This page shows what was measured, who it was measured in, and what that does not settle.
What Insulin glulisine does in the body
Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production.
From the FDA-approved label: Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin glulisine. Insulins inhibit lipolysis and proteolysis and enhance protein synthesis.
Why people take it. Glycemic control
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as protein.
FDA substance registry · 7XIY785AZD · read 2026-08-29
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.
No statement of the main limit is recorded.
The four opening statements run to 62 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.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
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.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Blood sugar
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
△Only a number moved16 registered test measure.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Body weight
∅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 moved1 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.
Cholesterol
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Focus
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
…Waiting for a reviewer1 registered performance measure of this kind.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Blood sugar
hba1c; 24 hour blood glucose levels; insulin doses; total daily insulin dose; blood glucose concentration; average blood glucose over 6 days; insulin levels; fractional and total glucose infusion rates
Body weight
body weight/body mass index
Cholesterol
fasting blood lipid profile
Focus
cognitive performance
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
△ Only a number moved
16 registered test measure.
— Not recorded
Harms were not a registered measure for this goal.
… Waiting for a reviewer
Who was studied is listed further down the page.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) ≤ 56 mg/dL [3.1 mmol/L]
✗ The study did not show it
Who was studied
NCT01121835
How many people
934
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Change in HbA1c From Baseline to Week 26
✗ The study did not show it
Who was studied
NCT01768559
How many people
894
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
HbA1c
✗ The study did not show it
Who was studied
NCT00174642
How many people
811
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM
✗ The study did not show it
Who was studied
NCT02688933
How many people
638
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - Intent To Treat (ITT) Population Without Good Clinical Practices (GCP) Noncompliant Sites)
✗ The study did not show it
Who was studied
NCT00384085
How many people
588
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
To compare improvements from baseline in patient reported outcomes (quality of life, treatment satisfaction) when aggressively treated with insulin glargine plus rapid acting insulin glulisine vs treatment with Premix insulin
✗ The study did not show it
Who was studied
NCT00135941
How many people
582
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 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 dayEvidence recorded. Walking, dressing, breathing, recovering.1 registered measure of this kind.
■Measured performanceEvidence recorded. How much was lifted, how far was run, how fast.1 registered measure of this kind.
□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.27 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□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 would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
hba1c
24 hour blood glucose levels
insulin doses
body weight/body mass index
urine albumin
total daily insulin dose
changes of glycosilated haemoglobin
hemoglobin a1c from baseline to week 12
glycosylated haemoglobin value 7
achieving glycosylated hemoglobin a1c 7 0 at week 60
and 17 more.
Meaningful
Things that change how a life goes, not only a number.
cognitive performance
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 (12)
symptomatic hypoglycemia
severe hypoglycemia
self monitored bg values
fasting blood lipid profile
hypoglycemic episodes
adverse events
infarct size absolute change from baseline at day 60
glycaemic parameters assessment
optimal glycemic control in inpatient cirrhotics
nitrotyrosine
fasting intact proinsulin
postprandial glycemia
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.
APIDRA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. APIDRA is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 )
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 APIDRA to improve glycemic control have been established in pediatric patients.”
US prescribing information · e7af6a7a-8046-4fb4-9979-4ec4230b23aa · read 2026-08-30
On older people, the label states: “In clinical trials, APIDRA was administered to 147 patients ≥65 years of age and 27 patients ≥75 years of age.”
US prescribing information · e7af6a7a-8046-4fb4-9979-4ec4230b23aa · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Available pharmacovigilance data have not established an association with insulin glulisine use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes.”
US prescribing information · e7af6a7a-8046-4fb4-9979-4ec4230b23aa · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Available data from published literature suggest that human insulin products, including APIDRA, are transferred into human milk.”
US prescribing information · e7af6a7a-8046-4fb4-9979-4ec4230b23aa · read 2026-08-30
On people with reduced liver function, the label states: “Patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent APIDRA dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3) ] .”
US prescribing information · e7af6a7a-8046-4fb4-9979-4ec4230b23aa · read 2026-08-30
On people with reduced kidney function, the label states: “Patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent APIDRA dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3) ] .”
US prescribing information · e7af6a7a-8046-4fb4-9979-4ec4230b23aa · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Given by a clinician
❝ 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
✎ 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
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S9.
