Glycemic Control Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-875 25 mg and 50 mg Compared to Placebo and Sitagliptin 100 mg When Used in Combination With Metformin in Subjects With Type 2 Diabetes
The purpose of this study is to evaluate the efficacy of 2 doses of TAK-875 (25 mg and 50 mg), once daily (QD), plus metformin compared to placebo plus metformin and sitagliptin plus metformin on lowering blood sugar.
TAK-875 is being developed at Takeda Global Research and Development, Inc. as an adjunct to
diet and exercise to improve glycemic control in participants with Type 2 Diabetes Mellitus
(T2DM) whose blood glucose level is inadequately controlled with metformin.
This study will evaluate the efficacy of TAK-875 (25 mg and 50 mg) plus metformin compared
to placebo plus metformin and sitagliptin plus metformin on glycemic control as measured by
change from baseline in glycosylated hemoglobin (HbA1c) over a 24-week Treatment Period.
Participants completing the 24-week Treatment Period may enter an optional 80-week extension
period for a total of 104 weeks of treatment.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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