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Insulin glargine 300 U/ml
Insulin glargine is a long-acting basal insulin that binds to insulin receptors on cells to promote glucose uptake and utilization, lowering blood glucose levels.
Insulin glargine is a long-acting basal insulin that binds to insulin receptors on cells to promote glucose uptake and utilization, lowering blood glucose levels. Used for Type 1 diabetes mellitus, Type 2 diabetes mellitus.
At a glance
| Generic name | Insulin glargine 300 U/ml |
|---|---|
| Also known as | HOE901 Toujeo, Toujeo, HOE901-U300 |
| Sponsor | Sanofi |
| Drug class | Long-acting basal insulin |
| Target | Insulin receptor |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | FDA-approved |
Mechanism of action
Insulin glargine is a recombinant human insulin analog modified to have an extended duration of action (up to 24 hours). It binds to the insulin receptor on target tissues including muscle, fat, and liver, facilitating glucose transport into cells and promoting glycogen synthesis while inhibiting gluconeogenesis. The 300 U/ml formulation is a higher concentration allowing for smaller injection volumes.
Approved indications
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
Common side effects
- Hypoglycemia
- Injection site reactions
- Weight gain
- Lipodystrophy
Key clinical trials
- iGlarLixi CGM Study in Chinese T2D Individuals After OADs (PHASE4)
- A Clinical Efficacy and Safety Study of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period (PHASE4)
- Evaluation of the Safety and Efficacy of Insulin Glargine 300 U/ml (Gla-300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus Uncontrolled on Oral Antihyperglycemic Drugs (PHASE4)
- Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment (PHASE4)
- Remote And Decentralised Innovative Approaches to Clinical Trials (RADIAL) (PHASE4)
- A Study to Observe How Insulin Glargine 300 U/ml is Working and is Tolerated in Elderly Patients ≥75 Years of Age With Type 2 Diabetes
- Efficacy and Safety of Dapagliflozin for the Hospital Management of Patients With Type 2 Diabetes (PHASE4)
- Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients (PHASE4)
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 300 U/ml CI brief — competitive landscape report
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- Sanofi portfolio CI