insulin glargine
insulin glargine: sourced relationships with 1 company · 12 clinical trials tracked · 1 FDA decision.
insulin glargine evidence translation
What we can confirm
1 FDA record · 12 tracked trials
What it means
What to watch
Prepared research question
How could insulin glargine → LLY affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 2 study sponsors
Related indications
Study sponsors
Dated Pipeline Records (2)
| Company | Dated record stage |
|---|---|
| ELI LILLY & Co (LLY) Reported 2015-12-16 · Current development: unknownSource Type 2 Diabetes | Phase 4 |
| ELI LILLY & Co (LLY) Reported 2015-12-16 · Current development: unknownSource for the treatment of diabetes. | Approved |
Clinical Trial Registry Records (12)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
Primary endpoint: Change in glycosylated haemoglobin (HbA1c)
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
Primary endpoint: Change in Glycated Haemoglobin (HbA1c)
A 26- Week, Multicenter, Open-Label, Single-Arm, Phase 4 Study to Assess The Safety of Lyumjev in Adult Patients With Type 2 Diabetes Mellitus in India
Primary endpoint: Percentage of Participants With at Least 1 Documented Hypoglycemic Event With Blood Glucose <54 Milligrams Per Deciliter (mg/dL)
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
Primary endpoint: Change in glycated haemoglobin (HbA1c)
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
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]
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
Primary endpoint: Difference in the Mean Change From Baseline to Week 24 in HbA1c Level (Gla-300 vs IDeg-100)
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
Primary endpoint: Change in HbA1c
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
Primary endpoint: Percentage of participants with Treatment Emergent Adverse Events (TEAEs)
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
Primary endpoint: Mean change in HbA1c from baseline to week 24
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
Primary endpoint: Change in Glycated Haemoglobin (HbA1c)
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with insulin glargine?
insulin glargine has dated SEC/FDA relationship records for ELI LILLY & Co.
How many clinical trials involve insulin glargine?
BioSniper tracks 12 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.