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

NCT ID: NCT00379769

Last Updated: 2017-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 4447 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2008-12-31

Brief 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.

Detailed 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).

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rosiglitazone in addition to background metformin

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.

Group Type: EXPERIMENTAL

Rosiglitazone

Intervention Type: DRUG

Rosiglitazone maximum 8 mg per day

Metformin

Intervention Type: DRUG

Metformin maximum permitted daily dose .

rosiglitazone in addition to background sulfonylurea

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.

Group Type: EXPERIMENTAL

Rosiglitazone

Intervention Type: DRUG

Rosiglitazone maximum 8 mg per day

Sulfonylurea

Intervention Type: DRUG

Sulfonylurea (SU) maximum permitted daily dose

Sulfonylurea in addition to background metformin

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.

Group Type: ACTIVE_COMPARATOR

Sulfonylurea

Intervention Type: DRUG

Sulfonylurea (SU) maximum permitted daily dose

Metformin

Intervention Type: DRUG

Metformin maximum permitted daily dose .

Metformin in addition to background sulfonylurea

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.

Group Type: ACTIVE_COMPARATOR

Sulfonylurea

Intervention Type: DRUG

Sulfonylurea (SU) maximum permitted daily dose

Metformin

Intervention Type: DRUG

Metformin maximum permitted daily dose .

Interventions

Rosiglitazone

Rosiglitazone maximum 8 mg per day

Intervention Type: DRUG

Sulfonylurea

Sulfonylurea (SU) maximum permitted daily dose

Intervention Type: DRUG

Metformin

Metformin maximum permitted daily dose .

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Miranda, New South Wales, Australia

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Randwick, New South Wales, Australia

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Carina Heights, Queensland, Australia

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Budapest, , Hungary

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Debrecen, , Hungary

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Szombathely, , Hungary

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Zalaegerszeg, , Hungary

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Reggio Calabria, Calabria, Italy

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Napoli, Campania, Italy

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Riga, , Latvia

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Kaunas, , Lithuania

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Kaunas, , Lithuania

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Kaunas, , Lithuania

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Kaunas, , Lithuania

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Christchurch, , New Zealand

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Bratislava, , Slovakia

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Gothenburg, , Sweden

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Gothenburg, , Sweden

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Gothenburg, , Sweden

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Helsingborg, , Sweden

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Köping, , Sweden

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Kristianstad, , Sweden

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Kungälv, , Sweden

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Linköpiing, , Sweden

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Linköping, , Sweden

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Lund, , Sweden

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Mora, , Sweden

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Nacka, , Sweden

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Norrköping, , Sweden

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Oskarshamn, , Sweden

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Skene, , Sweden

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Stockholm, , Sweden

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Uddevalla, , Sweden

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Umeå, , Sweden

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Uppsala, , Sweden

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Vadstena, , Sweden

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Dnipro, , Ukraine

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Kharkiv, , Ukraine

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Kiev, , Ukraine

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Kiev, , Ukraine

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Kyiv, , Ukraine

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Lviv, , Ukraine

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Vinnitsa, , Ukraine

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Cambridge, Cambridgeshire, United Kingdom

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Fowley, Cornwall, United Kingdom

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Chesterfield, Derbyshire, United Kingdom

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Chesterfield, Derbyshire, United Kingdom

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Airdrie, Lanarkshire, United Kingdom

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Glasgow, Lanarkshire, United Kingdom

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Hamilton, Lanarkshire, United Kingdom

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Motherwell, Lanarkshire, United Kingdom

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Leicester, Leicestershire, United Kingdom

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Northampton, Northamptonshire, United Kingdom

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Linwood, Renfrewshire, United Kingdom

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Paisley, Renfrewshire, United Kingdom

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Frome, Somerset, United Kingdom

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Glastonbury, Somerset, United Kingdom

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Westbury, Wiltshire, United Kingdom

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Airdrie, , United Kingdom

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Airdrie, , United Kingdom

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Ashford, , United Kingdom

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Chesterfield, , United Kingdom

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Chippenham, , United Kingdom

