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

Diabetes Mellitus, Type 2 Clinical Trial

— RECORD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00379769
• Other study ID #: BRL-049653/231
• Status: Completed
• Phase: Phase 3
• First received: September 21, 2006
• Last updated: March 21, 2017
• Start date: April 2001
• Est. completion date: December 2008

Study information

• Verified date: March 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4447
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Rosiglitazone
Rosiglitazone maximum 8 mg per day
• Sulfonylurea
Sulfonylurea (SU) maximum permitted daily dose
• Metformin
Metformin maximum permitted daily dose .

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Carina Heights	Queensland
Australia	GSK Investigational Site	Heidelberg	Victoria
Australia	GSK Investigational Site	Keswick	South Australia
Australia	GSK Investigational Site	Kippa Ring	Queensland
Australia	GSK Investigational Site	Malvern	Victoria
Australia	GSK Investigational Site	Miranda	New South Wales
Australia	GSK Investigational Site	North Adelaide	South Australia
Australia	GSK Investigational Site	Port Lincoln	South Australia
Australia	GSK Investigational Site	Randwick	New South Wales
Australia	GSK Investigational Site	Sherwood	Queensland
Australia	GSK Investigational Site	Wollongong	New South Wales
Belgium	GSK Investigational Site	Antwerpen
Belgium	GSK Investigational Site	Arlon
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Edegem
Belgium	GSK Investigational Site	Genk
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Kortrijk
Belgium	GSK Investigational Site	Liège
Belgium	GSK Investigational Site	Moerkerke
Belgium	GSK Investigational Site	Oostham
Belgium	GSK Investigational Site	Roeselare
Belgium	GSK Investigational Site	Sint Gillis-Waas
Belgium	GSK Investigational Site	Vilvoorde
Bulgaria	GSK Investigational Site	Pleven
Bulgaria	GSK Investigational Site	Plovdiv
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Varna
Croatia	GSK Investigational Site	Krapinske Toplice
Croatia	GSK Investigational Site	Rijeka
Croatia	GSK Investigational Site	Slavonski Brod
Croatia	GSK Investigational Site	Varaždin
Croatia	GSK Investigational Site	Zagreb
Czech Republic	GSK Investigational Site	Brno
Czech Republic	GSK Investigational Site	Ceske Budejovice
Czech Republic	GSK Investigational Site	Holice V Cechach
Czech Republic	GSK Investigational Site	Hradec Kralove
Czech Republic	GSK Investigational Site	Jindrichuv Hradec
Czech Republic	GSK Investigational Site	Ostrava Poruba
Czech Republic	GSK Investigational Site	Pisek
Czech Republic	GSK Investigational Site	Praha 2
Czech Republic	GSK Investigational Site	Praha 4
Czech Republic	GSK Investigational Site	Rakovnik
Czech Republic	GSK Investigational Site	Tabor
Czech Republic	GSK Investigational Site	Trutnov
Denmark	GSK Investigational Site	Aalborg
Denmark	GSK Investigational Site	Aarhus
Denmark	GSK Investigational Site	Copenhagen
Denmark	GSK Investigational Site	Glostrup
Denmark	GSK Investigational Site	Hilleroed
Denmark	GSK Investigational Site	København NV
Denmark	GSK Investigational Site	Koge
Denmark	GSK Investigational Site	Kolding
Denmark	GSK Investigational Site	Naestved
Denmark	GSK Investigational Site	Odense C
Denmark	GSK Investigational Site	Silkeborg
Denmark	GSK Investigational Site	Slagelse
Estonia	GSK Investigational Site	Paide
Estonia	GSK Investigational Site	Parnu
Estonia	GSK Investigational Site	Rakvere
Estonia	GSK Investigational Site	Saku
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Estonia	GSK Investigational Site	Viljandi
Finland	GSK Investigational Site	Espoo
Finland	GSK Investigational Site	Espoo
Finland	GSK Investigational Site	Hanko
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Hyvinkaa
Finland	GSK Investigational Site	Jyväskylä
Finland	GSK Investigational Site	Kerava
Finland	GSK Investigational Site	Kuopio
Finland	GSK Investigational Site	Lahti
Finland	GSK Investigational Site	Lappeenranta
Finland	GSK Investigational Site	Oulun kaupunki
Finland	GSK Investigational Site	Riihimäki
Finland	GSK Investigational Site	Rovaniemi
Finland	GSK Investigational Site	Seinajoki
Finland	GSK Investigational Site	Tampere
Finland	GSK Investigational Site	Turku
Finland	GSK Investigational Site	Turku
France	GSK Investigational Site	Amilly
France	GSK Investigational Site	Arras
France	GSK Investigational Site	Aspach le Bas 68700
France	GSK Investigational Site	Aubagne
France	GSK Investigational Site	Auchy les Hesdin
France	GSK Investigational Site	Azille
France	GSK Investigational Site	Beaumont Le Roger
France	GSK Investigational Site	Beaumont sur Leze
France	GSK Investigational Site	Belfort
