This page shows what was measured, who it was measured in, and what that does not settle.
What Alogliptin does in the body
Alogliptin blocks that enzyme, so the hormones last longer and their message is stronger.
Eating makes the gut release hormones that tell the pancreas to produce insulin, but only while blood sugar is high. An enzyme in the blood destroys those hormones within a couple of minutes. More insulin after meals, less of the hormone that tells the liver to make sugar, and no hypoglycaemia from the drug on its own, because the signal it amplifies switches itself off when blood sugar is normal.
Why people take it. Type 2 diabetes — a once-daily tablet that extends the gut hormone signal
What happened in people
A primary cardiovascular composite hazard ratio of 0.96 with an upper one-sided confidence boundary of 1.16 in 5,380 patients randomised within 90 days of an acute coronary syndrome
✎ 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.
EXAMINE: Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome (NCT00968708) · a recorded source, not a stored snapshot
The limit that matters most
The only DPP-4 inhibitor whose outcome trial was run entirely in patients within 90 days of an acute coronary syndrome
Where it acts
Plasma and endothelial surfaces where DPP-4 acts; downstream effects on pancreatic alpha and beta cells and on hepatic glucose output
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 · EEN99869SC · read 2026-08-29
Its recorded molecular formula is C18H21N5O2∙C7H6O2, weighing 461.51 daltons.
US prescribing information · f2ad6d21-8060-42c7-8b3f-ad80085dc022 · read 2026-08-30
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
The recorded use, written for a reader without medical training. Not signed off.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 127 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.
Formulation
A formulation is the exact made-up form a substance comes in.
A picture of it, and where the picture fails
It is like the difference between a whole bean and instant coffee.
Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.
What people get wrong. Two products with the same name are assumed to behave the same. They often do not.
The specific composition and physical form of a product, including salt, excipients and release profile.
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 26 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 moved4 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; achieving hba1c 7 after 36 month treatment; hba1c at week 26; hba1c change from baseline at week 24
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
4 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.
Composite of death from cardiovascular causes, non-fatal myocardial infarction or non-fatal stroke in patients randomised 15 to 90 days after acute myocardial infarction or unstable angina, against a non-inferiority margin of 1.3
✓ The study showed what it set out to show
Who was studied
EXAMINE (NCT00968708)
How many people
5380
Study design
Randomised double-blind placebo-controlled cardiovascular non-inferiority trial, median 18 months, up to 40 months
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
Hazard ratio 0.96, upper boundary of the one-sided repeated confidence interval 1.16, P < 0.001 for non-inferiority. Mean HbA1c difference -0.36 percentage points, P < 0.001
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. The label records 106 (3.9%) heart-failure hospitalisations on alogliptin against 89 (3.3%) on placebo. Acute pancreatitis was 10 (0.4%) against 7 (0.3%), and ALT above three times the reference limit 2.4% against 1.8%. Funded by Takeda Development Center Americas.
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 6.25 mg, 12.5 mg and 25 mg strengths
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
EXAMINE: Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome (NCT00968708) · a recorded source, not a stored snapshot
FDA approval letter, NDA 022271 (NESINA, alogliptin tablets), 25 January 2013 — records receipt on 27 December 2007, the 25 April 2012 complete response acti… · a recorded source, not a stored snapshot
Hospital admission for heart failure as a first event, extended MACE, and the composite of cardiovascular death and heart-failure admission
✓ The study showed what it set out to show
Who was studied
EXAMINE heart failure and mortality analysis (Zannad 2015)
How many people
5380
Study design
Prespecified exploratory and post-hoc analysis of the same randomised trial, median 533 days
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Heart-failure admission as first event hazard ratio 1.07 (95% CI 0.79 to 1.46); extended MACE 0.98 (95% CI 0.86 to 1.12); cardiovascular death plus heart-failure admission 1.00 (95% CI 0.82 to 1.21)
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. These are exploratory and post-hoc analyses. The counts differ from the label because this analysis counts heart-failure admission only when it was the first event, and the label counts all such admissions.
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 6.25 mg, 12.5 mg and 25 mg strengths
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
EXAMINE: Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome (NCT00968708) · a recorded source, not a stored snapshot
FDA approval letter, NDA 022271 (NESINA, alogliptin tablets), 25 January 2013 — records receipt on 27 December 2007, the 25 April 2012 complete response acti… · 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 eventNo evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
□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.9 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.
Start
Alogliptin
What a person takes: Oral tablet, once daily, in 6.25 mg, 12.5 mg and 25 mg strengths.
The measurement behind this step
A conventional immediate-release tablet of the benzoate salt. Alogliptin is largely excreted unchanged by the kidney rather than extensively metabolised, so renal function rather than hepatic enzyme activity is the dominant determinant of exposure — and which strength suits a given level of kidney function is a prescribing decision this page does not enter into.
Getting in
A meal triggers two short-lived gut hormones
Food reaching the small intestine causes cells there to release hormones into the blood that prime the pancreas for the glucose on its way.
╌╌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
GLP-1 from intestinal L cells and GIP from K cells. The label states these hormones cause insulin release from pancreatic beta cells in a glucose-dependent manner, and that in type 2 diabetes GLP-1 concentrations are reduced while the insulin response to GLP-1 is preserved.
EXAMINE: Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome (NCT00968708) · a recorded source, not a stored snapshot
Reaching the cell
An enzyme in the blood clips them apart within minutes
A protein-cutting enzyme circulating in blood removes the working end of both hormones almost as fast as they appear.
╌╌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
DPP-4 removes the N-terminal dipeptide from GLP-1 and GIP, inactivating both within minutes. That very short half-life is why the enzyme rather than the hormone is the practical oral drug target.
EXAMINE: Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome (NCT00968708) · a recorded source, not a stored snapshot
What it acts on
Alogliptin occupies the enzyme without reacting with it
The drug slots into the pocket where the enzyme grips the hormone and simply stays there. Unlike some others in the class it does not form a chemical bond with the enzyme.
╌╌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
A pyrimidinedione bearing a 2-cyanobenzyl group and an (R)-3-aminopiperidine whose primary amine occupies the S2 pocket. There is no nitrile warhead and no covalent adduct — inhibition is reversible and non-covalent, and selectivity over DPP-8, DPP-9 and fibroblast activation protein is a design requirement of the class.
EXAMINE: Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome (NCT00968708) · a recorded source, not a stored snapshot
The change it makes
The hormone signal survives longer and stays conditional on glucose
With the enzyme blocked, the gut hormones last longer and push harder — but only while blood sugar is high, which is why the drug alone does not cause hypoglycaemia.
╌╌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 alogliptin reduces fasting and post-prandial glucose "in a glucose-dependent manner". That conditionality caps the achievable effect: the measured HbA1c difference against placebo in EXAMINE was 0.36 percentage points.
EXAMINE: Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome (NCT00968708) · a recorded source, not a stored snapshot
The change it makes
The kidney removes the drug, largely unchanged
Unlike some drugs in the class, this one is not extensively broken down by the liver. It is filtered out by the kidney more or less as it went 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
Alogliptin is largely excreted unchanged in urine, so renal function is the dominant determinant of exposure and the metabolic drug-interaction profile is quiet compared with saxagliptin, whose active metabolite is generated by CYP3A4 and CYP3A5.
EXAMINE: Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome (NCT00968708) · a recorded source, not a stored snapshot
What that does for a person
HbA1c falls a third of a point, and no cardiovascular endpoint moves
Average blood sugar comes down slightly. Heart attacks, strokes and cardiovascular deaths came out the same as on placebo, in the highest-risk population anyone has tested this class 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
In EXAMINE, the primary composite hazard ratio was 0.96 with an upper one-sided confidence boundary of 1.16, and the exploratory extended composite in the Lancet analysis was 0.98 (95% CI 0.86 to 1.12). Heart-failure admission as first event was 1.07 (95% CI 0.79 to 1.46), while the label reports total heart-failure hospitalisations at 3.9% against 3.3%.
EXAMINE: Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome (NCT00968708) · 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.
glycosylated hemoglobin at week 26
glycosylated hemoglobin
glycosylated hemoglobin at week 52
glycosylated hemoglobin at week 104
hba1c
achieving hba1c 7 after 36 month treatment
hba1c at week 26
hemoglobin a1c
hba1c change from baseline at week 24
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 (17)
treatment emergent adverse events
adverse events
beta cell function evaluated from 75 ogtt
frequency of cancers
reporting one or more adverse drug reactions
reporting one or more serious adverse drug reactions
who had one or more adverse events
glycohemoglobin from baseline
adverse events and serious adverse events
overall gastrointestinal tolerability
serious adverse events
serious adverse drug reactions
unexpected adverse events
mace
modified mace
auclast
cmax
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. 21 hours hours
Read from the label, which states: “Elimination Alogliptin tablets was eliminated with a mean terminal half-life (t 1/2 ) of approximately 21 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 added to metformin. Now generic, though at United States acquisition cost it remains the most expensive drug on this page by a wide margin.
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 alogliptin tablets have not been established in pediatric patients.”
US prescribing information · f2ad6d21-8060-42c7-8b3f-ad80085dc022 · read 2026-08-30
On older people, the label states: “Of the total number of patients (N=9052) in clinical safety and efficacy trials treated with alogliptin tablets, 2,257 (24.9%) patients were 65 years and older and 386 (4.3%) patients were 75 years and older.”
