This page shows what was measured, who it was measured in, and what that does not settle.
What Saxagliptin Anhydrous does in the body
The pancreas makes more insulin after meals and less glucagon, and the liver stops pushing out extra sugar.
Eating triggers the gut to release hormones that tell the pancreas to release insulin — but only while blood sugar is actually high, which is why they do not cause hypoglycaemia. An enzyme circulating in the blood chews those hormones up within a couple of minutes. Saxagliptin plugs that enzyme, so the hormones survive longer and their signal is stronger.
Why people take it. Type 2 diabetes — a tablet that makes the gut hormone signal last longer
What happened in people
A hazard ratio of 1.00 (95% CI 0.89 to 1.12) for cardiovascular death, myocardial infarction or ischaemic stroke in 16,492 randomised patients over a median 2.1 years
✎ 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.
SAVOR-TIMI 53: Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications (NCT01107886) · a recorded source, not a stored snapshot
FDA prescribing information for saxagliptin tablets — sections 5.1 Pancreatitis, 5.2 Heart Failure, 5.4 Hypersensitivity-Related Events, 5.5 Arthralgia, 5.6 … · a recorded source, not a stored snapshot
The limit that matters most
That lowering HbA1c with saxagliptin reduces cardiovascular risk — the trial that tested it returned a hazard ratio of exactly 1.00, and its authors wrote that other approaches are necessary
Where it acts
Plasma and the endothelial surface, where DPP-4 circulates and is membrane-anchored; the downstream effect is on pancreatic alpha and beta cells
Kind of result
Living longer, or avoiding a major event
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 · 9GB927LAJW · read 2026-08-29
Its recorded molecular formula is C18H25N3O2•H2O, weighing 333.43.
US prescribing information · e286ffd4-c598-47fb-af06-2e15f7e6f99f · 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 122 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 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Blood sugar
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
△Only a number moved11 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
24 hour mean weighted glucose at week 4; changes in hba1c from baseline; hba1c at week 24; hba1c from baseline to week 16; hba1c; oral glucose tolerance test; glucose metabolism; postprandial glucose
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
11 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 cardiovascular death, myocardial infarction or ischaemic stroke, in patients with type 2 diabetes with a history of or at risk for cardiovascular events
✓ The study showed what it set out to show
Who was studied
SAVOR-TIMI 53 (NCT01107886)
How many people
16492
Study design
Randomised double-blind placebo-controlled cardiovascular outcome trial, median 2.1 years
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
Hazard ratio 1.00 (95% CI 0.89 to 1.12); P = 0.99 for superiority, P < 0.001 for non-inferiority. On-treatment analysis 1.03 (95% CI 0.91 to 1.17)
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. Hospitalisation for heart failure was higher on saxagliptin — 3.5% against 2.8%, hazard ratio 1.27 (95% CI 1.07 to 1.51, P = 0.007) — a finding now carried in a numbered warnings section of the label. Definite acute pancreatitis was confirmed in 17 of 8,240 against 9 of 8,173.
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 2.5 mg and 5 mg strengths
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
SAVOR-TIMI 53: Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications (NCT01107886) · a recorded source, not a stored snapshot
FDA prescribing information for saxagliptin tablets — sections 5.1 Pancreatitis, 5.2 Heart Failure, 5.4 Hypersensitivity-Related Events, 5.5 Arthralgia, 5.6 … · a recorded source, not a stored snapshot
openFDA Drugs@FDA — NDA 022350 (ONGLYZA, AstraZeneca AB, original approval 31 July 2009) (https://api.fda.gov/drug/drugsfda.json?search=products.brand_name:%… · a recorded source, not a stored snapshot
What we know
RNAWiki holds 1 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.21 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
Saxagliptin Anhydrous
What a person takes: Oral tablet, once daily, in 2.5 mg and 5 mg strengths.
The measurement behind this step
A conventional immediate-release tablet. Exposure to both saxagliptin and its active 5-hydroxy metabolite rises proportionally from 2.5 to 400 mg, variability is under 25%, and neither accumulates on repeated once-daily dosing. Both are renally eliminated, so the strength appropriate to a given level of kidney function is a prescribing decision this page does not enter into.
Getting in
A meal makes the gut release two short-lived hormones
When food reaches the small intestine, cells there release hormones into the blood that prime the pancreas for the glucose about to arrive.
