Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02787551 | 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 | PHASE3 | COMPLETED | 514 | — | — | Jul 6, 2016 | Nov 17, 2018 | Mar 25, 2022 | 124 | United States, Canada +7 |
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...