Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-week Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 and 50mg Compared With Placebo in Asia Pacific Subjects With Type 2 Diabetes
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.
;
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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