Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00279045
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01-03
• Study First Submitted: 2006-01-17
• Study First Submitted QC: 2006-01-17
• Study First Posted: 2006-01-19
• Primary Completion: 2006-06-01
• Study Completion: 2006-06-19
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-27
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4426

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time from randomization to the primary action point (monotherapy failure).

Secondary Outcome Measures

Name	Time	Method
Comparison of effects of long-term treatment with Rosiglitazone, Metformin, Glyburide: - maintenance/restoration of beta-cell function: HOMA IS, progression of microalbuminuria, fibrinolytic markers (PAI-1,fibrinogen, CRP).

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Wigan, United Kingdom