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insulin glargine

Generic: insulin glargine·Brand: Basaglar

insulin glargine: developed by 1 company · 11 clinical trials tracked · 1 FDA decision.

insulin glargine evidence translation

What we can confirm

1 FDA record · 11 tracked trials

What it means

Source-backed records connect insulin glargine to LLY; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could insulin glargine → LLY affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence8 indications · 2 study sponsors
Development Pipeline (2)
CompanyPhase
ELI LILLY & Co (LLY)
for the treatment of diabetes.
Approved
ELI LILLY & Co (LLY)
Type 2 Diabetes
Phase 4
Clinical Trials (11)showing 10 most recent

A 26-week Study Comparing the Efficacy and Safety of Once-weekly Insulin Icodec and Once-daily Insulin Glargine U100, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

NCT07076199·Phase 3·NVO
Recruiting

Primary endpoint: Change in glycosylated haemoglobin (HbA1c)

InterventionalRandomizedopen877 targetStarted 2025-08Completion 2027-0350 sites · United StatesNovo Nordisk A/S

A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec When Switching From Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults With Type 2 Diabetes

NCT06340854·Phase 3·NVO
Completed

Primary endpoint: Change in Glycated Haemoglobin (HbA1c)

InterventionalRandomizedopen412 enrolledStarted 2024-04Completion 2025-0650 sites · Bulgaria, Germany, India, United StatesNovo Nordisk A/S

A 40-week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL in Participants With Type 2 Diabetes Inadequately Controlled on Oral Anti Diabetic Drugs COMBINE 4

NCT06269107·Phase 3·NVO
Completed

Primary endpoint: Change in glycated haemoglobin (HbA1c)

InterventionalRandomizedopen485 enrolledStarted 2024-02Completion 2025-0750 sites · China, United StatesNovo Nordisk A/S

A Phase 3, Open-Label Study of Once Daily LY3502970 Compared With Insulin Glargine in Adult Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk

NCT05803421·Phase 3·LLY
Completed

Primary endpoint: Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) Death]

InterventionalRandomizedopen2,749 enrolledStarted 2023-04Completion 2026-0350 sites · United StatesEli Lilly and Company

A 24-Week, Multicenter, Randomized, Open-Label, Parallel-Group Trial Comparing the Efficacy and Safety of Insulin Glargine 300 U/mL (Gla-300) and Insulin Degludec 100 U/mL (IDeg-100) in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment: TRENT Trial

NCT05552859·Phase 4·SNY
Terminated

Primary endpoint: Difference in the Mean Change From Baseline to Week 24 in HbA1c Level (Gla-300 vs IDeg-100)

InterventionalRandomizedopen62 targetStarted 2022-12Completion 2023-0850 sites · Czechia, Hungary, Poland, United StatesSanofi

A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL Combined With Insulin Aspart, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin. COMBINE 3

NCT05013229·Phase 3·NVO
Completed

Primary endpoint: Change in HbA1c

InterventionalRandomizedopen679 enrolledStarted 2021-11Completion 2023-1150 sites · United StatesNovo Nordisk A/S

Multicentre Phase IV Single Arm Clinical Trial to evaluAte the saFety and Efficacy of Gla-300 in insUlin-naïve Patients With Type 2 DiAbetes uncontRolled on Oral Antihyperglycemic Drugs

NCT04980027·Phase 4·SNY
Completed

Primary endpoint: Percentage of participants with Treatment Emergent Adverse Events (TEAEs)

Interventionalopen228 enrolledStarted 2021-06Completion 2022-122 sites · IndiaSanofi

A 6-month, Multicenter, Prospective, Single-arm, Open-label, Phase IV Study Evaluating the Clinical Efficacy and Safety of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period

NCT05002933·Phase 4·SNY
Completed

Primary endpoint: Mean change in HbA1c from baseline to week 24

Interventionalopen570 enrolledStarted 2021-05Completion 2023-021 site · ChinaSanofi

A 26-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Bolus Insulin With or Without Non-insulin Anti-diabetic Drugs, in Subjects With Type 2 Diabetes on a Basal-bolus Regimen

NCT04880850·Phase 3·NVO
Completed

Primary endpoint: Change in Glycated Haemoglobin (HbA1c)

InterventionalRandomizedopen582 enrolledStarted 2021-05Completion 2022-0650 sites · United StatesNovo Nordisk A/S

Effectiveness and Safety of Once Weekly Insulin Icodec Used With DoseGuide Versus Once Daily Basal Insulin Analogues in an Insulin naïve Type 2 Diabetes Population in a Clinical Practice Setting

NCT04760626·Phase 3·NVO
Completed

Primary endpoint: Change in Glycated Haemoglobin (HbA1c)

InterventionalRandomizedopen1,085 enrolledStarted 2021-03Completion 2022-0850 sites · United StatesNovo Nordisk A/S
FDA Decisions1 records
Approval(LLY)FDA ↗
BLA205692Type 5 - New Formulation or New ManufacturerStandardSubcutaneousSolution

Frequently asked questions

Who is developing insulin glargine?

insulin glargine is being developed by ELI LILLY & Co.

How many clinical trials involve insulin glargine?

BioSniper tracks 11 clinical trials involving insulin glargine.

What is insulin glargine's latest FDA decision?

The most recent tracked FDA decision for insulin glargine is Approval, dated December 16, 2015.