RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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 a sulfonylurea(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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Metformin; Rosiglitazone

Criteria

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.

• Body mass index >25.0 kg/m2.

Exclusion Criteria:

• Patients receiving any other glucose lowering therapy which is not metformin or a sulfonylurea.

• 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.