No source is stored against this line.
What is in the pack
Sold as liquid, injection, solution, given by the oral, subcutaneous, intravenous route.
✎ 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∅Nothing found in the sources checked
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.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
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.
Insulin glulisine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2147 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
hypoglycaemia — 774 reaction mentions
premature baby — 236 reaction mentions
blood glucose increased — 225 reaction mentions
hyperglycaemia — 176 reaction mentions
blood glucose decreased — 153 reaction mentions
premature delivery — 147 reaction mentions
diabetic ketoacidosis — 125 reaction mentions
diabetes mellitus inadequate control — 114 reaction mentions
confusional state — 104 reaction mentions
loss of consciousness — 93 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
✎ 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
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
6 products list this as an active ingredient in the United States drug directory. 2 of them contain it and nothing else.
FDA National Drug Code directory · 63083-3037 · read 2026-08-29
They are sold as injection, solution and liquid, taken intravenous, oral and subcutaneous.
FDA National Drug Code directory · 63083-3037 · read 2026-08-29
The regulator's established pharmacologic class for it is insulin analog [epc] and insulin [chemical/ingredient].
FDA National Drug Code directory · 63083-3037 · read 2026-08-29
5 published labels name it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 68a65713-da9c-4f13-bc84-e45344b9dc64 · read 2026-08-29
Those labels are classed as human otc drug and human prescription drug.
US prescribing information · 68a65713-da9c-4f13-bc84-e45344b9dc64 · read 2026-08-29
901 marketed supplement labels list this ingredient, classed as botanical, non-nutrient/non-botanical and other combinations.
Those labels carry all other and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.
Apidra is intravenous at 3 DOSAGE FORMS AND STRENGTHS Injection: 100 units per mL (U-100), a clear and colorless solution available as: 10 mL multiple-dose vial 3 mL single-patient-use APIDRA SoloStar prefilled pen Injection 100 units/mL (U-100…, recorded as fda label in effect 2025-11-25 in the United States.
US prescribing information · e7af6a7a-8046-4fb4-9979-4ec4230b23aa · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Insulin glulisine 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
What nobody knows yet
Open questions, each with why it is open and what would close it.
How much did people take in the studies?
The sources RNAWiki checked hold nothing for this field.
Why it matters. A result belongs to an amount. Without the amount the result floats free.
What would answer it
A stored source that records 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 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 Insulin glulisine 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.
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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.
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Check any of this yourself
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Where else this substance is registered
FDA substance identifier (UNII)
7XIY785AZD
RxNorm concept
485210
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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
The earliest marketing start date recorded for a listed product is 19840815.
FDA National Drug Code directory · 63083-3037 · read 2026-08-29
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6 questions this page could not answer
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Recorded evidence blocks (8)
Q2
What did Insulin glulisine's largest trial (934 people) and its longest (5.7 years) measure?
934 people in Insulin glulisine's largest registered study, 5.7 years in its longest registered window, measuring Outcome measures: Post-prandial glucose and insulin concentrations. Outcome: In T1DM, insulin glulisine provides a better mimic of the physiological postprandial glucose disposal than RHI. ClinicalTrials.gov · 2026-09-01
39 phase4, 21 phase3, 11 phase1, 5 phase2, 4 na; NCT00927524; 2010-12; no ageing endpoint recorded. Last human test completed 2025, NCT04974528.
Interpretation These counts include studies where Insulin glulisine was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase4
39
phase3
21
phase1
11
phase2
5
na
4
Last recorded human testNCT04974528
2025-04-29
recorded 2026-09-01 · last checked 2026-09-04
Q3
Insulin glulisine was tested only in human — what did it show?
Outcome measures: Post-prandial glucose and insulin concentrations. Outcome: In T1DM, insulin glulisine provides a better mimic of the physiological… — the recorded outcome words.
