Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00949286
- Lead Sponsor
- The George Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8494
- Participated in ADVANCE
- Ability to provide informed consent
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major macrovascular events -a composite of non-fatal myocardial infarction, non-fatal stroke and death from any cardiovascular cause (based on investigator diagnosis) 2014 Death from any cause 2014
- Secondary Outcome Measures
Name Time Method Death from renal disease 2014 Death from any cardiovascular cause 2014 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 Composite of major macrovascular events and major clinical microvascular events 2014 Stroke (non-fatal and fatal) 2014 Requirement for renal replacement therapy (dialysis or transplantation) 2014 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 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 Myocardial infarction (non-fatal and fatal) 2014
Trial Locations
- Locations (172)
LCC 80 - Canberra Hospital
🇦🇺Garran, Australian Capital Territory, Australia
LCC 76 - The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
LCC 65 - Dandenong Hospital
🇦🇺Dandenong, Victoria, Australia
LCC 33 - The Northern Hospital
🇦🇺Epping, Victoria, Australia
LCC 32 - Austin & Repatriation Hospital
🇦🇺Heidelburg, Victoria, Australia
LCC 109 - Rural Clinical Trials Research Unit
🇦🇺Shepparton, Victoria, Australia
LCC 467 - Queen Elizabeth II Health Science Centre
🇨🇦Halifax, Nova Scotia, Canada
LCC 460 - Centre Hospitalier de L'universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
LCC 452 - Centre de recherche clinique de Laval
🇨🇦Laval, Quebec, Canada
LCC 453 - Centre hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
LCC 372- Fakultni Nemocnice
🇨🇿Ostrava-Poruba, Czech Republic
LCC 806 - Adelaide & Meadth Hospital
🇮🇪Tallaght, Ireland
LCC 741 - Madras Diabetic Research Foundation
🇮🇳Madras, India
LCC 514 - Beaumont Hospital
🇮🇪Dublin, Ireland
LCC 810 - Mater Hospital
🇮🇪Dublin, Ireland
LCC 270 - Institute of Cardiology
🇱🇹Kaunas, Lithuania
LCC 273 - Institute Psychophysiology and Rehabilitation
🇱🇹Palanga, Lithuania
LCC 903 - Hospital Ipoh
🇲🇾Ipoh, Malaysia
LCC 901 - Penang Medical College
🇲🇾Penang, Malaysia
Universiti Kebangsaan Malaysia & Universiti Teknologi MARA
🇲🇾Putrajaya, Malaysia
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, Netherlands
LCC 907 - East Avenue Medical Centre
🇵ðŸ‡Quezon City, Philippines
LCC 908 - Diabetes Foundation
🇵ðŸ‡Quezon City, Philippines
LCC 426 - NZOZ Specjalistyczna Poradnia Endokrynologii
🇵🇱Elbląg, Poland
LCC 382 - Puls Med
🇵🇱Katowice, Poland
LCC 383 - Klinika Chorob Metabolicznych
🇵🇱Krakow, Poland
LCC 389 - Zakład 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, Poland
LCC 421 - St Petersburg State Medical University
🇷🇺St Petersburg, Russian Federation
LCC 254 - Poliklinikou Vychod
🇸🇰Kosice, Slovakia
LCC 252 - Nemocnica s poliklinikou
🇸🇰Levice, Slovakia
LCC 253 - Nemocnica s poliklinikou
🇸🇰Lucenec, Slovakia
LCC 641 - The 2nd Aff Hospital of Harbin Medical University
🇨🇳Harbin, China
LCC 637 - Chinese Air Force General Hospital
🇨🇳Beijing, China
LCC 620 - Municipal Hospital of Chengdou
🇨🇳Chengdu, China
LCC 603 - Rujin Hospital
🇨🇳Shanghai, China
LCC 638 - Shanghai 6th People's Hospital
🇨🇳Shanghai, China
LCC 50 - Fremantle Hospital
🇦🇺Fremantle, Western Australia, Australia
LCC 660 - Shandong Academy of Medical Sciences
🇨🇳Jin'an, China
LCC 654 - The 3rd Aff Hospital of Jiangxi Medical University
🇨🇳Nanchang City, China
LCC 640 - 3rd Hospital of Tianjin City
🇨🇳Tianjin, China
LCC 28 - Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
LCC 78 - Wentworth Diabetes Centre
🇦🇺Penrith, New South Wales, Australia
LCC 42 - Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
LCC 74 - Redcliffe Hospital
🇦🇺Redcliffe, Queensland, Australia
LCC 56 - Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
LCC 55 - Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
LCC 23 - Wollongong Hospital
🇦🇺Wollongong, New South Wales, Australia
LCC 66 - Lyell McEwin Health
🇦🇺Elizabeth Vale, South Australia, Australia
LCC 114 - Townsville Mater Hospital
🇦🇺Townsville, Queensland, Australia
LCC 48 - Gosford
🇦🇺Gosford, New South Wales, Australia
LCC 59 - Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
LCC 613 - Cardiovascular Institute of Shanxi Province
🇨🇳Taiyuan, China
LCC 645 - Hospital of Kailuan
🇨🇳Tangshan, China
LCC 61 - Launceston General Hospital
🇦🇺Launceston, Tasmania, Australia
LCC 24 - Mater Hospital
🇦🇺Brisbane, Queensland, Australia
LCC 43 - Gold Coast Hospital
🇦🇺Southport, Queensland, Australia
LCC 627 - Peking Union Medical College Hospital
🇨🇳Beijing, China
LCC 470 - Hôpital Laval
🇨🇦Ste-Foy, Quebec, Canada
LCC 643 - 2nd Aff Hospital of Baotou Medical College
🇨🇳Baotou, China
LCC 628 - Capital Steel Hospital
🇨🇳Beijing, China
LCC 459 - University of Toronto
🇨🇦Toronto, Ontario, Canada
LCC 73 - Repatriation General Hospital
🇦🇺Daw Park, South Australia, Australia
LCC 626 - First Hospital of Peking University
🇨🇳Beijing, China
LCC 631 - Beijing Jiuxianqiao Hospital
🇨🇳Beijing, China
LCC 624 - The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou City, China
LCC 647 - First Hospital of Yang Quan City
🇨🇳Yangquan, China
LCC 310 - Hôpital Sud
🇫🇷Rennes, France
LCC 602 - Chinese PLA General Hospital
🇨🇳Beijing, China
LCC 644 - Baotou Iron & Steel Corporation's Hospital,
🇨🇳Baotou, China
LCC 454 University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
LCC 465 - St. Joseph's Health Centre
🇨🇦London, Ontario, Canada
LCC 437 - Metabolicke Centrum
🇨🇿Neratovice, Czech Republic
Lcc 435 - Ikem
🇨🇿Praha, Czech Republic
LCC 369- Masarykova Nemocnice
🇨🇿Usti nad Labem, Czech Republic
LCC 280 - Tallinn Central
🇪🇪Tallinn, Estonia
LCC 614 -The First Affiliated Hospital of Henan Medical University
🇨🇳Zhengzhou, China
LCC 616 - Center Hospital of Zhumadian City
🇨🇳Zhumadian, China
LCC 320 - CHU Angers
🇫🇷Angers, France
LCC 376 - CH Avignon - Hôpital Henri Duffaut
🇫🇷Avignon, France
LCC 375 - CH Nevers
🇫🇷Nevers, France
LCC 304 - CHU Hôpital Civil
🇫🇷Strasbourg, France
LCC 329 - CHU Bichat
🇫🇷Paris, France
LCC 902 - University of Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
LCC 618 - Hebei Academy of Medical Sciences
🇨🇳Shijiazhuang, China
LCC 646 - The 2nd Aff Hospital of Hebei Medical University
🇨🇳Shijiazhuang, China
LCC 639 - Metabolic Disease Hospital of Tianjin Medical University
🇨🇳Tianjin, China
LCC 374 - CHU Hôpital Jeanne d' Arc
🇫🇷Toul, France
LCC 831 - Warwick General Hospital
🇬🇧Warwick, United Kingdom
LCC 330 - Klinikyum der Universitat Munchen
🇩🇪Munich, Germany
LCC 12 - Christchurch Hospital
🇳🇿Christchurch, New Zealand
LCC 281 - Dept of Medicine
🇪🇪Tartu, Estonia
LCC 813 - Monklands Hospital
🇬🇧Airdrie, United Kingdom
LCC 1 - Wellington Hospital
🇳🇿Wellington, New Zealand
