Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled, 24-Week Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 50 mg Compared With 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 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.
;
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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