France	GSK Investigational Site	Belpech
France	GSK Investigational Site	Blotzheim
France	GSK Investigational Site	Bondy
France	GSK Investigational Site	BP 1542 Dijon
France	GSK Investigational Site	Broglie
France	GSK Investigational Site	Bully Les Mines	Nord-Pas-de-Calais
France	GSK Investigational Site	Calmont
France	GSK Investigational Site	Carbonne
France	GSK Investigational Site	Carcassonne
France	GSK Investigational Site	Carcassonne
France	GSK Investigational Site	Carcassonne 11000
France	GSK Investigational Site	Cassis
France	GSK Investigational Site	Castelnaudary
France	GSK Investigational Site	Catelnaudary
France	GSK Investigational Site	Cernay
France	GSK Investigational Site	Champhol
France	GSK Investigational Site	Chartres
France	GSK Investigational Site	Colmar
France	GSK Investigational Site	Corbeil Essonne
France	GSK Investigational Site	Coursan
France	GSK Investigational Site	Cuincy
France	GSK Investigational Site	Danjoutin
France	GSK Investigational Site	Dessenheim
France	GSK Investigational Site	Dieppe
France	GSK Investigational Site	Dunkerque
France	GSK Investigational Site	Epernon
France	GSK Investigational Site	Gemenos
France	GSK Investigational Site	Hanches
France	GSK Investigational Site	Hautot sur Mer
France	GSK Investigational Site	Husseren Wesserling
France	GSK Investigational Site	Kembs
France	GSK Investigational Site	La Barre En Ouche
France	GSK Investigational Site	La Verdière
France	GSK Investigational Site	Labarth-Sur-Leze
France	GSK Investigational Site	Labarthe-Sur-Leze
France	GSK Investigational Site	Le Grau Du Roi
France	GSK Investigational Site	Le Lherm 31600
France	GSK Investigational Site	Le Perray En Yvelines
France	GSK Investigational Site	Lezignan-Corbières
France	GSK Investigational Site	Maintenon
France	GSK Investigational Site	Marseille
France	GSK Investigational Site	Marseille
France	GSK Investigational Site	Marseille
France	GSK Investigational Site	Marseille
France	GSK Investigational Site	Marseille
France	GSK Investigational Site	Marseille
France	GSK Investigational Site	Marseille
France	GSK Investigational Site	Masevaux
France	GSK Investigational Site	Maubeuge
France	GSK Investigational Site	Monfort sur Risle
France	GSK Investigational Site	Mulhouse
France	GSK Investigational Site	Muret
France	GSK Investigational Site	Nassandres
France	GSK Investigational Site	Nevers cedex
France	GSK Investigational Site	Nogent le Phaye
France	GSK Investigational Site	Orbec
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Pierre Benite Cedex
France	GSK Investigational Site	Pierres
France	GSK Investigational Site	Pinsaguel
France	GSK Investigational Site	Roux Mesnil Bouteille
France	GSK Investigational Site	Rugles
France	GSK Investigational Site	Saint Leger sur Yvelines
France	GSK Investigational Site	Saint-Eulalie Badens
France	GSK Investigational Site	Seysses
France	GSK Investigational Site	Thann
France	GSK Investigational Site	Thiberville
France	GSK Investigational Site	Toulouse
France	GSK Investigational Site	Toulouse
France	GSK Investigational Site	Toulouse
France	GSK Investigational Site	Trebbes
France	GSK Investigational Site	Trebes
France	GSK Investigational Site	Valenciennes
France	GSK Investigational Site	Vogelsheim
France	GSK Investigational Site	Voves
France	GSK Investigational Site	Wittenheim
Germany	GSK Investigational Site	Bad Lauterberg	Niedersachsen
Germany	GSK Investigational Site	Beckum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Burgstaedt	Sachsen
Germany	GSK Investigational Site	Chemnitz	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Friedrichsthal	Saarland
Germany	GSK Investigational Site	Gau-Algesheim	Rheinland-Pfalz
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Kallstadt	Rheinland-Pfalz
Germany	GSK Investigational Site	Kronach	Bayern
Germany	GSK Investigational Site	Kronberg	Hessen
Germany	GSK Investigational Site	Lambrecht	Rheinland-Pfalz
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Menden	Nordrhein-Westfalen
Germany	GSK Investigational Site	Ober-Moerlen	Hessen
Germany	GSK Investigational Site	Offenbach	Hessen
Germany	GSK Investigational Site	Rhaunen	Rheinland-Pfalz
Germany	GSK Investigational Site	Sinsheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Speyer	Rheinland-Pfalz
Germany	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg
Germany	GSK Investigational Site	Suhl	Thueringen
Germany	GSK Investigational Site	Wetzlar	Hessen
Germany	GSK Investigational Site	Wuerzburg	Bayern
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Haidari, Athens
Greece	GSK Investigational Site	Ioannina
Greece	GSK Investigational Site	Maroussi
Greece	GSK Investigational Site	Patra
Greece	GSK Investigational Site	Patra
Greece	GSK Investigational Site	Piraeus-Athens
Greece	GSK Investigational Site	Piraeus-Athens
Greece	GSK Investigational Site	Thessaloniki
Greece	GSK Investigational Site	Thessalonikis
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Debrecen
Hungary	GSK Investigational Site	Eger
Hungary	GSK Investigational Site	Gyor
Hungary	GSK Investigational Site	Gyula
Hungary	GSK Investigational Site	Kurtag99
Hungary	GSK Investigational Site	Nyiregyháza
Hungary	GSK Investigational Site	Patkaj98
Hungary	GSK Investigational Site	Siofok
Hungary	GSK Investigational Site	Szentes
Hungary	GSK Investigational Site	Szombathely
Hungary	GSK Investigational Site	Veszprem
Hungary	GSK Investigational Site	Zalaegerszeg
Italy	GSK Investigational Site	Bari
Italy	GSK Investigational Site	Bologna	Emilia-Romagna
Italy	GSK Investigational Site	Brescia	Lombardia
Italy	GSK Investigational Site	Cagliari	Sardegna
Italy	GSK Investigational Site	Campobasso	Molise
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Nocera Inferiore (SA)	Campania
Italy	GSK Investigational Site	Palermo	Sicilia
Italy	GSK Investigational Site	Parma
Italy	GSK Investigational Site	Pisa	Toscana
Italy	GSK Investigational Site	Reggio Calabria	Calabria
Italy	GSK Investigational Site	Rimini	Emilia-Romagna
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Roma
Italy	GSK Investigational Site	Salerno	Campania
Italy	GSK Investigational Site	San Donato (MI)	Lombardia
Italy	GSK Investigational Site	Sassari	Sardegna
Italy	GSK Investigational Site	Torino	Piemonte
Italy	GSK Investigational Site	Treviglio (BG)	Lombardia
Latvia	GSK Investigational Site	Jekabpils
Latvia	GSK Investigational Site	Lagzdi60
Latvia	GSK Investigational Site	Limbazi
Latvia	GSK Investigational Site	Ogre
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Sturii59
Latvia	GSK Investigational Site	Tukums
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Klaipeda
Lithuania	GSK Investigational Site	Vilnius
Lithuania	GSK Investigational Site	Vilnius
Lithuania	GSK Investigational Site	Vilnius
Netherlands	GSK Investigational Site	Geleen
Netherlands	GSK Investigational Site	Groningen
Netherlands	GSK Investigational Site	Hengelo
Netherlands	GSK Investigational Site	Hoogvliet
Netherlands	GSK Investigational Site	Kerkrade
Netherlands	GSK Investigational Site	Landgraaf
Netherlands	GSK Investigational Site	Musselkanaal
Netherlands	GSK Investigational Site	Nijmegen
Netherlands	GSK Investigational Site	Oude Pekela
Netherlands	GSK Investigational Site	Ridderkerk
Netherlands	GSK Investigational Site	Rijswijk
Netherlands	GSK Investigational Site	Roosendaal
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	St. Willebrord
Netherlands	GSK Investigational Site	Zoetermeer
Netherlands	GSK Investigational Site	Zwijndrecht
Netherlands	GSK Investigational Site	Zwijndrecht
New Zealand	GSK Investigational Site	Christchurch
New Zealand	GSK Investigational Site	Dunedin
New Zealand	GSK Investigational Site	Hastings
New Zealand	GSK Investigational Site	Otahuhu, Auckland
New Zealand	GSK Investigational Site	Palmerston North
New Zealand	GSK Investigational Site	Takapuna, Auckland
New Zealand	GSK Investigational Site	Tauranga
New Zealand	GSK Investigational Site	Wellington
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Grudziadz
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Olsztyn
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Wroclaw
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucuresti
Romania	GSK Investigational Site	Bucuresti
Romania	GSK Investigational Site	Cluj-Napoca
Romania	GSK Investigational Site	Craiova
Romania	GSK Investigational Site	Iasi
Romania	GSK Investigational Site	Timisoara
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	St Petersburg
Russian Federation	GSK Investigational Site	St-Petersburg
Slovakia	GSK Investigational Site	Banska Bystrica
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Kosice
Slovakia	GSK Investigational Site	Kosice
Slovakia	GSK Investigational Site	Kysucke Nove Mesto
Slovakia	GSK Investigational Site	Lubochna
Slovakia	GSK Investigational Site	Lucenec
Slovakia	GSK Investigational Site	Presov
Slovakia	GSK Investigational Site	Prievidza
Slovakia	GSK Investigational Site	Sahy
Slovakia	GSK Investigational Site	Samorin
Slovakia	GSK Investigational Site	Trencin
Slovakia	GSK Investigational Site	Zilina
Spain	GSK Investigational Site	Badalona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Benidorm
Spain	GSK Investigational Site	Bilbao
Spain	GSK Investigational Site	Caceres
Spain	GSK Investigational Site	Cadiz
Spain	GSK Investigational Site	Granada
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Palma de Mallorca
Spain	GSK Investigational Site	Reus
