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 HbA1c at Week 24 [ 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 relative to baseline.
- Percentage of Participants With HbA1c <7% at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- Change in Fasting Plasma Glucose From Baseline to 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.
- Change From Baseline in 2-hour Postprandial Glucose (PPG) Following Oral Glucose Tolerance Test (OGTT) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]The change between the value of glucose after a meal, measured following OGTT collected at Week 24 relative to baseline. Oral glucose tolerance test measures glucose, insulin, and C-peptide through blood samples drawn at 0, 30, 60, 90, and 120 minutes following consumption of a 75 gram (g) glucose beverage.
|Study Start Date:||October 2012|
|Study Completion Date:||March 2014|
|Primary Completion Date:||February 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|