Clinical trial NCT00379769: RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
CV outcomes
rosiglitazone
Type II diabetes
sulfonylurea
RECORD
metformin
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-09-22
Enrollment: 4447
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events
timeFrame: Baseline through End of Study (up to 7.5 years)
measure: Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause
timeFrame: Baseline through End of Study (up to 7.5 years)
measure: 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
timeFrame: Baseline through End of Study (up to 7.5 years)
measure: 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
timeFrame: Baseline through End of Study (up to 7.5 years)
measure: Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions
timeFrame: Baseline through End of Study (up to 7.5 years)
measure: Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions
timeFrame: Baseline through End of Study (up to 7.5 years)
measure: Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions
timeFrame: Baseline through End of Study (up to 7.5 years)
measure: Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions
timeFrame: Baseline through End of Study (up to 7.5 years)
measure: Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions
timeFrame: Baseline through End of Study (up to 7.5 years)
measure: Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions
timeFrame: Baseline through End of Study (up to 7.5 years)
Secondary outcomes:
measure: Number of Participants With Cardiovascular Events and All-cause Deaths
timeFrame: Baseline through End of Study (up to 7.5 years)
measure: Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths
timeFrame: Baseline through End of Study (up to 7.5 years)
measure: Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum
timeFrame: Baseline through End of Study (up to 7.5 years)
measure: Number of Participants With CV/Microvascular Events
timeFrame: Baseline through End of Study (up to 7.5 years)
measure: Number of Participants With Glycaemic Failure Events
timeFrame: Baseline through to end of randomised dual therapy
measure: Number of Participants With Addition of Third Oral Agent/Switch to Insulin
timeFrame: Baseline through End of Study (up to 7.5 years)
measure: The Number of Participants Starting Insulin at Any Time During the Study
timeFrame: Baseline through End of Study (up to 7.5 years)
measure: Model Adjusted Change From Baseline in HbA1c at Month 60
timeFrame: Baseline and Month 60 of randomised dual therapy treatment period
measure: Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60
timeFrame: Baseline to Month 60 of the randomised dual therapy treatment period
measure: Model Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60
timeFrame: Baseline to Month 60 of the randomised dual therapy treatment period
measure: Number of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60
timeFrame: Baseline to Month 60 of the randomised dual therapy treatment period
measure: Model Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60
timeFrame: Baseline to Month 60 of the randomised dual therapy treatment phase
measure: Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC), Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids (FFAs) at Month 60
timeFrame: Baseline to Month 60 of the randomised dual therapy treatment phase
measure: Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC):High-density Lipoprotein (HDL) Cholesterol and Low-density Lipoprotein (LDL) Cholesterol:HDL Cholesterol Ratios at Month 60
timeFrame: Baseline to Month 60 of the randomised dual therapy treatment period
measure: Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60
timeFrame: Baseline to Month 60 of the randomised dual therapy treatment period
measure: Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60
timeFrame: Baseline to Month 60 of the randomised dual therapy treatment phase
measure: Model Adjusted Change From Baseline in Body Weight at Month 60
timeFrame: Baseline to Month 60 of the randomised dual therapy treatment phase
measure: Model Adjusted Change From Baseline in Alanine Aminotransferase at Month 60
timeFrame: Baseline to Month 60 of the randomised dual therapy treatment phase
measure: Model Adjusted Change From Baseline in Waist Circumference at Month 60
timeFrame: Baseline to Month 60 of the randomised dual therapy treatment phase
measure: Model Adjusted Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 60
timeFrame: Baseline to Month 60 of the randomised dual therapy treatment phase
measure: Model Adjusted Ratio to Baseline (Expressed as a Percentage) for C-Reactive Protein at Month 60
timeFrame: Baseline to Month 60 of the randomised dual therapy treatment phase
measure: Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Fibrinogen at Month 60
timeFrame: Baseline to Month 60 of the randomised dual therapy treatment phase
measure: Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Plasminogen Activator Inhibitor-1 (PAI-1) Antigen at Month 60
timeFrame: Baseline to Month 60 of the randomised dual therapy treatment phase
measure: Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Main Study + Observational Follow-up Combined
timeFrame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
measure: Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Observational Follow-up
timeFrame: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
measure: Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined
timeFrame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
measure: Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up
timeFrame: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
measure: Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined
timeFrame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
measure: Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up
timeFrame: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
measure: Number of Participants With a Bone Fracture Event - Overall and by Gender: Main Study and Observational Follow-up Combined
timeFrame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
measure: Number of Participants With a Bone Fracture Event - Overall and by Gender: Observational Follow-up
timeFrame: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
measure: Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Main Study + Observational Follow-up Combined
timeFrame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
measure: Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Observational Follow-up
timeFrame: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
measure: Number of Participants With an Event of Death Due to a Bone Fracture-related Event: Main Study + Observational Follow-up Combined
timeFrame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
measure: Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined
timeFrame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
measure: Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up
timeFrame: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
measure: Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined
timeFrame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
measure: Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined
timeFrame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
measure: Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined
timeFrame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
measure: Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up
timeFrame: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
measure: Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined
timeFrame: From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
measure: Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up
timeFrame: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
measure: Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up
timeFrame: From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Other outcomes:
Locations:
city: Miranda
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Randwick
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Wollongong
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Carina Heights
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Kippa Ring
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Sherwood
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Keswick
country: Australia
facility: GSK Investigational Site
state: South Australia
city: North Adelaide
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Port Lincoln
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Heidelberg
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Malvern
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facility: GSK Investigational Site
state: Victoria
city: Antwerpen
country: Belgium
facility: GSK Investigational Site
city: Arlon
country: Belgium
facility: GSK Investigational Site
city: Brussels
country: Belgium
facility: GSK Investigational Site
city: Edegem
country: Belgium
facility: GSK Investigational Site
city: Genk
country: Belgium
facility: GSK Investigational Site
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Kortrijk
country: Belgium
facility: GSK Investigational Site
city: Liège
country: Belgium
facility: GSK Investigational Site
city: Moerkerke
country: Belgium
facility: GSK Investigational Site
city: Oostham
country: Belgium
facility: GSK Investigational Site
city: Roeselare
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facility: GSK Investigational Site
city: Sint Gillis-Waas
country: Belgium
facility: GSK Investigational Site
city: Vilvoorde
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facility: GSK Investigational Site
city: Pleven
country: Bulgaria
facility: GSK Investigational Site
city: Plovdiv
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
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facility: GSK Investigational Site
city: Varna
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facility: GSK Investigational Site
city: Krapinske Toplice
country: Croatia
facility: GSK Investigational Site
city: Rijeka
country: Croatia
facility: GSK Investigational Site
city: Slavonski Brod
country: Croatia
facility: GSK Investigational Site
city: Varaždin
country: Croatia
facility: GSK Investigational Site
city: Zagreb
country: Croatia
facility: GSK Investigational Site
city: Brno
country: Czech Republic
facility: GSK Investigational Site
city: Ceske Budejovice
country: Czech Republic
facility: GSK Investigational Site
city: Holice V Cechach
country: Czech Republic
facility: GSK Investigational Site
city: Hradec Kralove
country: Czech Republic
facility: GSK Investigational Site
city: Jindrichuv Hradec
country: Czech Republic
facility: GSK Investigational Site
city: Ostrava Poruba
country: Czech Republic
facility: GSK Investigational Site
city: Pisek
country: Czech Republic
facility: GSK Investigational Site
city: Praha 2
country: Czech Republic
facility: GSK Investigational Site
city: Praha 4
country: Czech Republic
facility: GSK Investigational Site
city: Rakovnik
country: Czech Republic
facility: GSK Investigational Site
city: Tabor
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facility: GSK Investigational Site
city: Trutnov
country: Czech Republic
facility: GSK Investigational Site
city: Aalborg
country: Denmark
facility: GSK Investigational Site
city: Aarhus
country: Denmark
facility: GSK Investigational Site
city: Copenhagen
country: Denmark
facility: GSK Investigational Site
city: Glostrup
country: Denmark
facility: GSK Investigational Site
city: Hilleroed
country: Denmark
facility: GSK Investigational Site
city: Koge
country: Denmark
facility: GSK Investigational Site
city: Kolding
country: Denmark
facility: GSK Investigational Site
city: København NV
country: Denmark
facility: GSK Investigational Site
city: Naestved
country: Denmark
facility: GSK Investigational Site
city: Odense C
country: Denmark
facility: GSK Investigational Site
city: Silkeborg
country: Denmark
facility: GSK Investigational Site
city: Slagelse
country: Denmark
facility: GSK Investigational Site
city: Paide
country: Estonia
facility: GSK Investigational Site
city: Parnu
country: Estonia
facility: GSK Investigational Site
city: Rakvere
country: Estonia
facility: GSK Investigational Site
city: Saku
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Viljandi
country: Estonia
facility: GSK Investigational Site
city: Espoo
country: Finland
facility: GSK Investigational Site
city: Espoo
country: Finland
facility: GSK Investigational Site
city: Hanko
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Hyvinkaa
country: Finland
facility: GSK Investigational Site
city: Jyväskylä
country: Finland
facility: GSK Investigational Site
city: Kerava
country: Finland
facility: GSK Investigational Site
city: Kuopio
country: Finland
facility: GSK Investigational Site
city: Lahti
country: Finland
facility: GSK Investigational Site
city: Lappeenranta
country: Finland
facility: GSK Investigational Site
city: Oulun kaupunki
country: Finland
facility: GSK Investigational Site
city: Riihimäki
country: Finland
facility: GSK Investigational Site
city: Rovaniemi
country: Finland
facility: GSK Investigational Site
city: Seinajoki
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Bully Les Mines
country: France
facility: GSK Investigational Site
state: Nord-Pas-de-Calais
city: Amilly
country: France
facility: GSK Investigational Site
city: Arras
country: France
facility: GSK Investigational Site
city: Aspach le Bas 68700
country: France
facility: GSK Investigational Site
city: Aubagne
country: France
facility: GSK Investigational Site
city: Auchy les Hesdin
country: France
facility: GSK Investigational Site
city: Azille
country: France
facility: GSK Investigational Site
city: Beaumont Le Roger
country: France
facility: GSK Investigational Site
city: Beaumont sur Leze
country: France
facility: GSK Investigational Site
city: Belfort
country: France
facility: GSK Investigational Site
city: Belpech
country: France
facility: GSK Investigational Site
city: Blotzheim
country: France
facility: GSK Investigational Site
city: Bondy
country: France
facility: GSK Investigational Site
city: BP 1542 Dijon
country: France
facility: GSK Investigational Site
city: Broglie
country: France
facility: GSK Investigational Site
city: Calmont
country: France
facility: GSK Investigational Site
city: Carbonne
country: France
facility: GSK Investigational Site
city: Carcassonne 11000
country: France
facility: GSK Investigational Site
city: Carcassonne
country: France
facility: GSK Investigational Site
city: Carcassonne
country: France
facility: GSK Investigational Site
city: Cassis
country: France
facility: GSK Investigational Site
city: Castelnaudary
country: France
facility: GSK Investigational Site
city: Catelnaudary
country: France
facility: GSK Investigational Site
city: Cernay
country: France
facility: GSK Investigational Site
city: Champhol
country: France
facility: GSK Investigational Site
city: Chartres
country: France
facility: GSK Investigational Site
city: Colmar
country: France
facility: GSK Investigational Site
city: Corbeil Essonne
country: France
facility: GSK Investigational Site
city: Coursan
country: France
facility: GSK Investigational Site
city: Cuincy
country: France
facility: GSK Investigational Site
city: Danjoutin
country: France
facility: GSK Investigational Site
city: Dessenheim
country: France
facility: GSK Investigational Site
city: Dieppe
country: France
facility: GSK Investigational Site
city: Dunkerque
country: France
facility: GSK Investigational Site
city: Epernon
country: France
facility: GSK Investigational Site
city: Gemenos
country: France
facility: GSK Investigational Site
city: Hanches
country: France
facility: GSK Investigational Site
city: Hautot sur Mer
country: France
facility: GSK Investigational Site
city: Husseren Wesserling
country: France
facility: GSK Investigational Site
city: Kembs
country: France
facility: GSK Investigational Site
city: La Barre En Ouche
country: France
facility: GSK Investigational Site
city: La Verdière
country: France
facility: GSK Investigational Site
city: Labarth-Sur-Leze
country: France
facility: GSK Investigational Site
city: Labarthe-Sur-Leze
country: France
facility: GSK Investigational Site
city: Le Grau Du Roi
country: France
facility: GSK Investigational Site
city: Le Lherm 31600
country: France
facility: GSK Investigational Site
city: Le Perray En Yvelines
country: France
facility: GSK Investigational Site
city: Lezignan-Corbières
country: France
facility: GSK Investigational Site
city: Maintenon
country: France
facility: GSK Investigational Site
city: Marseille
country: France
facility: GSK Investigational Site
city: Marseille
country: France
facility: GSK Investigational Site
city: Marseille
country: France
facility: GSK Investigational Site
city: Marseille
country: France
facility: GSK Investigational Site
city: Marseille
country: France
facility: GSK Investigational Site
city: Marseille
country: France
facility: GSK Investigational Site
city: Marseille
country: France
facility: GSK Investigational Site
city: Masevaux
country: France
facility: GSK Investigational Site
city: Maubeuge
country: France
facility: GSK Investigational Site
city: Monfort sur Risle
country: France
facility: GSK Investigational Site
city: Mulhouse
country: France
facility: GSK Investigational Site
city: Muret
country: France
facility: GSK Investigational Site
city: Nassandres
country: France
facility: GSK Investigational Site
city: Nevers cedex
country: France
facility: GSK Investigational Site
city: Nogent le Phaye
country: France
facility: GSK Investigational Site
city: Orbec
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Pierre Benite Cedex
country: France
facility: GSK Investigational Site
city: Pierres
country: France
facility: GSK Investigational Site
city: Pinsaguel
country: France
facility: GSK Investigational Site
city: Roux Mesnil Bouteille
country: France
facility: GSK Investigational Site
city: Rugles
country: France
facility: GSK Investigational Site
city: Saint Leger sur Yvelines
country: France
facility: GSK Investigational Site
city: Saint-Eulalie Badens
country: France
facility: GSK Investigational Site
city: Seysses
country: France
facility: GSK Investigational Site
city: Thann
country: France
facility: GSK Investigational Site
city: Thiberville
country: France
facility: GSK Investigational Site
city: Toulouse
country: France
facility: GSK Investigational Site
city: Toulouse
country: France
facility: GSK Investigational Site
city: Toulouse
country: France
facility: GSK Investigational Site
city: Trebbes
country: France
facility: GSK Investigational Site
city: Trebes
country: France
facility: GSK Investigational Site
city: Valenciennes
country: France
facility: GSK Investigational Site
city: Vogelsheim
country: France
facility: GSK Investigational Site
city: Voves
country: France
facility: GSK Investigational Site
city: Wittenheim
country: France
facility: GSK Investigational Site
city: Heidelberg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Sinsheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Kronach
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kronberg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Ober-Moerlen
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Offenbach
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Wetzlar
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Bad Lauterberg
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Beckum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Menden
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Gau-Algesheim
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Kallstadt
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Lambrecht
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Rhaunen
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Speyer
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Friedrichsthal
country: Germany
facility: GSK Investigational Site
state: Saarland
city: Burgstaedt
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Chemnitz
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Suhl
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Haidari, Athens
country: Greece
facility: GSK Investigational Site
city: Ioannina
country: Greece
facility: GSK Investigational Site
city: Maroussi
country: Greece
facility: GSK Investigational Site
city: Patra
country: Greece
facility: GSK Investigational Site
city: Patra
country: Greece
facility: GSK Investigational Site
city: Piraeus-Athens
country: Greece
facility: GSK Investigational Site
city: Piraeus-Athens
country: Greece
facility: GSK Investigational Site
city: Thessalonikis
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Debrecen
country: Hungary
facility: GSK Investigational Site
city: Eger
country: Hungary
facility: GSK Investigational Site
city: Gyor
country: Hungary
facility: GSK Investigational Site
city: Gyula
country: Hungary
facility: GSK Investigational Site
city: Kurtag99
country: Hungary
facility: GSK Investigational Site
city: Nyiregyháza
country: Hungary
facility: GSK Investigational Site
city: Patkaj98
country: Hungary
facility: GSK Investigational Site
city: Siofok
country: Hungary
facility: GSK Investigational Site
city: Szentes
country: Hungary
facility: GSK Investigational Site
city: Szombathely
country: Hungary
facility: GSK Investigational Site
city: Veszprem
country: Hungary
facility: GSK Investigational Site
city: Zalaegerszeg
country: Hungary
facility: GSK Investigational Site
city: Reggio Calabria
country: Italy
facility: GSK Investigational Site
state: Calabria
city: Napoli
country: Italy
facility: GSK Investigational Site
state: Campania
city: Nocera Inferiore (SA)
country: Italy
facility: GSK Investigational Site
state: Campania
city: Salerno
country: Italy
facility: GSK Investigational Site
state: Campania
city: Bologna
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Rimini
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Brescia
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: San Donato (MI)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Treviglio (BG)
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Campobasso
country: Italy
facility: GSK Investigational Site
state: Molise
city: Torino
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Cagliari
country: Italy
facility: GSK Investigational Site
state: Sardegna
city: Sassari
country: Italy
facility: GSK Investigational Site
state: Sardegna
city: Palermo
country: Italy
facility: GSK Investigational Site
state: Sicilia
city: Pisa
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Bari
country: Italy
facility: GSK Investigational Site
city: Parma
country: Italy
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
city: Jekabpils
country: Latvia
facility: GSK Investigational Site
city: Lagzdi60
country: Latvia
facility: GSK Investigational Site
city: Limbazi
country: Latvia
facility: GSK Investigational Site
city: Ogre
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Sturii59
country: Latvia
facility: GSK Investigational Site
city: Tukums
country: Latvia
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Klaipeda
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Geleen
country: Netherlands
facility: GSK Investigational Site
city: Groningen
country: Netherlands
facility: GSK Investigational Site
city: Hengelo
country: Netherlands
facility: GSK Investigational Site
city: Hoogvliet
country: Netherlands
facility: GSK Investigational Site
city: Kerkrade
country: Netherlands
facility: GSK Investigational Site
city: Landgraaf
country: Netherlands
facility: GSK Investigational Site
city: Musselkanaal
country: Netherlands
facility: GSK Investigational Site
city: Nijmegen
country: Netherlands
facility: GSK Investigational Site
city: Oude Pekela
country: Netherlands
facility: GSK Investigational Site
city: Ridderkerk
country: Netherlands
facility: GSK Investigational Site
city: Rijswijk
country: Netherlands
facility: GSK Investigational Site
city: Roosendaal
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: St. Willebrord
country: Netherlands
facility: GSK Investigational Site
city: Zoetermeer
country: Netherlands
facility: GSK Investigational Site
city: Zwijndrecht
country: Netherlands
facility: GSK Investigational Site
city: Zwijndrecht
country: Netherlands
facility: GSK Investigational Site
city: Christchurch
country: New Zealand
facility: GSK Investigational Site
city: Dunedin
country: New Zealand
facility: GSK Investigational Site
city: Hastings
country: New Zealand
facility: GSK Investigational Site
city: Otahuhu, Auckland
country: New Zealand
facility: GSK Investigational Site
city: Palmerston North
country: New Zealand
facility: GSK Investigational Site
city: Takapuna, Auckland
country: New Zealand
facility: GSK Investigational Site
city: Tauranga
country: New Zealand
facility: GSK Investigational Site
city: Wellington
country: New Zealand
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Grudziadz
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Olsztyn
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucuresti
country: Romania
facility: GSK Investigational Site
city: Bucuresti
country: Romania
facility: GSK Investigational Site
city: Cluj-Napoca
country: Romania
facility: GSK Investigational Site
city: Craiova
country: Romania
facility: GSK Investigational Site
city: Iasi
country: Romania
facility: GSK Investigational Site
city: Timisoara
country: Romania
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: St Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Banska Bystrica
country: Slovakia
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Kosice
country: Slovakia
facility: GSK Investigational Site
city: Kosice
country: Slovakia
facility: GSK Investigational Site
city: Kysucke Nove Mesto
country: Slovakia
facility: GSK Investigational Site
city: Lubochna
country: Slovakia
facility: GSK Investigational Site
city: Lucenec
country: Slovakia
facility: GSK Investigational Site
city: Presov
country: Slovakia
facility: GSK Investigational Site
city: Prievidza
country: Slovakia
facility: GSK Investigational Site
city: Sahy
country: Slovakia
facility: GSK Investigational Site
city: Samorin
country: Slovakia
facility: GSK Investigational Site
city: Trencin
country: Slovakia
facility: GSK Investigational Site
city: Zilina
country: Slovakia
facility: GSK Investigational Site
city: Badalona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Benidorm
country: Spain
facility: GSK Investigational Site
city: Bilbao
country: Spain
facility: GSK Investigational Site
city: Caceres
country: Spain
facility: GSK Investigational Site
city: Cadiz
country: Spain
facility: GSK Investigational Site
city: Granada
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Palma de Mallorca
country: Spain
facility: GSK Investigational Site
city: Reus
country: Spain
facility: GSK Investigational Site
city: Santander
country: Spain
facility: GSK Investigational Site
city: Vazquc56
country: Spain
facility: GSK Investigational Site
city: Vizcaya
country: Spain
facility: GSK Investigational Site
city: Vizcaya
country: Spain
facility: GSK Investigational Site
city: Eksjö
country: Sweden
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Helsingborg
country: Sweden
facility: GSK Investigational Site
city: Kristianstad
country: Sweden
facility: GSK Investigational Site
city: Kungälv
country: Sweden
facility: GSK Investigational Site
city: Köping
country: Sweden
facility: GSK Investigational Site
city: Linköpiing
country: Sweden
facility: GSK Investigational Site
city: Linköping
country: Sweden
facility: GSK Investigational Site
city: Lund
country: Sweden
facility: GSK Investigational Site
city: Mora
country: Sweden
facility: GSK Investigational Site
city: Nacka
country: Sweden
facility: GSK Investigational Site
city: Norrköping
country: Sweden
facility: GSK Investigational Site
city: Oskarshamn
country: Sweden
facility: GSK Investigational Site
city: Skene
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Uddevalla
country: Sweden
facility: GSK Investigational Site
city: Umeå
country: Sweden
facility: GSK Investigational Site
city: Uppsala
country: Sweden
facility: GSK Investigational Site
city: Vadstena
country: Sweden
facility: GSK Investigational Site
city: Dnepropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kiev
country: Ukraine
facility: GSK Investigational Site
city: Kiev
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Lvov
country: Ukraine
facility: GSK Investigational Site
city: Vinnitsa
country: Ukraine
facility: GSK Investigational Site
city: Cambridge
country: United Kingdom
facility: GSK Investigational Site
state: Cambridgeshire
city: Fowley
country: United Kingdom
facility: GSK Investigational Site
state: Cornwall
city: Chesterfield
country: United Kingdom
facility: GSK Investigational Site
state: Derbyshire
city: Chesterfield
country: United Kingdom
facility: GSK Investigational Site
state: Derbyshire
city: Airdrie
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Hamilton
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Motherwell
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Leicester
country: United Kingdom
facility: GSK Investigational Site
state: Leicestershire
city: Northampton
country: United Kingdom
facility: GSK Investigational Site
state: Northamptonshire
city: Northampton
country: United Kingdom
facility: GSK Investigational Site
state: Northamptonshire
city: Linwood
country: United Kingdom
facility: GSK Investigational Site
state: Renfrewshire
city: Paisley
country: United Kingdom
facility: GSK Investigational Site
state: Renfrewshire
city: Frome
country: United Kingdom
facility: GSK Investigational Site
state: Somerset
city: Glastonbury
country: United Kingdom
facility: GSK Investigational Site
state: Somerset
city: Rugby
country: United Kingdom
facility: GSK Investigational Site
state: Warwickshire
city: Rugby
country: United Kingdom
facility: GSK Investigational Site
state: Warwickshire
city: Corsham
country: United Kingdom
facility: GSK Investigational Site
state: Wiltshire
city: Trowbridge
country: United Kingdom
facility: GSK Investigational Site
state: Wiltshire
city: Trowbridge
country: United Kingdom
facility: GSK Investigational Site
state: Wiltshire
city: Westbury
country: United Kingdom
facility: GSK Investigational Site
state: Wiltshire
city: Airdrie
country: United Kingdom
facility: GSK Investigational Site
city: Airdrie
country: United Kingdom
facility: GSK Investigational Site
city: Ashford
country: United Kingdom
facility: GSK Investigational Site
city: Bath
country: United Kingdom
facility: GSK Investigational Site
city: Chesterfield
country: United Kingdom
facility: GSK Investigational Site
city: Chippenham
country: United Kingdom
facility: GSK Investigational Site
city: Coatbridge
country: United Kingdom
facility: GSK Investigational Site
city: Colney
country: United Kingdom
facility: GSK Investigational Site
city: Cumbernauld
country: United Kingdom
facility: GSK Investigational Site
city: Dronfield
country: United Kingdom
facility: GSK Investigational Site
city: Dumbarton
country: United Kingdom
facility: GSK Investigational Site
city: East Kilbride
country: United Kingdom
facility: GSK Investigational Site
city: Falmouth
country: United Kingdom
facility: GSK Investigational Site
city: Garston, Watford
country: United Kingdom
facility: GSK Investigational Site
city: Gateshead
country: United Kingdom
facility: GSK Investigational Site
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
city: Hamilton
country: United Kingdom
facility: GSK Investigational Site
city: Harrow
country: United Kingdom
facility: GSK Investigational Site
city: Kirkintilloch
country: United Kingdom
facility: GSK Investigational Site
city: Leigh on Sea
country: United Kingdom
facility: GSK Investigational Site
city: Motherwell
country: United Kingdom
facility: GSK Investigational Site
city: Newcastle upon Tyne
country: United Kingdom
facility: GSK Investigational Site
city: Newport
country: United Kingdom
facility: GSK Investigational Site
city: Nottingham
country: United Kingdom
facility: GSK Investigational Site
city: Old Whittington, Chesterfield
country: United Kingdom
facility: GSK Investigational Site
city: Paisley
country: United Kingdom
facility: GSK Investigational Site
city: Penzance
country: United Kingdom
facility: GSK Investigational Site
city: Rubery, Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: Sheffield
country: United Kingdom
facility: GSK Investigational Site
city: Sheffield
country: United Kingdom
facility: GSK Investigational Site
city: Thornhill, Cardiff
country: United Kingdom
facility: GSK Investigational Site
city: Thornhill
country: United Kingdom
facility: GSK Investigational Site
city: Uddingston
country: United Kingdom
facility: GSK Investigational Site
city: Weston Super Mare
country: United Kingdom
facility: GSK Investigational Site
city: Wishaw
country: United Kingdom
facility: GSK Investigational Site
city: Woking
country: United Kingdom
facility: GSK Investigational Site
city: Worle, Weston-Super-Mare
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.