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Insulin glargine

  • 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 glargine does in the body

Once-daily background insulin for type 1 and type 2 diabetes

Ordinary insulin dissolves the moment it is injected, so it works fast and is gone in hours. Glargine is human insulin with two tiny chemical changes that make it insoluble at the pH of your body but soluble in the acidic liquid in the pen. When it hits the tissue under your skin it falls out of solution into a microscopic pile, and that pile then redissolves grain by grain over roughly a day. The insulin itself is unchanged; only the speed at which it becomes available has been re-engineered.

What happened in people

Same 24-week HbA1c as NPH insulin: 6.96% versus 6.97% in 756 patients

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.

The limit that matters most

That the trial hypoglycaemia advantage carries into usual care — a 25,489-patient cohort found an adjusted hazard ratio of 1.16, not below 1

Where it acts
Subcutaneous depot, then insulin receptors on liver, muscle and fat cells
Kind of result
A number that stands in for health
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 · 2ZM8CX04RZ · read 2026-08-29

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

A limit recorded against this substance. Not signed off as a reviewed claim.

The four opening statements run to 116 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.

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.

Receptor

A receptor is a part of a cell that a signal fits into.

A picture of it, and where the picture fails

A receptor is like a lock waiting for one key.

Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.

What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.

A protein that binds a specific ligand and converts that binding into a cellular response.

Pathway

A pathway is a chain of steps inside a cell, each one setting off the next.

A picture of it, and where the picture fails

A pathway is like a row of dominoes.

Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.

What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.

An ordered series of molecular interactions producing a defined cellular change.

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 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.
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 moved3 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Healthy ageingWaiting for a reviewer1 registered study measure of this kind. No reviewed result yet.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.
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.
Which registered measures put each goal on this table
Blood sugar
rate of type 1 diabetes per year; hba1c; hba1c from baseline to week 16; effect on change in average daily insulin dose; blood glucose level during study period; 24 hour blood glucose levels; insulin doses; total daily insulin dose
Body weight
body weight; body weight/body mass index; who achieved hba1c 7 4 minimal weight gain
Healthy ageing
mortality in the intensive care
Cholesterol
fasting blood lipid profile

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 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.

Composite of nonfatal myocardial infarction, nonfatal stroke or death from cardiovascular causes

The study did not show it

Who was studied
ORIGIN (NCT00069784)
How many people
12537
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
p = 0.63 (hazard ratio 1.02, 95% CI 0.94-1.11)
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. Severe hypoglycaemia 1.00 versus 0.31 per 100 person-years and a 2.1 kg median weight divergence are reported in the paper but rarely quoted alongside the neutral headline.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous injection, prefilled pen or 10 mL multiple-dose vial

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

Proportion reaching HbA1c 7% or less without documented nocturnal hypoglycaemia at 24 weeks

The study showed what it set out to show

Who was studied
Treat-to-Target (Riddle 2003; predates ClinicalTrials.gov registration)
How many people
756
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
p < 0.05 (33.2% versus 26.7%)
Repeated elsewhere
Replicated

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. 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. Subcutaneous injection, prefilled pen or 10 mL multiple-dose vial

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 2 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What happened in 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 Evidence recorded. Death, a heart attack, a stroke, a hospital stay.1 registered measure of this kind. 1 written-up study measured this and did not show a benefit.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  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.20 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 Evidence 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.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  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 changes in the bodyRead 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.

Where a source records it acting

  • Muscle: Lowers blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat

    US prescribing information · 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae · read 2026-08-27

  • Liver: Lowers blood glucose by inhibiting hepatic glucose production

    US prescribing information · 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae · read 2026-08-27

  1. Start

    Insulin glargine

    What a person takes: Subcutaneous injection, prefilled pen or 10 mL multiple-dose vial.

    The measurement behind this step

    Clear, colourless solution at 100 units/mL, given once daily at the same time each day. Must not be diluted or mixed in a syringe with any other insulin, because doing so destroys the pH-dependent precipitation the whole design depends on.

  2. Getting in

    Injected as a clear acidic solution

    The pen holds a clear liquid, not the cloudy suspension older long-acting insulins used. It is acidic, which is the only reason the insulin stays dissolved in the cartridge.

    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

    Formulated at pH 4. The two added B-chain arginines raise the isoelectric point of the molecule from about 5.4 to close to physiological pH, so it is fully soluble in the acidic vehicle and metastable at pH 7.4.

  3. Getting in

    Precipitates into a microscopic depot under the skin

    The moment it meets the neutral fluid of your tissue, it stops being soluble and settles into a tiny amorphous pile that then dissolves back very slowly.

    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

    Neutralisation in subcutaneous tissue drives the molecule through its isoelectric point, forming amorphous microprecipitates. Redissolution from the precipitate is the rate-limiting step for absorption, producing a relatively peakless profile over roughly 24 hours.

  4. Reaching the cell

    Enters the circulation as glargine and two active metabolites

    Enzymes in the tissue trim the two extra building blocks off the end, and what actually circulates is mostly a shortened form that behaves like ordinary human insulin.

    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

    Carboxypeptidase-mediated cleavage of the two B-chain arginines generates the M1 (21A-Gly-insulin) and M2 metabolites. M1 accounts for the majority of measurable exposure and has human-insulin-like receptor binding, which is the pharmacological reason the in vitro IGF-1 receptor affinity of the parent molecule did not produce a clinical mitogenic signal.

  5. What it acts on

    Binds the insulin receptor on liver, muscle and fat

    It docks onto the same receptor that your own insulin uses, on the surface of liver, muscle and fat cells.

    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

    Binding to the alpha subunits of the insulin receptor triggers trans-autophosphorylation of the beta-subunit tyrosine kinase domains, recruiting IRS-1 and IRS-2 and activating PI3K and Akt.

  6. The change it makes

    Shuts down liver glucose output and opens muscle glucose uptake

    Two things happen at once: the liver stops pouring stored sugar into the blood, and muscle and fat start taking sugar out of it.

    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

    Akt phosphorylates FOXO1 and suppresses transcription of PEPCK and glucose-6-phosphatase, cutting hepatic gluconeogenesis. In muscle and adipose tissue AS160 phosphorylation releases GLUT4-containing vesicles to the plasma membrane. Lipolysis and ketogenesis are simultaneously suppressed.

  7. What that does for a person

    Fasting and overnight glucose held flat for about a day

    The practical result is a stable overnight and between-meal blood sugar from one injection, which is what a background insulin is for.

    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

    Steady-state basal insulinaemia suppresses overnight hepatic glucose production. The trade-off measured in ORIGIN is roughly a threefold increase in severe hypoglycaemia and about 2 kg of weight relative to standard care.

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 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.

  • glycosylated hemoglobin
  • hba1c
  • hba1c from baseline to week 16
  • effect on change in average daily insulin dose
  • body weight
  • blood glucose level during study period
  • 24 hour blood glucose levels
  • insulin doses
  • body weight/body mass index
  • urine albumin

and 10 more.

Meaningful

Things that change how a life goes, not only a number.

  • mortality in the intensive care

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)
  • rate of type 1 diabetes per year
  • primary major macrovascular events
  • beta cell function after 52 weeks of therapy
  • safety
  • lesion volume expansion at 1 week
  • newborn birth weight
  • time within range during protocol
  • symptomatic hypoglycemia
  • severe hypoglycemia
  • self monitored bg values
  • fasting blood lipid profile
  • variation in morning fpg
  • who experienced a primary combined outcome
  • beta cell function c peptide auc
  • occurrence of adverse events
  • satisfaction
  • adverse events
  • a1c values
  • glycemic control

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.

  • Everyone with type 1 diabetes needs a basal insulin. In type 2 diabetes it is started when oral agents and injectable non-insulin drugs no longer reach the target. Insulin has been in clinical use since 1922.

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 LANTUS to improve glycemic control in pediatric patients with diabetes mellitus have been established.”

    US prescribing information · d5e07a0c-7e14-4756-9152-9fea485d654a · read 2026-08-30

  • On older people, the label states: “Of the total number of subjects in controlled clinical studies of patients with type 1 and type 2 diabetes who were treated with LANTUS, 15% (n=316) were ≥65 years of age and 2% (n=42) were ≥75 years of age.”

    US prescribing information · d5e07a0c-7e14-4756-9152-9fea485d654a · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes (see Data ) .”

    US prescribing information · d5e07a0c-7e14-4756-9152-9fea485d654a · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There are either no or only limited data on the presence of insulin glargine in human milk, the effects on breastfed infant, or the effects on milk production.”

    US prescribing information · d5e07a0c-7e14-4756-9152-9fea485d654a · read 2026-08-30

  • On people with reduced liver function, the label states: “The effect of hepatic impairment on the pharmacokinetics of LANTUS has not been studied.”

    US prescribing information · d5e07a0c-7e14-4756-9152-9fea485d654a · read 2026-08-30

  • On people with reduced kidney function, the label states: “The effect of kidney impairment on the pharmacokinetics of LANTUS has not been studied.”

    US prescribing information · d5e07a0c-7e14-4756-9152-9fea485d654a · read 2026-08-30

Where the result stopped carrying

  • The cardiovascular hypothesis behind ORIGIN failed on both coprimary outcomes
  • The 2009 observational cancer signal failed to replicate under randomisation and was retired
  • 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

Subcutaneous injection, prefilled pen or 10 mL multiple-dose vial

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

Clear, colourless solution at 100 units/mL, given once daily at the same time each day. Must not be diluted or mixed in a syringe with any other insulin, because doing so destroys the pH-dependent precipitation the whole design depends on.

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 takeRead from sources, not yet reviewed

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Worth asking a clinician aboutWritten into the record from the studies named on this page

Hypoglycaemia is the dose-limiting toxicity and can be fatal. Weight gain, injection-site reactions, lipodystrophy and hypokalaemia are the other label risks. Severe hypoglycaemia ran at 1.00 per 100 person-years in ORIGIN versus 0.31 on standard care.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

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 glargine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 10452 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • hypoglycaemia — 3628 reaction mentions
  • blood glucose increased — 2482 reaction mentions
  • blood glucose decreased — 792 reaction mentions
  • hyperglycaemia — 751 reaction mentions
  • diabetic ketoacidosis — 686 reaction mentions
  • diabetes mellitus inadequate control — 622 reaction mentions
  • glycosylated haemoglobin increased — 500 reaction mentions
  • premature baby — 390 reaction mentions
  • hypoglycaemic coma — 339 reaction mentions
  • blood glucose abnormal — 262 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

Subcutaneous injection, prefilled pen or 10 mL multiple-dose vial

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

Must not be diluted or mixed in a syringe with any other insulin, because doing so destroys the pH-dependent precipitation the whole design depends on.

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

  • 30 products list this as an active ingredient in the United States drug directory. 29 of them contain it and nothing else.

    FDA National Drug Code directory · 83257-011 · read 2026-08-29

  • They are sold as crystal, injection, solution, liquid and powder, taken oral and subcutaneous.

    FDA National Drug Code directory · 83257-011 · read 2026-08-29

  • The regulator's established pharmacologic class for it is insulin analog [epc] and insulin [cs].

    FDA National Drug Code directory · 83257-011 · read 2026-08-29

  • 18 published labels name it as an active ingredient. 17 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · d5e07a0c-7e14-4756-9152-9fea485d654a · read 2026-08-29

  • Those labels are classed as human otc drug and human prescription drug.

    US prescribing information · d5e07a0c-7e14-4756-9152-9fea485d654a · 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

  • BASAGLAR KwikPen is injection: solution in single-patient-use prefilled pens at 100 units/mL (U-100); 3 mL single-patient-use BASAGLAR KwikPen and BASAGLAR Tempo Pen, recorded as prescription product; fda label in effect 2026-06-16 in the United States.

    US prescribing information · 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae · read 2026-08-27

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 glargine 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

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 the trial hypoglycaemia advantage carries into usual care — a 25,489-patient cohort found an adjusted hazard ratio of 1.16, not below 1

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 normalising fasting glucose early prevents cardiovascular events, which ORIGIN was built to test and did not show

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 price reflects manufacturing difficulty; two published cost models put a sustainable annual price under $110

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 unclearRead 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 Insulin glargine 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.

