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)
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|ClinicalTrials.gov Identifier: NCT01647542|
Recruitment Status : Terminated (Due to potential concerns about liver safety (See Detailed Description))
First Posted : July 23, 2012
Results First Posted : August 19, 2015
Last Update Posted : November 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: TAK-875 Drug: TAK-875 Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||393 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||March 2014|
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
- Change From Baseline in HbA1c at Week 24 [ 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 relative to baseline.
- Percentage of Participants With HbA1c <7% at Week 24 [ Time Frame: Week 24 ]
- Change in Fasting Plasma Glucose From Baseline to Week 24 [ Time Frame: Baseline and Week 24 ]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 ]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.
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): NCT01647542
|Study Director:||Medical Director||Takeda|