Show the evidence
humanNCT00290043
biomarker; Outcome measures: Post-prandial glucose and insulin concentrations. Outcome: In T1DM, insulin glulisine provides a better mimic of the physiological postprandial glucose disposal than RHI.; 80
recorded 2026-09-01 · last checked 2026-09-04
Q4
7 of Insulin glulisine's trials stopped: accrual/recruitment, other?
terminated; "Due to Negative feasibility assessment of recruiting the planned number of subjects within the study timelines"
NCT01079364
terminated; "Slow recruitment"
NCT01081938
terminated; "Recruitment challenges"
NCT02048189
terminated; "recruitment difficulties"
1 further recorded trialNCT02503501
terminated; "Study will not have power to show a difference between groups."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Which of 24 hour blood glucose levels, a mean blood glucose concentration of less than 40 and a mean blood glucose concentration of less than 70 did Insulin glulisine's trials measure?
24 hour blood glucose levels, a mean blood glucose concentration of less than 40 and a mean blood glucose concentration of less than 70 lead 40 outcome terms across Insulin glulisine's trials. ClinicalTrials.gov · 2026-09-01
Interpretation severe hypoglycemia, insulin doses, self monitored bg values, body weight/body mass index, fasting blood lipid profile and urine albumin follow.
Show the evidence
hba1c
1
24 hour blood glucose levels
1
symptomatic hypoglycemia
1
severe hypoglycemia
1
insulin doses
1
self monitored bg values
1
14 more recorded rows
body weight/body mass index
1
fasting blood lipid profile
1
urine albumin
1
total daily insulin dose
1
changes of glycosilated haemoglobin
1
hemoglobin a1c from baseline to week 12
1
glycosylated haemoglobin value 7
1
achieving glycosylated hemoglobin a1c 7 0 at week 60
1
hypoglycemic episodes
1
adverse events
1
glycosylated haemoglobin
1
blood glucose concentration
1
infarct size absolute change from baseline at day 60
1
average blood glucose over 6 days
1
recorded 2026-09-01 · last checked 2026-09-04
Q6
Which 36 trials of Insulin glulisine posted no result?
Posted no result
36 of 36 completed trials
Registrations
NCT00290043, NCT00046150, NCT00135057, NCT00115570, NCT00562133 and NCT00135096, and 30 more
Completion dates
oldest 2002-03; newest 2023-11-28
Show the evidence
Trial
NCT00290043
2002-03
NCT00046150
2002-12
NCT00135057
2005-08
NCT00115570
2006-11
NCT00562133
2007-03
NCT00135096
2007-07
14 further recorded trials
NCT00135941
2007-09
NCT00824668
2007-10
NCT00135083
2007-11
NCT01159353
2008-04
NCT00272064
2008-05
NCT00526513
2008-05
NCT00969592
2008-06
NCT00539448
2008-12
NCT00964574
2010-07
NCT00927524
2010-12
NCT01013571
2012-01
NCT01121835
2012-03
NCT01212913
2012-05
NCT01203111
2012-07
Q7
At the median, Insulin glulisine's trials enrolled 107 people — anything larger?
Median enrolment
107
Largest enrolment
934
Registered trials counted
77
Q8
What do 2147 spontaneous reports say about Insulin glulisine — 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.
Insulin glulisine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2147 reaction mentions were counted: hypoglycaemia 774; premature baby 236; blood glucose increased 225; hyperglycaemia 176. open-targets-adr · CHEMBL1201613 · 2026-06-24
Show the evidence
hypoglycaemia
774
premature baby
236
blood glucose increased
225
hyperglycaemia
176
blood glucose decreased
153
premature delivery
147
4 more recorded rows
diabetic ketoacidosis
125
diabetes mellitus inadequate control
114
confusional state
104
loss of consciousness
93
recorded 2026-06-24 · last checked 2026-09-04
Q9
Was Insulin glulisine studied with fasting?
fasting is named in Insulin glulisine's label sentences: "Patients with fasting plasma glucose (FPG) <130 mg/dL and HbA1c 7.0%-10.0% while on insulin glargine were randomized to a basal-prandial group (stepwise addition of insulin glulisine) or a premixed insulin group (insulin aspart/insulin aspart protamine 30/70 starting with 6 IU twice daily)." openfda-label+europepmc · 2015-06-29
1 recorded statement; fasting
Show the evidence
fasting
Patients with fasting plasma glucose (FPG) <130 mg/dL and HbA1c 7.0%-10.0% while on insulin glargine were randomized to a basal-prandial group (stepwise addition of insulin glulisine) or a premixed insulin group (insulin aspart/insulin aspart protamine 30/70 starting with 6 IU twice daily).
recorded 2015-06-29 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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