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INSULIN GLULISINE (HMR1964)
Insulin glulisine is a rapid-acting insulin analog that binds to the insulin receptor to facilitate glucose uptake and utilization in peripheral tissues.
Insulin glulisine is a rapid-acting insulin analog that binds to the insulin receptor to facilitate glucose uptake and utilization in peripheral tissues. Used for Type 1 diabetes mellitus, Type 2 diabetes mellitus.
At a glance
| Generic name | INSULIN GLULISINE (HMR1964) |
|---|---|
| Also known as | Apidra |
| Sponsor | Sanofi |
| Drug class | Rapid-acting insulin analog |
| Target | Insulin receptor |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | FDA-approved |
Mechanism of action
Insulin glulisine is a recombinant human insulin analog engineered with amino acid substitutions (lysine at position B3 and glutamic acid at position B29) to accelerate absorption and onset of action compared to regular human insulin. It binds to insulin receptors on muscle and adipose tissue, promoting glucose uptake and storage while suppressing hepatic glucose production, thereby lowering blood glucose levels 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
- Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India) (PHASE3)
- A Study to Demonstrate Bioequivalence Between Insulin Glulisine U300 and Insulin Glulisine U100 After a Single Subcutaneous Dose Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus (PHASE1)
- Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients (PHASE3)
- Evaluation of the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 Diabetes Mellitus (DM) Patients Uncontrolled With a Basal Insulin or Premix Once a Day (PHASE4)
- Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus (PHASE4)
- Glulisine Pre- and Postmeal (PHASE1)
- Glulisine + Lantus in Type I Patients (PHASE3)
- Efficacy and Safety of Insulin Glulisine in Type 1 Diabetes Mellitus (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 GLULISINE (HMR1964) CI brief — competitive landscape report
- INSULIN GLULISINE (HMR1964) updates RSS · CI watch RSS
- Sanofi portfolio CI