Fasiglifam 25 mg BID vs 50 mg QD
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|ClinicalTrials.gov Identifier: NCT01982253|
Recruitment Status : Terminated (Due to potential concerns about liver safety (See Detailed Description))
First Posted : November 13, 2013
Results First Posted : October 7, 2016
Last Update Posted : October 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Fasiglifam Drug: Placebo to fasiglifam||Phase 2|
The drug being tested in this study is called fasiglifam. Fasiglifam is being tested to treat people who have diabetes. This study will look at glycemic control in people who take fasiglifam.
The study will enroll approximately 400 patients. Participants will be randomly assigned (by chance) to one of the three treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- Fasiglifam 25 mg twice a day
- Fasiglifam 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 twice each day throughout the study. All participants will be asked to record any time they have symptoms of hypoglycemia in a diary.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is 18 weeks. Participants will make 9 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 :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2 Randomized, Placebo-Controlled, Double-Blind Parallel-Group, Multicenter Study to Evaluate the Glycemic Effects and Safety of Fasiglifam 25 mg Twice Daily and 50 mg Once Daily on Glycemic Control in Subjects With Type 2 Diabetes|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Placebo Comparator: Placebo
Fasiglifam placebo-matching tablets, orally, twice daily for up to 12 weeks.
Drug: Placebo to fasiglifam
Fasiglifam placebo-matching tablets
Experimental: Fasiglifam 25 mg BID
Fasiglifam 25 mg tablets, orally, twice daily (BID) for up to 12 weeks.
Other Name: TAK-875
Experimental: Fasiglifam 50 mg QD +Placebo QD
Fasiglifam 50 mg tablets, orally once daily (QD) and fasiglifam placebo-matching tablets, orally, once daily for up to 12 weeks.
Other Name: TAK-875Drug: Placebo to fasiglifam
Fasiglifam placebo-matching tablets
- Change From Baseline in HbA1c at Week 12. [ Time Frame: Baseline and Week 12 ]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 12 or final visit relative to baseline.
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 [ Time Frame: Baseline and Week 12 ]The change between the FPG value collected at week 12 or final visit relative to baseline.
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): NCT01982253
Show 88 Study Locations
|Study Director:||Senior Medical Director, Clinical Science||Takeda|