Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-875 and Glimepiride · 1 trial · 1 indication
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax
(AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).
AUC(0-inf) is measure of area under the plasma concentration-time curve from time 0 to infinity after drug administration.
AUC(0-24) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau\]), where tau is the length of the dosing interval - 24 hours in this study).
| Arm | Type | Description |
|---|---|---|
| TAK-875 & Glimepiride QD | EXPERIMENTAL | TAK-875 50 mg, tablets, orally and glimepiride 2 mg, capsules, orally and glimepiride placebo matching capsules, orally, once daily on dosing days for up to 19 days. |
| Name | Type | Description |
|---|---|---|
| TAK-875 and Glimepiride | DRUG | - |
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...
TAK-875 is an investigational small molecule being developed for the treatment of type 2 diabetes mellitus. It has been studied in diabetic patients, with clinical trials focusing on its efficacy and safety in this population. The drug is in Phase 3 clinical development.
TAK-875 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company has conducted multiple clinical trials of the drug in Japan and the United States.
TAK-875 is in Phase 3 clinical development. It has completed three Phase 3 trials in Japan, including a double-blind comparative study, a long-term study, and an open-label study. The drug is investigational and not yet approved.
TAK-875 has completed three Phase 3 trials in Japan: NCT01433393, a double-blind comparative study with 192 patients; NCT01433406, a long-term study with 1222 patients; and NCT01433419, an open-label study with 333 patients. A Phase 1 drug-interaction study, NCT01496443, was also completed in the United States.
TAK-875 is not known to have alternative names. It is a distinct investigational compound developed by Takeda Pharmaceutical Company Limited for type 2 diabetes mellitus.