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Glargine U300
Glargine U300 is a long-acting basal insulin that binds to insulin receptors to promote glucose uptake and utilization in peripheral tissues while suppressing hepatic glucose production.
Glargine U300 is a long-acting basal insulin that binds to insulin receptors 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 | Glargine U300 |
|---|---|
| Also known as | Toujeo |
| Sponsor | University of Split, School of Medicine |
| Drug class | Long-acting basal insulin analog |
| Target | Insulin receptor |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | FDA-approved |
Mechanism of action
Glargine U300 is an ultra-long-acting insulin analog derived from insulin glargine, formulated at a higher concentration (300 units/mL) to provide an extended duration of action of up to 36 hours or more. It mimics endogenous insulin by activating insulin receptors on muscle and adipose tissue to facilitate glucose uptake, and simultaneously inhibits gluconeogenesis and glycogenolysis in the liver. This sustained basal insulin coverage helps maintain glycemic control throughout the day and night in patients with diabetes.
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Glargine U300 CI brief — competitive landscape report
- Glargine U300 updates RSS · CI watch RSS
- University of Split, School of Medicine portfolio CI