Official Title: “Clinical Evaluation of Rosiglitazone Malate (BRL49653C) in Patients With Type 2 Diabetes Mellitus (Monotherapy) - Double-Blind Comparative Study of Rosiglitazone Maleate vs. Pioglitazone Hydrochloride and Placebo -”

This study is designed to compare the efficacy and safety of BRL49653C versus pioglitazone and placebo.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Rosiglitazone

Primary Measures

• HbA1c change from baseline at Week 28.
  • Time Frame: 28 Weeks
    

Secondary Measures

• Efficacy variables (changes from baseline in FPG, fasting insulin, HOMA-IR and HOMA-beta) at stipulated date in each treatment group.
  • Time Frame: 28 Weeks
    

Inclusion criteria:

• Type 2 diabetes mellitus.
• Managed by diet therapy.
• Must have adequate blood, liver and kidney function.

Exclusion criteria:

• Serious cardiovascular disease or serious hepatic disease.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trial Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00297063

Study ID Number: AVD104742

ClinicalTrials.gov Identifier: NCT00297063

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency