 phase1, 13 phase2, 10 na or unstated; NCT00000620; 2012-12. Last human test completed 2025, NCT05073692.
Interpretation These counts include studies where Glimepiride was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase3
80
phase4
59
na
17
phase1
16
phase2
13
na or unstated
10
1 more recorded row
Last recorded human testNCT05073692
2025-03-12
recorded 2026-09-01 · last checked 2026-09-04
Q2
From mouse to human: where has Glimepiride shown mechanism-only?
Interpretation Changes of Cellular senescence markers — the recorded outcome words.
Show the evidence
mouse
mechanism-only
rat
mechanism-only
humanNCT05975528
mechanism-only; Changes of Cellular senescence markers; 192
recorded 2026-09-01 · last checked 2026-09-04
Q3
20 of Glimepiride's trials stopped: safety, accrual/recruitment, funding/business, other?
safety (2), accrual/recruitment (4), funding/business (3) and other (11): Glimepiride's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"The trial was terminated at week 195 due to an insufficient number of subjects remaining to obtain reasonable statistical power"; 20 of 192 registered studies
Show the evidence
Trial
NCT00294723
terminated; "The trial was terminated at week 195 due to an insufficient number of subjects remaining to obtain reasonable statistical power"
NCT00343980
terminated; "See termination reason in detailed description"
NCT00427154
terminated; "See termination reason in detailed description"
NCT00449605
terminated; "Company decision taken in light of demands by certain national health authorities"
NCT00469586
terminated; "See termination reason in detailed description"
NCT00939939
terminated; "Recruitment failure"
14 further recorded trials
NCT01408095
withdrawn; "Trial terminated no patients were screened or enrolled"
NCT01453049
terminated; "US FDA/EMA/SFDA decisions to rosiglitazone-containing medicines, ethic"
NCT01477853
terminated; "The study was terminated early by the Sponsor for business reasons."
NCT01481116
terminated; "Due to potential concerns about liver safety (See Detailed Description)"
NCT01678820
terminated; "Merck terminated the study for business reasons in November 2013."
NCT01829477
terminated; "Due to potential concerns about liver safety (See Detailed Description)"
NCT01910441
terminated; "The study was terminated due to the unavailability of Continuous Glucose Monitoring sensors (CGMS) which were required to assess the primary end-point."
NCT02072096
terminated; "The trial was terminated per protocol because of lack of feasibility."
NCT02373865
terminated; "Premature termination due to insufficient patient recruitement.."
NCT02484209
withdrawn; "Inclusion criteria too strict making it difficult to recruit in primary care"
NCT02728453
terminated; "Insufficient recruitment."
NCT02985242
terminated; "difficulties to recruit planned numbers of patients within reasonable time frame"
NCT03060980
terminated; "Decision by Sponsor"
NCT03118713
terminated; "Business decision due to enrollment challenges"
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Glimepiride used Amaryl (glimepiride) 1 mg — over how long?
20 recorded entries; human; also "Amaryl (glimepiride) 2 mg", "Amaryl (glimepiride) 4 mg", "Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg"
Show the evidence
human
NCT00131664
Amaryl (glimepiride) 1 mg
NCT00131664
Amaryl (glimepiride) 2 mg
NCT00131664
Amaryl (glimepiride) 4 mg
NCT00622284
Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg
NCT00648362
Glimepiride Tablets 1 mg
NCT00648362
Amaryl® Tablets 1 mg
14 more recorded rows
humanNCT00776490
Glimepiride 1mg Tablets
humanNCT00834340
Glimepiride 4 mg Tablets
humanNCT00834340
AMARYL® 4 mg Tablets
humanNCT01053689
Glimepiride tablets 1 mg
humanNCT01495013
1mg Glimepiride/10mg Atorvastatin FDC
humanNCT01495013
2mg Glimepiride/10mg Atorvastatin FDC
humanNCT01495013
3mg Glimepiride/10mg Atorvastatin FDC
humanNCT01495013
4mg Glimepiride/10mg Atorvastatin FDC
humanNCT01495013
1mg Glimepiride/20mg Atorvastatin FDC
humanNCT01495013
2mg Glimepiride/20mg Atorvastatin FDC
humanNCT01495013
3mg Glimepiride/20mg Atorvastatin FDC
humanNCT01495013
4mg Glimepiride/20mg Atorvastatin FDC
humanNCT01495013
1mg Glimepiride
humanNCT01495013
2mg Glimepiride
recorded 2026-09-01 · last checked 2026-09-04
Q5
More Glimepiride was worse in human: at what point?
U-shaped in human: "The hypoglycaemic sulphonylurea gliquidone was found, by conformation analysis, to display a U-shaped configuration, with hydrophobic cycles placed at the extremity of each branch and a peptidic bond placed at the bottom of the U. This configuration is similar to that recently observed with the hypoglycaemic…" Europe PMC · dose-response search · 2018-01-01
5 recorded sentences naming Glimepiride; U-shaped, biphasic, dose-response
Show the evidence
U-shapedPMID 8981549
"The hypoglycaemic sulphonylurea gliquidone was found, by conformation analysis, to display a U-shaped configuration, with hydrophobic cycles placed at the extremity of each branch and a peptidic bond placed at the bottom of the U. This configuration is similar to that recently observed with the hypoglycaemic sulphonylureas glimepiride and glibenclamide and non-sulphonylurea hypoglycaemic agents…"
biphasic
"Comparing the data between November 2014 to October 2015 and November 2015 to October 2016, we observed poorer results for the following items (therapeutic group (treatment of choice)): second-line antihyperglycaemic therapies (glicazide, glipizide, glimepiride); insulin treatment (intermediate and biphasic); lipid lowering medication (simvastatin); high-blood pressure medication…"
PMID 19692134
"During the screening period, we unified the sulfonylureas to glimepiride at 3mg/day for 8 weeks, and started biphasic insulin aspart 30 (Asp30Mix) once-daily injections for 16 weeks."
dose-responsePMID 11903417
"With single doses, there was a clear dose-response relationship for the reduction in AUC, with a statistically significant difference only between placebo (mean 1981, 95% confidence intervals (CI) 1883-2078) and 2 mg glimepiride (mean 1763, 95% CI 1665-1861)."
biphasicPMID 8777281
"At a pharmacological concentration glimepiride strongly stimulated beta-cell activity, producing a characteristic biphasic insulin release with a sharp first-phase secretory peak, followed by a prolonged and sustained second phase."
recorded 2018-01-01 · last checked 2026-09-04
Q6
Could one person measure Glimepiride's effect on primary major macrovascular events?
Primary major macrovascular events: measured in Glimepiride's trials.
Interpretation primary major macrovascular events is the recorded endpoint.
Show the evidence
biomarkers
primary major macrovascular events; 2026-09-01
hba1c from baseline to week 26; 2026-09-01
hba1c after 24 weeks; 2026-09-01
time to hba1c 8; 2026-09-01
a1c at month 6; 2026-09-01
carotid intima media thickness; 2026-09-01
14 more recorded rows
biomarkers
nominal change from baseline in atheroma volume; 2026-09-01
biomarkers
glycosylated haemoglobin a1c at week 52; 2026-09-01
biomarkers
glycosylated haemoglobin a1c at week 104; 2026-09-01
biomarkers
glycosylated haemoglobin a1c at week 156; 2026-09-01
biomarkers
hba1c change from baseline at week 12; 2026-09-01
biomarkers
hba1c; 2026-09-01
biomarkers
glycosylated a1c at week 26; 2026-09-01
biomarkers
glycosylated a1c at week 104; 2026-09-01
biomarkers
treatment difference in hba1c; 2026-09-01
biomarkers
treatment failure; 2026-09-01
biomarkers
time to treatment failure; 2026-09-01
biomarkers
glycosylated haemoglobin value 7; 2026-09-01
biomarkers
glycemic measure hba1c; 2026-09-01
biomarkers
glycosylated haemoglobin a1c; 2026-09-01
half life
2026-09-04; halfLife; 2026-06-22
human trials at or under30
25
smallest human trial
0; NCT01455883; PHASE3; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q7
Which of a1c at month 6, acetylcholine mediated forearm blood flow and adjusted mean change in hba1c levels did Glimepiride's trials measure?
a1c at month 6, acetylcholine mediated forearm blood flow and adjusted mean change in hba1c levels lead 40 outcome terms across Glimepiride's trials. ClinicalTrials.gov · 2026-09-01
time to hba1c 8, a1c at month 6, carotid intima media thickness, nominal change from baseline in atheroma volume, glycosylated haemoglobin a1c at week 52 and glycosylated haemoglobin a1c at week 104 follow.
Show the evidence
primary major macrovascular events
1
hba1c from baseline to week 26
1
hba1c after 24 weeks
1
time to hba1c 8
1
a1c at month 6
1
carotid intima media thickness
1
14 more recorded rows
nominal change from baseline in atheroma volume
1
glycosylated haemoglobin a1c at week 52
1
glycosylated haemoglobin a1c at week 104
1
glycosylated haemoglobin a1c at week 156
1
hba1c change from baseline at week 12
1
hba1c
1
glycosylated a1c at week 26
1
glycosylated a1c at week 104
1
treatment difference in hba1c
1
treatment failure
1
time to treatment failure
1
glycosylated haemoglobin value 7
1
glycemic measure hba1c
1
glycosylated haemoglobin a1c
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Glimepiride's 4 ongoing trials reports first?
