To evaluate the efficacy of fasiglifam 50 mg once daily compared to placebo on glycemic control as measured by glycosilated haemoglobin (HbA1c) over a 16-week treatment period in participants with Type 2 Diabetes Mellitus (T2DM) and chronic kidney disease (CKD) stage 4 or 5 on dialysis.
The drug being tested in this study is called fasiglifam. Fasiglifam is being tested to treat people who have diabetes and chronic kidney disease. This study will look at glycemic control in people who take fasiglifam in addition to standard antihyperglycemic therapy. The study will enroll approximately 164 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): * Fasiglifam 50 mg; * 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 in addition to their current antihyperglycemic therapy. All participants will be asked to record any time they have hypoglycemia signs and symptoms in a diary. This multi-center trial will be conducted in the United States and European regions. The overall time to participate in this study is approximately 57 weeks. Participants will make 17 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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Fasiglifam tablets
Fasiglifam placebo-matching tablets
Including any of the following alone or in combination: insulin, sulfonylurea, thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, meglitinides, alpha-glucosidase inhibitors or dipeptidyl peptidase-4 (DPP-4) inhibitors acceptable by local practice guidelines.
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Whittier, California, United States
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Westminster, Colorado, United States
Change from Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16
The change from Baseline in glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at Week 16.
Time frame: Baseline and Week 16
Percentage of participants with HbA1c <7.5% at Week 16
Time frame: Week 16
Change from Baseline in Fasting Plasma Glucose (FPG) at Week 16
Time frame: Baseline and Week 16
Change from Baseline in Total Daily Dose of Insulin at Week 52
Time frame: Baseline and Week 52
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Unnamed facility
Tampa, Florida, United States
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Rosedale, New York, United States
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Cincinnati, Ohio, United States
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Charleston, South Carolina, United States
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San Antonio, Texas, United States
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Pazardzhik, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
...and 20 more locations