Last reviewed 2026-04-22 · How we verify

Insulin glargine, 300U/mL

Insulin glargine is a long-acting basal insulin that binds to insulin receptors on cells to promote glucose uptake and reduce blood glucose levels.

Insulin glargine is a long-acting basal insulin that binds to insulin receptors on cells to promote glucose uptake and reduce blood glucose levels. Used for Type 1 diabetes mellitus, Type 2 diabetes mellitus.

At a glance

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 insulin receptors on muscle, fat, and liver cells, facilitating glucose uptake and storage while suppressing hepatic glucose production. The 300U/mL formulation is a concentrated version allowing smaller injection volumes for patients requiring high insulin doses.

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 Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before (PHASE3)
• Toujeo Versus NPH Self-titration Study (PHASE4)
• Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist (PHASE4)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Insulin glargine, 300U/mL CI brief — competitive landscape report
• Insulin glargine, 300U/mL updates RSS · CI watch RSS
• Sanofi portfolio CI