Spain	GSK Investigational Site	Santander
Spain	GSK Investigational Site	Vazquc56
Spain	GSK Investigational Site	Vizcaya
Spain	GSK Investigational Site	Vizcaya
Sweden	GSK Investigational Site	Eksjö
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Helsingborg
Sweden	GSK Investigational Site	Köping
Sweden	GSK Investigational Site	Kristianstad
Sweden	GSK Investigational Site	Kungälv
Sweden	GSK Investigational Site	Linköpiing
Sweden	GSK Investigational Site	Linköping
Sweden	GSK Investigational Site	Lund
Sweden	GSK Investigational Site	Mora
Sweden	GSK Investigational Site	Nacka
Sweden	GSK Investigational Site	Norrköping
Sweden	GSK Investigational Site	Oskarshamn
Sweden	GSK Investigational Site	Skene
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Uddevalla
Sweden	GSK Investigational Site	Umeå
Sweden	GSK Investigational Site	Uppsala
Sweden	GSK Investigational Site	Vadstena
Ukraine	GSK Investigational Site	Dnepropetrovsk
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kiev
Ukraine	GSK Investigational Site	Kiev
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Lvov
Ukraine	GSK Investigational Site	Vinnitsa
United Kingdom	GSK Investigational Site	Airdrie
United Kingdom	GSK Investigational Site	Airdrie
United Kingdom	GSK Investigational Site	Airdrie	Lanarkshire
United Kingdom	GSK Investigational Site	Ashford
United Kingdom	GSK Investigational Site	Bath
United Kingdom	GSK Investigational Site	Cambridge	Cambridgeshire
United Kingdom	GSK Investigational Site	Chesterfield
United Kingdom	GSK Investigational Site	Chesterfield	Derbyshire
United Kingdom	GSK Investigational Site	Chesterfield	Derbyshire
United Kingdom	GSK Investigational Site	Chippenham
United Kingdom	GSK Investigational Site	Coatbridge
United Kingdom	GSK Investigational Site	Colney
United Kingdom	GSK Investigational Site	Corsham	Wiltshire
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	Fowley	Cornwall
United Kingdom	GSK Investigational Site	Frome	Somerset
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	Glasgow	Lanarkshire
United Kingdom	GSK Investigational Site	Glasgow	Lanarkshire
United Kingdom	GSK Investigational Site	Glastonbury	Somerset
United Kingdom	GSK Investigational Site	Hamilton	Lanarkshire
United Kingdom	GSK Investigational Site	Hamilton
United Kingdom	GSK Investigational Site	Harrow
United Kingdom	GSK Investigational Site	Kirkintilloch
United Kingdom	GSK Investigational Site	Leicester	Leicestershire
United Kingdom	GSK Investigational Site	Leigh on Sea
United Kingdom	GSK Investigational Site	Linwood	Renfrewshire
United Kingdom	GSK Investigational Site	Motherwell	Lanarkshire
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	Northampton	Northamptonshire
United Kingdom	GSK Investigational Site	Northampton	Northamptonshire
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	Paisley	Renfrewshire
United Kingdom	GSK Investigational Site	Penzance
United Kingdom	GSK Investigational Site	Rubery, Birmingham
United Kingdom	GSK Investigational Site	Rugby	Warwickshire
United Kingdom	GSK Investigational Site	Rugby	Warwickshire
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	Trowbridge	Wiltshire
United Kingdom	GSK Investigational Site	Trowbridge	Wiltshire
United Kingdom	GSK Investigational Site	Uddingston
United Kingdom	GSK Investigational Site	Westbury	Wiltshire
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

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Australia,  Belgium,  Bulgaria,  Croatia,  Czech Republic,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Italy,  Latvia,  Lithuania,  Netherlands,  New Zealand,  Poland,  Romania,  Russian Federation,  Slovakia,  Spain,  Sweden,  Ukraine,  United Kingdom, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Number of Participants With Cardiovascular Events and All-cause Deaths	Composites of participants with first cardiovascular (CV) hospitalisations and CV death or all-cause death and individual first events of acute myocardial infarction (MI) , stroke, congestive heart failure (CHF), CV death, and all-cause death.	Baseline through End of Study (up to 7.5 years)
Secondary	Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths	The total number of events for individual components of cardiovascular (CV) hospitalisations and cardiovascular deaths were recorded. MI, myocardial infarction.	Baseline through End of Study (up to 7.5 years)
Secondary	Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum	Participants with first cardiovascular death (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) were recorded by study stratum.	Baseline through End of Study (up to 7.5 years)
