A Phase 2, Randomized, Double-Blind, Double-Dummy Placebo-and Active-Controlled, Multicenter Study to Determine the Efficacy and Safety of TAK-875 in Subjects With Type 2 Diabetes Mellitus
- Conditions
- E10-E10 Insulin-dependent diabetes mellitusInsulin-dependent diabetes mellitus
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 0
• Participant meets 1 of the following criteria: A historical diagnosis of type 2 diabetes mellitus without the chronic use of antidiabetic therapy within 8 weeks prior to Screening, and with at least an 8-week documented history of a diet and exercise plan at Screening. A historical diagnosis of mellitus and stable on at least 1500 mg per day or the respective (individually) maximal tolerated dose of metformin as monotherapy for at least 2 months prior to Screening.
• Has a glycosylated hemoglobin level at Screening between 7.5% and 10.0%, inclusive, if on metformin and greater than or equal to 7.5% to less than 11% if treated with diet and exercise alone.
• Has a fasting plasma glucose level less than 260 mg/dL, at Screening.
• Has a fasting C-peptide concentration greater than or equal to 0.8 ng/mL at Screening.
• If participant takes any chronic medications, the dose of these medications must have been stable (no change in dose or drug) for at least 4 weeks prior to Screening.
• Participant´s body mass index at Screening is greater than or equal to 23 and less than or equal to 45 kg/m2.
• Is able and willing to monitor glucose with a home glucose monitor and consistently record his or her own blood glucose concentrations.
• Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study and for 1 month after the last dose of study drug.
• Compliance with single-blind study medication during the Run-in Period is at least 80% and does not exceed 120% based on tablet counts performed by the study staff.
• Has systolic blood pressure greater than 160 mm Hg or diastolic pressure greater than 100 mm Hg at Screening or Baseline (as confirmed by repeat measurement 30 minutes after initial measurement).
• Has history of cancer that has been in remission for less than 5 years prior to Screening. A history of basal cell carcinoma or stage 1 squamous cell carcinoma of the skin is allowed.
• Has a creatine phosphokinase level greater than or equal to 5 times the upper limit of normal at Screening.
• Has a hemoglobin level of less than or equal to 12 g/dL (120 gm/L) for men and less than or equal to 10 g/dL (100 gm/L) for women at Screening.
• Has alanine aminotransferase and aspartate aminotransferase levels greater than or equal to 2.5 times upper limit of normal at Screening.
• Has a total bilirubin level greater than or equal to 1.5 mg/dL at Screening.
• The subject has a serum triglyceride concentration greater than or equal to 400 mg/dL at Screening.
• Has an estimated glomerular filtration rate less than or equal to 60 mL/min using the Modification of Diet in Renal Disease equation at Screening.
• Has abnormal thyroid-stimulating hormone levels.
• Has a positive test result for hepatitis B surface antigen or hepatitis C antibody or human immunodeficiency virus.
• Has macro-albuminuria at Screening
• Has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
• Has diabetic gastroparesis that in the investigator´s opinion is moderate or severe and hence may impair absorption of study medication.
• Has had coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, unstable angina pectoris, clinically significant abnormal electrocardiogram, cerebrovascular accident or transient ischemic attack within 6 months prior or at Screening.
• Has a history of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
• Received treatment with probucol within 1 year of randomization.
• Donated or received any blood products within 12 weeks prior to Screening.
• Received treatment for more than 7 days within 4 weeks or 8 weeks (depending on the medication) prior to Screening.
• Is on any insulin treatment.
• Received any investigational drug within 4 weeks prior to Screening.
• Is hypersensitive to TAK-875, its excipients or glimepiride.
• Has a history of drug abuse or a history of alcohol abuse within 2 years prior to Screening.
• Has any other physical or psychiatric disease or condition that in the judgment of the investigator may affect life expectancy or may make it difficult to successfully manage and follow the subject according to the protocol.
• Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Comparisons between treatments will be made using a covariance analysis (ANCOVA), with treatment and center as factors, baseline HbA 1 c as covariate and using the last advanced observation (UOA) to impute missing data. If appropriate, the centers may be accumulated. A 2-tailed test with a significance level of 5% will be used for the comparison between treatments. The ninety-five percent confidence intervals will be presented along with the p values. No adjustment will be made for multiple comparisons.<br>Measure:Change in HbA1c at Week 12 with respect to its Baseline value<br>Timepoints:Week 12<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Fasting plasma glucose measurement by laboratory tests performed during the study.<br>Measure:Change from Baseline in Fasting Plasma Glucose at Week 12<br>Timepoints:Week 12<br>;<br>Outcome name:Body weight assessment during the views in the duration of the study.<br>Measure:Change from Baseline in Body Weight at Week 12<br>Timepoints:Week 12<br>;<br>Outcome name:Fasting glucose measurement by laboratory tests performed during the study.<br>Measure:Incidence of Hypoglycemia During Double-Blind Treatment Period<br>Timepoints:During Double-Blind Treatment Period<br>