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Also known as Insulin glargine new formulation HOE901, Lantus®
Insulin glargine HOE901 · 4 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Insulin glargine new formulation (test T formulation) | EXPERIMENTAL | Once daily for 6 days |
| Insulin glargine new formulation (reference R formulation) | EXPERIMENTAL | Once daily for 6 days |
| Sequence 1 | EXPERIMENTAL | Reference (insulin glargine) - Test1 (insulin glargine - new formulation dose 1) - Test2 (insulin glargine - new formulation dose 2) |
| Sequence 2 | EXPERIMENTAL | Test1 (insulin glargine - new formulation dose 1) - Test2 (insulin glargine - new formulation dose 2) - Reference (insulin glargine) |
| Sequence 3 | EXPERIMENTAL | Test2 (insulin glargine - new formulation dose 2) - Reference (insulin glargine) - Test1 (insulin glargine - new formulation dose 1) |
| Cohort 1 | EXPERIMENTAL | Dose Level 1 |
| Cohort 2 | EXPERIMENTAL | Dose Level 2 |
| Lantus(insulin glargine)/lixisenatide on-site mix | EXPERIMENTAL | Single dose injection of an on site mix of Lantus U100 and lixisenatide (800µg/mL in Lantus U100) at one peri-umbilical site under fasting conditions |
| lixisenatide + Lantus (insulin glargine) | ACTIVE_COMPARATOR | Single dose, separate injection simultaneous injections of Lantus U100 and lixisenatide (100µg/mL) at opposite peri-umbilical sites within 1 minute under fasting conditions |
| Name | Type | Description |
|---|---|---|
| Insulin glargine new formulation HOE901 | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Insulin glargine HOE901 | DRUG | Pharmaceutical form:solution for injection Route of administration: subcutaneous |
| Insulin glargine - New formulation HOE901 | DRUG | Pharmaceutical form:solution for injection Route of administration: subcutaneous |
| Lixisenatide AVE0010 | DRUG | Pharmaceutical form:solution for injection Route of administration: subcutaneous |
Inclusion criteria : * Male or female subjects, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year * Total insulin dose of \< 1.2 U/kg/day * Minimum usual basal insulin dose ≥ 0.2 U/kg/day * Body weight between 50.0 kg and 110.0 kg, Body Mass Index betwe...
Insulin glargine HOE901 is an investigational insulin glargine formulation developed by Sanofi for the treatment of Type 1 Diabetes Mellitus. It is a small molecule that acts as an agonist at the insulin receptor (INSR). The program has completed Phase 1 clinical development, with three completed trials and no active trials.
Insulin glargine HOE901 is being studied for Type 1 Diabetes Mellitus, also referred to as Type 1 Diabetes. All completed trials enrolled adult patients with this condition, including studies conducted in Germany and Japan. It is an investigational product and has not been approved for commercial use.
Insulin glargine HOE901 targets the insulin receptor, or INSR, where it acts as an agonist. This receptor-mediated activity underlies its intended glucose-lowering effect in patients with Type 1 Diabetes Mellitus. The molecule is classified as a small molecule in the metabolic therapeutic area.
Sanofi is developing Insulin glargine HOE901. Sanofi trades under the ticker SNY. The company has sponsored the Phase 1 clinical program evaluating this new insulin glargine formulation in patients with Type 1 Diabetes Mellitus.
Insulin glargine HOE901 is in Phase 1 clinical development. Three Phase 1 trials have been completed, and there are currently no active trials. It is an investigational drug and has not been approved by the FDA or any other regulatory agency.
Insulin glargine HOE901 has been evaluated in completed Phase 1 trials including NCT01838083, a euglycemic clamp study in Germany; NCT01493115, a single-dose study in Japanese patients; NCT01349855, a repeated-dosing study in Germany; and NCT01146678, a relative bioavailability study. All trials enrolled patients with Type 1 Diabetes Mellitus.
Yes, Insulin glargine HOE901 is also known as Insulin glargine new formulation HOE901. Both names refer to the same Sanofi investigational insulin glargine product studied in Phase 1 trials for Type 1 Diabetes Mellitus.