Secondary	Number of Participants With CV/Microvascular Events	The number of participants with first cardiovascular or microvascular events (renal, foot, eye) were recorded.	Baseline through End of Study (up to 7.5 years)
Secondary	Number of Participants With Glycaemic Failure Events	Failure of glycaemic control was defined as two consecutive HbA1c values of =8.5 percent, or HbA1c =8.5percent at a single visit, after which the subject was either moved to the post-randomised treatment phase or triple therapy was started.	Baseline through to end of randomised dual therapy
Secondary	Number of Participants With Addition of Third Oral Agent/Switch to Insulin	The number of participants with addition of a third oral agent or switch to insulin from randomised dual combination treatment were recorded.	Baseline through End of Study (up to 7.5 years)
Secondary	The Number of Participants Starting Insulin at Any Time During the Study	The number of participants starting insulin at any time during the study was recorded.	Baseline through End of Study (up to 7.5 years)
Secondary	Model Adjusted Change From Baseline in HbA1c at Month 60	Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in HbA1c was calculated as the value at Month 60 minus the Baseline value.	Baseline and Month 60 of randomised dual therapy treatment period
Secondary	Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60	Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in fasting plasma glucose was calculated as the value at Month 60 minus the Baseline value.	Baseline to Month 60 of the randomised dual therapy treatment period
Secondary	Model Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60	Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in insulin and pro-insulin was calculated as the value at Month 60 minus the Baseline value.	Baseline to Month 60 of the randomised dual therapy treatment period
Secondary	Number of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60	Number of responders, i.e., participants meeting glycaemic targets (HbA1c less than or equal to 7 percent, FPG less than or equal to 7 mmol/L)	Baseline to Month 60 of the randomised dual therapy treatment period
Secondary	Model Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60	The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in HOMA beta-cell function and insulin sensitivity was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).	Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary	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	The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC, LDL cholesterol, HDL cholesterol, triglycerides, and FFAs was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).	Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary	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	The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in TC:HDL cholesterol and LDL cholesterol:HDL cholesterol was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).	Baseline to Month 60 of the randomised dual therapy treatment period
Secondary	Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60	The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in Apo-B was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).	Baseline to Month 60 of the randomised dual therapy treatment period
Secondary	Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60	The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in urinary albumin creatinine ratio was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).	Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary	Model Adjusted Change From Baseline in Body Weight at Month 60	Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in body weight was calculated as the value at Month 60 minus the Baseline value.	Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary	Model Adjusted Change From Baseline in Alanine Aminotransferase at Month 60	Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in alanine aminotransferase was calculated as the value at Month 60 minus the Baseline value.	Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary	Model Adjusted Change From Baseline in Waist Circumference at Month 60	Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in waist circumference was calculated as the value at Month 60 minus the Baseline value.	Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary	Model Adjusted Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 60	Model adjusted (adjusted for any imbalances in the baseline values between within treatment groups) change from baseline in SBP and DBP was calculated as the value at Month 60 minus the Baseline value.	Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary	Model Adjusted Ratio to Baseline (Expressed as a Percentage) for C-Reactive Protein at Month 60	The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in C-Reactive Protein was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).	Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary	Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Fibrinogen at Month 60	The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in fibrinogen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).	Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary	Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Plasminogen Activator Inhibitor-1 (PAI-1) Antigen at Month 60	The model adjusted (adjusted for any imbalances in the baseline [BL] values between within stratum treatment groups) ratio to BL in plasminogen activator inhibitor-1 (PAI-1) antigen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100*[GM^-1]).	Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary	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	The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.	From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary	Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Observational Follow-up	The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.	From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary	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	The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.	From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary	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	The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.	From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary	Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined	The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.	From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary	Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up	The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.	From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary	Number of Participants With a Bone Fracture Event - Overall and by Gender: Main Study and Observational Follow-up Combined	The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.	From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary	Number of Participants With a Bone Fracture Event - Overall and by Gender: Observational Follow-up	The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.	From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary	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	The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.	From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary	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	The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.	From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary	Number of Participants With an Event of Death Due to a Bone Fracture-related Event: Main Study + Observational Follow-up Combined	The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.	From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary	Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined	The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.	From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary	Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up	The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.	From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary	Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined	The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).	From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary	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	The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).	From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary	Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined	The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.	From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary	Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up	The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."	From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary	Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined	The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."	From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary	Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up	The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."	From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary	Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up	The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.	From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)

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