Efficacy and Safety In Poorly Controlled Type 2 Diabetics

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00044460
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2002-08-29
• Study First Submitted QC: 2002-08-29
• Study First Posted: 2002-08-30
• Primary Completion: 2003-04-10
• Study Completion: 2003-04-10
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-05
• Last Update Posted: 2017-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline to Week 24.

Secondary Outcome Measures

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