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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01456195 | Comparison of TAK-875 (Fasiglifam) With Placebo in Participants With Type 2 Diabetes | PHASE3 | COMPLETED | 421 | — | — | Nov 1, 2011 | Jul 1, 2013 | Apr 5, 2016 | 95 | United States, Argentina +6 |
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to Baseline. A mixed model repeated measures (MMRM) model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks. |
| Fasiglifam 25 mg | EXPERIMENTAL | Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks. |
| Fasiglifam 50 mg | EXPERIMENTAL | Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Fasiglifam placebo-matching tablets |
| Fasiglifam | DRUG | Fasiglifam tablets |
Inclusion Criteria: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any requi...