Comparison of TAK-875 With Sitagliptin When Used in Combination With Metformin in Patients With Type 2 Diabetes
The purpose of this study is to evaluate the efficacy of TAK-875 plus metformin compared with sitagliptin plus metformin on glycemic control over a 24-week Treatment Period.
Diabetes Mellitus, Type 2
Drug: TAK-875 Placebo
Drug: Sitagliptin Placebo
|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 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 ] [ Designated as safety issue: No ]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.
- Percentage of participants with HbA1c <7% at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The change between FPG collected at week 24 or final visit relative to baseline.
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: TAK-875 50 mg
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.
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: TAK-875 Placebo
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 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.
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|Study Director:||Medical Director||Takeda|