╌╌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 is released from intestinal L cells and GIP from K cells in response to nutrient arrival. The label states these hormones cause insulin release from pancreatic beta cells in a glucose-dependent manner. In type 2 diabetes GLP-1 concentrations are reduced while the insulin response to GLP-1 is preserved.
SAVOR-TIMI 53: Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications (NCT01107886) · a recorded source, not a stored snapshot
FDA prescribing information for saxagliptin tablets — sections 5.1 Pancreatitis, 5.2 Heart Failure, 5.4 Hypersensitivity-Related Events, 5.5 Arthralgia, 5.6 … · a recorded source, not a stored snapshot
Reaching the cell
An enzyme in the blood destroys them within minutes
A protein-cutting enzyme circulating in blood and anchored on blood vessel surfaces clips the ends off both hormones and switches them off almost immediately.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Dipeptidyl peptidase-4 removes the N-terminal dipeptide from GLP-1 and GIP, inactivating them within minutes of release. The half-life of intact active GLP-1 in plasma is of the order of a couple of minutes, which is what makes the enzyme, rather than the hormone, the practical drug target.
SAVOR-TIMI 53: Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications (NCT01107886) · a recorded source, not a stored snapshot
FDA prescribing information for saxagliptin tablets — sections 5.1 Pancreatitis, 5.2 Heart Failure, 5.4 Hypersensitivity-Related Events, 5.5 Arthralgia, 5.6 … · a recorded source, not a stored snapshot
What it acts on
Saxagliptin sits in the enzyme active site and blocks the cut
The drug is shaped like the end of the hormone the enzyme normally grabs, so the enzyme grabs the drug instead — and this time nothing gets cut.
╌╌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 cyanopyrrolidine nitrile forms a slowly reversible covalent adduct with the catalytic serine of DPP-4, giving competitive inhibition with a long residence time. Selectivity over the closely related DPP-8 and DPP-9 enzymes is a design requirement of the class, not an incidental property.
SAVOR-TIMI 53: Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications (NCT01107886) · a recorded source, not a stored snapshot
FDA prescribing information for saxagliptin tablets — sections 5.1 Pancreatitis, 5.2 Heart Failure, 5.4 Hypersensitivity-Related Events, 5.5 Arthralgia, 5.6 … · a recorded source, not a stored snapshot
The change it makes
The hormone signal lasts longer, and only while sugar is high
With the enzyme blocked, the gut hormones survive longer and their message to the pancreas is louder. Crucially, the message itself only works when blood sugar is elevated.
╌╌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 saxagliptin reduces fasting and post-prandial glucose "in a glucose-dependent manner". That dependence is the reason a DPP-4 inhibitor alone does not cause hypoglycaemia, and it is also the reason the effect size is modest compared with drugs that force insulin release unconditionally.
SAVOR-TIMI 53: Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications (NCT01107886) · a recorded source, not a stored snapshot
FDA prescribing information for saxagliptin tablets — sections 5.1 Pancreatitis, 5.2 Heart Failure, 5.4 Hypersensitivity-Related Events, 5.5 Arthralgia, 5.6 … · a recorded source, not a stored snapshot
What that does for a person
Insulin rises after meals and glucagon falls
Two things happen at once: the pancreas releases more insulin after eating, and it releases less of the hormone that tells the liver to make sugar.
╌╌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 raises glucose-dependent insulin secretion from beta cells and lowers glucagon secretion from alpha cells, reducing hepatic glucose production. Both arms contribute to the fall in fasting and post-prandial glucose that the label describes.
SAVOR-TIMI 53: Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications (NCT01107886) · a recorded source, not a stored snapshot
FDA prescribing information for saxagliptin tablets — sections 5.1 Pancreatitis, 5.2 Heart Failure, 5.4 Hypersensitivity-Related Events, 5.5 Arthralgia, 5.6 … · a recorded source, not a stored snapshot
What that does for a person
HbA1c falls, ischaemic events do not, and heart failure admissions rise
Average blood sugar comes down. Heart attacks and strokes stay exactly where they were. Admissions to hospital for heart failure went up by about a quarter in the trial that looked.
╌╌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 SAVOR-TIMI 53, the primary composite hazard ratio was 1.00 (95% CI 0.89 to 1.12) and hospitalisation for heart failure 1.27 (95% CI 1.07 to 1.51, p=0.007). The mechanism of the heart-failure signal is unresolved; DPP-4 has substrates beyond the incretins, including stromal cell-derived factor-1 and brain natriuretic peptide, which is a hypothesis rather than a demonstrated cause.
SAVOR-TIMI 53: Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications (NCT01107886) · a recorded source, not a stored snapshot
FDA prescribing information for saxagliptin tablets — sections 5.1 Pancreatitis, 5.2 Heart Failure, 5.4 Hypersensitivity-Related Events, 5.5 Arthralgia, 5.6 … · 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.
hemoglobin a1c changes from baseline at week 24
hemoglobin a1c at week 24
hemoglobin a1 at week 24
hemoglobin a1c change from baseline to week 52
hemoglobin a1c change from baseline to week 18
24 hour mean weighted glucose at week 4
changes in hba1c from baseline
hba1c at week 24
hba1c from baseline to week 16
hba1c
and 11 more.
Meaningful
Things that change how a life goes, not only a number.
No registered study measured anything of this kind.
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (19)
a1c changes from baseline at week 24 open label cohort
metformin pk parameter auc
metformin pk parameter cmax
metformin pk parameter t half
metformin pk parameter tmax
metformin mean cmax
metformin mean auc
metformin t half and t max
metformin auc
metformin cmax
arterial stiffness
endothelial function
adverse events occurrence
inhibition of dipeptidyl peptidase iv activity at trough
increase of regulatory foxp3+ t cells
oral disposition index
monocyte nfkb levels as detected by western blotting
dapagliflozin auc from time 0 extrapolated to infinite time
cell function
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Adults with type 2 diabetes, usually added to metformin, and particularly where hypoglycaemia is the constraint. It is now generic.
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 saxagliptin as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus have not been established. in pediatric patients..”
US prescribing information · e286ffd4-c598-47fb-af06-2e15f7e6f99f · read 2026-08-30
On older people, the label states: “In the seven, double-blind, controlled clinical safety and efficacy trials of saxagliptin, a total of 4751 (42%) of the 11301 patients randomized to saxagliptin were 65 years and over, and 1210 (10.7%) were 75 years and over.”
US prescribing information · e286ffd4-c598-47fb-af06-2e15f7e6f99f · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Limited data with saxagliptin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriages.”
US prescribing information · e286ffd4-c598-47fb-af06-2e15f7e6f99f · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of saxagliptin in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · e286ffd4-c598-47fb-af06-2e15f7e6f99f · read 2026-08-30
On people with reduced kidney function, the label states: “In a 12-week randomized placebo-controlled trial, saxagliptin 2.5 mg was administered orally to 85 patients with moderate (n=48) or severe (n=18) renal impairment or end-stage renal disease (ESRD) (n=19) [ see Clinical Studies (14) ].”
US prescribing information · e286ffd4-c598-47fb-af06-2e15f7e6f99f · read 2026-08-30
Where the result stopped carrying
Saxagliptin was the first modern diabetes drug whose mandatory cardiovascular outcome trial found a harm its registration programme had missed, and the label now carries a numbered heart-failure warning as a result
Superiority on the primary endpoint was not merely unmet — the point estimate was 1.00, with the confidence interval symmetric about no effect
Severe disabling arthralgia and bullous pemphigoid requiring hospitalisation were both added to the label from postmarketing reports after approval
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 2.5 mg and 5 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. 5 to 400 mg, variability is under 25%, and neither accumulates on repeated once-daily dosing. Both are renally eliminated, so the strength appropriate to a given level of kidney function is a prescribing decision this page does not enter into.
✎ 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
Saxagliptin alone does not cause hypoglycaemia, because the incretin signal it prolongs is itself glucose-dependent; combined with insulin or an insulin secretagogue the risk rises. Section 5.2 of the label carries the SAVOR heart-failure finding with its trial counts and asks prescribers to weigh risks and benefits in patients at higher risk, to monitor, and to consider discontinuation if heart failure develops. Postmarketing reports underlie warnings for acute pancreatitis, serious hypersensitivity including anaphylaxis and angioedema, severe and disabling arthralgia, and bullous pemphigoid requiring hospitalisation. It is not recommended in type 1 diabetes or diabetic ketoacidosis.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
SAVOR-TIMI 53: Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications (NCT01107886) · a recorded source, not a stored snapshot
FDA prescribing information for saxagliptin tablets — sections 5.1 Pancreatitis, 5.2 Heart Failure, 5.4 Hypersensitivity-Related Events, 5.5 Arthralgia, 5.6 … · 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.
Saxagliptin Anhydrous appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 417 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, once daily, in 2.5 mg and 5 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 to 400 mg, variability is under 25%, and neither accumulates on repeated once-daily dosing. Both are renally eliminated, so the strength appropriate to a given level of kidney function is a prescribing decision this page does not enter into.
✎ 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
25 products list this as an active ingredient in the United States drug directory. 18 of them contain it and nothing else.
FDA National Drug Code directory · 72205-438 · read 2026-08-29
They are sold as powder, tablet, film coated and tablet, film coated, extended release, taken oral.
FDA National Drug Code directory · 72205-438 · read 2026-08-29
The regulator's established pharmacologic class for it is dipeptidyl peptidase 4 inhibitor [epc] and dipeptidyl peptidase 4 inhibitors [moa].
FDA National Drug Code directory · 72205-438 · read 2026-08-29
6 published labels name it as an active ingredient. 3 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · cbf8677c-cafe-48bc-8844-0cc6547886bd · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · cbf8677c-cafe-48bc-8844-0cc6547886bd · read 2026-08-29
SAXAGLIPTIN is oral at 3 DOSAGE FORMS AND STRENGTHS • 2.5 mg: pale yellow to yellow, biconvex, round, film-coated tablets with “G74” printed on one side, in blue ink. • 5 mg: pink, biconvex, round, film-coated tablets with “G75” printed on on…, recorded as fda label in effect 2026-01-27 in the United States.
US prescribing information · e286ffd4-c598-47fb-af06-2e15f7e6f99f · read 2026-08-30
Recorded price in US: 1.04947–1.14048 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 12 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 Saxagliptin Anhydrous 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 lowering HbA1c with saxagliptin reduces cardiovascular risk — the trial that tested it returned a hazard ratio of exactly 1.00, and its authors wrote that other approaches are necessary
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 absence of hypoglycaemia makes the class clinically safer overall — the outcome trial found an excess of heart-failure hospitalisation instead
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 signal is explained by a known mechanism — DPP-4 has substrates beyond the incretins, and no causal pathway has been demonstrated
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 pancreatitis question is resolved — 26 adjudicated events across 16,413 patients cannot exclude a modest effect, and the label carries a warning built on postmarketing reports
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 Saxagliptin Anhydrous 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.
SAVOR-TIMI 53 found 27% more hospitalisations for heart failure
In plain words
The trial required to prove saxagliptin did not cause harm found harm — not the harm it was looking for. Heart attacks and strokes were unchanged. Admissions to hospital for heart failure rose from 2.8% to 3.5%, and the finding is now printed on the label.
What was measured
Hazard ratio and absolute rates of hospitalisation for heart failure over a median 2.1 years in 16,492 randomised patients
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
SAVOR-TIMI 53 randomised 16,492 patients with type 2 diabetes who had a history of, or were at risk for, cardiovascular events to saxagliptin or placebo, with physicians free to adjust other therapy, and followed them a median 2.1 years. More patients on saxagliptin were hospitalised for heart failure: 3.5% against 2.8%, hazard ratio 1.27 (95% CI 1.07 to 1.51, p=0.007). The FDA label reproduces the counts — 289 of 8,280 against 228 of 8,212 — and adds that patients with prior heart failure and those with renal impairment were at higher risk irrespective of treatment assignment. Section 5.2 of the label instructs prescribers to consider the risks and benefits before initiating in patients at higher risk of heart failure, to observe for signs and symptoms during therapy, to advise patients of the characteristic symptoms and to report them immediately, and to consider discontinuation if heart failure develops.
Written into the record, not signed off as a reviewed claim
On the endpoint it was built to test, the result was exactly nothing
In plain words
The primary endpoint was cardiovascular death, heart attack or ischaemic stroke. It happened to 7.3% of the saxagliptin group and 7.2% of the placebo group. The hazard ratio was 1.00.
