Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 94
Healthy volunteers: no

Brief summary:
This is a 26-week, multicenter, randomized, double-blind, placebo and active comparator-controlled, parallel-group study in participants with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. Pioglitazone is used as active comparator. The total duration of a participant's participation will be approximately 30 weeks, including a 2-week placebo lead-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period. Participants who complete the randomized portion of the study per protocol may have the opportunity to continue in a long-term extension study of active treatments.

Detailed description:

Arms:
arm 1: rivoglitazone HCl 0.5mg arm 2: rivoglitazone HCl 1.0 mg arm 3: rivoglitazone HCl 1.5 mg arm 4: placebo matching rivoglitazone HCl tablets arm 5: pioglitazone HCl 15 mg arm 6: pioglitazone HCl 30 mg arm 7: pioglitazone HCl 45 mg arm 8: matching placebo for pioglitazone

Interventions: intervention 1: Rivoglitazone HCl intervention 2: rivoglitazone HCl intervention 3: rivoglitazone HCl intervention 4: placebo intervention 5: pioglitazone HCl intervention 6: pioglitazone HCl intervention 7: pioglitazone HCl 45 mg intervention 8: placebo intervention 9: metformin
Intervention descriptions: intervention 1: 0.5 mg tablets administered orally, once daily intervention 2: 1.0 mg tablets administered orally, once daily intervention 3: 1.5 mg tablets administered orally, once daily intervention 4: placebo tablets matching rivoglitazone tablets administered orally, once daily intervention 5: 15 mg capsules administered orally, once daily intervention 6: 30 mg capsules administered orally, once daily intervention 7: 45 mg capsules administered orally, once daily intervention 8: placebo capsules for pioglitazone administered orally, once daily intervention 9: Oral tablets. Rescue medication.

Protocol document: