Phase 2B, Randomized, Double-Blind, Comparator- & Placebo-Controlled, Dose Ranging Study to Evaluate Safety, Tolerability & Efficacy of 3 Dose Levels of Mitoglitazone in Type 2 Diabetic Patients
Overview
- Phase
- Phase 2
- Intervention
- Mitoglitazone
- Conditions
- Type 2 Diabetes
- Sponsor
- Metabolic Solutions Development Company
- Enrollment
- 356
- Primary Endpoint
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Mitoglitazone 50 mg capsules
Mitoglitazone 50 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
Intervention: Mitoglitazone
Mitoglitazone 100 mg capsules
Mitoglitazone 100 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
Intervention: Mitoglitazone
Mitoglitazone 150 mg capsules
Mitoglitazone 150 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
Intervention: Mitoglitazone
Pioglitazone 45 mg capsules
Pioglitazone 45 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
Intervention: Pioglitazone
Matching placebo
Placebo capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12.
Time Frame: 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 Outcomes
- Presence of Edema Post Baseline During 12 Weeks Active Treatment(12 weeks)
- Change From Baseline in RBC(12 week)
- Changes in HDL Particle Size Subfractions From Baseline to Week 12(12 weeks)
- Change From Baseline in HbA1c(12 weeks)
- Percent Change From Baseline to Week 12 Endpoint in HMW Adiponectin(12 weeks)
- Change From Baseline to Week 12 Endpoint in Hematocrit(12 weeks)
- Change From Baseline in Hemoglobin(12 weeks)
- Change in Body Weight From Baseline to Week 12 Endpoint(12 weeks)
- Change From Baseline in Waist Circumference at Week 12 Endpoint(12 weeks)
- Changes in LDL Particle Size Subfractions From Baseline to Week 12(12 week)