TAK-875 (Fasiglifam) in Combination With Sitagliptin in Adults With Type 2 Diabetes
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Daily Oral Fasiglifam 25 mg and 50 mg Compared to Placebo When Used in Combination With Sitagliptin in Subjects With Type 2 Diabetes|
- Change from Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]The change from Baseline to Week 24 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).
- Percentage of participants with HbA1c <7% at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).
- Change from baseline in fasting plasma glucose at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]The change between the fasting plasma glucose value collected at week 24 relative to baseline.
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
TAK-875 placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally for up 24 weeks.
TAK-875 placebo-matching tablets
Experimental: TAK-875 25 mg
TAK-875 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally for up to 24 weeks
Experimental: TAK-875 50 mg
TAK-875 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally for up to 24 weeks
The drug being tested in this study is called TAK-875 (fasiglifam). Fasiglifam is being tested to treat people who have type 2 diabetes mellitus and are currently taking sitagliptin (with or without metformin). This study will evaluate glycemic control in people who take fasiglifam plus sitagliptin compared with placebo plus sitagliptin.
The study will enroll approximately 390 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need; all participants will be on 100 mg sitagliptin and may or may not be on metformin background treatment):
- fasiglifam 25 mg
- 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.
This multi-centre trial will be conducted in North America and Latin America. The overall time to participate in this study is approximately 38 weeks. Participants will make 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01829464
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|Study Director:||Medical Director, MD||Takeda|