MACE; A composite endpoint of cardiovascular death, heart transplantation, or worsening heart failure (defined as rehospitalization for heart failure or an emergency heart failure visit…; latest 2031-12-31
Show the evidence
Trial
NCT05220917
"Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study"; n 781430; "MACE"; 2027-09-30
NCT07288749
"Efficacy Evaluation of Glimepiride in Patients With Type 2 Diabetes Mellitus and Chronic Heart Failure With Reduced Ejection Fraction."; n 1484; "A composite endpoint of cardiovascular death, heart transplantation, or worsening heart failure (defined as rehospitalization for heart failure or an emergency heart failure visit requiring intravenous therapy)."; 2031-12-31
NCT07365358
"Evaluate the Efficacy and Safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients"; n 200; "Percentage of subjects who meet 3 conditions at the same time"; 2027-08
NCT07589387
"Hypertension Treatment in Nigeria: Hypertension Diabetes Integration Study- Formative Aim 3"; n 2800; "Dose of quarterly supportive supervision visits measured by the proportion of observed/expected visits during the implementation period."; 2030-01-31
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which 71 trials of Glimepiride posted no result?
Posted no result
71 of 71 completed trials
Registrations
NCT01509755, NCT00044447, NCT01511172, NCT00776490, NCT00776620 and NCT00633425, and 65 more
Completion dates
oldest 2001-10; newest 2022-07-01
Show the evidence
Trial
NCT01509755
2001-10
NCT00044447
2002-09
NCT01511172
2002-12
NCT00776490
2003-09
NCT00776620
2003-09
NCT00633425
2003-10
14 further recorded trials
NCT01052909
2003-12
NCT01053689
2003-12
NCT00353691
2004-11
NCT00648362
2004-12
NCT00650533
2004-12
NCT00619697
2005-03
NCT00099944
2005-10
NCT00225264
2006-05
NCT00331851
2007-04
NCT00318422
2007-05
NCT00437554
2007-07
NCT01511692
2007-09
NCT00106340
2008-05-20
NCT00562250
2008-08
Q10
At the median, Glimepiride's trials enrolled 192 people — anything larger?
Median enrolment
192
Largest enrolment
1499650
Registered trials counted
192
Q11
What do 2301 spontaneous reports say about Glimepiride — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Glimepiride appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2301 reaction mentions were counted: hypoglycaemia 1161; hypoglycaemic coma 157; acute kidney injury 142; blood glucose increased 141. open-targets-adr · CHEMBL1481 · 2026-06-24
Show the evidence
hypoglycaemia
1161
hypoglycaemic coma
157
acute kidney injury
142
blood glucose increased
141
diabetes mellitus inadequate control
133
lactic acidosis
132
4 more recorded rows
loss of consciousness
124
drug interaction
120
renal impairment
106
hyperhidrosis
85
recorded 2026-06-24 · last checked 2026-09-04
Q12
Glimepiride and Cytochrome P450: shared by which compounds?
Cytochrome P450 appear in Glimepiride's recorded interaction sentences, 2 in all. openfda-label+europepmc · 2026-06-22
Interpretation drug_interactions
Show the evidence
Cytochrome P450
drug_interactions
(7.2) Cytochrome P450 2C9 interactions: Inhibitors and inducers of cytochrome P450 2C9 may affect glycemic control by altering glimepiride plasma concentrations.
drug_interactions
7.3 Cytochrome P450 2C9 Interactions There may be an interaction between glimepiride and inhibitors (e.g., fluconazole) and inducers (e.g., rifampin) of cytochrome P450 2C9.
recorded 2026-06-22 · last checked 2026-09-04
Q13
Was Glimepiride studied with fasting?
fasting is named in Glimepiride's label sentences: "Fasting glucose decreased with both glimepiride and sitagliptin compared with placebo (P = 0.002)." openfda-label+europepmc · 2026-06-22
1 recorded statement; fasting
Show the evidence
fasting
Fasting glucose decreased with both glimepiride and sitagliptin compared with placebo (P = 0.002).
recorded 2026-06-22 · last checked 2026-09-04
Q14
What is recorded about Glimepiride and AMPK?
"Mechanistically, glimepiride exerted these effects through AMPK activation, leading to subsequent suppression of the ERK/MMP7 signaling pathway." — where Glimepiride and AMPK appear together. Europe PMC · pathway abstract search · 2025-07-12
"Mechanistically, glimepiride exerted these effects through AMPK activation, leading to subsequent suppression of the ERK/MMP7 signaling pathway."
PMID 15694373
"In the present study, to clarify the mechanism by which insulin resistance is improved, we investigated the effects of glimepiride on AMP-activated protein kinase (AMPK) and peroxisome proliferator-activated receptor-gamma (PPAR gamma) activity, using cultured adipocytes and muscle cells."
NAD+
PMID 18640379
"Sulfonylureas (glibenclamide and glimepiride, but not gliclazide) and nateglinide stimulated ROS production via protein kinase C-dependent activation of NAD(P)H oxidase and consequently caused beta-cell apoptosis in vitro."
PMID 7564897
"Glimepiride is an oral sulfonylurea drug; nicotinamide is an inhibitor of poly (ADP-ribose) synthetase and a precursor of NAD."
recorded 2025-07-12 · last checked 2026-09-04
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