Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fasiglifam (TAK-875) Compared to Placebo as Add-on to Preexisting Antihyperglycemic Therapy Over 16 Weeks With 36-week Extension in Type 2 Diabetic Subjects With Chronic Kidney Disease Stage 4 or Stage 5 on Dialysis
To evaluate the efficacy of fasiglifam 50 mg once daily compared to placebo on glycemic control as measured by glycosilated haemoglobin (HbA1c) over a 16-week treatment period in participants with Type 2 Diabetes Mellitus (T2DM) and chronic kidney disease (CKD) stage 4 or 5 on dialysis.
The drug being tested in this study is called fasiglifam. Fasiglifam is being tested to
treat people who have diabetes and chronic kidney disease. This study will look at glycemic
control in people who take fasiglifam in addition to standard antihyperglycemic therapy.
The study will enroll approximately 164 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):
- Fasiglifam 50 mg;
- 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 in addition to their current antihyperglycemic therapy. All participants will be asked
to record any time they have hypoglycemia signs and symptoms in a diary.
This multi-center trial will be conducted in the United States and European regions. The
overall time to participate in this study is approximately 57 weeks.
Participants will make 17 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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