Fasiglifam in Type 2 Diabetic Subjects With Chronic Kidney Disease Stage 4 or 5 on Hemodialysis (NCT02015780) | Clinical Trial Compass
WithdrawnPhase 3
Fasiglifam in Type 2 Diabetic Subjects With Chronic Kidney Disease Stage 4 or 5 on Hemodialysis
Stopped: Due to potential concerns about liver safety (See Detailed Description)
United States0Started 2013-12
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
✓. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures.
✓. Male or female and 18 years of age or older with a historical diagnosis of Type 2 diabetes mellitus (T2DM).
✓. Is on antihyperglycemic therapy that is acceptable by local practice guidelines, 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. Existing glucose-lowering therapy must have remained stable in regimen without significant changes in dosage based on investigator judgment for ≥8 weeks before study entry.
✓. Has for ≥ 3 months prior to Screening, chronic kidney disease (CKD) stage 4 (defined as estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73 m\^2 by Modification of Diet in Renal Disease (MDRD) formula), or CKD stage 5 on dialysis (ie eGFR \<15 ml/min/1.73 m\^2 by MDRD formula).
✓. Has an HbA1c level ≥7.5 and ≤10.5%, inclusive, and fasting plasma glucose \<270 mg/dL (15.0 mmol/L) at Screening.
✓. Has a C-peptide level ≥ 0.33 mmol/L at Screening.
✓. Has a body mass index (BMI) ≤45 kg/m\^2 at Screening.
Exclusion criteria
✕. Has received any investigational compound within 30 days prior to Screening or has received an investigational antihyperglycemic drug within the 3 months prior to Screening.
What they're measuring
1
Change from Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16
✕. Was randomized into a previous fasiglifam (TAK-875) study.
✕. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
✕. Received any blood products within 12 weeks prior to Screening.
✕. Has a hemoglobin ≤9 g/dL (≤90 g/L) at Screening.
✕. Has a systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg at Screening.
✕. Has history of cancer that has been in remission for \<5 years prior to Screening. Exception: A history of basal cell carcinoma or stage 1 squamous cell carcinoma of the skin is allowed.
✕. Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels \>2.0 x upper limit of normal (ULN) at Screening.