Clinical trial NCT00949286: Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study
Official title: Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Lead sponsor: The George Institute
Sponsor class: OTHER
Collaborators: name: Servier
First posted: 2009-07-30
Enrollment: 8494
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All living participants who took part in the ADVANCE study

Brief summary: The study is designed to determine the long term, post trial effects of the two interventions studied in ADVANCE (routine blood pressure lowering with perindopril-indapamide as compared with placebo and intensive gliclazide-MR based glucose control as compared to standard guideline based glucose control) in individuals with type 2 diabetes at high risk of cardiovascular events. The long term, post randomization effects of the two study interventions will be investigated separately as they were for the main trial. This study will clarify and quantify the long-term, post trial (often referred to as legacy) effects of these two interventions in a broader population of patients with type 2 diabetes from high and low to middle income countries, and in the setting of comprehensive cardiovascular risk factor treatment. With the ADVANCE trial infrastructure and surveillance system already in place, the implementation of extended follow-up will be feasible. The conclusions of this follow up study will have profound clinical implications for the care of patients with type 2 diabetes around the world.

Detailed description: The long term, post randomization effects of the two study interventions will be investigated separately as they were for the main trial. This study will clarify and quantify the long-term, post trial (often referred to as legacy) effects of these two interventions in a broader population of patients with type 2 diabetes from high and low to middle income countries, and in the setting of comprehensive cardiovascular risk factor treatment. With the ADVANCE trial infrastructure and surveillance system already in place, the implementation of extended follow-up will be feasible. The conclusions of this follow up study will have profound clinical implications for the care of patients with type 2 diabetes around the world.

Eligibility criteria: Inclusion Criteria:

* Participated in ADVANCE
* Ability to provide informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Major macrovascular events -a composite of non-fatal myocardial infarction, non-fatal stroke and death from any cardiovascular cause (based on investigator diagnosis)
timeFrame: 2014
measure: Death from any cause
timeFrame: 2014
Secondary outcomes:
measure: Death from any cardiovascular cause
timeFrame: 2014
measure: Major clinical microvascular events - a composite of requirement for renal replacement therapy, death from renal disease and development of severe diabetes-related eye disease
timeFrame: 2014
measure: Composite of major macrovascular events and major clinical microvascular events
timeFrame: 2014
measure: Stroke (non-fatal and fatal)
timeFrame: 2014
measure: Requirement for renal replacement therapy (dialysis or transplantation)
timeFrame: 2014
measure: Death from renal disease
timeFrame: 2014
measure: Development of severe diabetes-related eye disease defined as the requirement for retinal photocoagulation or similar treatment and development of diabetes-related blindness in either eye in a participant known not to have this condition at study entry
timeFrame: 2014
measure: Major hypoglycaemia - an episode associated with transient central nervous system dysfunction without other apparent cause in which the individual was unable to treat him/herself and had help from another person to administer glucose or glucagon
timeFrame: 2014
measure: Myocardial infarction (non-fatal and fatal)
timeFrame: 2014
Other outcomes:
Locations:
city: Garran
country: Australia
facility: LCC 80 - Canberra Hospital
state: Australian Capital Territory
city: Camperdown
country: Australia
facility: LCC 28 - Royal Prince Alfred Hospital
state: New South Wales
city: Gosford
country: Australia
facility: LCC 48 - Gosford
state: New South Wales
city: Liverpool
country: Australia
facility: LCC 59 - Liverpool Hospital
state: New South Wales
city: Penrith
country: Australia
facility: LCC 78 - Wentworth Diabetes Centre
state: New South Wales
city: Randwick
country: Australia
facility: LCC 56 - Prince of Wales Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: LCC 55 - Royal North Shore Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: LCC 23 - Wollongong Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: LCC 24 - Mater Hospital
state: Queensland
city: Brisbane
country: Australia
facility: LCC 42 - Princess Alexandra Hospital
state: Queensland
city: Redcliffe
country: Australia
facility: LCC 74 - Redcliffe Hospital
state: Queensland
city: Southport
country: Australia
facility: LCC 43 - Gold Coast Hospital
state: Queensland
city: Townsville
country: Australia
facility: LCC 114 - Townsville Mater Hospital
state: Queensland
city: Daw Park
country: Australia
facility: LCC 73 - Repatriation General Hospital
state: South Australia
city: Elizabeth Vale
country: Australia
facility: LCC 66 - Lyell McEwin Health
state: South Australia
city: Launceston
country: Australia
facility: LCC 61 - Launceston General Hospital
state: Tasmania
city: Dandenong
country: Australia
facility: LCC 65 - Dandenong Hospital
state: Victoria
city: Epping
country: Australia
facility: LCC 33 - The Northern Hospital
state: Victoria
city: Heidelburg
country: Australia
facility: LCC 32 - Austin & Repatriation Hospital
state: Victoria
city: Melbourne
country: Australia
facility: LCC 76 - The Alfred Hospital
state: Victoria
city: Shepparton
country: Australia
facility: LCC 109 - Rural Clinical Trials Research Unit
state: Victoria
city: Fremantle
country: Australia
facility: LCC 50 - Fremantle Hospital
state: Western Australia
city: Calgary
country: Canada
facility: LCC 468 - Calgary Metabolic Education and Research Centre
state: Alberta
city: Vancouver
country: Canada
facility: LCC 454 University of British Columbia
state: British Columbia
city: Halifax
country: Canada
facility: LCC 467 - Queen Elizabeth II Health Science Centre
state: Nova Scotia
city: London
country: Canada
facility: LCC 465 - St. Joseph's Health Centre
state: Ontario
city: Toronto
country: Canada
facility: LCC 459 - University of Toronto
state: Ontario
city: Laval
country: Canada
facility: LCC 452 - Centre de recherche clinique de Laval
state: Quebec
city: Montreal
country: Canada
facility: LCC 453 - Centre hospitalier de l'Universite de Montreal
state: Quebec
city: Sherbrooke
country: Canada
facility: LCC 460 - Centre Hospitalier de L'universitaire de Sherbrooke
state: Quebec
city: Sherbrooke
country: Canada
facility: LCC 466 - Centre de recherche d'endocrinologie
state: Quebec
city: Ste-Foy
country: Canada
facility: LCC 470 - Hôpital Laval
state: Quebec
city: Baotou
country: China
facility: LCC 643 - 2nd Aff Hospital of Baotou Medical College
city: Baotou
country: China
facility: LCC 644 - Baotou Iron & Steel Corporation's Hospital,
city: Beijing
country: China
facility: LCC 600 - Center Hospital of Aviation
city: Beijing
country: China
facility: LCC 601 - 305 Hospital of Chinese PLA
city: Beijing
country: China
facility: LCC 602 - Chinese PLA General Hospital
city: Beijing
country: China
facility: LCC 623 - Beijing 306 Hospital
city: Beijing
country: China
facility: LCC 626 - First Hospital of Peking University
city: Beijing
country: China
facility: LCC 627 - Peking Union Medical College Hospital
city: Beijing
country: China
facility: LCC 628 - Capital Steel Hospital
city: Beijing
country: China
facility: LCC 629 - Aff Beijing Tongren Hospital
city: Beijing
country: China
facility: LCC 630 - Beijing Hypertension League Institute
city: Beijing
country: China
facility: LCC 631 - Beijing Jiuxianqiao Hospital
city: Beijing
country: China
facility: LCC 632 - Dept Endocrinology Beijing 306 Hospital
city: Beijing
country: China
facility: LCC 633 - Cardiovascular Institute & Fu Wai Hospital
city: Beijing
country: China
facility: LCC 634 - Beijing Anzhen Hospital
city: Beijing
country: China
facility: LCC 637 - Chinese Air Force General Hospital
city: Benxi
country: China
facility: LCC 661 - Institute of Gerontology of Benxi City
city: Binzhou
country: China
facility: LCC 607 - People's Hospital of Binzhou City
city: Changsha
country: China
facility: LCC 609 - Xiang-ya Hospital,
city: Chengdu
country: China
facility: LCC 620 - Municipal Hospital of Chengdou
city: Chengdu
country: China
facility: LCC 657 - The 1st Aff Hospital
city: Dalian
country: China
facility: LCC 610 - Second Affiliated Hospital of Dalian Medical University
city: Fuzhou City
country: China
facility: LCC 624 - The First Affiliated Hospital of Fujian Medical University
city: Guiyang
country: China
facility: LCC 658 - The 1st Aff Hospital of Guiyang Medical College
city: Harbin
country: China
facility: LCC 641 - The 2nd Aff Hospital of Harbin Medical University
city: Hefei
country: China
facility: LCC 653 - Aff Hospital of Anhui Medical University
city: Huhehot
country: China
facility: LCC 642 - The Institute of Aged Gerontology of Inner Mongolia
city: Jin'an
country: China
facility: LCC 606 - Shandong Academy of Medical Sciences,
city: Jin'an
country: China
facility: LCC 660 - Shandong Academy of Medical Sciences
city: Lianyungang
country: China
facility: LCC 622 - The First People's Hospital of Lianyungang City
city: Nanchang City
country: China
facility: LCC 654 - The 3rd Aff Hospital of Jiangxi Medical University
city: Nanchang City
country: China
facility: LCC 655 - The 1st Aff Hospital of Jiangxi Medical College
city: Nanjing City
country: China
facility: LCC 651 - Jiangsu Institute of Geriatrics,
city: Ning
country: China
facility: LCC 619 - The First Hospital of Ning Bo City Municipal
city: Qingdao
country: China
facility: LCC 608 - Qingdao City Hospital
city: Shanghai
country: China
facility: LCC 603 - Rujin Hospital
city: Shanghai
country: China
facility: LCC 635 -Aff Ruijin Hospital of Shanghai Second Medical University
city: Shanghai
country: China
facility: LCC 636 - Chang Zheng Hospital of Shanghai
city: Shanghai
country: China
facility: LCC 638 - Shanghai 6th People's Hospital
city: Shenyang
country: China
facility: LCC 611 - Hua Tai Hospital
city: Shijiazhuang
country: China
facility: LCC 618 - Hebei Academy of Medical Sciences
city: Shijiazhuang
country: China
facility: LCC 646 - The 2nd Aff Hospital of Hebei Medical University
city: Taiyuan
country: China
facility: LCC 613 - Cardiovascular Institute of Shanxi Province
city: Tangshan
country: China
facility: LCC 645 - Hospital of Kailuan
city: Tianjin
country: China
facility: LCC 639 - Metabolic Disease Hospital of Tianjin Medical University
city: Tianjin
country: China
facility: LCC 640 - 3rd Hospital of Tianjin City
city: Yangquan
country: China
facility: LCC 647 - First Hospital of Yang Quan City
city: Zhengzhou
country: China
facility: LCC 614 -The First Affiliated Hospital of Henan Medical University
city: Zhumadian
country: China
facility: LCC 616 - Center Hospital of Zhumadian City
city: Neratovice
country: Czech Republic
facility: LCC 437 - Metabolicke Centrum
city: Ostrava-Poruba
country: Czech Republic
facility: LCC 372- Fakultni Nemocnice
city: Pisek
country: Czech Republic
facility: LCC 438 - Diabetologicka ambulance
city: Praha
country: Czech Republic
facility: Lcc 435 - Ikem
city: Usti nad Labem
country: Czech Republic
facility: LCC 369- Masarykova Nemocnice
city: Tallinn
country: Estonia
facility: LCC 280 - Tallinn Central
city: Tartu
country: Estonia
facility: LCC 281 - Dept of Medicine
city: Angers
country: France
facility: LCC 320 - CHU Angers
city: Avignon
country: France
facility: LCC 376 - CH Avignon - Hôpital Henri Duffaut
city: Nevers
country: France
facility: LCC 375 - CH Nevers
city: Nimes
country: France
facility: LCC 373 - CHU Hopital Caremeau
city: Paris
country: France
facility: LCC 329 - CHU Bichat
city: Poitiers
country: France
facility: LCC 315 - Hôpital Jean Bernard la Miletrie
city: Rennes
country: France
facility: LCC 310 - Hôpital Sud
city: Strasbourg
country: France
facility: LCC 304 - CHU Hôpital Civil
city: Toul
country: France
facility: LCC 374 - CHU Hôpital Jeanne d' Arc
city: Dresden
country: Germany
facility: LCC 377 - Zentrum fur Klinische Studien
city: Munich
country: Germany
facility: LCC 330 - Klinikyum der Universitat Munchen
city: Balatonfured
country: Hungary
facility: LCC 336 - Heart Center Foundation-DRC Ltd
city: Budapest
country: Hungary
facility: LCC 335 - Bajcsy Zsilinszky Kórház
city: Delhi
country: India
facility: Lcc 740 - Aiims
city: Hyderabad
country: India
facility: LCC 744 - Care Hospital
city: Madras
country: India
facility: LCC 741 - Madras Diabetic Research Foundation
city: Ballinasloe
country: Ireland
facility: LCC 832 - Portincula Hospital
city: Dublin
country: Ireland
facility: LCC 514 - Beaumont Hospital
city: Dublin
country: Ireland
facility: LCC 810 - Mater Hospital
city: Dublin
country: Ireland
facility: LCC 817 - St James Hospital
city: Tallaght
country: Ireland
facility: LCC 806 - Adelaide & Meadth Hospital
city: Milan
country: Italy
facility: LCC 418 - Ospedale San Gerado
city: Kaunas
country: Lithuania
facility: LCC 270 - Institute of Cardiology
city: Palanga
country: Lithuania
facility: LCC 273 - Institute Psychophysiology and Rehabilitation
city: Ipoh
country: Malaysia
facility: LCC 903 - Hospital Ipoh
city: Kota Bharu
country: Malaysia
facility: LCC 904 - Universiti Sains Malaysia
city: Kuala Lumpur
country: Malaysia
facility: LCC 902 - University of Malaya Medical Centre
city: Penang
country: Malaysia
facility: LCC 901 - Penang Medical College
city: Putrajaya
country: Malaysia
facility: Universiti Kebangsaan Malaysia & Universiti Teknologi MARA
city: Eindhoven
country: Netherlands
facility: LCC 352 - Justus Medical Research
city: Etten-Leur
country: Netherlands
facility: LCC 354 - Stichting Huisartsen Laboratorium
city: Groningen
country: Netherlands
facility: LCC 347 - Martini Ziekenhuis
city: Groningen
country: Netherlands
facility: LCC 850 - Andromed Groningen
city: Rotterdam
country: Netherlands
facility: LCC 351 - Andromed Rotterdam
city: Rotterdam
country: Netherlands
facility: LCC 852 - Andromed Baarn
city: Velp
country: Netherlands
facility: LCC 851 - Andromed Oost
city: Zeist
country: Netherlands
facility: LCC 356 - Huisartsenpraktijk Tollenslaan
city: Auckland
country: New Zealand
facility: LCC 11 - Middlemore Hospital
city: Auckland
country: New Zealand
facility: LCC 14 - North Shore Hospital
city: Christchurch
country: New Zealand
facility: LCC 12 - Christchurch Hospital
city: Hastings
country: New Zealand
facility: LCC 5 - Hawkes Bay Hospital
city: Palmerston North
country: New Zealand
facility: LCC 2 - Palmerston North Hospital
city: Timaru
country: New Zealand
facility: LCC 91 - Timaru Hospital
city: Waikato
country: New Zealand
facility: LCC 6 Waikato Hospital
city: Wellington
country: New Zealand
facility: LCC 1 - Wellington Hospital
city: Makati City
country: Philippines
facility: LCC 909 - Makati Medical Center
state: Manila
city: Manila
country: Philippines
facility: LCC 906 - Philippine General Hospital
city: Quezon City
country: Philippines
facility: LCC 907 - East Avenue Medical Centre
city: Quezon City
country: Philippines
facility: LCC 908 - Diabetes Foundation
city: Elbląg
country: Poland
facility: LCC 426 - NZOZ Specjalistyczna Poradnia Endokrynologii
city: Katowice
country: Poland
facility: LCC 382 - Puls Med
city: Krakow
country: Poland
facility: LCC 381 - I Klinika Kardiologii
city: Krakow
country: Poland
facility: LCC 383 - Klinika Chorob Metabolicznych
city: Krakow
country: Poland
facility: LCC 389 - Zakład Angiologii
city: Krakow
country: Poland
facility: LCC 390 - Klinika Choroby Wiencowej
city: Kutno
country: Poland
facility: LCC 380 - I Oddzial Chorob Wewnetrznych
city: Olsztyn
country: Poland
facility: LCC 392 - Osrodek Diabetologii
city: Poznan
country: Poland
facility: LCC 378 - Klinika Nefrologii
city: Radom
country: Poland
facility: LCC 394 - II Oddzial Chorob Wewnetrznvch
city: Moscow
country: Russian Federation
facility: LCC 420 - Russian Peoples Friendship University
city: St Petersburg
country: Russian Federation
facility: LCC 421 - St Petersburg State Medical University
city: St Petersburg
country: Russian Federation
facility: LCC 424 - Research Institute of Cardiology
city: Kosice
country: Slovakia
facility: LCC 254 - Poliklinikou Vychod
city: Levice
country: Slovakia
facility: LCC 252 - Nemocnica s poliklinikou
city: Lucenec
country: Slovakia
facility: LCC 253 - Nemocnica s poliklinikou
city: Aberdeen
country: United Kingdom
facility: LCC 517 - Aberdeen Royal Infirmary
city: Airdrie
country: United Kingdom
facility: LCC 813 - Monklands Hospital
city: Bath
country: United Kingdom
facility: LCC 819 - Royal United Hospital
city: Birmingham
country: United Kingdom
facility: LCC 815 - City Hospital
city: Byfleet
country: United Kingdom
facility: LCC 821 - West Byfleet Health Centre
city: Glasgow
country: United Kingdom
facility: LCC 594 - Glasgow Royal Infirmary
city: Isle of Wight
country: United Kingdom
facility: LCC 826 - St Mary's Hospital
city: Leicester
country: United Kingdom
facility: LCC 533 - Leicester Royal Infirmary
city: Liverpool
country: United Kingdom
facility: LCC 809 - Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: LCC 543 - St Mary's
city: Manchester
country: United Kingdom
facility: LCC 511 - Manchester Royal Infirmary
city: Northampton
country: United Kingdom
facility: LCC 829 - Northampton General Hospital
city: Nuneaton
country: United Kingdom
facility: LCC 830 - George Eliot Hospital
city: Paisley
country: United Kingdom
facility: LCC 812 - Royal Alexandra Hospital
city: Plymouth
country: United Kingdom
facility: LCC 816 - Peninsula Medical School Headquarters
city: Reading
country: United Kingdom
facility: LCC 820 - The Diabetes Centre
city: Sheffield
country: United Kingdom
facility: LCC 827 - Northern General Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Hallamshire
city: Warwick
country: United Kingdom
facility: LCC 831 - Warwick General Hospital
Study officials:
affiliation: The George Institute
name: John P Chalmers
role: PRINCIPAL_INVESTIGATOR
affiliation: The George Institute
name: Stephen MacMahon
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel A; ADVANCE Collaborative Group; MacMahon S, Chalmers J, Neal B, Woodward M, Billot L, Harrap S, Poulter N, Marre M, Cooper M, Glasziou P, Grobbee DE, Hamet P, Heller S, Liu LS, Mancia G, Mogensen CE, Pan CY, Rodgers A, Williams B. Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial. Lancet. 2007 Sep 8;370(9590):829-40. doi: 10.1016/S0140-6736(07)61303-8.
citation: ADVANCE Collaborative Group; Patel A, MacMahon S, Chalmers J, Neal B, Billot L, Woodward M, Marre M, Cooper M, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Liu L, Mancia G, Mogensen CE, Pan C, Poulter N, Rodgers A, Williams B, Bompoint S, de Galan BE, Joshi R, Travert F. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2560-72. doi: 10.1056/NEJMoa0802987. Epub 2008 Jun 6.
citation: Wang N, Harris K, Hamet P, Harrap S, Mancia G, Poulter N, Williams B, Zoungas S, Woodward M, Chalmers J, Rodgers A. Cumulative Systolic Blood Pressure Load and Cardiovascular Risk in Patients With Diabetes. J Am Coll Cardiol. 2022 Sep 20;80(12):1147-1155. doi: 10.1016/j.jacc.2022.06.039.
citation: Oshima M, Jun M, Ohkuma T, Toyama T, Wada T, Cooper ME, Hadjadj S, Hamet P, Harrap S, Mancia G, Marre M, Williams B, Chalmers J, Woodward M, Perkovic V; ADVANCE Collaborative Group. The relationship between eGFR slope and subsequent risk of vascular outcomes and all-cause mortality in type 2 diabetes: the ADVANCE-ON study. Diabetologia. 2019 Nov;62(11):1988-1997. doi: 10.1007/s00125-019-4948-4. Epub 2019 Jul 13.
citation: Mohammedi K, Woodward M, Hirakawa Y, Zoungas S, Colagiuri S, Hamet P, Harrap S, Poulter N, Matthews DR, Marre M, Chalmers J; ADVANCE Collaborative Group. Presentations of major peripheral arterial disease and risk of major outcomes in patients with type 2 diabetes: results from the ADVANCE-ON study. Cardiovasc Diabetol. 2016 Sep 2;15(1):129. doi: 10.1186/s12933-016-0446-x.
citation: Wong MG, Perkovic V, Chalmers J, Woodward M, Li Q, Cooper ME, Hamet P, Harrap S, Heller S, MacMahon S, Mancia G, Marre M, Matthews D, Neal B, Poulter N, Rodgers A, Williams B, Zoungas S; ADVANCE-ON Collaborative Group. Long-term Benefits of Intensive Glucose Control for Preventing End-Stage Kidney Disease: ADVANCE-ON. Diabetes Care. 2016 May;39(5):694-700. doi: 10.2337/dc15-2322. Epub 2016 Mar 22.
citation: Zoungas S, Chalmers J, Neal B, Billot L, Li Q, Hirakawa Y, Arima H, Monaghan H, Joshi R, Colagiuri S, Cooper ME, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Lisheng L, Mancia G, Marre M, Matthews DR, Mogensen CE, Perkovic V, Poulter N, Rodgers A, Williams B, MacMahon S, Patel A, Woodward M; ADVANCE-ON Collaborative Group. Follow-up of blood-pressure lowering and glucose control in type 2 diabetes. N Engl J Med. 2014 Oct 9;371(15):1392-406. doi: 10.1056/NEJMoa1407963. Epub 2014 Sep 19.