Comparison of Fasiglifam (TAK-875) With Sitagliptin When Used in Combination With Metformin in Patients With Type 2 Diabetes
|Diabetes Mellitus, Type 2||Drug: Fasiglifam (TAK-875) Drug: Fasiglifam (TAK-875) Placebo Drug: Sitagliptin Drug: Sitagliptin Placebo Drug: Metformin||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline and Week 24 ]The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 or final visit relative to Baseline. A negative change from Baseline indicated improvement.
- Percentage of Participants With HbA1c <7% at Week 24 [ Time Frame: Week 24 ]The percentage of participants with glycosylated hemoglobin less than 7% after 24 weeks of treatment.
- Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline and Week 24 ]The change between FPG collected at week 24 or final visit relative to Baseline. A negative change from Baseline indicated improvement.
|Study Start Date:||June 2013|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: Fasiglifam 50 mg
Fasiglifam (TAK-875) 50 mg tablets, orally, once daily, Sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
Drug: Fasiglifam (TAK-875)
Fasiglifam (TAK-875) tabletsDrug: Sitagliptin Placebo
Sitagliptin placebo-matching tabletsDrug: Metformin
Active Comparator: Sitagliptin 100 mg
Sitagliptin 100 mg, tablets, once daily, TAK-875 placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
Drug: Fasiglifam (TAK-875) Placebo
Fasiglifam (TAK-875) placebo-matching tabletsDrug: Sitagliptin
Sitagliptin tabletsDrug: Metformin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01834274
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|Study Director:||Medical Director||Takeda|