US prescribing information · f2ad6d21-8060-42c7-8b3f-ad80085dc022 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Limited data with alogliptin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage.”
US prescribing information · f2ad6d21-8060-42c7-8b3f-ad80085dc022 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of alogliptin in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · f2ad6d21-8060-42c7-8b3f-ad80085dc022 · read 2026-08-30
On people with reduced liver function, the label states: “No dose adjustments are required in patients with mild to moderate hepatic impairment (Child-Pugh Grade A and B) [see Clinical Pharmacology (12.3) ] .”
US prescribing information · f2ad6d21-8060-42c7-8b3f-ad80085dc022 · read 2026-08-30
On people with reduced kidney function, the label states: “A total of 602 adult patients with moderate renal impairment (eGFR ≥30 and <60 mL/min/1.73 m 2 ) and 4 patients with severe renal impairment/end-stage renal disease (eGFR <30 mL/min/1.73 m 2 or <15 mL/min/1.73 m 2 , respectively) at baseline were treated with alogliptin tablets in clinical trials in patients with type 2 diabetes mellitus.”
US prescribing information · f2ad6d21-8060-42c7-8b3f-ad80085dc022 · read 2026-08-30
Where the result stopped carrying
The original application was not approved; a complete response action letter was issued on 25 April 2012 and the drug reached the market five years and a month after filing
Approval carried postmarketing requirements for hepatotoxicity, acute pancreatitis, hypersensitivity reactions, cardiovascular events, serious hypoglycaemia and renal impairment — six named serious risks the trials had not resolved
Severe disabling arthralgia, bullous pemphigoid requiring hospitalisation, Stevens-Johnson syndrome and fatal hepatic failure all reached the label from postmarketing reports rather than from the trials
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.
A different form was studied
The studied form is not the form on the shelf.
On this record: This record is linked to 1 related forms. Evidence does not carry across all of them.
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 (9)
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 6.25 mg, 12.5 mg and 25 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 the benzoate salt.
✎ 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. The rest of the recorded wording: Alogliptin is largely excreted unchanged by the kidney rather than extensively metabolised, so renal function rather than hepatic enzyme activity is the dominant determinant of exposure — and which strength suits a given level of kidney function is a prescribing decision this page does not enter into.
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
Alogliptin alone does not cause hypoglycaemia because the incretin signal it prolongs is glucose-dependent; risk rises when it is combined with insulin or an insulin secretagogue. The label carries warnings for acute pancreatitis, heart failure (with the EXAMINE counts stated), serious hypersensitivity reactions including anaphylaxis, angioedema and Stevens-Johnson syndrome, fatal and non-fatal hepatic failure, severe and disabling arthralgia, and bullous pemphigoid requiring hospitalisation. Four of those six came from postmarketing reports rather than from the trials. The FDA required enhanced pharmacovigilance on serious hepatic abnormalities, fatal pancreatitis, haemorrhagic or necrotising pancreatitis and severe hypersensitivity at the time of approval.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
EXAMINE: Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome (NCT00968708) · a recorded source, not a stored snapshot
Reports sent to a regulator
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.
Alogliptin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 289 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
pemphigoid — 62 reaction mentions
pancreatitis — 34 reaction mentions
hypoglycaemia — 33 reaction mentions
interstitial lung disease — 33 reaction mentions
pancreatitis acute — 33 reaction mentions
rhabdomyolysis — 24 reaction mentions
blood glucose increased — 21 reaction mentions
cerebral infarction — 20 reaction mentions
hepatic function abnormal — 15 reaction mentions
lactic acidosis — 14 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 6.25 mg, 12.5 mg and 25 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
A recorded note compares this form with the others that are sold. It is kept below, word for word.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
The recorded note, unchanged: Alogliptin is largely excreted unchanged by the kidney rather than extensively metabolised, so renal function rather than hepatic enzyme activity is the dominant determinant of exposure — and which strength suits a given level of kidney function is a prescribing decision this page does not enter into.
No source is stored against this line.
What is recorded as being sold
6 published labels name it as an active ingredient. 6 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · f2ad6d21-8060-42c7-8b3f-ad80085dc022 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · f2ad6d21-8060-42c7-8b3f-ad80085dc022 · read 2026-08-29
Alogliptin is oral at 3 DOSAGE FORMS AND STRENGTHS 25 mg tablets are light red, oval, biconvex, film-coated, with "TAK ALG-25" printed on one side. 12.5 mg tablets are yellow, oval, biconvex, film-coated, with "TAK ALG-12.5" printed on one s…, recorded as fda label in effect 2025-01-28 in the United States.
US prescribing information · f2ad6d21-8060-42c7-8b3f-ad80085dc022 · read 2026-08-30
Recorded price in US: 4.92307–5.18042 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 3 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.
Evidence on this page does not automatically apply to this one.
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 Alogliptin 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 alogliptin reduces cardiovascular risk — EXAMINE was a non-inferiority trial and its conclusion is that event rates "were not increased"
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 heart-failure question is settled in either direction — the same trial supports a labelled warning and a published null result, depending on how the endpoint is counted
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 a 0.36 percentage-point HbA1c improvement is clinically meaningful on its own — no outcome has been shown to follow from it for this drug or this class
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 class postmarketing harms are rare enough to disregard — the FDA required five years of enhanced surveillance for four of them at the time of approval
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 Alogliptin 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.
EXAMINE tested it in the sickest population any DPP-4 trial enrolled
In plain words
Patients were randomised within 15 to 90 days of a heart attack or an admission for unstable angina — the highest-risk moment in the disease. Over a median 18 months, cardiovascular death, heart attack and stroke occurred in 11.3% on alogliptin and 11.8% on placebo.
What was measured
Hazard ratio for the primary three-point cardiovascular composite and mean HbA1c difference over a median 18 months in 5,380 post-acute-coronary-syndrome patients
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
EXAMINE randomised 5,380 patients with type 2 diabetes and either acute myocardial infarction or unstable angina requiring hospitalisation within the previous 15 to 90 days, to alogliptin or placebo on top of existing antihyperglycaemic and cardiovascular therapy, in a double-blind non-inferiority trial with a prespecified margin of 1.3. Follow-up ran up to 40 months with a median of 18. A primary endpoint event — the composite of death from cardiovascular causes, non-fatal myocardial infarction or non-fatal stroke — occurred in 305 patients on alogliptin (11.3%) and 316 on placebo (11.8%): hazard ratio 0.96, upper boundary of the one-sided repeated confidence interval 1.16, p<0.001 for non-inferiority. HbA1c was significantly lower on alogliptin, mean difference -0.36 percentage points (p<0.001). Incidences of hypoglycaemia, cancer, pancreatitis and initiation of dialysis were similar. The trial was funded by Takeda Development Center Americas.
Written into the record, not signed off as a reviewed claim
The heart-failure number reads two ways, and the label carries the larger one
In plain words
The label says 3.9% of alogliptin patients and 3.3% of placebo patients were hospitalised for heart failure. The trial group published a dedicated analysis of the same data reporting 3.1% and 2.9% and concluding the drug did not increase heart failure risk. Both are true; they count different things.
What was measured
Heart-failure hospitalisation counts and rates under two endpoint definitions in the same 5,380-patient trial, with the hazard ratio for first-event analysis
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Section 5.2 of the FDA label states that in EXAMINE, 106 (3.9%) patients treated with alogliptin and 89 (3.3%) treated with placebo were hospitalised for congestive heart failure, and requires prescribers to weigh risks and benefits before initiating in patients at risk. Zannad and colleagues then published a prespecified and post-hoc analysis of the same trial in the Lancet: among 5,380 patients followed a median 533 days, hospital admission for heart failure as the first event occurred in 85 (3.1%) on alogliptin and 79 (2.9%) on placebo, hazard ratio 1.07 (95% CI 0.79 to 1.46). The exploratory extended MACE endpoint was 16.0% against 16.5%, hazard ratio 0.98 (95% CI 0.86 to 1.12). The composite of cardiovascular death and heart-failure admission gave 1.00 (95% CI 0.82 to 1.21) and did not differ by baseline BNP; NT-pro-BNP fell similarly in both arms. Their stated interpretation is that alogliptin did not increase the risk of heart failure outcomes. The difference between 106 and 85 is the difference between all hospitalisations and first events only, and it is the reason the same trial supports a label warning and a published null result at once.
Written into the record, not signed off as a reviewed claim
Five years and a complete response letter from filing to approval
In plain words
The application was submitted at the end of 2007. The FDA did not approve it until January 2013, after issuing a complete response letter in 2012 and after the manufacturer had run a cardiovascular outcome trial. Approval came with required postmarketing surveillance for six separate serious risks.
What was measured
Dates of application receipt, complete response action and approval, and the enumerated serious risks requiring postmarketing surveillance
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The FDA approval letter for NDA 022271 records that the new drug application was dated and received on 27 December 2007, that the submission dated 26 July 2012 constituted a complete response to an action letter dated 25 April 2012, and that approval took effect on 25 January 2013 — five years and one month after filing. The letter imposes postmarketing requirements under section 505(o), stating that spontaneous adverse event reporting and the FDA pharmacovigilance system would not be sufficient to assess signals of serious risks of hepatotoxicity, acute pancreatitis, hypersensitivity reactions, cardiovascular events, serious hypoglycaemia and renal impairment. Requirement 2007-4 mandates enhanced pharmacovigilance with specialised follow-up on serious hepatic abnormalities, fatal pancreatitis, haemorrhagic or necrotising pancreatitis and severe hypersensitivity reactions, continuing for five years from approval for the pancreatitis categories.