What was measured
Hazard ratios for the primary composite of cardiovascular death, myocardial infarction or ischaemic stroke, and for the major secondary composite, in 16,492 patients
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
A primary endpoint event occurred in 613 patients on saxagliptin and 609 on placebo — 7.3% and 7.2% by two-year Kaplan-Meier estimate — hazard ratio 1.00 (95% CI 0.89 to 1.12), p=0.99 for superiority and p<0.001 for non-inferiority. The on-treatment analysis agreed at 1.03 (95% CI 0.91 to 1.17). The major secondary endpoint, a broader composite adding hospitalisation for unstable angina, coronary revascularisation and heart failure, occurred in 1,059 against 1,034 patients — 12.8% and 12.4% — hazard ratio 1.02 (95% CI 0.94 to 1.11, p=0.66). The trial authors concluded that DPP-4 inhibition with saxagliptin did not increase or decrease the rate of ischaemic events, and that "although saxagliptin improves glycemic control, other approaches are necessary to reduce cardiovascular risk in patients with diabetes."
Written into the record, not signed off as a reviewed claim
This is the trial that justified making outcome trials compulsory
In plain words
After rosiglitazone, the FDA started requiring every new diabetes drug to prove it did not increase cardiovascular risk. Saxagliptin was among the first drugs put through that requirement, and it was the first whose trial found a problem the licensing programme had missed entirely.
What was measured
The heart-failure hazard ratio detectable only at 16,492 patients and a median 2.1 years, against a registration programme powered on HbA1c
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The DPP-4 inhibitors were licensed on HbA1c in phase 3 programmes that were not designed or powered to detect a difference in heart-failure hospitalisation. The signal in SAVOR-TIMI 53 emerged only because 16,492 patients were followed with adjudicated endpoints over a median 2.1 years — roughly two orders of magnitude more patient-years than a registration programme provides. The consequence was a labelling change rather than a withdrawal: the current United States label devotes a numbered warnings section to heart failure and reproduces the trial counts. The same class effect discussion appears on the alogliptin label. What changed was not the drug but what is known about it, and the mechanism by which that knowledge arrived was a regulatory requirement introduced because of a different drug entirely.
Written into the record, not signed off as a reviewed claim
Acute pancreatitis was numerically higher and not statistically distinguishable
In plain words
Pancreatitis was the safety worry that dominated discussion of this class before the trial. In 16,413 patients it occurred in 17 on saxagliptin and 9 on placebo — 0.2% against 0.1%.
What was measured
Confirmed definite acute pancreatitis counts and rates by arm in the cardiovascular outcome trial, with pre-existing risk factor prevalence
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The FDA label reports that in SAVOR, definite acute pancreatitis was confirmed in 17 of 8,240 patients receiving saxagliptin (0.2%) against 9 of 8,173 receiving placebo (0.1%). Pre-existing risk factors for pancreatitis were identified in 15 of the 17 saxagliptin cases (88%) and in all 9 placebo cases. The published trial reports rates of adjudicated acute pancreatitis as similar between groups at 0.3% and 0.2%, and chronic pancreatitis at below 0.1% and 0.1%. The label nonetheless carries a numbered pancreatitis warning on the strength of postmarketing reports, instructing prompt discontinuation if pancreatitis is suspected. Twenty-six events across sixteen thousand patients is a small enough number that the confidence interval around any ratio would be wide, and the label does not present one.
Written into the record, not signed off as a reviewed claim
Two class harms were only discovered after approval
In plain words
Severe disabling joint pain and a blistering skin disease serious enough to require hospital admission were both added to the labels of this drug class from postmarketing reports, not from the trials that licensed them.
What was measured
Postmarketing-derived warnings for arthralgia, bullous pemphigoid and serious hypersensitivity added to the label after approval
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The current saxagliptin label carries two warnings derived entirely from postmarketing surveillance. Section 5.5 states that severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors, and instructs prescribers to consider the drug as a possible cause of severe joint pain and to discontinue if appropriate. Section 5.6 states that there have been postmarketing reports of bullous pemphigoid requiring hospitalisation in patients taking DPP-4 inhibitors, instructs that patients be told to report blisters or erosions, and requires discontinuation if bullous pemphigoid is suspected. Section 5.4 records postmarketing reports of serious hypersensitivity reactions including anaphylaxis, angioedema and exfoliative skin conditions. None of these appeared in the registration programme; all are class findings that accumulated after tens of millions of patient-exposures.
