The purpose of this study is to evaluate the efficacy of fasiglifam (TAK-875) plus metformin compared with sitagliptin plus metformin on glycemic control over a 24-week Treatment Period.
The drug being tested in this study is called TAK-875. TAK-875 is being tested to treat people who have type 2 diabetes. This study will look at glycemic control in people who take TAK-875 in addition to metformin. The study will enroll approximately 620 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 50 mg * Sitagliptin 100 mg All participants will be asked to take one tablet at the same time each day throughout the study. All participants will be asked to self-monitor their blood glucose levels and document any increases in blood glucose or symptoms of hypoglycemia in a diary. This multi-center trial will be conducted in the United States, Latin America, Europe and Asia. The overall time to participate in this study is up to 42 weeks and participants will make up to 15 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
96
Fasiglifam (TAK-875) tablets
Fasiglifam (TAK-875) placebo-matching tablets
Sitagliptin tablets
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
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 or final visit relative to Baseline. A negative change from Baseline indicated improvement.
Time frame: Baseline and Week 24
Percentage of Participants With HbA1c <7% at Week 24
The percentage of participants with glycosylated hemoglobin less than 7% after 24 weeks of treatment.
Time frame: Week 24
Change From Baseline in Fasting Plasma Glucose (FPG)
The change between FPG collected at week 24 or final visit relative to Baseline. A negative change from Baseline indicated improvement.
Time frame: Baseline and Week 24
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Sitagliptin placebo-matching tablets
Metformin tablets
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Huntsville, Alabama, United States
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Chandler, Arizona, United States
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Glendale, Arizona, United States
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Little Rock, Arkansas, United States
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Fresno, California, United States
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Garden Grove, California, United States
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Modesto, California, United States
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San Diego, California, United States
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Thousand Oaks, California, United States
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Lakewood, Colorado, United States
...and 94 more locations