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

Daiichi Sankyo Co., Ltd.150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Type 2 Diabetes

Interventions

Rivoglitazone HClDRUG

0.5 mg rivoglitazone HCl tablets once daily for 12 weeks

rivoglitazone HClDRUG

1.0 mg rivoglitazone HCl tablets once daily for 12 weeks

rivoglitazone HClDRUG

1.5 mg rivoglitazone HCl tablets once daily for 12 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Hong Kong, China

Outcomes

Primary Outcomes

Change in HbA1c from baseline for rivoglitazone HCl compared to that for placebo

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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