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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
393
TAK-875 tablets
TAK-875 placebo-matching tablets
Change From Baseline in HbA1c at Week 24
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 24 relative to baseline.
Time frame: Baseline and Week 24
Percentage of Participants With HbA1c <7% at Week 24
Time frame: Week 24
Change in Fasting Plasma Glucose From Baseline to Week 24
The change between the fasting plasma glucose value collected at Week 24 relative to baseline.
Time frame: Baseline and Week 24
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following Oral Glucose Tolerance Test (OGTT) at Week 24
The change between the value of glucose after a meal, measured following OGTT collected at Week 24 relative to baseline. Oral glucose tolerance test measures glucose, insulin, and C-peptide through blood samples drawn at 0, 30, 60, 90, and 120 minutes following consumption of a 75 gram (g) glucose beverage.
Time frame: Baseline and Week 24
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Brookvale, New South Wales, Australia
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Maroubra, New South Wales, Australia
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Mosman, New South Wales, Australia
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Woy Woy, New South Wales, Australia
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Elizabeth Vale, South Australia, Australia
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Hefei, Anhui, China
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Beijing, Beijing Municipality, China
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Beijing,P.R., Beijing Municipality, China
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Chongqing, Chongqing Municipality, China
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Fuzhou, Fujian, China
...and 41 more locations