GSK Investigational Site

Coatbridge, , United Kingdom

GSK Investigational Site

Colney, , United Kingdom

GSK Investigational Site

Cumbernauld, , United Kingdom

GSK Investigational Site

Dronfield, , United Kingdom

GSK Investigational Site

Dumbarton, , United Kingdom

GSK Investigational Site

East Kilbride, , United Kingdom

GSK Investigational Site

Falmouth, , United Kingdom

GSK Investigational Site

Garston, Watford, , United Kingdom

GSK Investigational Site

Gateshead, , United Kingdom

GSK Investigational Site

Glasgow, , United Kingdom

GSK Investigational Site

Glasgow, , United Kingdom

GSK Investigational Site

Hamilton, , United Kingdom

GSK Investigational Site

Harrow, , United Kingdom

GSK Investigational Site

Kirkintilloch, , United Kingdom

GSK Investigational Site

Leigh-on-Sea, , United Kingdom

GSK Investigational Site

Motherwell, , United Kingdom

GSK Investigational Site

Newcastle upon Tyne, , United Kingdom

GSK Investigational Site

Newport, , United Kingdom

GSK Investigational Site

Nottingham, , United Kingdom

GSK Investigational Site

Old Whittington, Chesterfield, , United Kingdom

GSK Investigational Site

Paisley, , United Kingdom

GSK Investigational Site

Penzance, , United Kingdom

GSK Investigational Site

Rubery, Birmingham, , United Kingdom

GSK Investigational Site

Sheffield, , United Kingdom

GSK Investigational Site

Sheffield, , United Kingdom

GSK Investigational Site

Thornhill, , United Kingdom

GSK Investigational Site

Thornhill, Cardiff, , United Kingdom

GSK Investigational Site

Uddingston, , United Kingdom

GSK Investigational Site

Weston-super-Mare, , United Kingdom

GSK Investigational Site

Wishaw, , United Kingdom

GSK Investigational Site

Woking, , United Kingdom

GSK Investigational Site

Worle, Weston-Super-Mare, , United Kingdom

Countries

Australia; Belgium; Bulgaria; Croatia; Czechia; Denmark; Estonia; Finland; France; Germany; Greece; Hungary; Italy; Latvia; Lithuania; Netherlands; New Zealand; Poland; Romania; Russia; Slovakia; Spain; Sweden; Ukraine; United Kingdom

References

Home PD, Jones NP, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Komajda M, Curtis P; RECORD Study Group. Rosiglitazone RECORD study: glucose control outcomes at 18 months. Diabet Med. 2007 Jun;24(6):626-34. doi: 10.1111/j.1464-5491.2007.02160.x.

Reference Type: BACKGROUND

PMID: 17517066 (View on PubMed)

Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Dargie H, Komajda M, Gubb J, Biswas N, Jones NP. Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD): study design and protocol. Diabetologia. 2005 Sep;48(9):1726-35. doi: 10.1007/s00125-005-1869-1. Epub 2005 Jul 16.

Reference Type: BACKGROUND

PMID: 16025252 (View on PubMed)

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. doi: 10.1056/NEJMoa073394. Epub 2007 Jun 5.

Reference Type: BACKGROUND

PMID: 17551159 (View on PubMed)

Home PD, Pocock SJ, Beck-Nielsen H, Curtis PS, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJ; RECORD Study Team. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet. 2009 Jun 20;373(9681):2125-35. doi: 10.1016/S0140-6736(09)60953-3. Epub 2009 Jun 6.

Reference Type: BACKGROUND

PMID: 19501900 (View on PubMed)

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. doi: 10.1186/1475-2840-7-10.

Reference Type: BACKGROUND

PMID: 18435852 (View on PubMed)

Jones NP, Curtis PS, Home PD. Cancer and bone fractures in observational follow-up of the RECORD study. Acta Diabetol. 2015 Jun;52(3):539-46. doi: 10.1007/s00592-014-0691-y. Epub 2014 Dec 19.

Reference Type: DERIVED

PMID: 25524432 (View on PubMed)

MacDonald MR, Petrie MC, Home PD, Komajda M, Jones NP, Beck-Nielsen H, Gomis R, Hanefeld M, Pocock SJ, Curtis PS, McMurray JJ. Incidence and prevalence of unrecognized myocardial infarction in people with diabetes: a substudy of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) study. Diabetes Care. 2011 Jun;34(6):1394-6. doi: 10.2337/dc10-2398. Epub 2011 May 11.

Reference Type: DERIVED

PMID: 21562320 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

BRL-049653/231

Identifier Type: -

Identifier Source: org_study_id