This page shows what was measured, who it was measured in, and what that does not settle.
What Nateglinide does in the body
Type 2 diabetes — the fastest and weakest of the meal-time tablets
Insulin-producing cells stay quiet because potassium leaks out of them through an open channel. Nateglinide plugs that channel, the cell becomes electrically active, calcium rushes in, and insulin is released. The molecule is a modified amino acid rather than a sulfonylurea, it works within an hour, and half of it is gone within about ninety minutes — which is why it is taken around meals rather than once a day.
What happened in people
A diabetes-incidence hazard ratio of 1.07 (95% CI 1.00 to 1.15, p=0.05) against placebo over a median 5.0 years in 9,306 participants — 36% against 34%
✎ 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.
The weakest HbA1c effect of the oral drugs in this batch, and the only one whose outcome trial failed outright
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.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 41X3PWK4O2 · read 2026-08-29
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 114 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.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
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.
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 16 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 moved3 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.
Focus
∅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.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅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
cerebral glucose metabolism; glucose tolerance; postprandial glucose excursion at the end of the study
Focus
verbal memory; selective attention
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
3 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.
Three co-primary outcomes — incident diabetes, a core composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or heart-failure hospitalisation, and an extended composite adding unstable angina and revascularisation
✗ The study did not show it
Who was studied
NAVIGATOR, nateglinide comparison (NCT00097786)
How many people
9306
Study design
Double-blind randomised two-by-two factorial trial, median 5.0 years for incident diabetes and 6.5 years for vital status
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Diabetes: hazard ratio 1.07 (95% CI 1.00 to 1.15), P = 0.05. Core cardiovascular composite: 0.94 (95% CI 0.82 to 1.09), P = 0.43. Extended composite: 0.93 (95% CI 0.83 to 1.03), P = 0.16. All three after adjustment for multiple testing
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. Nateglinide increased the risk of hypoglycaemia. The diabetes point estimate of 1.07 favours placebo, in the population and for the outcome the drug was given to affect.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet taken in relation to meals, in 60 mg and 120 mg strengths
Interval reported. 95% CI 1
Written into the record, not signed off as a reviewed claim.
FDA prescribing information for nateglinide tablets USP — sections 5.1 Hypoglycemia, 5.2 Macrovascular Outcomes, 11 Description, 12.1 Mechanism of Action and… · a recorded source, not a stored snapshot
HbA1c reduction against placebo, against repaglinide and against metformin, with mortality and morbidity as co-equal review outcomes
✗ The study did not show it
Who was studied
Cochrane review of meglitinide analogues, nateglinide comparisons
How many people
3781
Study design
Systematic review and meta-analysis of 15 randomised trials of at least 10 weeks
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
HbA1c reduction of 0.2 to 0.6 percentage points for nateglinide across placebo-controlled studies; greater reduction with repaglinide in two direct comparisons of 342 participants
Repeated elsewhere
Partially Replicated
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 reviewers state that no included study reported the effect of meglitinides on mortality or morbidity. NAVIGATOR answered that question for nateglinide three years later, and the answer was negative on all three co-primary endpoints.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet taken in relation to meals, in 60 mg and 120 mg strengths
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
FDA prescribing information for nateglinide tablets USP — sections 5.1 Hypoglycemia, 5.2 Macrovascular Outcomes, 11 Description, 12.1 Mechanism of Action and… · a recorded source, not a stored snapshot
What we know
RNAWiki holds 2 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 eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.2 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.6 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.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
■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.
Start
Nateglinide
What a person takes: Oral tablet taken in relation to meals, in 60 mg and 120 mg strengths.
The measurement behind this step
A conventional immediate-release tablet of a practically water-insoluble modified amino acid. The pharmacokinetics are what tie the drug to meals rather than to a time of day: peak concentration within one hour when taken before eating, and an elimination half-life of about 1.5 hours. Taken under fasting conditions the plasma profile shows multiple peaks, an effect the label notes is diminished when the drug is taken before a meal. Meal composition does not change absorption, though peak levels are lower before a liquid meal than a solid one.
Getting in
A modified amino acid, absorbed within the hour
The molecule is an amino acid with a ring attached — chemically unlike the older diabetes tablets. About three-quarters of a dose gets into the blood, peaking within an hour when taken before food.
╌╌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
The label names it (-)-N-[(trans-4-isopropylcyclohexane)carbonyl]-D-phenylalanine and states it is structurally unrelated to the oral sulfonylurea secretagogues. Absolute bioavailability is approximately 73%, peak concentration occurs within one hour before a meal, and protein binding is 98%, primarily to albumin.
It engages the beta-cell potassium channel from its own site
The target is the same potassium gate that the sulfonylureas close, but the drug grips it differently because it is a different kind of molecule entirely.
╌╌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
The label states nateglinide "interacts with the ATP-sensitive potassium channel on pancreatic beta-cells". The binding site is distinct from the classical sulfonylurea site on SUR1, and the association and dissociation kinetics are much faster, which is what produces the brief early insulin burst rather than a sustained one.
With the potassium gate shut, charge builds inside the cell, calcium channels open, and calcium floods in.
╌╌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
The label describes the sequence directly: the subsequent depolarisation of the beta cell opens the calcium channel, producing calcium influx and insulin secretion. It adds that the mechanism is highly tissue selective, with low affinity for heart and skeletal muscle.
Insulin comes out quickly and stops quickly. The label says the amount released depends on how high blood sugar is and falls off when it is low.
╌╌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
The extent of insulin release is described as glucose-dependent and diminishing at low glucose levels. The measured consequence is a smaller HbA1c effect than repaglinide — 0.2 to 0.6 percentage points against 0.1 to 2.1 across placebo-controlled trials — and, in NAVIGATOR, an increased risk of hypoglycaemia nonetheless.
Two liver enzymes clear it, and one minor product is as strong as the drug
The liver breaks it down using mainly one enzyme. Most of the products are weaker than the drug, but one minor one is just as potent.
╌╌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 70% CYP2C9 and 30% CYP3A4, by hydroxylation followed by glucuronide conjugation. The label states the major metabolites are less potent antidiabetic agents than nateglinide but that "the isoprene minor metabolite possesses potency similar to that of the parent compound". Elimination half-life is approximately 1.5 hours; 83% is recovered in urine and 10% in faeces.
HbA1c falls slightly — and five years of trial found nothing else
Average blood sugar comes down a little. In the only large long-term trial, diabetes was not prevented, cardiovascular events were not reduced, and hypoglycaemia went up.
╌╌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
NAVIGATOR: diabetes 36% against 34%, hazard ratio 1.07 (95% CI 1.00 to 1.15, p=0.05); core cardiovascular composite 0.94 (95% CI 0.82 to 1.09, p=0.43); extended composite 0.93 (95% CI 0.83 to 1.03, p=0.16); increased hypoglycaemia. The label states no clinical study has conclusively established macrovascular risk reduction with nateglinide.
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.
plasma beta amyloid levels
cerebral glucose metabolism
inflammatory markers in spinal fluid
glucose tolerance
hemoglobin a1c
postprandial glucose excursion at the end of the study
Meaningful
Things that change how a life goes, not only a number.
hospitalization for incident heart failure
hospitalization for acute pancreatitis
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 (8)
verbal memory
selective attention
beta amyloid in spinal fluid
endothelial function
7 smbg
bioequivalence on cmax and auc parameters
cmax
incident pancreatic cancer
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 1.5 hours hours
Read from the label, which states: “Elimination In healthy volunteers and patients with type 2 diabetes mellitus, nateglinide plasma concentrations declined with an average elimination half-life of approximately 1.5 hours.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
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 where meal times are irregular. It is the weakest glucose-lowering agent in this batch and the second most expensive tablet in it.
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 safety and effectiveness of Nateglinide Tablets have not been established in pediatric patients.”
US prescribing information · b41f4180-96a7-411d-b827-5021e534f556 · read 2026-08-30
On older people, the label states: “436 patients 65 years and older, and 80 patients 75 years and older were exposed to Nateglinide Tablets in clinical studies.”
US prescribing information · b41f4180-96a7-411d-b827-5021e534f556 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary The available data from published literature and the applicant’s pharmacovigilance with use of Nateglinide Tablets in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.”
US prescribing information · b41f4180-96a7-411d-b827-5021e534f556 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk summary There are no data on the presence of nateglinide in human milk, the effects on the breastfeeding infant, or the effects on milk production.”
US prescribing information · b41f4180-96a7-411d-b827-5021e534f556 · read 2026-08-30
On people with reduced liver function, the label states: “No dose adjustment is recommended for patients with mild hepatic impairment.”
US prescribing information · b41f4180-96a7-411d-b827-5021e534f556 · read 2026-08-30
On people with reduced kidney function, the label states: “No dosage adjustment is recommended in patients with mild to severe renal impairment [see Clinical Pharmacology (12.3) ].”
US prescribing information · b41f4180-96a7-411d-b827-5021e534f556 · read 2026-08-30
Where the result stopped carrying
All three co-primary endpoints of NAVIGATOR failed simultaneously, in 9,306 participants over five years
The diabetes-prevention estimate came out at 1.07 with a confidence interval whose lower bound touches no effect — the hypothesis the trial was built on was rejected, not merely unproven
The Cochrane review had already recorded that no trial of the class had reported mortality or morbidity; when one finally did, the drug did not benefit either
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 taken in relation to meals, in 60 mg and 120 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 modified amino acid. 5 hours. Taken under fasting conditions the plasma profile shows multiple peaks, an effect the label notes is diminished when the drug is taken before a meal. Meal composition does not change absorption, though peak levels are lower before a liquid meal than a solid one.
✎ 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.
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 can occur and can be severe, causing seizures and, rarely, death; the label notes that awareness may be blunted in longstanding diabetes, diabetic neuropathy, beta-blocker use or recurrent hypoglycaemia, and that impaired concentration and reaction time create risk while driving or operating machinery. NAVIGATOR found an increased risk of hypoglycaemia over five years. Weight gain occurs. Clearance is 70% dependent on CYP2C9, so inhibitors of that enzyme raise exposure. The label states there have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with nateglinide.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
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.
Nateglinide appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 170 reaction mentions were counted. One report can name several reactions.
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 taken in relation to meals, in 60 mg and 120 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
5 hours. Taken under fasting conditions the plasma profile shows multiple peaks, an effect the label notes is diminished when the drug is taken before a meal. Meal composition does not change absorption, though peak levels are lower before a liquid meal than a solid one.
✎ 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
26 products list this as an active ingredient in the United States drug directory. 26 of them contain it and nothing else.
FDA National Drug Code directory · 62147-0080 · read 2026-08-29
They are sold as powder, tablet, tablet, coated and tablet, film coated, taken oral.
FDA National Drug Code directory · 62147-0080 · read 2026-08-29
The regulator's established pharmacologic class for it is glinide [epc] and potassium channel antagonists [moa].
FDA National Drug Code directory · 62147-0080 · read 2026-08-29
10 published labels name it as an active ingredient. 10 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · a82817dd-f8c4-4172-ba86-63c2beef456a · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · a82817dd-f8c4-4172-ba86-63c2beef456a · read 2026-08-29
NATEGLINIDE is oral at 3 DOSAGE FORMS AND STRENGTHS 60 mg tablets: Pink, round shaped, biconvex, film-coated tablets, debossed with “N7” on one side and plain on other side. 120 mg tablets: Yellow, oval shaped, biconvex, film-coated tablets,…, recorded as fda label in effect 2024-12-03 in the United States.
US prescribing information · b41f4180-96a7-411d-b827-5021e534f556 · read 2026-08-30
Recorded price in US: 0.1902–0.23447 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 18 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 Nateglinide 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 nateglinide delays the onset of type 2 diabetes — the largest trial of exactly that hypothesis returned a hazard ratio of 1.07, favouring placebo
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 treating post-meal glucose spikes prevents cardiovascular events — both cardiovascular composites in NAVIGATOR were non-significant, and acarbose failed the same hypothesis in the ACE trial
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 glucose-dependent secretion and cardiac channel selectivity make the drug clinically safe — the trial that could have shown this instead found increased hypoglycaemia
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 higher acquisition price reflects a therapeutic advantage — within this class the cheaper drug has the larger measured HbA1c effect
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 Nateglinide 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.
NAVIGATOR failed all three co-primary endpoints in 9,306 participants
In plain words
A five-year trial gave nateglinide or placebo to 9,306 people with pre-diabetes and either heart disease or its risk factors. It measured three things: whether diabetes developed, and two composites of cardiovascular events. None of the three improved.
What was measured
Hazard ratios for incident diabetes and for the core and extended composite cardiovascular outcomes over a median 5.0 years in 9,306 randomised participants
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
NAVIGATOR assigned 9,306 participants with impaired glucose tolerance and either cardiovascular disease or cardiovascular risk factors to nateglinide or placebo in a two-by-two factorial design with valsartan or placebo, on top of a lifestyle modification programme, and followed them a median 5.0 years for incident diabetes and 6.5 years for vital status. After adjustment for multiple testing, nateglinide did not significantly reduce the cumulative incidence of diabetes (36% against 34%, hazard ratio 1.07, 95% CI 1.00 to 1.15, p=0.05), the core composite cardiovascular outcome of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for heart failure (7.9% against 8.3%, hazard ratio 0.94, 95% CI 0.82 to 1.09, p=0.43), or the extended composite adding hospitalisation for unstable angina and arterial revascularisation (14.2% against 15.2%, hazard ratio 0.93, 95% CI 0.83 to 1.03, p=0.16). Nateglinide did increase the risk of hypoglycaemia. The stated conclusion is that assignment to nateglinide for five years did not reduce the incidence of diabetes or the co-primary composite cardiovascular outcomes.
Written into the record, not signed off as a reviewed claim
The diabetes hazard ratio pointed the wrong way
In plain words
Nateglinide was given to people with pre-diabetes precisely because it was expected to delay the onset of diabetes. Over five years, 36% of the drug group developed diabetes against 34% on placebo. The estimate favoured placebo.
What was measured
Cumulative incidence of diabetes and hazard ratio with 95% confidence interval, nateglinide against placebo, over a median 5.0 years
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The cumulative incidence of diabetes in NAVIGATOR was 36% on nateglinide and 34% on placebo, with a hazard ratio of 1.07 (95% CI 1.00 to 1.15) and p=0.05 after adjustment for multiple testing. That interval touches 1.00 at its lower bound and reaches 1.15 at its upper, so the data are compatible with no effect and with a modest increase, and are not compatible with the reduction the hypothesis predicted. For comparison, acarbose reduced conversion to diabetes in the same population type with a relative hazard of 0.75 in STOP-NIDDM and 0.82 in ACE, and metformin has repeatedly done so. This is not a case of an underpowered trial: 9,306 participants over five years with 2,300-odd diabetes diagnoses is more than adequate to detect the effect that was expected. The result is an answer, not an absence of one.
Written into the record, not signed off as a reviewed claim
It is the weakest glucose-lowering drug in this batch
In plain words
Pooling every placebo-controlled trial of at least ten weeks, nateglinide lowered average blood sugar by between 0.2 and 0.6 percentage points. Repaglinide, in the same review, ranged from 0.1 to 2.1.
What was measured
Range of HbA1c reduction against placebo, and head-to-head comparisons against repaglinide and metformin, across pooled randomised trials
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Cochrane review of meglitinide analogues included fifteen trials with 3,781 participants. Across eleven placebo-controlled studies, nateglinide reduced HbA1c by 0.2 to 0.6 percentage points against 0.1 to 2.1 for repaglinide. Two trials directly comparing the two, totalling 342 participants, found greater HbA1c reduction on repaglinide. One study of 355 participants comparing nateglinide against metformin found a similar or slightly less marked effect for nateglinide. Weight gain was generally greater with meglitinides than with metformin, up to three kilograms in three months; diarrhoea occurred less frequently and hypoglycaemia more frequently, but rarely severely enough to require assistance. The reviewers state that no included study reported the effect of meglitinides on mortality or morbidity — a statement that was true of nateglinide at the time and was answered three years later by NAVIGATOR, in the negative.
Written into the record, not signed off as a reviewed claim
Glucose-dependence and tissue selectivity are label claims from assays
In plain words
The label states that insulin release on this drug falls off when blood sugar is low, and that the drug barely touches the equivalent channels in heart and muscle. Both are laboratory findings. The trial that tested clinical consequences found more hypoglycaemia and no cardiovascular benefit.
What was measured
That glucose-dependent secretion and cardiac channel selectivity make nateglinide clinically safe — the largest trial ever run on it found more hypoglycaemia and no cardiovascular benefit
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The mechanism section states that "the extent of insulin release is glucose dependent and diminishes at low glucose levels" and that "nateglinide is highly tissue selective with low affinity for heart and skeletal muscle". Both describe in vitro pharmacology. The clinical readouts run the other way: NAVIGATOR reported that nateglinide increased the risk of hypoglycaemia, and neither cardiovascular composite improved. The label separately carries, under section 5.2, the statement that there have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with nateglinide. A mechanistic argument for safety that has been tested and not confirmed is weaker evidence than one that has never been tested, not stronger.
Source
FDA prescribing information for nateglinide tablets USP, sections 12.1 and 5.2; NAVIGATOR Study Group, N Engl J Med 2010;362:1463-1476
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
In and out in about ninety minutes, with an equipotent minor metabolite
In plain words
Roughly three-quarters of a dose reaches the blood, it peaks within an hour when taken before food, and half of it is cleared in about an hour and a half. One of its minor breakdown products is as strong as the drug itself.
What was measured
Absolute bioavailability, time to peak, volume of distribution, protein binding, elimination half-life, CYP fraction and radiolabelled recovery
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The label reports absolute bioavailability of approximately 73%, peak plasma concentration within one hour when taken immediately before a meal, a steady-state volume of distribution of about 10 L, serum protein binding of 98% — primarily to albumin — and an average elimination half-life of approximately 1.5 hours. Pharmacokinetics are linear from 60 mg to 240 mg with no accumulation over seven days of three-times-daily dosing. Metabolism is predominantly by CYP2C9 (70%) and to a lesser extent CYP3A4 (30%), by hydroxylation followed by glucuronidation. The major metabolites are less potent than the parent, but the label states the minor isoprene metabolite "possesses potency similar to that of the parent compound". Eighty-three percent of a radiolabelled dose is excreted in urine and a further 10% in faeces.
Source
FDA prescribing information for nateglinide tablets USP, sections 11 Description and 12.3 Pharmacokinetics
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
It costs six times glimepiride for a smaller measured effect
In plain words
At what United States pharmacies pay, nateglinide is 23.45 cents a tablet against 3.73 cents for glimepiride — and it is taken with each meal rather than once a day. The measured HbA1c effect is smaller and the outcome trial failed.
What was measured
That a higher acquisition price reflects a therapeutic advantage — on the measured HbA1c effect and on the outcome trial record, the opposite ordering holds within this class
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The CMS National Average Drug Acquisition Cost survey effective 19 August 2026 puts the median across 18 listed nateglinide products at US$0.2345 per tablet, against US$0.0373 across 56 glimepiride products, US$0.0464 across 75 glipizide products and US$0.0937 across 17 repaglinide products. Nateglinide is therefore the most expensive secretagogue in this batch and the second most expensive oral drug in it after alogliptin. On measured effect it sits at the bottom: 0.2 to 0.6 HbA1c percentage points against placebo in the Cochrane pooling, below repaglinide in direct comparison, and similar to or slightly below metformin. This page observes the price and the effect side by side; it does not have data on how prescribing responded to either, and it does not claim to.
Source
CMS National Average Drug Acquisition Cost survey, 19 August 2026 file; Black C et al., Cochrane Database Syst Rev 2007;(2):CD004654
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
How many documents were read
9 documents were read for this substance.
RNAWiki source record
9 of them state the same halfLife, and they agree.
RNAWiki source record
9 of them state the same bioavailability, and they agree.
RNAWiki source record
9 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
41X3PWK4O2
RxNorm concept
311919
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
9 approved applications cover products containing this substance. The earliest was NDA021204, approved 20001222 to NOVARTIS.
This order is fixed in code and does not count clicks or time on the page.
What is not here
3 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.
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 D-phenylalanine derivative that closes the beta-cell potassium channel for a fast, short insulin burst, lowering HbA1c by 0.2 to 0.6 percentage points across placebo-controlled trials — and the only drug on this site whose 9,306-participant, five-year outcome trial failed all three of its co-primary endpoints simultaneously, with the diabetes-prevention hazard ratio landing at 1.07 in favour of placebo.
Recorded evidence blocks (13)
Q1
What did Nateglinide's largest trial (1499650 people) and its longest (5.2 years) measure?
1499650 people in Nateglinide's largest registered study, 5.2 years in its longest registered window, measuring Verbal memory (main study). ClinicalTrials.gov · 2026-09-01
9 phase4, 3 na or unstated, 3 phase1, 2 phase3, 1 phase2; NCT00858013; 2014-06-25; no ageing endpoint recorded. Last human test completed 2015, NCT02456428.
Interpretation These counts include studies where Nateglinide 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
phase4
9
na or unstated
3
phase1
3
phase3
2
phase2
1
Last recorded human testNCT02456428
2015-05
recorded 2026-09-01 · last checked 2026-09-04
Q2
Nateglinide was tested only in human — what did it show?
