Conditions: Type 2 Diabetes Mellitus
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 10
Healthy volunteers: no

Brief summary:
To evaluate the efficacy of fasiglifam 25 mg twice daily (BID) and fasiglifam 50 mg once daily (QD) on glycemic control in adults with type 2 diabetes who are inadequately controlled on diet and exercise alone.

Detailed description:
The drug being tested in this study is called fasiglifam. Fasiglifam is being tested to treat people who have diabetes. This study will look at glycemic control in people who take fasiglifam.

The study will enroll approximately 400 patients. Participants will be randomly assigned (by chance) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* Fasiglifam 25 mg twice a day
* Fasiglifam 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 twice each day throughout the study. All participants will be asked to record any time they have symptoms of hypoglycemia in a diary.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 18 weeks. Participants will make 9 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: Fasiglifam placebo-matching tablets, orally, twice daily for up to 12 weeks. arm 2: Fasiglifam 25 mg tablets, orally, twice daily (BID) for up to 12 weeks. arm 3: Fasiglifam 50 mg tablets, orally once daily (QD) and fasiglifam placebo-matching tablets, orally, once daily for up to 12 weeks.

Interventions: intervention 1: Fasiglifam intervention 2: Placebo to fasiglifam
Intervention descriptions: intervention 1: Fasiglifam tablets intervention 2: Fasiglifam placebo-matching tablets

Protocol document: