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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Rosiglitazone; Drug: Metformin; Drug: Sulfonylurea

Study type: Interventional

Funder types: Industry

Identifiers

NCT00379769

BRL-049653/231

Details and patient eligibility

About

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.

Full description

A RECORD follow-up study is being performed to monitor the incidence of cancer and bone fractures in RECORD patients for a period of 4 years after the end of the main RECORD study (2008 - 2012).

Enrollment: 4,447 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,447 participants in 4 patient groups

rosiglitazone in addition to background metformin

Experimental group

Description:

Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.

Treatment:

Drug: Rosiglitazone

Drug: Metformin

rosiglitazone in addition to background sulfonylurea

Experimental group

Description:

Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.

Treatment:

Drug: Rosiglitazone

Drug: Sulfonylurea

Sulfonylurea in addition to background metformin

Active Comparator group

Description:

Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.

Treatment:

Drug: Metformin

Drug: Sulfonylurea

Metformin in addition to background sulfonylurea

Active Comparator group

Description:

Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.

Treatment:

Drug: Metformin

Drug: Sulfonylurea