Conditions: Type 2 Diabetes Mellitus
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 393
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of TAK-875 in Asia Pacific adults with type 2 diabetes mellitus (T2DM).

Detailed description:
The drug being tested in this study is called TAK-875. TAK-875 is being tested to treat people who have diabetes.

The study will enroll approximately 750 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* TAK-875 25 mg once daily
* TAK-875 50 mg once daily
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient

All participants will be asked to take one tablet at the same time each day throughout the study. All participants will be asked to record any time they have low blood sugar symptoms in a diary.

This multi-centre trial will be conducted the Asia Pacific region. The overall time to participate in this study is 30 weeks. Participants will make 13 visits to the clinic.

Due to potential concerns about liver safety, on balance, the benefits of treating patients with fasiglifam (TAK-875) do not outweigh the potential risks.

For this reason, Takeda has decided voluntarily to terminate the development activities for fasiglifam.

Arms:
arm 1: TAK-875 25 mg tablets, orally, once daily for up to 24 weeks. arm 2: TAK-875 50 mg tablets, orally, once daily for up to 24 weeks. arm 3: TAK-875 placebo-matching tablets, orally, once daily for up to 24 weeks.

Interventions: intervention 1: TAK-875 intervention 2: TAK-875 Placebo
Intervention descriptions: intervention 1: TAK-875 tablets intervention 2: TAK-875 placebo-matching tablets

Protocol document: