Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Insulin glargine new formulation HOE901
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...