Source
FDA prescribing information for saxagliptin tablets, sections 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
The active metabolite carries three times the exposure of the parent drug
In plain words
The liver converts saxagliptin into a second compound that also blocks the enzyme, and there is about three times as much of it in the blood. Both are cleared by the kidney, so kidney function changes total active drug more than a parent-drug measurement suggests.
What was measured
That saxagliptin plasma concentration describes the drug exposure — the active 5-hydroxy metabolite carries roughly three times the area under the curve, and both depend on renal clearance
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The label reports that after a single 5 mg oral dose in healthy subjects, mean plasma area under the curve was 78 ng·h/mL for saxagliptin and 214 ng·h/mL for the active metabolite 5-hydroxysaxagliptin, with peak concentrations of 24 and 47 ng/mL respectively. Exposure to both increases proportionally from 2.5 to 400 mg, variability is under 25%, and neither accumulates on repeated once-daily dosing. Formation of the metabolite is by CYP3A4 and CYP3A5, so strong inhibitors of those enzymes shift the parent-to-metabolite ratio. Both species are renally eliminated. A page describing this drug purely in terms of the parent compound is describing a quarter of the circulating active material.
Source
FDA prescribing information for saxagliptin tablets, section 12.3 Pharmacokinetics
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
3 documents were read for this substance.
RNAWiki source record
3 of them state the same tMax, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
9GB927LAJW
CAS registry number
945667-22-1
PubChem compound
53297473
ChEMBL
CHEMBL385517
ChEBI
71271
RxNorm concept
857974
EMA substance identifier
100000170516
DrugBank
DB06335
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
16 approved applications cover products containing this substance. The earliest was NDA022350, approved 20090731 to ASTRAZENECA AB.
This order is fixed in code and does not count clicks or time on the page.
What is not here
4 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A competitive inhibitor of the enzyme that destroys the gut hormones GLP-1 and GIP, which lowers blood sugar without causing hypoglycaemia on its own — and which, in a 16,492-patient randomised trial, changed the rate of cardiovascular death, heart attack and ischaemic stroke by nothing at all (hazard ratio 1.00) while raising hospitalisation for heart failure by 27% (hazard ratio 1.27, 95% CI 1.07 to 1.51, p=0.007), a finding now written into its label.
Recorded evidence blocks (13)
Q1
What did Saxagliptin Anhydrous's largest trial (1499650 people) and its longest (13 years) measure?
1499650 people in Saxagliptin Anhydrous's largest registered study, 13 years in its longest registered window, measuring Relative hazard of composite outcome of Stroke, MI, and Mortality. ClinicalTrials.gov · 2026-09-01
39 phase3, 35 phase4, 19 phase1, 9 na or unstated, 7 phase2, 6 na, 1 early phase1; NCT02969798; 2027-07; no ageing endpoint recorded. Last human test completed 2024, NCT03199053.
Interpretation These counts include studies where Saxagliptin Anhydrous 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
39
phase4
35
phase1
19
na or unstated
9
phase2
7
na
6
2 more recorded rows
early phase1
1
Last recorded human testNCT03199053
2024-01-03
recorded 2026-09-01 · last checked 2026-09-04
Q2
From mouse to human: where has Saxagliptin Anhydrous shown lifespan?
Could one person measure Saxagliptin Anhydrous's effect on hemoglobin a1c changes from baseline at week 24?
Hemoglobin a1c changes from baseline at week 24: measured in Saxagliptin Anhydrous's trials.
hemoglobin a1c changes from baseline at week 24 is the recorded endpoint.
Show the evidence
biomarkers
hemoglobin a1c changes from baseline at week 24; 2026-09-01
a1c changes from baseline at week 24 open label cohort; 2026-09-01
hemoglobin a1c at week 24; 2026-09-01
hemoglobin a1 at week 24; 2026-09-01
hemoglobin a1c change from baseline to week 52; 2026-09-01
hemoglobin a1c change from baseline to week 18; 2026-09-01
14 more recorded rows
biomarkers
24 hour mean weighted glucose at week 4; 2026-09-01
biomarkers
changes in hba1c from baseline; 2026-09-01
biomarkers
metformin pk parameter auc; 2026-09-01
biomarkers
metformin pk parameter cmax; 2026-09-01
biomarkers
metformin pk parameter t half; 2026-09-01
biomarkers
metformin pk parameter tmax; 2026-09-01
biomarkers
metformin mean cmax; 2026-09-01
biomarkers
metformin mean auc; 2026-09-01
biomarkers
metformin t half and t max; 2026-09-01
biomarkers
hba1c at week 24; 2026-09-01
biomarkers
metformin auc; 2026-09-01
biomarkers
metformin cmax; 2026-09-01
biomarkers
hba1c from baseline to week 16; 2026-09-01
biomarkers
hba1c; 2026-09-01
half life
2026-09-04; halfLife; 2026-01-27
human trials at or under30
31
smallest human trial
0; NCT01305551; PHASE1; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q6
Which of 24 hour mean weighted glucose at week 4, a1c changes from baseline at week 24 open label cohort and adverse events occurrence did Saxagliptin Anhydrous's trials measure?
24 hour mean weighted glucose at week 4, a1c changes from baseline at week 24 open label cohort and adverse events occurrence lead 40 outcome terms across Saxagliptin Anhydrous's trials. ClinicalTrials.gov · 2026-09-01
hemoglobin a1 at week 24, hemoglobin a1c change from baseline to week 52, hemoglobin a1c change from baseline to week 18, 24 hour mean weighted glucose at week 4, changes in hba1c from baseline and metformin pk parameter auc follow.
Show the evidence
hemoglobin a1c changes from baseline at week 24
1
a1c changes from baseline at week 24 open label cohort
1
hemoglobin a1c at week 24
1
hemoglobin a1 at week 24
1
hemoglobin a1c change from baseline to week 52
1
hemoglobin a1c change from baseline to week 18
1
14 more recorded rows
24 hour mean weighted glucose at week 4
1
changes in hba1c from baseline
1
metformin pk parameter auc
1
metformin pk parameter cmax
1
metformin pk parameter t half
1
metformin pk parameter tmax
1
metformin mean cmax
1
metformin mean auc
1
metformin t half and t max
1
hba1c at week 24
1
metformin auc
1
metformin cmax
1
hba1c from baseline to week 16
1
hba1c
1
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which of Saxagliptin Anhydrous's 2 ongoing trials reports first?
"Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)"; n 700; "Beta cell function"; 2027-07
NCT05220917
"Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study"; n 781430; "MACE"; 2027-09-30
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which 34 trials of Saxagliptin Anhydrous posted no result?
Posted no result
34 of 34 completed trials
Registrations
NCT00770302, NCT00935467, NCT00857558, NCT01441869, NCT01242228 and NCT01319357, and 28 more
Completion dates
oldest 2008-10; newest 2023-08-31
Show the evidence
Trial
NCT00770302
2008-10
NCT00935467
2009-08
NCT00857558
2010-05
NCT01441869
2011-12
NCT01242228
2012-06-06
NCT01319357
2013-04
14 further recorded trials
NCT01755494
2013-04
NCT01552018
2014-02
NCT01922817
2014-04
NCT02060201
2014-05
NCT01521312
2014-09
NCT01782261
2015-02
NCT02475499
2015-04
NCT02476760
2015-04
NCT02456428
2015-05
NCT01552005
2015-06
NCT02920801
2015-07
NCT01267448
2015-07-25
NCT02304081
2016-08
NCT02315495
2016-08-26
Q9
At the median, Saxagliptin Anhydrous's trials enrolled 103 people — anything larger?
Median enrolment
103
Largest enrolment
1499650
Registered trials counted
115
Q10
What do 417 spontaneous reports say about Saxagliptin Anhydrous — 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.
Saxagliptin Anhydrous appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 417 reaction mentions were counted: pancreatitis 104; blood glucose increased 65; hypoglycaemia 63; oedema peripheral 58. open-targets-adr · CHEMBL1201743 · 2026-06-24
Show the evidence
pancreatitis
104
blood glucose increased
65
hypoglycaemia
63
oedema peripheral
58
pancreatitis acute
38
cardiac failure
37
4 more recorded rows
pancreatic carcinoma
22
acute lymphocytic leukaemia
11
hypoglycaemic coma
11
pain
8
recorded 2026-06-24 · last checked 2026-09-04
Q11
Saxagliptin Anhydrous and CYP3A4, CYP1A2 and P-GLYCOPROTEIN: shared by which compounds?
CYP3A4, CYP1A2 and P-GLYCOPROTEIN appear in Saxagliptin Anhydrous's recorded interaction sentences, 4 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2pharmacokinetics
In in vitro studies, saxagliptin and its active metabolite did not inhibit CYP1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1, or 3A4, or induce CYP1A2, 2B6, 2C9, or 3A4.
CYP3A4
pharmacokinetics
Elimination Metabolism The metabolism of saxagliptin is primarily mediated by cytochrome P450 3A4/5 (CYP3A4/5).
pharmacokinetics
Therefore, strong CYP3A4/5 inhibitors and inducers will alter the pharmacokinetics of saxagliptin and its active metabolite [ see Drug Interactions (7.1) ].
pharmacokinetics
Drug Interaction Studies In Vitro Assessment of Drug Interactions The metabolism of saxagliptin is primarily mediated by CYP3A4/5.
recorded 2026-08-30 · last checked 2026-09-04
Q12
Was Saxagliptin Anhydrous studied with fasting and exercise?
fasting and exercise are named in Saxagliptin Anhydrous's label sentences: "ACCES (ACute and Chronic Effects of Saxagliptin) was a randomized, placebo-controlled, double-blind, controlled phase 2, pilot study aiming to examine in obese patients with impaired glucose tolerance (IGT) the acute effects and the effects after 12 weeks of treatment by saxagliptin on glucose…" openfda-label+europepmc · 2026-08-30
2 recorded statements; fasting, exercise
Show the evidence
fasting
ACCES (ACute and Chronic Effects of Saxagliptin) was a randomized, placebo-controlled, double-blind, controlled phase 2, pilot study aiming to examine in obese patients with impaired glucose tolerance (IGT) the acute effects and the effects after 12 weeks of treatment by saxagliptin on glucose levels at fasting and postprandially after a standard breakfast, and on glucose tolerance.
exercise
Participants were previously treated with once-daily dapagliflozin (5, 10 mg), saxagliptin (2.5, 5 mg), or placebo as an add-on to diet, exercise, metformin, and/or insulin for 52 weeks, plus a 52-week nontreatment follow-up period.
recorded 2026-08-30 · last checked 2026-09-04
Q13
What is recorded about Saxagliptin Anhydrous and mTOR?
"Saxagliptin may be a promising intervention against ethanol-evoked gastropathy by activating AMPK/mTOR-driven autophagy and inhibiting NLRP3 inflammasome." — where Saxagliptin Anhydrous and mTOR appear together. Europe PMC · pathway abstract search · 2026-01-19
"Saxagliptin may be a promising intervention against ethanol-evoked gastropathy by activating AMPK/mTOR-driven autophagy and inhibiting NLRP3 inflammasome."
AMPKPMID 34166711
"Saxagliptin may be a promising intervention against ethanol-evoked gastropathy by activating AMPK/mTOR-driven autophagy and inhibiting NLRP3 inflammasome."
autophagy
PMID 34166711
"Saxagliptin may be a promising intervention against ethanol-evoked gastropathy by activating AMPK/mTOR-driven autophagy and inhibiting NLRP3 inflammasome."
PMID 41565199
"DPP4 destabilized FTH1 via NCOA4-mediated ferritinophagy, proven by concordant rescue effects of chloroquine (autophagy inhibition) and saxagliptin (DPP4 inhibition) on FTH1 preservation."
AMPK
PMID 35258398
"Saxagliptin, an anti-diabetic agent with inhibitory effects against dipeptidyl peptidase 4 (DPP-4), has been recently reported to induce the activation of the AMPK pathway."
PMID 35258398
"The AMPK pathway in ODIM-cultured MC3T3-E1 cells was significantly activated by Saxagliptin, and the functions of Saxagliptin in promoting osteogenic differentiation were abolished by compound C, the inhibitor of the AMPK pathway."
recorded 2026-01-19 · last checked 2026-09-04
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