Placebo Controlled Dose-Response Study of Rivoglitazone in Type 2 Diabetes

Daiichi Sankyo Co., Ltd.250 enrolled

Overview

The purpose of this study is to assess the efficacy response of rivoglitazone HCl on the change in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

250

Conditions

Type 2 Diabetes

Interventions

Rivoglitazone HClDRUG

0.5 mg tablets once daily for 12 weeks

rivoglitazone HClDRUG

1.0 mg tablets once daily for 12 weeks

rivoglitazone HClDRUG

1.5 mg tablets once daily for 12 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * type 2 diabetes mellitus * HbA1c \>6.5% and \<10% * FPG \>126 mg/dL (7mmol/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 * impaired hepatic function * CHF or history of CHF (NYHA stage I - IV) * uncontrolled hypertension

Locations (3)

Unnamed facility

Fukuoka, Japan

Unnamed facility

Osaka, Japan

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

Change in HbA1c from baseline for rivoglitazone compared to placebo

Time frame: 12 weeks

Secondary Outcomes

Change in Fasting Plasma Glucose from baseline for rivoglitazone HCl compared to placebo

Time frame: 12 weeks

Data from ClinicalTrials.gov

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