Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fasiglifam · 1 trial · 1 indication
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...
Fasiglifam is an investigational small molecule being developed for the treatment of type 2 diabetes mellitus. It is being studied as a potential therapy to help manage blood sugar levels in adults with this condition. The drug is currently in clinical development and has not been approved for use.
Fasiglifam is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda is listed on the stock exchange under the ticker symbol TAK. The company is conducting clinical trials to evaluate the safety and efficacy of Fasiglifam for type 2 diabetes.
Fasiglifam is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial was a randomized, double-blind, placebo-controlled study designed to assess the drug's effects in participants with type 2 diabetes.
Fasiglifam has been studied in a Phase 3 clinical trial with the identifier NCT01456195. This completed trial compared Fasiglifam with placebo in 421 participants with type 2 diabetes. The study was conducted in multiple countries, including the United States, Argentina, Bulgaria, Guatemala, Hungary, Mexico, Slovakia, and Ukraine.
Yes, Fasiglifam is also known as TAK-875. The clinical trial NCT01456195, which evaluated the drug in participants with type 2 diabetes, used the name TAK-875 in its official title. Both names refer to the same investigational compound being developed by Takeda.