2 recorded entries; human; also "Starlix tablets 120 mg"
Show the evidence
human
NCT00928889
Nateglinide 120 mg
NCT01159158
Starlix tablets 120 mg
recorded 2026-09-01 · last checked 2026-09-04
Q4
More Nateglinide 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 · 2001-09-01
4 recorded sentences naming Nateglinide; U-shaped, biphasic, dose-response
Show the evidence
U-shaped
PMID 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…"
PMID 8615868
"Non-sulfonylurea hypoglycemic agents of the meglitinide family such as S3075, repaglinide, KAD-1229, and A-4166, were found to display a comparable U-shaped conformation by molecular modelling, with hydrophobic cycles placed at the extremity of each branch and a peptidic bond placed at the bottom of the U. A comparable conformation was observed with the hypoglycemic sulfonylureas glibenclamide…"
biphasicPMID 11472274
"Nateglinide and KAD-1229 clearly stimulate biphasic insulin secretion in vitro and in vivo and their effects are rapidly reversible, whereas the effects of repaglinide and BTS 67 582 are prolonged well beyond their removal from perfusion media in vitro or their clearance in vivo."
dose-responsePMID 9543688
"The dose-response curve of the insulin secretion to glucose was shifted to the left side by AY-4166."
recorded 2001-09-01 · last checked 2026-09-04
Q5
Nateglinide's half-life is 1.5 hours — which schedules were studied?
1.5 hours, the half-life Nateglinide's label states. openfda-label · e920b343-f53e-7487-e053-2995a90a719a · 2026-08-30
bioavailability 73% %.
Show the evidence
half life
1.5 hours hours; Elimination In healthy volunteers and patients with type 2 diabetes mellitus, nateglinide plasma concentrations declined with an average elimination half-life of approximately 1.5 hours.
tmax
Following oral administration immediately prior to a meal, the mean peak plasma nateglinide concentrations (C max ) generally occur within 1 hour (T max ) after dosing.
bioavailability
73% %; Absorption Absolute bioavailability of nateglinide is approximately 73%.
metabolism
Metabolism In vitro drug metabolism studies indicate that nateglinide is predominantly metabolized by the cytochrome P450 isozyme CYP2C9 (70%) and to a lesser extent CYP3A4 (30%).
recorded 2026-08-30 · last checked 2026-09-04
Q6
Could one person measure Nateglinide's effect on verbal memory?
Verbal memory: measured in Nateglinide's trials.
Interpretation verbal memory is the recorded endpoint.
Show the evidence
biomarkers
verbal memory; 2026-09-01
selective attention; 2026-09-01
plasma beta amyloid levels; 2026-09-01
cerebral glucose metabolism; 2026-09-01
inflammatory markers in spinal fluid; 2026-09-01
beta amyloid in spinal fluid; 2026-09-01
10 more recorded rows
biomarkers
endothelial function; 2026-09-01
biomarkers
glucose tolerance; 2026-09-01
biomarkers
hemoglobin a1c; 2026-09-01
biomarkers
7 smbg; 2026-09-01
biomarkers
postprandial glucose excursion at the end of the study; 2026-09-01
biomarkers
bioequivalence on cmax and auc parameters; 2026-09-01
biomarkers
cmax; 2026-09-01
biomarkers
hospitalization for incident heart failure; 2026-09-01
biomarkers
incident pancreatic cancer; 2026-09-01
biomarkers
hospitalization for acute pancreatitis; 2026-09-01
15; NCT00319189; PHASE4; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; COMPLETED
Q7
Which of 7 smbg, beta amyloid in spinal fluid and bioequivalence on cmax and auc parameters did Nateglinide's trials measure?
7 smbg, beta amyloid in spinal fluid and bioequivalence on cmax and auc parameters lead 16 outcome terms across Nateglinide's trials. ClinicalTrials.gov · 2026-09-01
cerebral glucose metabolism, inflammatory markers in spinal fluid, beta amyloid in spinal fluid, endothelial function, glucose tolerance and hemoglobin a1c follow.
Show the evidence
verbal memory
1
selective attention
1
plasma beta amyloid levels
1
cerebral glucose metabolism
1
inflammatory markers in spinal fluid
1
beta amyloid in spinal fluid
1
10 more recorded rows
endothelial function
1
glucose tolerance
1
hemoglobin a1c
1
7 smbg
1
postprandial glucose excursion at the end of the study
1
bioequivalence on cmax and auc parameters
1
cmax
1
hospitalization for incident heart failure
1
incident pancreatic cancer
1
hospitalization for acute pancreatitis
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which 12 trials of Nateglinide posted no result?
