Comparison of Fasiglifam (TAK-875) With Sitagliptin When Used in Combination With Metformin in Patients With Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT01834274|
Recruitment Status : Terminated (Due to potential concerns about liver safety (See Detailed Description))
First Posted : April 17, 2013
Results First Posted : September 28, 2015
Last Update Posted : September 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Fasiglifam (TAK-875) Drug: Fasiglifam (TAK-875) Placebo Drug: Sitagliptin Drug: Sitagliptin Placebo Drug: Metformin||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
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) tablets
Drug: Sitagliptin Placebo
Sitagliptin placebo-matching tablets
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 tablets
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834274
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|Study Director:||Medical Director||Takeda|