LCC 817 - St James Hospital
🇮🇪Dublin, Ireland
LCC 373 - CHU Hopital Caremeau
🇫🇷Nimes, France
LCC 829 - Northampton General Hospital
🇬🇧Northampton, United Kingdom
LCC 14 - North Shore Hospital
🇳🇿Auckland, New Zealand
LCC 517 - Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
LCC 2 - Palmerston North Hospital
🇳🇿Palmerston North, New Zealand
LCC 5 - Hawkes Bay Hospital
🇳🇿Hastings, New Zealand
LCC 381 - I Klinika Kardiologii
🇵🇱Krakow, Poland
LCC 594 - Glasgow Royal Infirmary
🇬🇧Glasgow, United Kingdom
LCC 418 - Ospedale San Gerado
🇮🇹Milan, Italy
LCC 315 - Hôpital Jean Bernard la Miletrie
🇫🇷Poitiers, France
LCC 815 - City Hospital
🇬🇧Birmingham, United Kingdom
LCC 821 - West Byfleet Health Centre
🇬🇧Byfleet, United Kingdom
LCC 826 - St Mary's Hospital
🇬🇧Isle of Wight, 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 830 - George Eliot Hospital
🇬🇧Nuneaton, United Kingdom
LCC 812 - Royal Alexandra Hospital
🇬🇧Paisley, United Kingdom
LCC 827 - Northern General Hospital
🇬🇧Sheffield, United Kingdom
LCC 466 - Centre de recherche d'endocrinologie
🇨🇦Sherbrooke, Quebec, Canada
LCC 600 - Center Hospital of Aviation
🇨🇳Beijing, China
LCC 601 - 305 Hospital of Chinese PLA
🇨🇳Beijing, China
LCC 623 - Beijing 306 Hospital
🇨🇳Beijing, China
LCC 632 - Dept Endocrinology Beijing 306 Hospital
🇨🇳Beijing, China
LCC 629 - Aff Beijing Tongren Hospital
🇨🇳Beijing, China
LCC 630 - Beijing Hypertension League Institute
🇨🇳Beijing, China
LCC 634 - Beijing Anzhen Hospital
🇨🇳Beijing, China
LCC 633 - Cardiovascular Institute & Fu Wai 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 657 - The 1st Aff Hospital
🇨🇳Chengdu, China
LCC 610 - Second Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, 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 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 635 -Aff Ruijin Hospital of Shanghai Second Medical University
🇨🇳Shanghai, China
LCC 636 - Chang Zheng Hospital of Shanghai
🇨🇳Shanghai, China
LCC 611 - Hua Tai Hospital
🇨🇳Shenyang, China
LCC 438 - Diabetologicka ambulance
🇨🇿Pisek, Czech Republic
LCC 377 - Zentrum fur Klinische Studien
🇩🇪Dresden, Germany
Lcc 740 - Aiims
🇮🇳Delhi, India
LCC 832 - Portincula Hospital
🇮🇪Ballinasloe, Ireland
LCC 336 - Heart Center Foundation-DRC Ltd
ðŸ‡ðŸ‡ºBalatonfured, Hungary
LCC 335 - Bajcsy Zsilinszky Kórház
ðŸ‡ðŸ‡ºBudapest, Hungary
LCC 744 - Care Hospital
🇮🇳Hyderabad, India
LCC 904 - Universiti Sains Malaysia
🇲🇾Kota Bharu, Malaysia
LCC 11 - Middlemore Hospital
🇳🇿Auckland, New Zealand
LCC 909 - Makati Medical Center
🇵ðŸ‡Makati City, Manila, Philippines
LCC 6 Waikato Hospital
🇳🇿Waikato, New Zealand
LCC 91 - Timaru Hospital
🇳🇿Timaru, New Zealand
LCC 906 - Philippine General Hospital
🇵ðŸ‡Manila, Philippines
LCC 424 - Research Institute of Cardiology
🇷🇺St Petersburg, Russian Federation
LCC 420 - Russian Peoples Friendship University
🇷🇺Moscow, Russian Federation
LCC 819 - Royal United Hospital
🇬🇧Bath, United Kingdom
LCC 533 - Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
LCC 820 - The Diabetes Centre
🇬🇧Reading, United Kingdom
LCC 816 - Peninsula Medical School Headquarters
🇬🇧Plymouth, United Kingdom
Sheffield Hallamshire
🇬🇧Sheffield, United Kingdom
LCC 658 - The 1st Aff Hospital of Guiyang Medical College
🇨🇳Guiyang, China
LCC 622 - The First People's Hospital of Lianyungang City
🇨🇳Lianyungang, China
LCC 468 - Calgary Metabolic Education and Research Centre
🇨🇦Calgary, Alberta, Canada