Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study

Diabetes Mellitus, Type 2 Clinical Trial

— ADVANCE-ON  

Official title:

Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949286
• Other study ID #: ADVANCE-ON
• Status: Completed
• Phase: N/A
• First received: July 28, 2009
• Last updated: May 15, 2014
• Start date: January 2010
• Est. completion date: February 2014

Study information

• Verified date: April 2014
• Source: The George Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeAustralia: National Health and Medical Research CouncilCanada: Ethics Review CommitteeChina: Ethics CommitteeCzech Republic: Ethics CommitteeEstonia: The State Agency of MedicineFrance: Institutional Ethical CommitteeGermany: Ethics CommissionHungary: National Institute of PharmacyIndia: Institutional Review BoardIreland: Medical Ethics Research CommitteeItaly: Ethics CommitteeLithuania: Bioethics CommitteeMalaysia: Ministry of HealthNetherlands: Independent Ethics CommitteeNew Zealand: Institutional Review BoardPhilippines: Department of HealthPoland: Ethics CommitteeRussia: Ethics CommitteeSlovakia: State Institute for Drug ControlUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8494
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participated in ADVANCE

• Ability to provide informed consent

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Vascular Diseases

Locations

Country	Name	City	State
Australia	LCC 24 - Mater Hospital	Brisbane	Queensland
Australia	LCC 42 - Princess Alexandra Hospital	Brisbane	Queensland
Australia	LCC 28 - Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	LCC 65 - Dandenong Hospital	Dandenong	Victoria
Australia	LCC 73 - Repatriation General Hospital	Daw Park	South Australia
Australia	LCC 66 - Lyell McEwin Health	Elizabeth Vale	South Australia
Australia	LCC 33 - The Northern Hospital	Epping	Victoria
Australia	LCC 50 - Fremantle Hospital	Fremantle	Western Australia
Australia	LCC 80 - Canberra Hospital	Garran	Australian Capital Territory
Australia	LCC 48 - Gosford	Gosford	New South Wales
Australia	LCC 32 - Austin & Repatriation Hospital	Heidelburg	Victoria
Australia	LCC 61 - Launceston General Hospital	Launceston	Tasmania
Australia	LCC 59 - Liverpool Hospital	Liverpool	New South Wales
Australia	LCC 76 - The Alfred Hospital	Melbourne	Victoria
Australia	LCC 78 - Wentworth Diabetes Centre	Penrith	New South Wales
Australia	LCC 56 - Prince of Wales Hospital	Randwick	New South Wales
Australia	LCC 74 - Redcliffe Hospital	Redcliffe	Queensland
Australia	LCC 109 - Rural Clinical Trials Research Unit	Shepparton	Victoria
Australia	LCC 43 - Gold Coast Hospital	Southport	Queensland
Australia	LCC 55 - Royal North Shore Hospital	St Leonards	New South Wales
Australia	LCC 114 - Townsville Mater Hospital	Townsville	Queensland
Australia	LCC 23 - Wollongong Hospital	Wollongong	New South Wales
Canada	LCC 468 - Calgary Metabolic Education and Research Centre	Calgary	Alberta
Canada	LCC 467 - Queen Elizabeth II Health Science Centre	Halifax	Nova Scotia
Canada	LCC 452 - Centre de recherche clinique de Laval	Laval	Quebec
Canada	LCC 465 - St. Joseph's Health Centre	London	Ontario
Canada	LCC 453 - Centre hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	LCC 460 - Centre Hospitalier de L'universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	LCC 466 - Centre de recherche d'endocrinologie	Sherbrooke	Quebec
Canada	LCC 470 - Hôpital Laval	Ste-Foy	Quebec
Canada	LCC 459 - University of Toronto	Toronto	Ontario
Canada	LCC 454 University of British Columbia	Vancouver	British Columbia
China	LCC 643 - 2nd Aff Hospital of Baotou Medical College	Baotou
China	LCC 644 - Baotou Iron & Steel Corporation's Hospital,	Baotou
China	LCC 600 - Center Hospital of Aviation	Beijing
China	LCC 601 - 305 Hospital of Chinese PLA	Beijing
China	LCC 602 - Chinese PLA General Hospital	Beijing
China	LCC 623 - Beijing 306 Hospital	Beijing
China	LCC 626 - First Hospital of Peking University	Beijing
China	LCC 627 - Peking Union Medical College Hospital	Beijing
China	LCC 628 - Capital Steel Hospital	Beijing
China	LCC 629 - Aff Beijing Tongren Hospital	Beijing
China	LCC 630 - Beijing Hypertension League Institute	Beijing
China	LCC 631 - Beijing Jiuxianqiao Hospital	Beijing
China	LCC 632 - Dept Endocrinology Beijing 306 Hospital	Beijing
China	LCC 633 - Cardiovascular Institute & Fu Wai Hospital	Beijing
China	LCC 634 - Beijing Anzhen Hospital	Beijing
China	LCC 637 - Chinese Air Force General Hospital	Beijing
China	LCC 661 - Institute of Gerontology of Benxi City	Benxi
China	LCC 607 - People's Hospital of Binzhou City	Binzhou
China	LCC 609 - Xiang-ya Hospital,	Changsha
China	LCC 620 - Municipal Hospital of Chengdou	Chengdu
China	LCC 657 - The 1st Aff Hospital	Chengdu
China	LCC 610 - Second Affiliated Hospital of Dalian Medical University	Dalian
China	LCC 624 - The First Affiliated Hospital of Fujian Medical University	Fuzhou City
China	LCC 658 - The 1st Aff Hospital of Guiyang Medical College	Guiyang
China	LCC 641 - The 2nd Aff Hospital of Harbin Medical University	Harbin
China	LCC 653 - Aff Hospital of Anhui Medical University	Hefei
China	LCC 642 - The Institute of Aged Gerontology of Inner Mongolia	Huhehot
China	LCC 606 - Shandong Academy of Medical Sciences,	Jin'an
China	LCC 660 - Shandong Academy of Medical Sciences	Jin'an
China	LCC 622 - The First People's Hospital of Lianyungang City	Lianyungang
China	LCC 654 - The 3rd Aff Hospital of Jiangxi Medical University	Nanchang City
China	LCC 655 - The 1st Aff Hospital of Jiangxi Medical College	Nanchang City
China	LCC 651 - Jiangsu Institute of Geriatrics,	Nanjing City
China	LCC 619 - The First Hospital of Ning Bo City Municipal	Ning
China	LCC 608 - Qingdao City Hospital	Qingdao
China	LCC 603 - Rujin Hospital	Shanghai
China	LCC 635 -Aff Ruijin Hospital of Shanghai Second Medical University	Shanghai
China	LCC 636 - Chang Zheng Hospital of Shanghai	Shanghai
China	LCC 638 - Shanghai 6th People's Hospital	Shanghai
China	LCC 611 - Hua Tai Hospital	Shenyang
China	LCC 618 - Hebei Academy of Medical Sciences	Shijiazhuang
China	LCC 646 - The 2nd Aff Hospital of Hebei Medical University	Shijiazhuang
China	LCC 613 - Cardiovascular Institute of Shanxi Province	Taiyuan
China	LCC 645 - Hospital of Kailuan	Tangshan
China	LCC 639 - Metabolic Disease Hospital of Tianjin Medical University	Tianjin
China	LCC 640 - 3rd Hospital of Tianjin City	Tianjin
China	LCC 647 - First Hospital of Yang Quan City	Yangquan
China	LCC 614 -The First Affiliated Hospital of Henan Medical University	Zhengzhou
China	LCC 616 - Center Hospital of Zhumadian City	Zhumadian
Czech Republic	LCC 437 - Metabolicke Centrum	Neratovice
Czech Republic	LCC 372- Fakultni Nemocnice	Ostrava-Poruba
Czech Republic	LCC 438 - Diabetologicka ambulance	Pisek
Czech Republic	Lcc 435 - Ikem	Praha
Czech Republic	LCC 369- Masarykova Nemocnice	Usti nad Labem
Estonia	LCC 280 - Tallinn Central	Tallinn
Estonia	LCC 281 - Dept of Medicine	Tartu
France	LCC 320 - CHU Angers	Angers
France	LCC 376 - CH Avignon - Hôpital Henri Duffaut	Avignon
France	LCC 375 - CH Nevers	Nevers
France	LCC 373 - CHU Hopital Caremeau	Nimes
France	LCC 329 - CHU Bichat	Paris
France	LCC 315 - Hôpital Jean Bernard la Miletrie	Poitiers
France	LCC 310 - Hôpital Sud	Rennes
France	LCC 304 - CHU Hôpital Civil	Strasbourg
France	LCC 374 - CHU Hôpital Jeanne d' Arc	Toul
Germany	LCC 377 - Zentrum fur Klinische Studien	Dresden
Germany	LCC 330 - Klinikyum der Universitat Munchen	Munich
Hungary	LCC 336 - Heart Center Foundation-DRC Ltd	Balatonfured
Hungary	LCC 335 - Bajcsy Zsilinszky Kórház	Budapest
India	Lcc 740 - Aiims	Delhi
India	LCC 744 - Care Hospital	Hyderabad
India	LCC 741 - Madras Diabetic Research Foundation	Madras
Ireland	LCC 832 - Portincula Hospital	Ballinasloe
Ireland	LCC 514 - Beaumont Hospital	Dublin
Ireland	LCC 810 - Mater Hospital	Dublin
Ireland	LCC 817 - St James Hospital	Dublin
Ireland	LCC 806 - Adelaide & Meadth Hospital	Tallaght
Italy	LCC 418 - Ospedale San Gerado	Milan
Lithuania	LCC 270 - Institute of Cardiology	Kaunas
Lithuania	LCC 273 - Institute Psychophysiology and Rehabilitation	Palanga
Malaysia	LCC 903 - Hospital Ipoh	Ipoh
Malaysia	LCC 904 - Universiti Sains Malaysia	Kota Bharu
Malaysia	LCC 902 - University of Malaya Medical Centre	Kuala Lumpur
Malaysia	LCC 901 - Penang Medical College	Penang
Malaysia	Universiti Kebangsaan Malaysia & Universiti Teknologi MARA	Putrajaya
Netherlands	LCC 352 - Justus Medical Research	Eindhoven
Netherlands	LCC 354 - Stichting Huisartsen Laboratorium	Etten-Leur
Netherlands	LCC 347 - Martini Ziekenhuis	Groningen
Netherlands	LCC 850 - Andromed Groningen	Groningen
Netherlands	LCC 351 - Andromed Rotterdam	Rotterdam
Netherlands	LCC 852 - Andromed Baarn	Rotterdam
Netherlands	LCC 851 - Andromed Oost	Velp
Netherlands	LCC 356 - Huisartsenpraktijk Tollenslaan	Zeist
New Zealand	LCC 11 - Middlemore Hospital	Auckland
New Zealand	LCC 14 - North Shore Hospital	Auckland
New Zealand	LCC 12 - Christchurch Hospital	Christchurch
New Zealand	LCC 5 - Hawkes Bay Hospital	Hastings
New Zealand	LCC 2 - Palmerston North Hospital	Palmerston North
New Zealand	LCC 91 - Timaru Hospital	Timaru
New Zealand	LCC 6 Waikato Hospital	Waikato
New Zealand	LCC 1 - Wellington Hospital	Wellington
Philippines	LCC 909 - Makati Medical Center	Makati City	Manila
Philippines	LCC 906 - Philippine General Hospital	Manila
Philippines	LCC 907 - East Avenue Medical Centre	Quezon City
Philippines	LCC 908 - Diabetes Foundation	Quezon City
Poland	LCC 426 - NZOZ Specjalistyczna Poradnia Endokrynologii	Elblag
Poland	LCC 382 - Puls Med	Katowice
Poland	LCC 381 - I Klinika Kardiologii	Krakow
Poland	LCC 383 - Klinika Chorob Metabolicznych	Krakow
Poland	LCC 389 - Zaklad Angiologii	Krakow
Poland	LCC 390 - Klinika Choroby Wiencowej	Krakow
Poland	LCC 380 - I Oddzial Chorob Wewnetrznych	Kutno
Poland	LCC 392 - Osrodek Diabetologii	Olsztyn
Poland	LCC 378 - Klinika Nefrologii	Poznan
Poland	LCC 394 - II Oddzial Chorob Wewnetrznvch	Radom
Russian Federation	LCC 420 - Russian Peoples Friendship University	Moscow
Russian Federation	LCC 421 - St Petersburg State Medical University	St Petersburg
Russian Federation	LCC 424 - Research Institute of Cardiology	St Petersburg
Slovakia	LCC 254 - Poliklinikou Vychod	Kosice
Slovakia	LCC 252 - Nemocnica s poliklinikou	Levice
Slovakia	LCC 253 - Nemocnica s poliklinikou	Lucenec
United Kingdom	LCC 517 - Aberdeen Royal Infirmary	Aberdeen
United Kingdom	LCC 813 - Monklands Hospital	Airdrie
United Kingdom	LCC 819 - Royal United Hospital	Bath
United Kingdom	LCC 815 - City Hospital	Birmingham
United Kingdom	LCC 821 - West Byfleet Health Centre	Byfleet
United Kingdom	LCC 594 - Glasgow Royal Infirmary	Glasgow
United Kingdom	LCC 826 - St Mary's Hospital	Isle of Wight
United Kingdom	LCC 533 - Leicester Royal Infirmary	Leicester
United Kingdom	LCC 809 - Royal Liverpool University Hospital	Liverpool
United Kingdom	LCC 543 - St Mary's	London
United Kingdom	LCC 511 - Manchester Royal Infirmary	Manchester
United Kingdom	LCC 829 - Northampton General Hospital	Northampton
United Kingdom	LCC 830 - George Eliot Hospital	Nuneaton
United Kingdom	LCC 812 - Royal Alexandra Hospital	Paisley
United Kingdom	LCC 816 - Peninsula Medical School Headquarters	Plymouth
United Kingdom	LCC 820 - The Diabetes Centre	Reading
United Kingdom	LCC 827 - Northern General Hospital	Sheffield
United Kingdom	Sheffield Hallamshire	Sheffield
United Kingdom	LCC 831 - Warwick General Hospital	Warwick

Sponsors (2)

Lead Sponsor	Collaborator
The George Institute	Servier

Countries where clinical trial is conducted

Australia,  Canada,  China,  Czech Republic,  Estonia,  France,  Germany,  Hungary,  India,  Ireland,  Italy,  Lithuania,  Malaysia,  Netherlands,  New Zealand,  Philippines,  Poland,  Russian Federation,  Slovakia,  United Kingdom, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major macrovascular events -a composite of non-fatal myocardial infarction, non-fatal stroke and death from any cardiovascular cause (based on investigator diagnosis)		2014	No
Primary	Death from any cause		2014	No
Secondary	Death from any cardiovascular cause		2014	No
Secondary	Major clinical microvascular events - a composite of requirement for renal replacement therapy, death from renal disease and development of severe diabetes-related eye disease		2014	No
Secondary	Composite of major macrovascular events and major clinical microvascular events		2014	No
Secondary	Stroke (non-fatal and fatal)		2014	No
Secondary	Requirement for renal replacement therapy (dialysis or transplantation)		2014	No
Secondary	Death from renal disease		2014	No
Secondary	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		2014	No
Secondary	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		2014	No
Secondary	Myocardial infarction (non-fatal and fatal)		2014	No