Conditions: Type 2 Diabetes
Keywords: Diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 356
Healthy volunteers: no

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.

Arms:
arm 1: Mitoglitazone 50 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days. arm 2: Mitoglitazone 100 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days. arm 3: Mitoglitazone 150 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days. arm 4: Pioglitazone 45 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days. arm 5: Placebo capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.

Interventions: intervention 1: Mitoglitazone intervention 2: Mitoglitazone intervention 3: Mitoglitazone intervention 4: Pioglitazone intervention 5: Placebo
Intervention descriptions: intervention 1: 50 mg capsules, once daily for 84 days intervention 2: Mitoglitazone 100 mg capsules, once daily for 84 days intervention 3: Mitoglitazone 150 mg capsules, once daily for 84 days intervention 4: Pioglitazone 45 mg, once daily for 84 days intervention 5: Placebo, once daily for 84 days

Protocol document: