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Insulin glulisine

  • Hormone
  • Given by a clinician
  • Identity checked
  • Sources last checked 2026-09-04

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 peopleRead 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.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
Blood sugarNothing 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 weightNothing 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.
CholesterolNothing 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.
FocusNothing 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 peopleRead 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 peopleRead 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.

  1. Living longer, or avoiding a major event No evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
  2. What a body can do day to day Evidence recorded. Walking, dressing, breathing, recovering.1 registered measure of this kind.
  3. Measured performance Evidence recorded. How much was lifted, how far was run, how fast.1 registered measure of this kind.
  4. Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.27 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  8. Cells in a dish No evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
  9. A guess from software No 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 takeRead 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 unclearRead 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 takeRead 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 takeRead 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 takeNothing 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 unclearRead 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.

    NIH Dietary Supplement Label Database · 219567 · read 2026-08-29

  • 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.

    NIH Dietary Supplement Label Database · 219567 · read 2026-08-29

  • 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 takeRead 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 unclearRead 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.

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 peopleRead 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.

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)

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 test NCT04974528
    2025-04-29

recorded 2026-09-01 · last checked 2026-09-04

Insulin glulisine was tested only in human — what did it show?


human: biomarker (80): the rungs where Insulin glulisine has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Outcome measures: Post-prandial glucose and insulin concentrations. Outcome: In T1DM, insulin glulisine provides a better mimic of the physiological… — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human biomarker
Show the evidence
  • human NCT00290043
    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

7 of Insulin glulisine's trials stopped: accrual/recruitment, other?


accrual/recruitment (5) and other (2): Insulin glulisine's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Due to technical issues relating to the Electronic diary data."; 7 of 80 registered studies

Show the evidence

Trial

  • NCT00283049
    terminated; "Due to technical issues relating to the Electronic diary data."
  • NCT00467636
    terminated; "Difficulty recruiting (early discharge scheme initiated)"
  • NCT00670228
    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 trial NCT02503501
    terminated; "Study will not have power to show a difference between groups."

recorded 2026-09-01 · last checked 2026-09-04

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

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

At the median, Insulin glulisine's trials enrolled 107 people — anything larger?


Median enrolment
107
Largest enrolment
934
Registered trials counted
77

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

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 registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201613
PubChem CID
16136701
CAS number
207748-29-6
RxCUI
400008
Trade name
Apidra, Ins apidra, Ins apidra opticlik, Ins apidra optiset, Ins apidra solostar, Apidra SoloStar
Also called
Glulisine apidra, Insulina glulisina, Insuline glulisine, Insulin, glulisine, human, Insulin glulisine recombinant, glulisine, glulisine insulin, insulin, prandial insulin, INSULIN GLULISINE RECOMBINANT [ORANGE BOOK], INSULIN GLULISINE [EMA EPAR], INSULIN GLULISINE [JAN]
Development code
HMR 1964, HMR1964
Sources (8)

Sources

2 more sources
  • openfda-label+europepmc K1:7XIY785AZD ·
  • national registers US, EU, CA ·

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

How these records are assembled · Which registers were checked

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  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 8 source rows
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  • canonical metadata passed: slug and display name present
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