Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of Mitoglitazone in Type 2 Diabetic Patients
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT01103414
- Lead Sponsor
- Metabolic Solutions Development Company
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of three dose levels of Mitoglitazone™ (MSDC-0160) in patients with type 2 diabetes.
- Detailed Description
The primary study objectives are to characterize the reduction in fasting plasma glucose in response to three different doses of Mitoglitazone as compared to placebo following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes and to investigate the safety and tolerability of three different doses of Mitoglitazone following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 356
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pioglitazone 45 mg capsules Pioglitazone Pioglitazone 45 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days. Mitoglitazone 50 mg capsules Mitoglitazone Mitoglitazone 50 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days. Mitoglitazone 100 mg capsules Mitoglitazone Mitoglitazone 100 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days. Matching placebo Placebo Placebo capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days. Mitoglitazone 150 mg capsules Mitoglitazone Mitoglitazone 150 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
- Primary Outcome Measures
Name Time Method Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12. Baseline, Week 12 Change from baseline in fasting plasma glucose in response to three different doses of Mitoglitazone as compared to pioglitazone following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes.
- Secondary Outcome Measures
Name Time Method Presence of Edema Post Baseline During 12 Weeks Active Treatment 12 weeks Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on presence of edema following once-daily dosing for 12 weeks
Change From Baseline in RBC 12 week Change from baseline at week 12 endpoint in red blood cell concentration
Changes in HDL Particle Size Subfractions From Baseline to Week 12 12 weeks Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on HDL particle size profile as characterized by changes in NMR analysis of subfractions following once-daily dosing for 12 weeks
Change From Baseline in HbA1c 12 weeks Change from baseline in plasma glucose measured by hemoglobin A1c in response to three different doses of Mitoglitazone and pioglitazone as compared to placebo following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes.
Percent Change From Baseline to Week 12 Endpoint in HMW Adiponectin 12 weeks Percent change from baseline to week 12 endpoint in high molecular weight adiponectin
Change From Baseline to Week 12 Endpoint in Hematocrit 12 weeks Change from baseline to week 12 endpoint in hematocrit as an indication of fluid retention
Change From Baseline in Hemoglobin 12 weeks Change from baseline at week 12 endpoint in hemoglobin concentration
Change in Body Weight From Baseline to Week 12 Endpoint 12 weeks Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on body weight following once-daily dosing for 12
Change From Baseline in Waist Circumference at Week 12 Endpoint 12 weeks Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on waist circumference following once-daily dosing for 12 weeks
Changes in LDL Particle Size Subfractions From Baseline to Week 12 12 week Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on LDL particle size profile as characterized by changes in NMR analysis of subfractions following once-daily dosing for 12 weeks