A 24-week Randomized, Double-Blind, Parallel-Group, Multicenter Study to Demonstrate the Efficacy and Safety of Two Different Rosiglitazone Dosing Regimens, 4mg OD and 8mg OD, in Poorly-Controlled Drug Naive Patients With Type 2 Diabetes Mellitus

GlaxoSmithKline0 sites142 target enrollmentMay 2002

ConditionsDiabetes Mellitus, Type 2

Drugsrosiglitazone

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 2
Sponsor: GlaxoSmithKline
Enrollment: 142
Primary Endpoint: Change in HbA1c from baseline to Week 24.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to gain safety and efficacy information in patients with type 2 diabetes, who have not previously taken any oral antidiabetic medications, and who have an HbA1c value of greater than or equal to 10%, despite diet and exercise.

Registry

clinicaltrials.gov

Start Date

May 2002

End Date

April 10, 2003

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Change in HbA1c from baseline to Week 24.

Secondary Outcomes

Change in FPG (fasting plasma glucose) from baseline to Week 24; characterize the effects of rosiglitazone on the albumin-creatinine ratio at Week 24.