Placebo and Active Comparator Controlled Dose Response Study of Rivoglitazone in Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Dose and Active Comparator-Controlled Dose-Response Study of Rivoglitazone (CS-011) in Patients With Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Rivoglitazone HCl
* Drug: rivoglitazone HCl
* Drug: rivoglitazone HCl
* Drug: pioglitazone HCl
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>0.5 mg rivoglitazone HCl tablets once daily for 12 weeks | Drug: Rivoglitazone HCl<br>* 0.5 mg rivoglitazone HCl tablets once daily for 12 weeks<br>|
| Experimental: 2<br>1.0 mg rivoglitazone HCl tablets once daily for 12 weeks | Drug: rivoglitazone HCl<br>* 1.0 mg rivoglitazone HCl tablets once daily for 12 weeks<br>|
| Experimental: 3<br>1.5 mg rivoglitazone HCl tablets once daily for 12 weeks | Drug: rivoglitazone HCl<br>* 1.5 mg rivoglitazone HCl tablets once daily for 12 weeks<br>|
| Active Comparator: 4<br>30 mg pioglitazone HCl capsules once daily for 12 weeks | Drug: pioglitazone HCl<br>* 30 mg capsules once daily for 12 weeks<br>|
| Placebo Comparator: 5<br>Matching rivoglitazone HCL placebo tablets and/or matching pioglitazone HCL placebo capsules | Drug: placebo<br>* matching tablets or capsule once daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline for rivoglitazone HCl compared to that for placebo |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rivoglitazone HCl, pioglitazone HCl, thiazolidinedione, peroxisome proliferator-activated receptor gamma (PPAR gamma), type 2 diabetes mellitus