Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lixisenatide AVE0010 · 2 trials · 1 indication
| 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) |
| 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 |
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 being developed for the treatment of Type 2 Diabetes Mellitus. It is a small molecule GLP1R agonist studied in Phase 3 clinical trials, both as monotherapy and in combination with oral anti-diabetic treatment in patients with Type 2 Diabetes Mellitus.
Lixisenatide AVE0010 targets GLP1R, the glucagon-like peptide-1 receptor, and acts as an agonist at this receptor. This receptor target is central to its mechanism of action in metabolic disease, specifically in the management of Type 2 Diabetes Mellitus.
Lixisenatide AVE0010 is developed by Sanofi, which trades under the ticker SNY. Sanofi is the company responsible for advancing this GLP1R agonist through clinical development for Type 2 Diabetes Mellitus.
Lixisenatide AVE0010 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 3 trials have been completed, with no active trials currently ongoing.
Lixisenatide AVE0010 has been studied in two completed Phase 3 trials: NCT01960179, which evaluated safety and tolerability as monotherapy in patients with Type 2 Diabetes, and NCT01940965, which assessed safety and tolerability in combination with oral anti-diabetic treatment. Both trials were conducted in Japan.
Lixisenatide AVE0010 is also known as lixisenatide. The AVE0010 designation is an internal code used during development. Both names refer to the same GLP1R agonist small molecule developed by Sanofi for Type 2 Diabetes Mellitus.