Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1912
Healthy volunteers: no

Brief summary:
This is a 26-week study in subjects with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. The total duration of a subject's participation will be approximately 30 weeks, including a 2-week placebo run-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period.

Detailed description:

Arms:
arm 1: None arm 2: Rivoglitazone 1.0 mg arm 3: Rivoglitazone 1.5 mg arm 4: Pioglitazone 45 mg

Interventions: intervention 1: Pioglitazone intervention 2: Placebo intervention 3: Rivoglitazone intervention 4: Rivoglitazone
Intervention descriptions: intervention 1: 45 mg over-encapsulated tablet administered orally, once daily intervention 2: Rivoglitazone-matching placebo administered as a tablet orally, once daily or a pioglitazone-matching placebo administered as an over-encapsulated tablet orally, once daily capsule intervention 3: 1.0 mg tablet administered orally, once daily intervention 4: 1.5 mg tablet administered orally, once daily

Protocol document: