Conditions: Diabetes Mellitus, Type 2
Keywords: Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 421
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the efficacy and safety of TAK-875 (fasiglifam), once daily (QD), in participants with type 2 diabetes mellitus (T2DM).

Detailed description:
TAK-875 is being developed at Takeda Development Center, Inc. as an adjunct to diet and exercise to improve glycemic control in patients with T2DM.

This study will investigate TAK-875 in participants with type 2 diabetes mellitus who have been treated with only diet and exercise for at least 12 weeks prior to Screening, who have taken ≤7 days of any antidiabetic agent within the 12 weeks prior to Screening, and whose glycemic control is inadequate.

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

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

Protocol document: