Placebo and Active Comparator Controlled Dose Response Study of Rivoglitazone in Type 2 Diabetes
Phase 2
Completed
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT00575874
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- Brief Summary
The purpose of the study is to assess the efficacy response of rivoglitazone HCl compared to pioglitazone HCl on the placebo-corrected change from baseline in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- type 2 diabetes
- HbA1c >6.5% and <10.0%
- FPG >126 mg/dL (7 mmol/L) and < 270 mg/dL (15 mmol/L)
Exclusion Criteria
- History of type 1 diabetes
- History of ketoacidosis
- Current insulin therapy
- C-peptide <0.5ng/mL
- Imparied hepatic function
- NYHA Class II-IV cardiac status or hospitalization for CHF or EF<40%
- uncontrolled hypertension
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5 placebo Matching rivoglitazone HCL placebo tablets and/or matching pioglitazone HCL placebo capsules 2 rivoglitazone HCl 1.0 mg rivoglitazone HCl tablets once daily for 12 weeks 1 rivoglitazone HCl 0.5 mg rivoglitazone HCl tablets once daily for 12 weeks 4 pioglitazone HCl 30 mg pioglitazone HCl capsules once daily for 12 weeks 3 rivoglitazone HCl 1.5 mg rivoglitazone HCl tablets once daily for 12 weeks
- Primary Outcome Measures
Name Time Method Change in HbA1c from baseline for rivoglitazone HCl compared to that for placebo 12 weeks
- Secondary Outcome Measures
Name Time Method Change in Fasting Plasma Glucose from baseline for rivoglitazone HCl compared to that for placebo. Change in HbA1c from baseline compared to that for pioglitazone HCl 12 weeks