RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00379769

Purpose

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.

Condition	Intervention	Phase
Type II Diabetes	Drug: sulfonylurea Drug: rosiglitazone Drug: metformin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Rosiglitazone Rosiglitazone Maleate Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

The primary efficacy variable is the time to reach the combined endpoint of cardiovascular death and/or cardiovascular hospitalisation. [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

Secondary Outcome 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. [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Enrollment:	4447
Study Start Date:	April 2001
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
add-on medication: Active Comparator 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.	Drug: sulfonylurea 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. Drug: rosiglitazone 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. Drug: metformin 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.

Arms

Assigned Interventions

add-on medication: Active Comparator

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.

Drug: sulfonylurea

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.

Drug: rosiglitazone

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.

Drug: metformin

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.

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379769

Show 458 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Komajda M, Curtis P, Hanefeld M, Beck-Nielsen H, Pocock SJ, Zambanini A, Jones NP, Gomis R, Home PD; RECORD Study Group. Effect of the addition of rosiglitazone to metformin or sulfonylureas versus metformin/sulfonylurea combination therapy on ambulatory blood pressure in people with type 2 diabetes: a randomized controlled trial (the RECORD study). Cardiovasc Diabetol. 2008 Apr 24;7:10.

Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJ; RECORD Study Group. Rosiglitazone evaluated for cardiovascular outcomes--an interim analysis. N Engl J Med. 2007 Jul 5;357(1):28-38. Epub 2007 Jun 5.

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	BRL-049653/231
Study First Received:	September 21, 2006
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00379769 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

diabetes
rosiglitazone
metformin
sulfonylurea

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Metformin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Rosiglitazone
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 03, 2009