Every line above can be traced to the study named beside it. Follow the link and read it.

Treat-to-Target: same HbA1c as NPH, fewer patients reaching it with nocturnal hypoglycaemia
In plain words
In 756 people with type 2 diabetes, glargine and NPH insulin brought average blood sugar to the same place. The difference was in how many got there without night-time lows.
What was measured
HbA1c 6.96% versus 6.97%; 33.2% versus 26.7% reaching target free of documented nocturnal hypoglycaemia
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Randomised, open-label, 24-week trial. 756 overweight adults on one or two oral agents added bedtime glargine or NPH titrated to a fasting plasma glucose target of 100 mg/dL. End-point HbA1c was 6.96% with glargine and 6.97% with NPH; mean fasting plasma glucose 117 versus 120 mg/dL. 33.2% versus 26.7% reached HbA1c 7% or less without documented nocturnal hypoglycaemia (p < 0.05), and rates of other symptomatic hypoglycaemia categories were 21-48% lower with glargine.
Source
Riddle MC, Rosenstock J, Gerich J. Diabetes Care 2003;26:3080-3086
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
ORIGIN: normalising fasting glucose with basal insulin did not reduce cardiovascular events
In plain words
The largest trial ever run on this drug asked whether driving fasting sugar to normal with insulin would prevent heart attacks and strokes. Over more than six years, it did not.
What was measured
Hazard ratio 1.02 (95% CI 0.94-1.11), p = 0.63 for the first coprimary cardiovascular outcome
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
ORIGIN randomised 12,537 people with cardiovascular risk factors plus impaired fasting glucose, impaired glucose tolerance or type 2 diabetes to glargine targeting fasting glucose 95 mg/dL or less, versus standard care. Median follow-up 6.2 years. First coprimary outcome (nonfatal MI, nonfatal stroke or cardiovascular death) 2.94 versus 2.85 events per 100 person-years, hazard ratio 1.02 (95% CI 0.94-1.11), p = 0.63. Second coprimary outcome hazard ratio 1.04, p = 0.27. Severe hypoglycaemia 1.00 versus 0.31 per 100 person-years. Median weight rose 1.6 kg on glargine and fell 0.5 kg on standard care.
Source
ORIGIN Trial Investigators. N Engl J Med 2012;367:319-328
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The 2009 cancer scare was raised by observational data and retired by a randomised trial
In plain words
A large German insurance database suggested in 2009 that glargine might raise cancer risk. Three years later a randomised trial with over 12,000 people and six years of follow-up found no difference at all.
What was measured
That in vitro IGF-1 receptor affinity plus a database association demonstrates a real cancer risk in patients
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Hemkens and colleagues analysed 127,031 patients in a German statutory insurance fund and reported a dose-adjusted hazard ratio for malignancy of 1.31 (95% CI 1.20-1.42) at a 50 IU daily dose of glargine versus human insulin, with no signal for aspart or lispro. Mean follow-up was only 1.63 years and dose was strongly confounded by indication. ORIGIN then reported cancer hazard ratio 1.00 (95% CI 0.88-1.13, p = 0.97) after a median 6.2 years of randomised exposure. The field moved from a mitogenicity concern to a resolved question, and the mechanism proposed for it — glargine IGF-1 receptor affinity — did not translate into events.
Source
Hemkens LG et al. Diabetologia 2009;52:1732-1744, superseded by ORIGIN, N Engl J Med 2012;367:319-328
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
The trial hypoglycaemia advantage did not reproduce in ordinary practice
In plain words
In a Kaiser Permanente cohort of 25,489 people starting basal insulin, the analogue that costs several times more did not send fewer people to the emergency department for low blood sugar, and did not control blood sugar better.
What was measured
That the reduction in documented nocturnal hypoglycaemia seen in a titrated 24-week trial translates into fewer severe hypoglycaemic events in usual care
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Retrospective cohort, Kaiser Permanente Northern California, 2006-2015. 1,928 patients initiated a basal analogue and 23,561 initiated NPH. Hypoglycaemia-related emergency department visits or hospital admissions were 11.9 per 1,000 person-years with analogues versus 8.8 with NPH; between-group difference 3.1 (95% CI -1.5 to 7.7), p = 0.07. In 4,428 propensity-matched patients the adjusted hazard ratio was 1.16 (95% CI 0.71-1.78). HbA1c fell from 9.4% to 8.2% on analogues and from 9.4% to 7.9% on NPH.
Source
Lipska KJ et al. JAMA 2018;320:53-62
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
Nothing in the manufacturing explains the price
In plain words
Two independent published models put the sustainable cost-based price of a year of basal insulin analogue at under a hundred dollars. The US paid many multiples of that until list prices were cut in 2023 and 2024.
What was measured
That the price of an insulin analogue reflects what it costs to manufacture, or the difficulty of making it
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Gotham, Barber and Hill modelled active ingredient cost, formulation and operating expense plus a profit margin and estimated biosimilar prices of $78-$108 per patient per year for insulin glargine and $48-$71 for regular human insulin. Barber and colleagues updated the model in 2024 and put a once-daily basal analogue regimen at $72 per patient per year including pen and needles. RAND, for HHS ASPE, found US average gross manufacturer prices of $98.70 per standard unit in 2018 against $8.81 across 32 other OECD countries, 8.1 times the non-US average. Sanofi cut the Lantus US list price 78% effective 1 January 2024.
Source
Gotham D et al. BMJ Glob Health 2018;3:e000850; Barber MJ et al. JAMA Netw Open 2024;7:e243474; Mulcahy AW, Schwam D. RAND for HHS ASPE, 2020
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
Progression from pre-diabetes to diabetes was reduced, at p = 0.05
In plain words
Among the minority of ORIGIN participants who did not have diabetes at the start, fewer developed it. The result sat exactly on the conventional significance threshold and was measured three months after treatment stopped.
What was measured
30% versus 35% new diabetes; odds ratio 0.80 (95% CI 0.64-1.00), p = 0.05
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In the 1,456 ORIGIN participants without diabetes at baseline, new diabetes was diagnosed approximately three months after therapy was stopped in 30% of the glargine group versus 35% of the standard-care group; odds ratio 0.80 (95% CI 0.64-1.00), p = 0.05. This was a secondary outcome in a trial whose coprimary outcomes were both neutral, and the confidence interval touches unity.
Source
ORIGIN Trial Investigators. N Engl J Med 2012;367:319-328
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

Where else this substance is registered

FDA substance identifier (UNII)
2ZM8CX04RZ
CAS registry number
160337-95-1
PubChem compound
118984454
RxNorm concept
274783

Checks this page had to pass

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  • 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

  • Passed

    Safety mode resolved

    Suppression classes recorded: S9.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead 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

  • 3 approved applications cover products containing this substance. The earliest was BLA205692, approved 20151216 to ELI LILLY AND CO.

    Drugs@FDA application register · BLA205692 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · BLA205692 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19840815.

    FDA National Drug Code directory · 83257-011 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

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.
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  • Other ways to the same goal — found nothing in the sources checked.
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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.

Swapping one amino acid and adding two arginines shifts insulin so it precipitates in the subcutaneous tissue and dissolves back slowly over about a day; in the registration trial that reached the same HbA1c as NPH insulin (6.96% versus 6.97%) while more patients got there without documented nocturnal hypoglycaemia.

Recorded evidence blocks (10)

What did Insulin glargine's largest trial (714582 people) and its longest (14 years) measure?


714582 people in Insulin glargine's largest registered study, 14 years in its longest registered window, measuring Mortality in the Intensive Care Unit (ICU). ClinicalTrials.gov · 2026-09-01

218 phase3, 215 phase4, 90 phase2, 87 phase1, 81 na, 17 na or unstated, 11 early phase1; NCT00535925; 2019-05. Last human test completed 2026, NCT06688123.

