Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 and 50mg in Asia Pacific Adults With Type 2 Diabetes (GRAND-307)
The purpose of this study is to evaluate the efficacy and safety of TAK-875 in Asia Pacific adults with type 2 diabetes mellitus (T2DM).
|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, Placebo-Controlled, 24-week Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 and 50mg Compared With Placebo in Asia Pacific 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 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 less than 7.0% [ Time Frame: Week 24 ] [ Designated as safety issue: No ]The percentage of Participants with HbA1C less than 7.0% (as a percent of the total number of Participants in the study).
- Change from Baseline in fasting plasma glucose [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]The change from Baseline to Week 24 in fasting plasma glucose (the amount of glucose in blood after fasting for at least 10 hours).
- Change from Baseline in 2-hour postprandial glucose following oral glucose tolerance test [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]During the oral glucose tolerance test (OGTT), patients will be given a standardized glucose solution to drink within 5 minutes after fasting for at least 10 hours prior. 2 hours after consuming the solution (postprandial), blood samples will be taken for glucose measurements. OGTT will be performed at Baseline and again at Week 24.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: TAK-875 25 mg
TAK-875 25 mg tablets, orally, once daily for up to 24 weeks.
Experimental: TAK-875 50 mg
TAK-875 50 mg tablets, orally, once daily for up to 24 weeks.
Placebo Comparator: Placebo
TAK-875 placebo-matching tablets, orally, once daily for up to 24 weeks.
Drug: TAK-875 Placebo
TAK-875 placebo-matching tablets
The drug being tested in this study is called TAK-875. TAK-875 is being tested to treat people who have diabetes.
The study will enroll approximately 750 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 25 mg once daily
- TAK-875 50 mg once daily
- 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. All participants will be asked to record any time they have low blood sugar symptoms in a diary.
This multi-centre trial will be conducted the Asia Pacific region. The overall time to participate in this study is 30 weeks. Participants will make 13 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: NCT01647542
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|Study Director:||Medical Director||Takeda|