Source
FDA approval letter, NDA 022271 (NESINA, alogliptin tablets), 25 January 2013 (Reference ID 3250798), postmarketing requirement 2007-4
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
Acute pancreatitis and liver enzyme rises were numerically higher in both datasets
In plain words
Pancreatitis occurred in 0.2% of glycaemic-control trial patients on alogliptin against under 0.1% on comparators, and in 0.4% against 0.3% in the cardiovascular trial. Liver enzyme rises above three times normal occurred in 2.4% against 1.8% in the same trial.
What was measured
Acute pancreatitis and ALT elevation rates by arm in glycaemic control trials and in the cardiovascular outcome trial
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The label reports that in glycaemic control trials, acute pancreatitis occurred in 6 patients (0.2%) on alogliptin 25 mg and 2 (<0.1%) on active comparators or placebo; in EXAMINE it occurred in 10 (0.4%) against 7 (0.3%). It states that whether patients with a history of pancreatitis are at increased risk is unknown. For hepatic effects, the label records postmarketing reports of fatal and non-fatal hepatic failure, noting some reports contain insufficient information to establish probable cause; in glycaemic control trials alanine aminotransferase rose above three times the upper limit of normal in 1.3% on alogliptin against 1.7% on comparators, but in EXAMINE the same threshold was crossed by 2.4% on alogliptin against 1.8% on placebo. Each of these numbers is small, and each points the same way in the larger dataset — which is the pattern that produced six named postmarketing surveillance requirements rather than a contraindication.
Source
FDA prescribing information for alogliptin tablets, sections 5.1 Pancreatitis and 5.4 Hepatic Effects
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
A 0.36 percentage-point HbA1c difference is the entire measured benefit
In plain words
Over 18 months in 5,380 people, average blood sugar was about a third of a percentage point lower on alogliptin. Nothing else was better. That is the whole of what the trial demonstrated.
What was measured
That a 0.36 percentage-point HbA1c improvement translates into a clinical benefit — the trial that measured it was designed to exclude harm, and every cardiovascular estimate it produced sits on top of no effect
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
EXAMINE was a non-inferiority trial designed to exclude a hazard ratio above 1.3 for major adverse cardiovascular events; it was not designed to show benefit, and it did not. The measured efficacy outcome was a mean HbA1c difference of -0.36 percentage points against placebo (p<0.001). The primary composite was 0.96 with an upper confidence boundary of 1.16, and the exploratory extended composite in the Lancet analysis was 0.98 (95% CI 0.86 to 1.12). The trial authors concluded that rates of major adverse cardiovascular events "were not increased" — an absence of harm, stated as such. No trial of alogliptin has demonstrated a reduction in any clinical event, and the class as a whole has none.
Written into the record, not signed off as a reviewed claim
Three class warnings came from postmarketing reports, not from the trials
In plain words
Severe disabling joint pain, a blistering skin disease requiring hospital admission, and serious allergic reactions including Stevens-Johnson syndrome were all added to the label after approval, from reports collected in ordinary use.
What was measured
Warnings added to the label from postmarketing surveillance rather than from the registration or outcome trials
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Section 5.3 of the label records postmarketing reports of serious hypersensitivity reactions including anaphylaxis, angioedema and severe cutaneous adverse reactions including Stevens-Johnson syndrome, and advises caution in patients with a history of angioedema with another DPP-4 inhibitor because cross-reactivity is unknown. Section 5.5 records severe and disabling arthralgia reported in patients taking DPP-4 inhibitors, to be considered as a possible cause of severe joint pain. Section 5.6 records postmarketing reports of bullous pemphigoid requiring hospitalisation, with instructions that patients be told to report blisters or erosions and that the drug be discontinued if it is suspected. Section 5.4 records fatal and non-fatal hepatic failure. None of these appeared in the registration programme. All are class findings that accumulated only once exposure ran to millions of patient-years — which is the argument for the enhanced pharmacovigilance the FDA required at approval.
Source
FDA prescribing information for alogliptin tablets, sections 5.3, 5.4, 5.5 and 5.6
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
6 documents were read for this substance.
RNAWiki source record
6 of them state the same halfLife, and they agree.
RNAWiki source record
6 of them state the same bioavailability, and they agree.
RNAWiki source record
6 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
EEN99869SC
RxNorm concept
1368006
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
1 approved application covers products containing this substance.
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 DPP-4 inhibitor licensed in 2013 after five years and a complete response letter, whose 5,380-patient outcome trial in people randomised within 90 days of a heart attack found major cardiovascular events at 11.3% against 11.8% on placebo and an HbA1c difference of 0.36 percentage points — and whose heart-failure result reads as 3.9% against 3.3% on the label and as a hazard ratio of 1.07 with a confidence interval from 0.79 to 1.46 in the dedicated analysis published by the trial group.
Recorded evidence blocks (14)
Q1
What did Alogliptin's largest trial (781430 people) and its longest (6.2 years) measure?
781430 people in Alogliptin's largest registered study, 6.2 years in its longest registered window, measuring Cmax: Maximum Observed Plasma Concentration for Alogliptin. ClinicalTrials.gov · 2026-09-01
31 phase3, 11 phase2, 9 na or unstated, 8 phase4, 7 phase1, 1 na; NCT05220917; 2027-09-30; no ageing endpoint recorded. Last human test completed 2024, NCT03499704.
Interpretation These counts include studies where Alogliptin 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
31
phase2
11
na or unstated
9
phase4
8
phase1
7
na
1
1 more recorded row
Last recorded human testNCT03499704
2024-01-16
recorded 2026-09-01 · last checked 2026-09-04
Q2
From mouse to human: where has Alogliptin shown lifespan?
3 recorded entries; human; also "Alogliptin Benzoate 25 mg", "Alogliptin Benzoate 12.5 mg"
Show the evidence
human
NCT01632007
Alogliptin 25 mg
NCT05363384
Alogliptin Benzoate 25 mg
NCT05363592
Alogliptin Benzoate 12.5 mg
recorded 2026-09-01 · last checked 2026-09-04
Q5
Alogliptin's half-life is 21 hours — which schedules were studied?
21 hours, the half-life Alogliptin's label states. openfda-label · b25f155a-1259-47c2-aa3b-7c1356e4c7f6 · 2026-08-30
bioavailability 100% %.
Show the evidence
half life
21 hours hours; Elimination Alogliptin tablets was eliminated with a mean terminal half-life (t 1/2 ) of approximately 21 hours.
tmax
Absorption After administration of single, oral doses up to 800 mg in healthy subjects, the peak plasma alogliptin concentration (median T max ) occurred one to two hours after dosing.
bioavailability
100% %; The absolute bioavailability of alogliptin tablets is approximately 100%.
metabolism
Metabolism Alogliptin does not undergo extensive metabolism and 60% to 71% of the dose is excreted as unchanged drug in the urine.
recorded 2026-08-30 · last checked 2026-09-04
Q6
Could one person measure Alogliptin's effect on glycosylated hemoglobin at week 26?
Glycosylated hemoglobin at week 26: measured in Alogliptin's trials.
glycosylated hemoglobin at week 26 is the recorded endpoint.
Show the evidence
biomarkers
glycosylated hemoglobin at week 26; 2026-09-01
treatment emergent adverse events; 2026-09-01
glycosylated hemoglobin; 2026-09-01
glycosylated hemoglobin at week 52; 2026-09-01
glycosylated hemoglobin at week 104; 2026-09-01
hba1c; 2026-09-01
14 more recorded rows
biomarkers
adverse events; 2026-09-01
biomarkers
beta cell function evaluated from 75 ogtt; 2026-09-01
biomarkers
frequency of cancers; 2026-09-01
biomarkers
reporting one or more adverse drug reactions; 2026-09-01
biomarkers
reporting one or more serious adverse drug reactions; 2026-09-01
biomarkers
who had one or more adverse events; 2026-09-01
biomarkers
glycohemoglobin from baseline; 2026-09-01
biomarkers
achieving hba1c 7 after 36 month treatment; 2026-09-01
biomarkers
adverse events and serious adverse events; 2026-09-01
biomarkers
hba1c at week 26; 2026-09-01
biomarkers
hemoglobin a1c; 2026-09-01
biomarkers
overall gastrointestinal tolerability; 2026-09-01
biomarkers
serious adverse events; 2026-09-01
biomarkers
serious adverse drug reactions; 2026-09-01
half life
2026-09-04; halfLife; hours; 21 hours; 2026-08-30
human trials at or under30
4
smallest human trial
0; NCT03042325; PHASE4; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q7
Which of achieving hba1c 7 after 36 month treatment, adverse events and adverse events and serious adverse events did Alogliptin's trials measure?
achieving hba1c 7 after 36 month treatment, adverse events and adverse events and serious adverse events lead 26 outcome terms across Alogliptin's trials. ClinicalTrials.gov · 2026-09-01
glycosylated hemoglobin at week 52, glycosylated hemoglobin at week 104, hba1c, adverse events, beta cell function evaluated from 75 ogtt and frequency of cancers follow.
Show the evidence
glycosylated hemoglobin at week 26
1
treatment emergent adverse events
1
glycosylated hemoglobin
1
glycosylated hemoglobin at week 52
1
glycosylated hemoglobin at week 104
1
hba1c
1
14 more recorded rows
adverse events
1
beta cell function evaluated from 75 ogtt
1
frequency of cancers
1
reporting one or more adverse drug reactions
1
reporting one or more serious adverse drug reactions
1
who had one or more adverse events
1
glycohemoglobin from baseline
1
achieving hba1c 7 after 36 month treatment
1
adverse events and serious adverse events
1
hba1c at week 26
1
hemoglobin a1c
1
overall gastrointestinal tolerability
1
serious adverse events
1
serious adverse drug reactions
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Alogliptin's 2 ongoing trials reports first?
"Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study"; n 781430; "MACE"; 2027-09-30
NCT07093476
"Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin"; n 171; "HbA1c"; 2027-04
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which 11 trials of Alogliptin posted no result?
Posted no result
11 of 11 completed trials
Registrations
NCT01242228, NCT01521962, NCT01632007, NCT02683226, NCT02508168 and NCT02231021, and 5 more
Completion dates
oldest 2012-06-06; newest 2024-01-16
Show the evidence
Trial
NCT01242228
2012-06-06
NCT01521962
2013-03
NCT01632007
2013-07-01
NCT02683226
2015-07
NCT02508168
2016-04
NCT02231021
2019-01-28
5 further recorded trials
NCT03794336
2020-12-14
NCT05782192
2022-03-25
NCT05363384
2022-07-12
NCT05363592
2022-07-25
NCT03499704
2024-01-16
Q10
At the median, Alogliptin's trials enrolled 337.5 people — anything larger?
Median enrolment
337.5
Largest enrolment
781430
Registered trials counted
60
Q11
What do 289 spontaneous reports say about Alogliptin — 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.
Alogliptin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 289 reaction mentions were counted: pemphigoid 62; pancreatitis 34; hypoglycaemia 33; interstitial lung disease 33. open-targets-adr · CHEMBL227529 · 2026-06-24
Show the evidence
pemphigoid
62
pancreatitis
34
hypoglycaemia
33
interstitial lung disease
33
pancreatitis acute
33
rhabdomyolysis
24
4 more recorded rows
blood glucose increased
21
cerebral infarction
20
hepatic function abnormal
15
lactic acidosis
14
recorded 2026-06-24 · last checked 2026-09-04
Q12
Alogliptin and CYP2D6, CYP3A4 and CYP1A2: shared by which compounds?
CYP2D6, CYP3A4 and CYP1A2 appear in Alogliptin's recorded interaction sentences, 9 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2pharmacokinetics
Effect of Other Drugs on the Pharmacokinetic Exposure of Alogliptin In Vitro Studies Effect of Alogliptin on CYP Enzymes Alogliptin is neither an inducer of CYP1A2, CYP2B6, CYP2C9, CYP2C19 and CYP3A4, nor an inhibitor of CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP3A4 and CYP2D6 at clinically relevant concentrations.
CYP2B6pharmacokinetics
Effect of Other Drugs on the Pharmacokinetic Exposure of Alogliptin In Vitro Studies Effect of Alogliptin on CYP Enzymes Alogliptin is neither an inducer of CYP1A2, CYP2B6, CYP2C9, CYP2C19 and CYP3A4, nor an inhibitor of CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP3A4 and CYP2D6 at clinically relevant concentrations.
CYP2C19pharmacokinetics
Effect of Other Drugs on the Pharmacokinetic Exposure of Alogliptin In Vitro Studies Effect of Alogliptin on CYP Enzymes Alogliptin is neither an inducer of CYP1A2, CYP2B6, CYP2C9, CYP2C19 and CYP3A4, nor an inhibitor of CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP3A4 and CYP2D6 at clinically relevant concentrations.
CYP2C8pharmacokinetics
Effect of Other Drugs on the Pharmacokinetic Exposure of Alogliptin In Vitro Studies Effect of Alogliptin on CYP Enzymes Alogliptin is neither an inducer of CYP1A2, CYP2B6, CYP2C9, CYP2C19 and CYP3A4, nor an inhibitor of CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP3A4 and CYP2D6 at clinically relevant concentrations.
CYP2C9pharmacokinetics
Effect of Other Drugs on the Pharmacokinetic Exposure of Alogliptin In Vitro Studies Effect of Alogliptin on CYP Enzymes Alogliptin is neither an inducer of CYP1A2, CYP2B6, CYP2C9, CYP2C19 and CYP3A4, nor an inhibitor of CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP3A4 and CYP2D6 at clinically relevant concentrations.
CYP2D6
pharmacokinetics
In vitro data indicate that CYP2D6 and CYP3A4 contribute to the limited metabolism of alogliptin.
pharmacokinetics
Effect of Other Drugs on the Pharmacokinetic Exposure of Alogliptin In Vitro Studies Effect of Alogliptin on CYP Enzymes Alogliptin is neither an inducer of CYP1A2, CYP2B6, CYP2C9, CYP2C19 and CYP3A4, nor an inhibitor of CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP3A4 and CYP2D6 at clinically relevant concentrations.
CYP3A4
pharmacokinetics
In vitro data indicate that CYP2D6 and CYP3A4 contribute to the limited metabolism of alogliptin.
pharmacokinetics
Effect of Other Drugs on the Pharmacokinetic Exposure of Alogliptin In Vitro Studies Effect of Alogliptin on CYP Enzymes Alogliptin is neither an inducer of CYP1A2, CYP2B6, CYP2C9, CYP2C19 and CYP3A4, nor an inhibitor of CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP3A4 and CYP2D6 at clinically relevant concentrations.
recorded 2026-08-30 · last checked 2026-09-04
Q13
Was Alogliptin studied with fasting and exercise?
fasting and exercise are named in Alogliptin's label sentences: "Compared with placebo, alogliptin treatment led to a greater decrease in fasting plasma glucose (FPG) and a higher percentage of subjects who achieved HbA1c targets of ≤ 6.5% and ≤ 7.0%." openfda-label+europepmc · 2026-08-30
2 recorded statements; fasting, exercise
Show the evidence
fasting
Compared with placebo, alogliptin treatment led to a greater decrease in fasting plasma glucose (FPG) and a higher percentage of subjects who achieved HbA1c targets of ≤ 6.5% and ≤ 7.0%.
exercise
A phase IV, multicentre, randomized, double-blind, parallel-group, comparative study was conducted in Japanese subjects with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control, despite treatment with alogliptin in addition to diet and/or exercise therapy.
recorded 2026-08-30 · last checked 2026-09-04
Q14
What is recorded about Alogliptin and mTOR?
"These results demonstrate that alogliptin ameliorates inflammation and OS and consequently modulates the AMPK/mTOR axis along with targeting autophagy and apoptosis, leading to the alleviation of DN." — where Alogliptin and mTOR appear together. Europe PMC · pathway abstract search · 2024-12-09
"These results demonstrate that alogliptin ameliorates inflammation and OS and consequently modulates the AMPK/mTOR axis along with targeting autophagy and apoptosis, leading to the alleviation of DN."
AMPKPMID 39662777
"These results demonstrate that alogliptin ameliorates inflammation and OS and consequently modulates the AMPK/mTOR axis along with targeting autophagy and apoptosis, leading to the alleviation of DN."
autophagyPMID 39662777
"These results demonstrate that alogliptin ameliorates inflammation and OS and consequently modulates the AMPK/mTOR axis along with targeting autophagy and apoptosis, leading to the alleviation of DN."
mTORPMID 34357376
"Simultaneously, treatment with liraglutide or alogliptin significantly increased GLP-1 receptor expression and adenosine monophosphate-activated protein kinase (AMPK) phosphorylation and downregulated the phosphorylation of mammalian target of rapamycin (mTOR), p70 ribosomal S6 protein kinase, and eukaryotic translation initiation factor 4E binding protein 1 in spontaneous hypertension rats."
AMPKPMID 34357376
"Simultaneously, treatment with liraglutide or alogliptin significantly increased GLP-1 receptor expression and adenosine monophosphate-activated protein kinase (AMPK) phosphorylation and downregulated the phosphorylation of mammalian target of rapamycin (mTOR), p70 ribosomal S6 protein kinase, and eukaryotic translation initiation factor 4E binding protein 1 in spontaneous hypertension rats."
mTORPMID 34357376
"In summary, our study suggests that liraglutide or alogliptin protects the heart against cardiac hypertrophy by regulating the expression of AngII/AT1R/ACE2 and activating the AMPK/mTOR pathway, and GLP-1 agonist can be used in the treatment of patients with cardiac hypertrophy."
1 more recorded row
AMPKPMID 34357376
"In summary, our study suggests that liraglutide or alogliptin protects the heart against cardiac hypertrophy by regulating the expression of AngII/AT1R/ACE2 and activating the AMPK/mTOR pathway, and GLP-1 agonist can be used in the treatment of patients with cardiac hypertrophy."
autophagy
PMID 30447331
"Autophagy in PVAT was decreased in obese mice and alogliptin intervention activated autophagy."
PMID 30447331
"Further, addition of glucagon-like peptide-1 (GLP-1) but not alogliptin alone activated autophagy."
sirtuinPMID 32905193
"Accordingly, the current study aimed to investigate the potential therapeutic benefit of alogliptin (Alo), a DPP-IV inhibitor, against CP-induced hepatotoxicity through enhancing PI3K/Akt/SIRT1 pathway."
recorded 2024-12-09 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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