Official Title: “A Long Term, Open Label, Randomised Study in Patients With Type 2 Diabetes, Comparing the Combination of Rosiglitazone and Either Metformin or Sulphonylurea With Metformin Plus Sulphonylurea on Cardiovascular Endpoints and Glycaemia”

This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week run-in period will be followed by a median of 6 years of treatment with study medication in addition to continuation of background glucose lowering therapy. Patients inadequately controlled on background metformin will be randomised to receive, in addition to metformin, either rosiglitazone or an Su (glibenclamide, gliclazide or glimepiride) in a ratio of 1:1. Patients inadequately controlled on background Su will be randomised to receive, in addition to Su, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of patients receiving background metformin and Su at entry will be entered into the study.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Intervention(s) in this Clinical Trial

• Drug: rosiglitazone
• Drug: metformin
• Drug: sulfonylurea

Primary Measures

• The primary efficacy variable is the time to reach the combined endpoint of cardiovascular death and/or cardiovascular hospitalisation.

Secondary Measures

• To compare glycaemic control after 18 months (subset interim analysis). To compare ambulatory bp parameters after 6 months and 12 months. To compare the time to reach the combined cardiovascular (CV) endpoint of CV death and/or CV hospitalisation.

Inclusion Criteria:

• Patients with type II diabetes mellitus as defined by 1999 World Health Organisation criteria.
• Glycated haemoglobin (HbA1c) >7.0 % to = 9.0 % at visit 1.
• Use of an oral glucose lowering agent for a minimum of 6 months prior to screening and unchanged for 2 months prior to screening.
• BMI >25.0 kg/m2.

Exclusion Criteria:

• Patients not receiving any other glucose lowering therapy which is not metformin or a sulphonylurea.
• Patients with systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg.
• Patients who have required the use of insulin for glycaemic control at any time in the past.
• Hospitalisation for any major cardiovascular event in the last 3 months.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 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 Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00379769

Study ID Number: BRL-049653/231

ClinicalTrials.gov Identifier: NCT00379769

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency