Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-875 · 8 trials · 4 indications
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 12 relative to baseline.
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 25 mg | EXPERIMENTAL | - |
| TAK-875 50 mg | EXPERIMENTAL | - |
| Glimepiride | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Placebo QD | PLACEBO_COMPARATOR | - |
| TAK-875 25 mg QD | EXPERIMENTAL | - |
| TAK-875 50 mg QD | EXPERIMENTAL | - |
| Sitagliptin 100 mg QD | EXPERIMENTAL | - |
| TAK-875 25 mg QD + Sitagliptin 100 mg QD | EXPERIMENTAL | - |
| TAK-875 50 mg QD + Sitagliptin 100 mg QD | EXPERIMENTAL | - |
| TAK-875 6.25 mg QD | EXPERIMENTAL | - |
| TAK-875 100 mg QD | EXPERIMENTAL | - |
| TAK-875 200 mg QD | EXPERIMENTAL | - |
| Glimepiride 2 mg or 4mg QD | ACTIVE_COMPARATOR | - |
| 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. |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TAK-875 | DRUG | - |
| Glimepiride | DRUG | - |
| Placebo | DRUG | - |
| Sitagliptin | DRUG | Sitagliptin 100 mg, tablets, orally, once daily for up to 12 weeks. |
| TAK-875 and Sitagliptin | DRUG | TAK-875 25 mg, tablets, orally, once daily and sitagliptin 100 mg tablets, orally, once daily for up to 12 weeks. |
| TAK-875 and Glimepiride | DRUG | - |
Inclusion Criteria: * The participant is an outpatient. * The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. Exclusion Criteria: * The participant has any serious cardiac disease, serious cerebro...
TAK-875 is an investigational small molecule developed by Takeda Pharmaceutical Company Limited for type 2 diabetes mellitus. It has been studied in diabetic patients, including pharmacokinetic assessments, and reached Phase 3 clinical development. It is not described as an approved medicine.
TAK-875 was studied for the treatment of type 2 diabetes mellitus and in diabetic patients. Its clinical program included Phase 3 studies in Japan evaluating the drug in adults aged 20 years and older, along with a Phase 1 drug-interaction study conducted in the United States.
TAK-875 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda sponsored the clinical trial program for the compound, including the Phase 3 studies conducted in Japan and the Phase 1 drug-interaction study run in the United States.
TAK-875 reached Phase 3 clinical development. Three completed trials are recorded for the program, and no trials are currently listed as active. The Phase 3 studies were conducted in Japan, while a Phase 1 drug-interaction study took place in the United States.
TAK-875 has been evaluated in completed trials including NCT01585792, a Phase 3 double-blind comparative study; NCT01433419, a Phase 3 open-label study; NCT01433406, a Phase 3 long-term study; and NCT01496443, a Phase 1 glimepiride drug-interaction study. Total enrollment across these trials was 1,747 participants.
No. TAK-875 and glimepiride are different agents. Glimepiride appears in the TAK-875 development program as the comparator in a Phase 1 drug-interaction study, NCT01496443, which examined pharmacokinetics in 28 participants. TAK-875 is the investigational Takeda compound, while glimepiride is a separate diabetes medication.