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lixisenatide AVE0010 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| lixisenatide | EXPERIMENTAL | lixisenatide monotherapy by group (Group 1: 52-week treatment; Group 2: 24-week treatment) |
| Lixisenatide + Biguanide | EXPERIMENTAL | 52-week treatment with Lixisenatide in combination with biguanide (usual maintenance dose in the label) |
| Lixisenatide + TZD | EXPERIMENTAL | 52-week treatment with lixisenatide in combination with TZD (usual maintenance dose in the label) |
| Lixisenatide + alpha-GI | EXPERIMENTAL | 52-week treatment with Lixisenatide in combination with alpha-GI (usual maintenance dose in the label) |
| Lixisenatide + Glinide | EXPERIMENTAL | 52-week treatment with Lixisenatide in combination with glinide (usual maintenance dose in the label) |
| 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 |
|---|---|---|
| lixisenatide AVE0010 | DRUG | Pharmaceutical form:solution Route of administration: Subcutaneous injection |
| biguanide | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| TZD | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| alpha-GI | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| glinide | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| Insulin glargine HOE901 | DRUG | Pharmaceutical form:solution for injection Route of administration: subcutaneous |
Inclusion criteria: * Patients with type 2 diabetes mellitus diagnosed for at least 2 months. * Not treated with anti-diabetic drug or treated with a stable dose of 1 oral anti-diabetic drug (OAD) for at least 3 months prior to screening visit. Previous OAD (if any) have to be stopped at Visit 1.1 ...
Lixisenatide AVE0010 is an investigational small molecule being developed for Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus. It is studied in combination with oral anti-diabetic treatment or as monotherapy in patients with Type 2 Diabetes. The drug is in clinical development and has not been approved.
Lixisenatide AVE0010 is developed by Sanofi, a company traded under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug's safety, tolerability, and bioavailability in patients with diabetes.
Lixisenatide AVE0010 is in Phase 1 clinical development. While some completed trials are Phase 3, the overall development stage is Phase 1. The drug is investigational and not yet approved for any indication.
Lixisenatide AVE0010 has completed two clinical trials: NCT01146678, a Phase 1 study of different formulations with insulin glargine in Type 1 Diabetes, and NCT01940965, a Phase 3 study in combination with oral anti-diabetic treatment in Type 2 Diabetes. Both trials are completed.
Yes, Lixisenatide AVE0010 is also known as AVE0010. The drug is referred to by both names in clinical research, and the name AVE0010 is used in trial registrations and scientific literature.