Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
liraglutide · 1 trial · 1 indication
Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least squares (LS) mean and standard error (SE) were obtained from Mixed-effect model with repeated measures (MMRM) to account for missing data using all available post baseline data during the 26 week treatment period.
Change in HbA1c was calculated by subtracting baseline value from Week 52 value.
| Arm | Type | Description |
|---|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | EXPERIMENTAL | Core period: FRC injected subcutaneously once daily (QD) for 26 weeks on top of oral anti-diabetic drug (OAD) therapy. Dose individually adjusted. Single arm extension period: Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted. |
| GLP-1 Receptor Agonist | ACTIVE_COMPARATOR | Core period: GLP-1 RA receptor agonist (liraglutide QD, exenatide twice daily \[BID\], exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization. |
| Name | Type | Description |
|---|---|---|
| Insulin glargine/lixisenatide fixed ratio combination | DRUG | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
| liraglutide | DRUG | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
| exenatide | DRUG | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
| exenatide extended-release | DRUG | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
| albiglutide | DRUG | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
| dulaglutide | DRUG | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
| Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor) | DRUG | Pharmaceutical form: tablet Route of administration: oral If previously taken, doses to remain stable through the study. |
Inclusion criteria : * Participants with type 2 diabetes mellitus diagnosed at least 1 year prior to screening visit. * Participants who were treated with one of the following GLP-1 receptor agonists for at least 4 months prior to screening visit 1 (V1), and with stable dose for at least 3 months p...
Liraglutide is used for the treatment of Type 2 Diabetes Mellitus. It is being developed by Sanofi and is currently in Phase 3 clinical development. The drug is a small molecule and is being studied in a clinical trial to evaluate its efficacy and safety in patients with this condition.
The specific molecular target of liraglutide is not provided in the available information. Therefore, the mechanism of action for this drug is not described here. Liraglutide is being studied for its effects in patients with Type 2 Diabetes Mellitus, but the target is not specified.
Liraglutide is being developed by Sanofi, a company traded under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug's efficacy and safety for the treatment of Type 2 Diabetes Mellitus.
Liraglutide is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a Phase 3 trial to assess its safety and efficacy in patients with Type 2 Diabetes Mellitus.
Liraglutide is being studied in a Phase 3 clinical trial with the identifier NCT02787551. This trial is titled 'Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period'. The trial has been completed and enrolled 514 participants.
Liraglutide is not the same as insulin glargine/lixisenatide. In the clinical trial NCT02787551, liraglutide is being compared against a fixed ratio combination of insulin glargine and lixisenatide. Liraglutide is a separate drug being evaluated for the treatment of Type 2 Diabetes Mellitus.