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Insulin glargine U100 (HOE901)
Insulin glargine is a long-acting basal insulin that binds to the insulin receptor to promote glucose uptake and utilization in peripheral tissues while suppressing hepatic glucose production.
Insulin glargine is a long-acting basal insulin that binds to the insulin receptor to promote glucose uptake and utilization in peripheral tissues while suppressing hepatic glucose production. Used for Type 1 diabetes mellitus, Type 2 diabetes mellitus.
At a glance
| Generic name | Insulin glargine U100 (HOE901) |
|---|---|
| Also known as | Lantus |
| Sponsor | Sanofi |
| Drug class | Long-acting basal insulin |
| Target | Insulin receptor |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
Insulin glargine is a recombinant human insulin analog engineered with amino acid substitutions to provide a prolonged, peakless duration of action (up to 24 hours). It binds to insulin receptors on muscle, adipose, and liver cells, facilitating glucose transport and storage while inhibiting gluconeogenesis and lipolysis. The U100 formulation delivers 100 units per milliliter and is designed for once-daily subcutaneous administration in diabetes management.
Approved indications
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
Common side effects
- Hypoglycemia
- Injection site reactions
- Weight gain
- Lipodystrophy
Key clinical trials
- 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 (PHASE3)
- Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 2 Diabetes (PHASE3)
- Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes (PHASE3)
- A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Insulin-naive Subjects With Type 2 Diabetes Mellitus (T2DM) (PHASE3)
- A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Type 2 Diabetes Mellitus Subjects (T2DM) Treated With Basal + Prandial Insulin (PHASE3)
- A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE) (PHASE3)
- A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes (PHASE3)
- A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Insulin glargine U100 (HOE901) CI brief — competitive landscape report
- Insulin glargine U100 (HOE901) updates RSS · CI watch RSS
- Sanofi portfolio CI