Posted no result
12 of 12 completed trials
Registrations
NCT00319189, NCT01160029, NCT00238472, NCT00259168, NCT00212290 and NCT01159158, and 6 more
Completion dates
oldest 2003-11; newest 2015-05
Show the evidence
Trial
NCT00319189
2003-11
NCT01160029
2004-10
NCT00238472
2005-06
NCT00259168
2006-03
NCT00212290
2006-12
NCT01159158
2007-02
6 further recorded trials
NCT00402909
2007-08
NCT00437918
2008-03
NCT01316107
2012-10-19
NCT02475499
2015-04
NCT02476760
2015-04
NCT02456428
2015-05
Q9
At the median, Nateglinide's trials enrolled 86.5 people — anything larger?
Median enrolment
86.5
Largest enrolment
1499650
Registered trials counted
16
Q10
What do 170 spontaneous reports say about Nateglinide — 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.
Nateglinide appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 170 reaction mentions were counted: hypoglycaemia 36; blood glucose increased 18; disease progression 18; alanine aminotransferase increased 16. open-targets-adr · CHEMBL783 · 2026-06-24
Show the evidence
hypoglycaemia
36
blood glucose increased
18
disease progression
18
alanine aminotransferase increased
16
aspartate aminotransferase increased
16
gamma-glutamyltransferase increased
15
4 more recorded rows
decreased appetite
14
glycosylated haemoglobin increased
14
chest pain
12
blood alkaline phosphatase increased
11
recorded 2026-06-24 · last checked 2026-09-04
Q11
Nateglinide and CYP2C9 and CYP3A4: shared by which compounds?
CYP2C9 and CYP3A4 appear in Nateglinide's recorded interaction sentences, 4 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP2C9
pharmacokinetics
Metabolism In vitro drug metabolism studies indicate that Nateglinide Tablets are predominantly metabolized by the cytochrome P450 isozyme CYP2C9 (70%) and to a lesser extent CYP3A4 (30%).
pharmacokinetics
Drug Interactions: In vitro assessment of drug interactions Nateglinide Tablets are a potential inhibitor of the CYP2C9 isoenzyme in vivo as indicated by its ability to inhibit the in vitro metabolism of tolbutamide.
CYP3A4
pharmacokinetics
Metabolism In vitro drug metabolism studies indicate that Nateglinide Tablets are predominantly metabolized by the cytochrome P450 isozyme CYP2C9 (70%) and to a lesser extent CYP3A4 (30%).
pharmacokinetics
Inhibition of CYP3A4 metabolic reactions was not detected in in vitro experiments.
recorded 2026-08-30 · last checked 2026-09-04
Q12
Was Nateglinide studied with fasting and exercise?
fasting and exercise are named in Nateglinide's label sentences: "The two main criteria for diagnosing T2DM were a fasting plasma glucose level ≥ 7.0 mmol/L or a 2-hour post challenge glucose ≥ 11.1 mmol/L. T2DM developed in 1674/4645 (36.0%) participants in the nateglinide group and in 1580/4661 (33.9%) in the placebo group (HR 1.07; 95% CI 1.00 to 1.15; P =…" openfda-label+europepmc · 2026-08-30
2 recorded statements; fasting, exercise
Show the evidence
fasting
The two main criteria for diagnosing T2DM were a fasting plasma glucose level ≥ 7.0 mmol/L or a 2-hour post challenge glucose ≥ 11.1 mmol/L. T2DM developed in 1674/4645 (36.0%) participants in the nateglinide group and in 1580/4661 (33.9%) in the placebo group (HR 1.07; 95% CI 1.00 to 1.15; P = 0.05; moderate-quality evidence).
exercise
Enrolled patients had received treatment with diet and exercise in the previous 3 months with glycosylated haemoglobin (HbA1c) 7-10%, and were randomized to receive mitiglinide (n = 111, 5-20 mg/meal) or nateglinide (n = 114,60-120 mg/meal) for 16 weeks.
recorded 2026-08-30 · last checked 2026-09-04
Q13
What is recorded about Nateglinide and NAD+?
"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." — where Nateglinide and NAD+ appear together. Europe PMC · pathway abstract search · 2008-08-01
NAD+; PMID 18640379
Show the evidence
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."
recorded 2008-08-01 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 10 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
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