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Also known as Insulin glulisine (U300), Insulin glulisine (HMR1964), Insulin glulisine QD, Apidra®
Insulin glulisine · 20 trials · 11 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Administration of Insulin Glulisine |
| 2 | ACTIVE_COMPARATOR | Administration of Lispro |
| I | EXPERIMENTAL | - |
| II | ACTIVE_COMPARATOR | - |
| Insulin Glulisine | EXPERIMENTAL | Insulin Glulisine (100UI/ml), at least twice daily, in association with basal insulin therapy (NPH insulin or insulin glargine for a maximum of 26 weeks |
| Insulin Lispro | ACTIVE_COMPARATOR | Insulin Lispro (100UI/ml) Subcutaneous (SC) injection , at least twice daily, in association with basal insulin therapy (NPH insulin or insulin glargine ) for a maximum of 30 weeks |
| 3 | EXPERIMENTAL | Twice daily: * Insulin glulisine Dosing: Supper, Lunch, Breakfast * Monitoring Needed at: Bedtime, Pre-Supper, Pre-Lunch |
| Insulin glulisine (U300) - Test formulation | EXPERIMENTAL | Insulin glulisine (U300) will be given as a single subcutaneous (SC) dose on Day 1 of each period under fasting conditions according to the random list and assigned sequence. Glucose, insulin aspart (IV) and heparin will be used for clamp procedure. NPH insulin (if necessary) and insulin aspart (SC) will be handed out at screening to change insulin regimen and glucagon at Day 1 to treat cases of severe hypoglycemia. |
| Insulin glulisine - Reference formulation | ACTIVE_COMPARATOR | Insulin glulisine (U100) will be given as a single SC dose on Day 1 of each period under fasting conditions according to the random list and assigned sequence. Glucose, insulin aspart (IV) and heparin will be used for clamp procedure. NPH insulin (if necessary) and insulin aspart (SC) will be handed out at screening to change insulin regimen and glucagon at Day 1 to treat cases of severe hypoglycemia. |
| insulin glulisine + insulin aspart | EXPERIMENTAL | insulin glulisine (1 day) + wash-out (7 days) + insulin aspart (1 day) |
| insulin aspart + insulin glulisine | EXPERIMENTAL | insulin glulisine (1 day) + wash-out (7 days) + insulin aspart (1 day) |
| Name | Type | Description |
|---|---|---|
| Insulin Glulisine | DRUG | 3 times a day before each meal |
| Lispro | DRUG | 3 times a day before each meal |
| Insulin Glargine | DRUG | once daily |
| Metformin | DRUG | 1000 mg b.i.d, since the qualification phase, oral |
| insulin glulisine / insulin glargine | DRUG | insulin glargine administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00 |
| insulin glulisin / insulin detemir | DRUG | insulin detemir administered subcutaneously by the patient once a day, in the evening, between 18.30 and 24.00 |
| insulin lispro | DRUG | Subcutaneous injection |
| NPH insulin | DRUG | subcutaneous injection twice daily |
| Insulin Therapy | DRUG | NPH (70%) plus regular insulin or insulin aspart (30%) |
| Insulin glulisine (HMR1964) | DRUG | - |
| Insulin glulisine (U300) | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Insulin aspart | DRUG | Pharmaceutical form: solution Route of administration: intravenous/subcutaneous |
| Glucagon | DRUG | Pharmaceutical form: Powder and solvent for solution for injection Route of administration: subcutaneous |
| Glucose | DRUG | Pharmaceutical form: solution Route of administration: intravenous |
| Heparin | DRUG | Pharmaceutical form: solution Route of administration: intravenous |
Inclusion Criteria: * Type 1 or type 2 diabetic patients * Measure HbA1c 6.5% to 11.0% at visit 1 * More than 3 months of continuous insulin treatment immediately prior to study entry Exclusion Criteria: * Pregnant women The above information is not intended to contain all considerations relevan...
Insulin glulisine is a rapid-acting insulin used to treat diabetes mellitus, including type 1 and type 2 diabetes. It is studied for use in insulin-dependent diabetes and is administered subcutaneously to control blood glucose levels, often in combination with a longer-acting insulin such as insulin glargine.
Insulin glulisine works as an agonist at the insulin receptor (INSR). By binding to and activating INSR, it mimics the action of endogenous insulin, promoting glucose uptake into skeletal muscle and fat tissue and inhibiting hepatic glucose production, thereby lowering blood glucose levels.
Insulin glulisine is being developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical trials evaluating this drug.
Insulin glulisine is in Phase 3 clinical development. It has completed nine trials, including Phase 3 studies, but is not yet approved. The development program includes both Phase 1 and Phase 3 trials, with no active trials currently listed.
Insulin glulisine has been studied in completed trials including NCT02910518, a Phase 1 bioequivalence study of U300 versus U100 in type 1 diabetes; NCT01159353, a Phase 1 pharmacodynamic study in type 2 diabetes; NCT00467376, a Phase 3 trial in type 1 or 2 diabetes; and NCT00397553, a Phase 3 trial in type 1 diabetes.
Yes, insulin glulisine is also known as insulin glulisine (U300), insulin glulisine (HMR1964), insulin glulisine QD, and insulin glulisine / insulin glargine. These alternative names refer to the same drug or its combination with insulin glargine.