Interpretation These counts include studies where Insulin glargine 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
    218
  • phase4
    215
  • phase2
    90
  • phase1
    87
  • na
    81
  • na or unstated
    17
2 more recorded rows
  • early phase1
    11
  • Last recorded human test NCT06688123
    2026-04-22

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

From mouse to human: where has Insulin glargine shown lifespan?


mouse: mechanism-only, rat: mechanism-only and human: lifespan (697): the rungs where Insulin glargine has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Mortality in the Intensive Care Unit (ICU) — the recorded outcome words.

Yeast C. elegans Drosophila Mouse mechanism-onlyRat mechanism-onlyDog Non-human primate Human lifespan
Show the evidence
  • mouse
    mechanism-only
  • rat
    mechanism-only
  • human NCT00107601
    lifespan; Mortality in the Intensive Care Unit (ICU); 697

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

55 of Insulin glargine's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, other?


safety (4), futility/efficacy (3), accrual/recruitment (20), funding/business (5) and other (23): Insulin glargine's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Active Duty principle investigator currently deployed"; 55 of 697 registered studies

Show the evidence

Trial

  • NCT00160485
    withdrawn; "Active Duty principle investigator currently deployed"
  • NCT00237471
    terminated; "difficulty recruiting patients"
  • NCT00283049
    terminated; "Due to technical issues relating to the Electronic diary data."
  • NCT00366301
    terminated; "Interim analyses demonstrated futility. Thus, recruitment curtailed 10/08."
  • NCT00437164
    terminated; "Company decision not related to safety."
  • NCT00500240
    terminated; "Terminated early due to futility."
14 further recorded trials
  • NCT00564018
    terminated; "Presumed loss of clinical equipoise between the agents being investigated"
  • NCT00615381
    withdrawn; "Study was not initiated and has been withdrawn due to lack of appropriate cases"
  • NCT00627471
    terminated; "Low recruitment in spite of strategies implemented"
  • NCT00670228
    terminated; "Due to Negative feasibility assessment of recruiting the planned number of subjects within the study timelines"
  • NCT00678145
    terminated; "Protocol was terminated due to enrollment + feasibility issues. Aim 2 not conducted. Aims 1 + 3 were conducted in part. During Aim 3 the IRB requested that the study be transitioned under a new protocol (2018-9208) in order to simplify…"
  • NCT00700622
    terminated; "Sponsor stopped development of the MedTone inhaler in favor of an improved device (Gen2 inhaler)"
  • NCT00762190
    terminated; "Hepatic safety signal identified."
  • NCT00837759
    terminated; "Changes to study personnel."
  • NCT00850161
    withdrawn; "Business purposes."
  • NCT00869414
    terminated; "PI deceased"
  • NCT00943709
    withdrawn; "lack of accrual"
  • NCT00950534
    terminated; "due to poor recruitment"
  • NCT00995501
    terminated; "Per interim analysis, for futility."
  • NCT01051011
    terminated; "high discontinuation rates mainly due to GI tolerability and implementation of risk mitigation plan to address hypersensitivity reactions"

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

Human studies of Insulin glargine used Insulin Glargine 0.5 u/kg body wt SC — over how long?


studies of Insulin glargine used the recorded amount. ClinicalTrials.gov · 2026-09-01

7 recorded entries; human; also "Insulin Glargine 0.5 u/kg body wt SC", "Insulin Glargine 1.0 u/kg body wt SC", "Insulin Glargine 1.5 u/kg body wt SC"

Show the evidence

human

  • NCT00574912
    Insulin Glargine 0.5 u/kg body wt SC
  • NCT00574912
    Insulin Glargine 1.0 u/kg body wt SC
  • NCT00574912
    Insulin Glargine 1.5 u/kg body wt SC
  • NCT00574912
    Insulin Glargine 2.0 u/kg body wt SC
  • NCT02161055
    Insulin Injection(10mL:400u), manufactured by Wanbang Biochemical Pharmaceutical Co., Ltd. Lot No. 1307230, No. 1302225, No. 1307210.
  • NCT02735044
    Insulin glargine (100 units /mL)
1 more recorded row
  • human NCT03260868
    Insulin glargine, 300 units per milliliter (U/mL)

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

Which of 24 hour blood glucose levels, a1c values and addendum 24 week endpoint hba1c did Insulin glargine's trials measure?


24 hour blood glucose levels, a1c values and addendum 24 week endpoint hba1c lead 40 outcome terms across Insulin glargine's trials. ClinicalTrials.gov · 2026-09-01

hba1c, beta cell function after 52 weeks of therapy, hba1c from baseline to week 16, mortality in the intensive care, safety and effect on change in average daily insulin dose follow.

Show the evidence
  • rate of type 1 diabetes per year
    1
  • primary major macrovascular events
    1
  • glycosylated hemoglobin
    1
  • hba1c
    1
  • beta cell function after 52 weeks of therapy
    1
  • hba1c from baseline to week 16
    1
14 more recorded rows
  • mortality in the intensive care
    1
  • safety
    1
  • effect on change in average daily insulin dose
    1
  • lesion volume expansion at 1 week
    1
  • body weight
    1
  • newborn birth weight
    1
  • time within range during protocol
    1
  • blood glucose level during study period
    1
  • 24 hour blood glucose levels
    1
  • symptomatic hypoglycemia
    1
  • severe hypoglycemia
    1
  • insulin doses
    1
  • self monitored bg values
    1
  • body weight/body mass index
    1

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

Which of Insulin glargine's 14 ongoing trials reports first?


14 registered trials of Insulin glargine are open; earliest completion 2025-02-10. ClinicalTrials.gov · 2026-09-01

Change in LH Pulse Amplitude Before and After Acute or Chronic FFA Administration; the proportion of patients with HbA1c < 7.0% without experiencing hypoglycemia and without weight gain,with a superiority margin of 3%; latest 2028-05-31

Show the evidence

Trial

  • NCT02653092
    "Reprometabolic Syndrome Mediates Subfertility in Obesity"; n 84; "Change in LH Pulse Amplitude Before and After Acute or Chronic FFA Administration"; 2026-12-11
  • NCT03087032
    "Liraglutide-bolus vs Glargine-bolus Therapy in Overweight/Obese Type 2 Diabetes Patients (LiraGooD)"; n 164; "the proportion of patients with HbA1c < 7.0% without experiencing hypoglycemia and without weight gain,with a superiority margin of 3%"; 2025-02-10
  • NCT03241706
    "Liver Glycogen and Hypoglycemia in Humans"; n 40; "Epinephrine"; 2028-05-31
  • NCT03527537
    "Gestational Diabetes and Pharmacotherapy (GAP)"; n 416; "Composite Neonatal Outcome"; 2026-10-01
  • NCT03665207
    "Tight Versus Liberal Blood Glucose Control in Adult Critically Ill Patients"; n 9230; "Duration of ICU dependency"; 2026-11
  • NCT03899402
    "Triple Therapy in T1DM"; n 78; "Change in HbA1c following dapagliflozin"; 2026-06-30
8 further recorded trials
  • NCT05098470
    "Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity"; n 100; "Contribution of gluconeogenesis (GNG) to endogenous glucose production (EGP)"; 2026-07-29
  • NCT05553093
    "Effects of Tirzepatide and Insulin Glargine on Glucolipid Metabolism and Brain Function in Patients With Type 2 Diabetes"; n 150; "blood sugar changes"; 2027-10-31
  • NCT06419777
    "Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes"; n 430; "Neonatal Composite Outcome"; 2026-05
  • NCT06419803
    "Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2)"; n 430; "Neonatal Composite Outcome"; 2026-05
  • NCT06619301
    "RCT Glargine vs NPH for Treatment of DM in Pregnancy"; n 160; "Hypoglycemia"; 2027-01-01
  • NCT06671587
    "iGlarLixi CGM Study in Chinese T2D Individuals After OADs"; n 678; "Superiority of mean change in the percentage of TIR [3.9-10.0 mmol/L (70-180 mg/dL)]"; 2026-09-18
  • NCT07076199
    "A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes"; n 877; "Change in glycosylated haemoglobin (HbA1c)"; 2027-03-01
  • NCT07173712
    "Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes"; n 324; "Proportion of subjects with optimal glycemic control"; 2027-12-31

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

Which 282 trials of Insulin glargine posted no result?


Posted no result
282 of 282 completed trials
Registrations
NCT00360815, NCT00001624, NCT00431665, NCT00653341, NCT00358124 and NCT01336751, and 276 more
Completion dates
oldest 1993-04; newest 2024-08-02
Show the evidence

Trial

  • NCT00360815
    1993-04
  • NCT00001624
    2000-03
  • NCT00431665
    2000-06
  • NCT00653341
    2001-10
  • NCT00358124
    2002-06
  • NCT01336751
    2002-12
14 further recorded trials
  • NCT00312104
    2003-03
  • NCT01720303
    2003-04-10
  • NCT00004984
    2003-06
  • NCT00551356
    2003-07
  • NCT00390728
    2003-08
  • NCT00399724
    2003-08
  • NCT00540709
    2003-09
  • NCT00814008
    2003-12
  • NCT00537251
    2004-02
  • NCT00354939
    2004-03
  • NCT00598793
    2004-03
  • NCT00063128
    2004-04
  • NCT00563225
    2004-04
  • NCT00576368
    2004-04

At the median, Insulin glargine's trials enrolled 119.5 people — anything larger?


Median enrolment
119.5
Largest enrolment
714582
Registered trials counted
694

What do 10452 spontaneous reports say about Insulin glargine — 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 glargine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 10452 reaction mentions were counted: hypoglycaemia 3628; blood glucose increased 2482; blood glucose decreased 792; hyperglycaemia 751. open-targets-adr · CHEMBL1201497 · 2026-06-24

Show the evidence
  • hypoglycaemia
    3628
  • blood glucose increased
    2482
  • blood glucose decreased
    792
  • hyperglycaemia
    751
  • diabetic ketoacidosis
    686
  • diabetes mellitus inadequate control
    622
4 more recorded rows
  • glycosylated haemoglobin increased
    500
  • premature baby
    390
  • hypoglycaemic coma
    339
  • blood glucose abnormal
    262

recorded 2026-06-24 · last checked 2026-09-04

What is recorded about Insulin glargine and IGF-1?


"To develop a long-acting formulation of native human insulin with a similar pharmacodynamics (PD) profile as the insulin analogue insulin glargine (Lantus®, Sanofi-Aventis) with the expectation of retaining native human insulin's superior safety profile as insulin glargine is able to activate the insulin-like growth factor 1 (IGF-1)…" — where Insulin glargine and IGF-1 appear together. Europe PMC · pathway abstract search · 2013-05-08

IGF-1; PMID 22203325, 23653049, 16842489

Show the evidence

IGF-1

  • PMID 22203325
    "To develop a long-acting formulation of native human insulin with a similar pharmacodynamics (PD) profile as the insulin analogue insulin glargine (Lantus®, Sanofi-Aventis) with the expectation of retaining native human insulin's superior safety profile as insulin glargine is able to activate the insulin-like growth factor 1 (IGF-1) receptor and is linked to a number of malignancies at a higher…"
  • PMID 23653049
    "The IR signalling pattern of AspB10 in vivo is distinctly different from that of human insulin and insulin glargine, and might challenge the notion that activation of IGF1R plays a role in the observed carcinogenic effect of AspB10."
  • PMID 16842489
    "Assuming a higher binding affinity of insulin glargine to pituitary IGF-1 receptors, serum IGF-1 concentrations should decrease via negative feedback."

recorded 2013-05-08 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201497
PubChem CID
118984454
CAS number
160337-95-1
RxCUI
274783
Trade name
Abasaglar, Abasaglar kwikpen, Basaglar, Ins lantus, Ins lantus opticlik, Ins lantus optiset, Ins lantus solostar, Insulin glargine component of basaglar, Insulin glargine component of soliqua 100/33, Lantus, Toujeo, Toujeo solostar
Also called
Basalin, Basalog, Galactus, Glargin, Glargine, Glaricon, Insulina glargina, Insuline glargine, Insulin glargine aglr, Insulin glargine recombinant, Insulin glargine yfgn, Lantus r
Development code
HOE 71GT, HOE 901, HOE901, LY-2963016, LY2963016, MK-1293
Salt form
gan & lee insulin glargine injection
Sources (9)

Sources

3 more sources

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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  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 9 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
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