Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes

Daiichi Sankyo441 enrolled

Overview

This is a 6-month study to evaluate the effects of monotherapy with rivoglitazone, an insulin sensitizer, on glycemic control in newly identified type 2 diabetics or diabetics not adequately treated with other antidiabetic agents. The study tests rivoglitazone and uses a placebo and active treatment group for comparison.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

441

Conditions

Type 2 Diabetes

Interventions

RivoglitazoneDRUG

PioglitazoneDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes in male or female patients * Between 18 and 75 years of age * With a HbA1c greater than or equal to 7.5% and less than 10.5% at randomization Exclusion Criteria: * Type 1 diabetics or type 2 diabetics currently on insulin therapy * Patients unwilling or unable to discontinue their anti-diabetic medication(s) * History of ketoacidosis * History of therapy with rosiglitazone, troglitazone, pioglitazone

Locations (74)

Outcomes

Primary Outcomes

Change in HbA1c

Secondary Outcomes

FPG, Lipids, hsCRP, Adiponectin

Data from ClinicalTrials.gov

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Unnamed facility

Birmingham, Alabama, United States

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Columbiana, Alabama, United States

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Huntsville, Alabama, United States

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Muscle Shoals, Alabama, United States

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Hot Springs, Arkansas, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Searcy, Arkansas, United States

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Sherwood, Arkansas, United States

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Los Angeles, California, United States

...and 64 more locations