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Insulin glargine (U300)
Insulin glargine (U300) is a long-acting basal insulin that binds to insulin receptors on muscle and fat cells to promote glucose uptake and reduce blood glucose levels.
Insulin glargine (U300) is a long-acting basal insulin that binds to insulin receptors on muscle and fat cells to promote glucose uptake and reduce blood glucose levels. Used for Type 1 diabetes mellitus, Type 2 diabetes mellitus.
At a glance
| Generic name | Insulin glargine (U300) |
|---|---|
| Also known as | HOE901 Toujeo, Toujeo, HOE901, HOE901, HOE901, Toujeo, Gla-300, HOE901, Toujeo, Toujeo Solostar |
| 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 with an extended duration of action due to its formulation and pharmacokinetic properties. The U300 formulation (300 units/mL) provides a higher concentration, allowing for smaller injection volumes while maintaining steady basal insulin levels for approximately 24 hours or longer. It works by mimicking endogenous insulin to regulate glucose metabolism and maintain euglycemia in diabetic patients.
Approved indications
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
Common side effects
- Hypoglycemia
- Injection site reactions
- Weight gain
- Lipodystrophy
Key clinical trials
- Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes (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)
- Degludec Glargine U300 Hospital Study (NA)
- Effectiveness of a Diabetes Focused Discharge Order Set Among Poorly Controlled Hospitalized Patients Transitioning to Glargine U300 Insulin (NA)
- Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients (PHASE4)
- Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost.
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 |