RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes
RECORD
A Long Term, Open Label, Randomised Study in Patients With Type 2 Diabetes, Comparing the Combination of Rosiglitazone and Either Metformin or Sulfonylurea With Metformin Plus Sulfonylurea on Cardiovascular Endpoints and Glycaemia
1 other identifier
interventional
4,447
24 countries
436
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus-type-2
Started Apr 2001
Longer than P75 for phase_3 diabetes-mellitus-type-2
436 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 21, 2006
CompletedFirst Posted
Study publicly available on registry
September 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
November 13, 2009
CompletedMarch 23, 2017
March 1, 2017
7.7 years
September 21, 2006
August 24, 2009
March 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events
The number of participants with cardiovascular death events (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation events (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) was recorded.
Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause
All deaths identified during the original record study and discovered after the re-adjudication efforts began were included.
Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions
IR was based on original RECORD endpoint definitions. CV death= no unequivocal non-CV cause (sudden death, death from acute vascular events, heart failure, acute MI, other CV causes, and deaths adjudicated as unknown cause). MI event=hospitalization + elevation of specific cardiac biomarkers above the upper limit of normal + cardiac ischemia symptoms/new pathological electrocardiogram findings. Stroke event=hospitalization + rapidly developed clinical signs of focal/global disturbance of cerebral function for more than 24 hours, with no apparent cause other than a vascular origin.
Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions
Independent re-adjudication was based on the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions. CV death included death resulting from an acute MI; sudden cardiac death and death due to heart failure, stroke, and to other CV causes. Deaths of unknown cause were counted as CV deaths. MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.
Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions
The number of participants with a CV death (or unknown) as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. CV death was defined as any death for which an unequivocal non-CV cause could not be established. CV death included death following heart failure, death following acute myocardial infarction (MI), sudden death, death due to acute vascular events, and other CV causes. Deaths due to unknown causes were classified as "unknown deaths," but were counted as CV deaths for the analysis of this endpoint.
Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions
The number of participants with a CV (or unknown) death as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. CV death included death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, and death due to other CV causes. Deaths of unknown cause were counted as CV deaths.
Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions
The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. An event of MI was defined as hospitalization plus elevation of cardiac biomarkers troponin (TN) I and/or TNT above the upper limit of normal (ULN) or creatinine kinase (CK) MB (M=muscle type; B=brain type) isoenzyme \>= 2x the ULN or CK \> 2x the ULN plus typical symptoms of cardiac ischemia or new pathological electrocardiogram findings, or cause of death adjudicated as MI.
Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions
The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions
Par. with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. A stroke event=hospitalization plus rapidly developed clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours (unless interrupted by thrombolysis, surgery, or death), with no apparent cause other than a vascular origin, including par. presenting clinical signs/symptoms suggestive of subarachnoid haemorrhage/intracerebral haemorrhage/cerebral ischemic necrosis or cause of death adjudicated as stroke.
Baseline through End of Study (up to 7.5 years)
Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions
The number of participants with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.
Baseline through End of Study (up to 7.5 years)
Secondary Outcomes (43)
Number of Participants With Cardiovascular Events and All-cause Deaths
Baseline through End of Study (up to 7.5 years)
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths
Baseline through End of Study (up to 7.5 years)
Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum
Baseline through End of Study (up to 7.5 years)
Number of Participants With CV/Microvascular Events
Baseline through End of Study (up to 7.5 years)
Number of Participants With Glycaemic Failure Events
Baseline through to end of randomised dual therapy
- +38 more secondary outcomes
Study Arms (4)
rosiglitazone in addition to background metformin
EXPERIMENTALParticipants 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.
rosiglitazone in addition to background sulfonylurea
EXPERIMENTALParticipants 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.
Sulfonylurea in addition to background metformin
ACTIVE COMPARATORParticipants 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.
Metformin in addition to background sulfonylurea
ACTIVE COMPARATORParticipants 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.
Interventions
Rosiglitazone maximum 8 mg per day
Sulfonylurea (SU) maximum permitted daily dose
Metformin maximum permitted daily dose .
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (446)
GSK Investigational Site
Miranda, New South Wales, 2228, Australia
GSK Investigational Site
Randwick, New South Wales, 2031, Australia
GSK Investigational Site
Wollongong, New South Wales, 2500, Australia
GSK Investigational Site
Carina Heights, Queensland, 4152, Australia
GSK Investigational Site
Kippa-Ring, Queensland, 4021, Australia
GSK Investigational Site
Sherwood, Queensland, 4075, Australia
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Keswick, South Australia, 5035, Australia
GSK Investigational Site
North Adelaide, South Australia, 5006, Australia
GSK Investigational Site
Port Lincoln, South Australia, 5606, Australia
GSK Investigational Site
Heidelberg, Victoria, 3084, Australia
GSK Investigational Site
Malvern, Victoria, 3144, Australia
GSK Investigational Site
Antwerp, 2000, Belgium
GSK Investigational Site
Arlon, 6700, Belgium
GSK Investigational Site
Brussels, 1090, Belgium
GSK Investigational Site
Edegem, 2650, Belgium
GSK Investigational Site
Genk, 3600, Belgium
GSK Investigational Site
Ghent, 9000, Belgium
GSK Investigational Site
Kortrijk, 8500, Belgium
GSK Investigational Site
Liège, 4000, Belgium
GSK Investigational Site
Moerkerke, 8340, Belgium
GSK Investigational Site
Oostham, 3945, Belgium
GSK Investigational Site
Roeselare, 8800, Belgium
GSK Investigational Site
Sint-Gillis-Waas, 9170, Belgium
GSK Investigational Site
Vilvoorde, 1800, Belgium
GSK Investigational Site
Pleven, 5800, Bulgaria
GSK Investigational Site
Plovdiv, 4002, Bulgaria
GSK Investigational Site
Sofia, 1233, Bulgaria
GSK Investigational Site
Sofia, 1301, Bulgaria
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Sofia, 1303, Bulgaria
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Sofia, 1431/1000, Bulgaria
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Sofia, 1606, Bulgaria
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Varna, 9010, Bulgaria
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Krapinske Toplice, 49217, Croatia
GSK Investigational Site
Rijeka, 51000, Croatia
GSK Investigational Site
Slavonski Brod, 35000, Croatia
GSK Investigational Site
Varaždin, 42000, Croatia
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Zagreb, 10000, Croatia
GSK Investigational Site
Brno, 625 00, Czechia
GSK Investigational Site
České Budějovice, 370 87, Czechia
GSK Investigational Site
Holice V Cechach, 534 01, Czechia
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Hradec Králové, 500 05, Czechia
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Jindřichův Hradec, 377 38, Czechia
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Ostrava Poruba, 708 52, Czechia
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Písek, 397 01, Czechia
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Prague, 128 42, Czechia
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Prague, 140 21, Czechia
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Rakovník, 269 01, Czechia
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Tábor, 390 00, Czechia
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Trutnov, 541 21, Czechia
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Aalborg, DK-9100, Denmark
GSK Investigational Site
Aarhus, Denmark
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Copenhagen, 2300, Denmark
GSK Investigational Site
Glostrup Municipality, Denmark
GSK Investigational Site
Hilleroed, 3400, Denmark
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Kolding, DK-6000, Denmark
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København NV, Denmark
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Køge, 4600, Denmark
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Næstved, 4700, Denmark
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Odense C, DK-5000, Denmark
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Silkeborg, 8600, Denmark
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Slagelse, 4200, Denmark
GSK Investigational Site
Paide, 72714, Estonia
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Pärnu, 80018, Estonia
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Rakvere, 44316, Estonia
GSK Investigational Site
Saku, 75501, Estonia
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Tallinn, 10138, Estonia
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Tallinn, 1162, Estonia
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Tallinn, 11911, Estonia
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Tallinn, 13415, Estonia
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Tartu, Estonia
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Viljandi, 71024, Estonia
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Espoo, 02600, Finland
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Espoo, 02710, Finland
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Hanko, 10900, Finland
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Helsinki, 00150, Finland
GSK Investigational Site
Helsinki, 00810, Finland
GSK Investigational Site
Helsinki, 00930, Finland
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Hyvinkää, 05800, Finland
GSK Investigational Site
Jyväskylä, 40100, Finland
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Kerava, 04200, Finland
GSK Investigational Site
Kuopio, 70210, Finland
GSK Investigational Site
Lahti, 15850, Finland
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Lappeenranta, 53100, Finland
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Oulun Kaupunki, 90015, Finland
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Riihimäki, 11130, Finland
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Rovaniemi, Finland
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Seinäjoki, 60220, Finland
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Tampere, 33100, Finland
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Turku, 20100, Finland
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Turku, 20700, Finland
GSK Investigational Site
Bully-les-Mines, Hauts-de-France, 62160, France
GSK Investigational Site
Amilly, 28300, France
GSK Investigational Site
Arras, 62000, France
GSK Investigational Site
Aspach-le-Bas, 68700, France
GSK Investigational Site
Aubagne, 13400, France
GSK Investigational Site
Auchy-lès-Hesdin, 62770, France
GSK Investigational Site
Azille, 11700, France
GSK Investigational Site
Beaumont-le-Roger, 21170, France
GSK Investigational Site
Beaumont-sur-Lèze, 31870, France
GSK Investigational Site
Belfort, 90000, France
GSK Investigational Site
Belpech, 11420, France
GSK Investigational Site
Blotzheim, France
GSK Investigational Site
Bondy, 93143, France
GSK Investigational Site
BP 1542 Dijon, 21034, France
GSK Investigational Site
Broglie, 27270, France
GSK Investigational Site
Calmont, 31560, France
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Carbonne, 31390, France
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Carcassonne, 11000, France
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Carcassonne, France
GSK Investigational Site
Cassis, 13260, France
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Castelnaudary, 11400, France
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Catelnaudary, 11400, France
GSK Investigational Site
Cernay, 68700, France
GSK Investigational Site
Champhol, 28300, France
GSK Investigational Site
Chartres, 28000, France
GSK Investigational Site
Colmar, 68000, France
GSK Investigational Site
Corbeil Essonne, 91014, France
GSK Investigational Site
Coursan, 11110, France
GSK Investigational Site
Cuincy, 59553, France
GSK Investigational Site
Danjoutin, 90400, France
GSK Investigational Site
Dessenheim, 68600, France
GSK Investigational Site
Dieppe, 76200, France
GSK Investigational Site
Dunkirk, 59385, France
GSK Investigational Site
Épernon, 28230, France
GSK Investigational Site
Gémenos, 13420, France
GSK Investigational Site
Hanches, 28130, France
GSK Investigational Site
Hautot-sur-Mer, 76550, France
GSK Investigational Site
Husseren-Wesserling, 68470, France
GSK Investigational Site
Kembs, 68680, France
GSK Investigational Site
La Barre-en-Ouche, 27330, France
GSK Investigational Site
La Verdière, 83560, France
GSK Investigational Site
Labarth-Sur-Leze, 31860, France
GSK Investigational Site
Labarthe-sur-Lèze, 31860, France
GSK Investigational Site
Le Grau-du-Roi, 30240, France
GSK Investigational Site
Le Lherm 31600, 31600, France
GSK Investigational Site
Le Perray-en-Yvelines, 78610, France
GSK Investigational Site
Lezignan-Corbières, 11200, France
GSK Investigational Site
Maintenon, 28130, France
GSK Investigational Site
Marseille, 13001, France
GSK Investigational Site
Marseille, 13003, France
GSK Investigational Site
Marseille, 13008, France
GSK Investigational Site
Marseille, 13011, France
GSK Investigational Site
Marseille, 13013, France
GSK Investigational Site
Marseille, 13014, France
GSK Investigational Site
Marseille, 13016, France
GSK Investigational Site
Masevaux, 68290, France
GSK Investigational Site
Maubeuge, 59600, France
GSK Investigational Site
Monfort Sur Risle, 27290, France
GSK Investigational Site
Mulhouse, 68100, France
GSK Investigational Site
Muret, 31600, France
GSK Investigational Site
Nassandres, 27550, France
GSK Investigational Site
Nevers, 58033, France
GSK Investigational Site
Nogent-le-Phaye, 28630, France
GSK Investigational Site
Orbec, 14290, France
GSK Investigational Site
Paris, 75730, France
GSK Investigational Site
Pierre-Bénite, 69495, France
GSK Investigational Site
Pierres, 28130, France
GSK Investigational Site
Pinsaguel, 31120, France
GSK Investigational Site
Roux Mesnil Bouteille, 76370, France
GSK Investigational Site
Rugles, 27250, France
GSK Investigational Site
Saint Leger Sur Yvelines, 78610, France
GSK Investigational Site
Saint-Eulalie Badens, 11800, France
GSK Investigational Site
Seysses, 31600, France
GSK Investigational Site
Thann, 68800, France
GSK Investigational Site
Thiberville, 27230, France
GSK Investigational Site
Toulouse, 31000, France
GSK Investigational Site
Toulouse, 31400, France
GSK Investigational Site
Toulouse, 31500, France
GSK Investigational Site
Trebbes, 01800, France
GSK Investigational Site
Trèbes, 11800, France
GSK Investigational Site
Valenciennes, 59322, France
GSK Investigational Site
Vogelsheim, 68600, France
GSK Investigational Site
Voves, 28150, France
GSK Investigational Site
Wittenheim, 68270, France
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69120, Germany
GSK Investigational Site
Sinsheim, Baden-Wurttemberg, 74889, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70197, Germany
GSK Investigational Site
Kronach, Bavaria, 96317, Germany
GSK Investigational Site
Würzburg, Bavaria, 97070, Germany
GSK Investigational Site
Hamburg, Hamburg, 20249, Germany
GSK Investigational Site
Kronberg, Hesse, 61476, Germany
GSK Investigational Site
Ober-Mörlen, Hesse, 61239, Germany
GSK Investigational Site
Offenbach, Hesse, 63071, Germany
GSK Investigational Site
Wetzlar, Hesse, 35578, Germany
GSK Investigational Site
Bad Lauterberg im Harz, Lower Saxony, 37431, Germany
GSK Investigational Site
Beckum, North Rhine-Westphalia, 59269, Germany
GSK Investigational Site
Menden, North Rhine-Westphalia, 58706, Germany
GSK Investigational Site
Gau-Algesheim, Rhineland-Palatinate, 55435, Germany
GSK Investigational Site
Kallstadt, Rhineland-Palatinate, 67169, Germany
GSK Investigational Site
Lambrecht, Rhineland-Palatinate, 67466, Germany
GSK Investigational Site
Rhaunen, Rhineland-Palatinate, 55624, Germany
GSK Investigational Site
Speyer, Rhineland-Palatinate, 67346, Germany
GSK Investigational Site
Friedrichsthal, Saarland, 66299, Germany
GSK Investigational Site
Burgstädt, Saxony, 09217, Germany
GSK Investigational Site
Chemnitz, Saxony, 09130, Germany
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Leipzig, Saxony, 04103, Germany
GSK Investigational Site
Suhl, Thuringia, 98529, Germany
GSK Investigational Site
Athens, 115 27, Greece
GSK Investigational Site
Athens, 11521, Greece
GSK Investigational Site
Athens, 11527, Greece
GSK Investigational Site
Athens, 18537, Greece
GSK Investigational Site
Haidari, Athens, 12462, Greece
GSK Investigational Site
Ioannina, 45001, Greece
GSK Investigational Site
Marousi, 15123, Greece
GSK Investigational Site
Pátrai, 26335, Greece
GSK Investigational Site
Pátrai, 26500, Greece
GSK Investigational Site
Piraeus-Athens, 18454, Greece
GSK Investigational Site
Piraeus-Athens, 18536, Greece
GSK Investigational Site
Thessaloniki, 564 29, Greece
GSK Investigational Site
Thessalonikis, 57010, Greece
GSK Investigational Site
Budapest, 1062, Hungary
GSK Investigational Site
Budapest, 1083, Hungary
GSK Investigational Site
Budapest, 1096, Hungary
GSK Investigational Site
Budapest, 1097, Hungary
GSK Investigational Site
Budapest, 1115, Hungary
GSK Investigational Site
Budapest, 1125, Hungary
GSK Investigational Site
Budapest, 1145, Hungary
GSK Investigational Site
Debrecen, 4043, Hungary
GSK Investigational Site
Eger, Hungary
GSK Investigational Site
Győr, 9024, Hungary
GSK Investigational Site
Gyula, 5701, Hungary
GSK Investigational Site
Kurtag99, Hungary
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Nyiregyháza, 4400, Hungary
GSK Investigational Site
Patkaj98, Hungary
GSK Investigational Site
Siófok, 8601, Hungary
GSK Investigational Site
Szentes, 6600, Hungary
GSK Investigational Site
Szombathely, 9700, Hungary
GSK Investigational Site
Veszprém, 8200, Hungary
GSK Investigational Site
Zalaegerszeg, 8900, Hungary
GSK Investigational Site
Reggio Calabria, Calabria, 89100, Italy
GSK Investigational Site
Napoli, Campania, 80136, Italy
GSK Investigational Site
Nocera Inferiore (SA), Campania, 84014, Italy
GSK Investigational Site
Salerno, Campania, 84100, Italy
GSK Investigational Site
Bologna, Emilia-Romagna, 40138, Italy
GSK Investigational Site
Rimini, Emilia-Romagna, 47900, Italy
GSK Investigational Site
Rome, Lazio, 00155, Italy
GSK Investigational Site
Rome, Lazio, 00168, Italy
GSK Investigational Site
Genoa, Liguria, 16132, Italy
GSK Investigational Site
Brescia, Lombardy, 25123, Italy
GSK Investigational Site
Milan, Lombardy, 20162, Italy
GSK Investigational Site
San Donato (MI), Lombardy, 20097, Italy
GSK Investigational Site
Treviglio (BG), Lombardy, 13115, Italy
GSK Investigational Site
Campobasso, Molise, 86100, Italy
GSK Investigational Site
Turin, Piedmont, 10122, Italy
GSK Investigational Site
Cagliari, Sardinia, 09127, Italy
GSK Investigational Site
Sassari, Sardinia, 07100, Italy
GSK Investigational Site
Palermo, Sicily, 90127, Italy
GSK Investigational Site
Pisa, Tuscany, 56126, Italy
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Bari, 70124, Italy
GSK Investigational Site
Parma, 43100, Italy
GSK Investigational Site
Roma, 00168, Italy
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Jēkabpils, LV 5201, Latvia
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Lagzdi60, Latvia
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Limbaži, LV 4001, Latvia
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Ogre, LV 5001, Latvia
GSK Investigational Site
Riga, 1006, Latvia
GSK Investigational Site
Riga, LV 1011, Latvia
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Riga, LV 1057, Latvia
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Riga, LV1002, Latvia
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Sturii59, Latvia
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Tukums, LV 3100, Latvia
GSK Investigational Site
Kaunas, LT-47144, Lithuania
GSK Investigational Site
Kaunas, LT-49476, Lithuania
GSK Investigational Site
Kaunas, LT-50009, Lithuania
GSK Investigational Site
Kaunas, LT-51270, Lithuania
GSK Investigational Site
Klaipėda, 92304, Lithuania
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Vilnius, LT 08661, Lithuania
GSK Investigational Site
Vilnius, LT-04318, Lithuania
GSK Investigational Site
Vilnius, LT-10103, Lithuania
GSK Investigational Site
Geleen, 6160 BB, Netherlands
GSK Investigational Site
Groningen, 9711 SG, Netherlands
GSK Investigational Site
Hengelo, 7555 DL, Netherlands
GSK Investigational Site
Hoogvliet, 3192 JN, Netherlands
GSK Investigational Site
Kerkrade, 6461 XP, Netherlands
GSK Investigational Site
Landgraaf, 6373 JS, Netherlands
GSK Investigational Site
Musselkanaal, 9581 AD, Netherlands
GSK Investigational Site
Nijmegen, 6525 EC, Netherlands
GSK Investigational Site
Oude Pekela, 9665 AR, Netherlands
GSK Investigational Site
Ridderkerk, 2985 BV, Netherlands
GSK Investigational Site
Rijswijk, 2281 AK, Netherlands
GSK Investigational Site
Roosendaal, 4701 LJ, Netherlands
GSK Investigational Site
Rotterdam, 3021 HC, Netherlands
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Rotterdam, 3082 KC, Netherlands
GSK Investigational Site
Sint Willebrord, 4711 EG, Netherlands
GSK Investigational Site
Zoetermeer, 2724 EK, Netherlands
GSK Investigational Site
Zwijndrecht, 3331 AE, Netherlands
GSK Investigational Site
Zwijndrecht, 3334 XA, Netherlands
GSK Investigational Site
Christchurch, 8011, New Zealand
GSK Investigational Site
Dunedin, 9016, New Zealand
GSK Investigational Site
Hastings, Private Bag 9014, New Zealand
GSK Investigational Site
Otahuhu, Auckland, 2025, New Zealand
GSK Investigational Site
Palmerston North, 4410, New Zealand
GSK Investigational Site
Takapuna, Auckland, 0620, New Zealand
GSK Investigational Site
Tauranga, 3112, New Zealand
GSK Investigational Site
Wellington, 6002, New Zealand
GSK Investigational Site
Bialystok, 15-276, Poland
GSK Investigational Site
Bydgoszcz, 85 822, Poland
GSK Investigational Site
Gdansk, 80 211, Poland
GSK Investigational Site
Grudziądz, 86-300, Poland
GSK Investigational Site
Krakow, 31 261, Poland
GSK Investigational Site
Krakow, 31 501, Poland
GSK Investigational Site
Lodz, 90 030, Poland
GSK Investigational Site
Lublin, 02 081, Poland
GSK Investigational Site
Lublin, 20-718, Poland
GSK Investigational Site
Olsztyn, 10 461, Poland
GSK Investigational Site
Poznan, 60-834, Poland
GSK Investigational Site
Poznan, 61 696, Poland
GSK Investigational Site
Warsaw, 01 887, Poland
GSK Investigational Site
Warsaw, 01-337, Poland
GSK Investigational Site
Warsaw, 02 507, Poland
GSK Investigational Site
Warsaw, 02-042, Poland
GSK Investigational Site
Wroclaw, 50-127, Poland
GSK Investigational Site
Bucharest, 011234, Romania
GSK Investigational Site
Bucharest, 020475, Romania
GSK Investigational Site
Bucharest, 022448, Romania
GSK Investigational Site
Cluj-Napoca, 400006, Romania
GSK Investigational Site
Craiova, 2000642, Romania
GSK Investigational Site
Iași, 700111, Romania
GSK Investigational Site
Timișoara, 293406, Romania
GSK Investigational Site
Moscow, 115 280, Russia
GSK Investigational Site
Moscow, 117049, Russia
GSK Investigational Site
Moscow, 125367, Russia
GSK Investigational Site
Moscow, 129110, Russia
GSK Investigational Site
Saint Petersburg, 194291, Russia
GSK Investigational Site
Saint Petersburg, 195257, Russia
GSK Investigational Site
Banská Bystrica, 975 17, Slovakia
GSK Investigational Site
Bratislava, 811 08, Slovakia
GSK Investigational Site
Bratislava, 813 69, Slovakia
GSK Investigational Site
Bratislava, 82102, Slovakia
GSK Investigational Site
Bratislava, 82108, Slovakia
GSK Investigational Site
Košice, 040 11, Slovakia
GSK Investigational Site
Košice, 041 90, Slovakia
GSK Investigational Site
Kysucké Nové Mesto, 024 01, Slovakia
GSK Investigational Site
Lučenec, 984 01, Slovakia
GSK Investigational Site
Ľubochňa, 034 91, Slovakia
GSK Investigational Site
Prešov, 08001, Slovakia
GSK Investigational Site
Prievidza, 97201, Slovakia
GSK Investigational Site
Šahy, 936 01, Slovakia
GSK Investigational Site
Šamorín, 931 01, Slovakia
GSK Investigational Site
Trenčín, 911 01, Slovakia
GSK Investigational Site
Žilina, 010 01, Slovakia
GSK Investigational Site
Badalona, 08911, Spain
GSK Investigational Site
Barcelona, 08025, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Benidorm, 03500, Spain
GSK Investigational Site
Bilbao, 48903, Spain
GSK Investigational Site
Cadiz, 11009, Spain
GSK Investigational Site
Cáceres, 10003, Spain
GSK Investigational Site
Granada, 18012, Spain
GSK Investigational Site
Madrid, 28034, Spain
GSK Investigational Site
Madrid, 28040, Spain
GSK Investigational Site
Palma de Mallorca, 7014, Spain
GSK Investigational Site
Reus, 43201, Spain
GSK Investigational Site
Santander, 38008, Spain
GSK Investigational Site
Vazquc56, Spain
GSK Investigational Site
Vizcaya, 48910, Spain
GSK Investigational Site
Vizcaya, 48920, Spain
GSK Investigational Site
Eksjö, SE-575 81, Sweden
GSK Investigational Site
Gothenburg, SE-413 45, Sweden
GSK Investigational Site
Gothenburg, SE-416 65, Sweden
GSK Investigational Site
Gothenburg, SE-417 17, Sweden
GSK Investigational Site
Helsingborg, SE-254 37, Sweden
GSK Investigational Site
Köping, SE-73181, Sweden
GSK Investigational Site
Kristianstad, SE-291 85, Sweden
GSK Investigational Site
Kungälv, SE-442 83, Sweden
GSK Investigational Site
Linköpiing, SE-582 25, Sweden
GSK Investigational Site
Linköping, SE-582 46, Sweden
GSK Investigational Site
Lund, SE-221 85, Sweden
GSK Investigational Site
Mora, SE-792 85, Sweden
GSK Investigational Site
Nacka, SE-131 83, Sweden
GSK Investigational Site
Norrköping, SE-602 20, Sweden
GSK Investigational Site
Oskarshamn, SE-572 28, Sweden
GSK Investigational Site
Skene, SE-511 62, Sweden
GSK Investigational Site
Stockholm, SE-182 88, Sweden
GSK Investigational Site
Uddevalla, SE-451 40, Sweden
GSK Investigational Site
Umeå, SE-901 85, Sweden
GSK Investigational Site
Uppsala, SE-751 25, Sweden
GSK Investigational Site
Vadstena, SE-592 32, Sweden
GSK Investigational Site
Dnipro, 49044, Ukraine
GSK Investigational Site
Kharkiv, 61002, Ukraine
GSK Investigational Site
Kiev, 02175, Ukraine
GSK Investigational Site
Kiev, 04114, Ukraine
GSK Investigational Site
Kyiv, 01004, Ukraine
GSK Investigational Site
Lviv, 79010, Ukraine
GSK Investigational Site
Vinnitsa, 21010, Ukraine
GSK Investigational Site
Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom
GSK Investigational Site
Fowley, Cornwall, PL23 1DT, United Kingdom
GSK Investigational Site
Chesterfield, Derbyshire, S40 4TF, United Kingdom
GSK Investigational Site
Chesterfield, Derbyshire, S44 6DE, United Kingdom
GSK Investigational Site
Airdrie, Lanarkshire, ML6 0JS, United Kingdom
GSK Investigational Site
Glasgow, Lanarkshire, G51 4TF, United Kingdom
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom
GSK Investigational Site
Hamilton, Lanarkshire, ML3 0DR, United Kingdom
GSK Investigational Site
Motherwell, Lanarkshire, ML1 3JX, United Kingdom
GSK Investigational Site
Leicester, Leicestershire, LE1 5WW, United Kingdom
GSK Investigational Site
Northampton, Northamptonshire, NN1 5BD, United Kingdom
GSK Investigational Site
Northampton, Northamptonshire, NN5 7AQ, United Kingdom
GSK Investigational Site
Linwood, Renfrewshire, United Kingdom
GSK Investigational Site
Paisley, Renfrewshire, PA1 1UB, United Kingdom
GSK Investigational Site
Frome, Somerset, BA11 1EZ, United Kingdom
GSK Investigational Site
Glastonbury, Somerset, BA6 9LP, United Kingdom
GSK Investigational Site
Rugby, Warwickshire, CV21 3SP, United Kingdom
GSK Investigational Site
Rugby, Warwickshire, CV22 5PX, United Kingdom
GSK Investigational Site
Corsham, Wiltshire, SN13 9DL, United Kingdom
GSK Investigational Site
Trowbridge, Wiltshire, BA14 8QA, United Kingdom
GSK Investigational Site
Trowbridge, Wiltshire, BA14 9AR, United Kingdom
GSK Investigational Site
Westbury, Wiltshire, BA13 3JD, United Kingdom
GSK Investigational Site
Airdrie, ML6 0JH, United Kingdom
GSK Investigational Site
Airdrie, ML6 0JU, United Kingdom
GSK Investigational Site
Ashford, TW15 2TU, United Kingdom
GSK Investigational Site
Bath, BA2 3HT, United Kingdom
GSK Investigational Site
Chesterfield, S40 1LE, United Kingdom
GSK Investigational Site
Chippenham, SN15 2SB, United Kingdom
GSK Investigational Site
Coatbridge, ML5 3AP, United Kingdom
GSK Investigational Site
Colney, NR4 7UY, United Kingdom
GSK Investigational Site
Cumbernauld, G67 3BE, United Kingdom
GSK Investigational Site
Dronfield, S18 1RU, United Kingdom
GSK Investigational Site
Dumbarton, G82 1PW, United Kingdom
GSK Investigational Site
East Kilbride, G75 8RG, United Kingdom
GSK Investigational Site
Falmouth, TR11 2LH, United Kingdom
GSK Investigational Site
Garston, Watford, WD2 6EB, United Kingdom
GSK Investigational Site
Gateshead, NE9 6SX, United Kingdom
GSK Investigational Site
Glasgow, G5 OPQ, United Kingdom
GSK Investigational Site
Glasgow, United Kingdom
GSK Investigational Site
Hamilton, ML3 8AA, United Kingdom
GSK Investigational Site
Harrow, HA3 7LT, United Kingdom
GSK Investigational Site
Kirkintilloch, G66 1JB, United Kingdom
GSK Investigational Site
Leigh-on-Sea, SS9 2SQ, United Kingdom
GSK Investigational Site
Motherwell, ML1 2PS, United Kingdom
GSK Investigational Site
Newcastle upon Tyne, NE1 4LP, United Kingdom
GSK Investigational Site
Newport, PO30 5TG, United Kingdom
GSK Investigational Site
Nottingham, NG5 1PB, United Kingdom
GSK Investigational Site
Old Whittington, Chesterfield, S41 9JZ, United Kingdom
GSK Investigational Site
Paisley, PA3 2DY, United Kingdom
GSK Investigational Site
Penzance, TR18 4JH, United Kingdom
GSK Investigational Site
Rubery, Birmingham, B45 9JT, United Kingdom
GSK Investigational Site
Sheffield, S5 7QB, United Kingdom
GSK Investigational Site
Sheffield, S5 7TW, United Kingdom
GSK Investigational Site
Thornhill, DG3 5AA, United Kingdom
GSK Investigational Site
Thornhill, Cardiff, CF14 9BB, United Kingdom
GSK Investigational Site
Uddingston, G71 5SU, United Kingdom
GSK Investigational Site
Weston-super-Mare, BS23 4BP, United Kingdom
GSK Investigational Site
Wishaw, ML2 7BQ, United Kingdom
GSK Investigational Site
Woking, GU21 1TD, United Kingdom
GSK Investigational Site
Worle, Weston-Super-Mare, BS22 6AJ, United Kingdom
Related Publications (7)
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.
PMID: 17517066BACKGROUNDHome 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.
PMID: 16025252BACKGROUNDHome 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.
PMID: 17551159BACKGROUNDHome 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.
PMID: 19501900BACKGROUNDKomajda 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.
PMID: 18435852BACKGROUNDJones 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.
PMID: 25524432DERIVEDMacDonald 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.
PMID: 21562320DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2006
First Posted
September 22, 2006
Study Start
April 1, 2001
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
March 23, 2017
Results First Posted
November 13, 2009
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.