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

NCT ID: NCT00949286

Last Updated: 2014-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8494 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-02-28

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Participated in ADVANCE
* Ability to provide informed consent

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Servier

INDUSTRY

Sponsor Role collaborator

The George Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John P Chalmers

Role: PRINCIPAL_INVESTIGATOR

The George Institute

Stephen MacMahon

Role: PRINCIPAL_INVESTIGATOR

The George Institute

Locations

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LCC 80 - Canberra Hospital

Garran, Australian Capital Territory, Australia

Site Status

LCC 28 - Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

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LCC 48 - Gosford

Gosford, New South Wales, Australia

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LCC 59 - Liverpool Hospital

Liverpool, New South Wales, Australia

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LCC 78 - Wentworth Diabetes Centre

Penrith, New South Wales, Australia

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LCC 56 - Prince of Wales Hospital

Randwick, New South Wales, Australia

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LCC 55 - Royal North Shore Hospital

St Leonards, New South Wales, Australia

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LCC 23 - Wollongong Hospital

Wollongong, New South Wales, Australia

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LCC 24 - Mater Hospital

Brisbane, Queensland, Australia

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LCC 42 - Princess Alexandra Hospital

Brisbane, Queensland, Australia

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LCC 74 - Redcliffe Hospital

Redcliffe, Queensland, Australia

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LCC 43 - Gold Coast Hospital

Southport, Queensland, Australia

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LCC 114 - Townsville Mater Hospital

Townsville, Queensland, Australia

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LCC 73 - Repatriation General Hospital

Daw Park, South Australia, Australia

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LCC 66 - Lyell McEwin Health

Elizabeth Vale, South Australia, Australia

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LCC 61 - Launceston General Hospital

Launceston, Tasmania, Australia

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LCC 65 - Dandenong Hospital

Dandenong, Victoria, Australia

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LCC 33 - The Northern Hospital

Epping, Victoria, Australia

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LCC 32 - Austin & Repatriation Hospital

Heidelburg, Victoria, Australia

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LCC 76 - The Alfred Hospital

Melbourne, Victoria, Australia

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LCC 109 - Rural Clinical Trials Research Unit

Shepparton, Victoria, Australia

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LCC 50 - Fremantle Hospital

Fremantle, Western Australia, Australia

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LCC 468 - Calgary Metabolic Education and Research Centre

Calgary, Alberta, Canada

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LCC 454 University of British Columbia

Vancouver, British Columbia, Canada

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LCC 467 - Queen Elizabeth II Health Science Centre

Halifax, Nova Scotia, Canada

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LCC 465 - St. Joseph's Health Centre

London, Ontario, Canada

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LCC 459 - University of Toronto

Toronto, Ontario, Canada

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LCC 452 - Centre de recherche clinique de Laval

Laval, Quebec, Canada

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LCC 453 - Centre hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

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LCC 460 - Centre Hospitalier de L'universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

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LCC 466 - Centre de recherche d'endocrinologie

Sherbrooke, Quebec, Canada

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LCC 470 - Hôpital Laval

Ste-Foy, Quebec, Canada

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LCC 643 - 2nd Aff Hospital of Baotou Medical College

Baotou, , China

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LCC 644 - Baotou Iron & Steel Corporation's Hospital,

Baotou, , China

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LCC 600 - Center Hospital of Aviation

Beijing, , China

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LCC 601 - 305 Hospital of Chinese PLA

Beijing, , China

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LCC 602 - Chinese PLA General Hospital

Beijing, , China

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LCC 623 - Beijing 306 Hospital

Beijing, , China

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LCC 626 - First Hospital of Peking University

Beijing, , China

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LCC 627 - Peking Union Medical College Hospital

Beijing, , China

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LCC 628 - Capital Steel Hospital

Beijing, , China

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LCC 629 - Aff Beijing Tongren Hospital

Beijing, , China

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LCC 630 - Beijing Hypertension League Institute

Beijing, , China

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LCC 631 - Beijing Jiuxianqiao Hospital

Beijing, , China

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LCC 632 - Dept Endocrinology Beijing 306 Hospital

Beijing, , China

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LCC 633 - Cardiovascular Institute & Fu Wai Hospital

Beijing, , China

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LCC 634 - Beijing Anzhen Hospital

Beijing, , China

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LCC 637 - Chinese Air Force General Hospital

Beijing, , China

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LCC 661 - Institute of Gerontology of Benxi City

Benxi, , China

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LCC 607 - People's Hospital of Binzhou City

Binzhou, , China

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LCC 609 - Xiang-ya Hospital,

Changsha, , China

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LCC 620 - Municipal Hospital of Chengdou

Chengdu, , China

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LCC 657 - The 1st Aff Hospital

Chengdu, , China

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LCC 610 - Second Affiliated Hospital of Dalian Medical University

Dalian, , China

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LCC 624 - The First Affiliated Hospital of Fujian Medical University

Fuzhou, , China

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LCC 658 - The 1st Aff Hospital of Guiyang Medical College

Guiyang, , China

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LCC 641 - The 2nd Aff Hospital of Harbin Medical University

Harbin, , China

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LCC 653 - Aff Hospital of Anhui Medical University

Hefei, , China

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LCC 642 - The Institute of Aged Gerontology of Inner Mongolia

Hohhot, , China

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LCC 606 - Shandong Academy of Medical Sciences,

Jin’an, , China

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LCC 660 - Shandong Academy of Medical Sciences

Jin’an, , China

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LCC 622 - The First People's Hospital of Lianyungang City

Lianyungang, , China

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LCC 654 - The 3rd Aff Hospital of Jiangxi Medical University

Nanchang, , China

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LCC 655 - The 1st Aff Hospital of Jiangxi Medical College

Nanchang, , China

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LCC 651 - Jiangsu Institute of Geriatrics,

Nanjing, , China

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LCC 608 - Qingdao City Hospital

Qingdao, , China

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LCC 603 - Rujin Hospital

Shanghai, , China

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LCC 635 -Aff Ruijin Hospital of Shanghai Second Medical University

Shanghai, , China

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LCC 636 - Chang Zheng Hospital of Shanghai

Shanghai, , China

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LCC 638 - Shanghai 6th People's Hospital

Shanghai, , China

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LCC 611 - Hua Tai Hospital

Shenyang, , China

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LCC 618 - Hebei Academy of Medical Sciences

Shijiazhuang, , China

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LCC 646 - The 2nd Aff Hospital of Hebei Medical University

Shijiazhuang, , China

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LCC 613 - Cardiovascular Institute of Shanxi Province

Taiyuan, , China

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LCC 645 - Hospital of Kailuan

Tangshan, , China

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LCC 639 - Metabolic Disease Hospital of Tianjin Medical University

Tianjin, , China

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LCC 640 - 3rd Hospital of Tianjin City

Tianjin, , China

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LCC 619 - The First Hospital of Ning Bo City Municipal

Xinning, , China

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LCC 647 - First Hospital of Yang Quan City

Yangquan, , China

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LCC 614 -The First Affiliated Hospital of Henan Medical University

Zhengzhou, , China

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LCC 616 - Center Hospital of Zhumadian City

Zhumadian, , China

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LCC 437 - Metabolicke Centrum

Neratovice, , Czechia

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LCC 372- Fakultni Nemocnice

Ostrava-Poruba, , Czechia

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LCC 438 - Diabetologicka ambulance

Písek, , Czechia

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Lcc 435 - Ikem

Prague, , Czechia

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LCC 369- Masarykova Nemocnice

Ústí nad Labem, , Czechia

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LCC 280 - Tallinn Central

Tallinn, , Estonia

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LCC 281 - Dept of Medicine

Tartu, , Estonia

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LCC 320 - CHU Angers

Angers, , France

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LCC 376 - CH Avignon - Hôpital Henri Duffaut

Avignon, , France

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LCC 375 - CH Nevers

Nevers, , France

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LCC 373 - CHU Hopital Caremeau

Nîmes, , France

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LCC 329 - CHU Bichat

Paris, , France

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LCC 315 - Hôpital Jean Bernard la Miletrie

Poitiers, , France

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LCC 310 - Hôpital Sud

Rennes, , France

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LCC 304 - CHU Hôpital Civil

Strasbourg, , France

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LCC 374 - CHU Hôpital Jeanne d' Arc

Toul, , France

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LCC 377 - Zentrum fur Klinische Studien

Dresden, , Germany

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LCC 330 - Klinikyum der Universitat Munchen

Munich, , Germany

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LCC 336 - Heart Center Foundation-DRC Ltd

Balatonfüred, , Hungary

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LCC 335 - Bajcsy Zsilinszky Kórház

Budapest, , Hungary

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Lcc 740 - Aiims

Delhi, , India

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LCC 744 - Care Hospital

Hyderabad, , India

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LCC 741 - Madras Diabetic Research Foundation

Madras, , India

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LCC 832 - Portincula Hospital

Ballinasloe, , Ireland

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LCC 514 - Beaumont Hospital

Dublin, , Ireland

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LCC 810 - Mater Hospital

Dublin, , Ireland

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LCC 817 - St James Hospital

Dublin, , Ireland

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LCC 806 - Adelaide & Meadth Hospital

Tallaght, , Ireland

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LCC 418 - Ospedale San Gerado

Milan, , Italy

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LCC 270 - Institute of Cardiology

Kaunas, , Lithuania

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LCC 273 - Institute Psychophysiology and Rehabilitation

Palanga, , Lithuania

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LCC 901 - Penang Medical College

George Town, , Malaysia

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LCC 903 - Hospital Ipoh

Ipoh, , Malaysia

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LCC 904 - Universiti Sains Malaysia

Kota Bharu, , Malaysia

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LCC 902 - University of Malaya Medical Centre

Kuala Lumpur, , Malaysia

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Universiti Kebangsaan Malaysia & Universiti Teknologi MARA

Putrajaya, , Malaysia

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LCC 352 - Justus Medical Research

Eindhoven, , Netherlands

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LCC 354 - Stichting Huisartsen Laboratorium

Etten-Leur, , Netherlands

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LCC 347 - Martini Ziekenhuis

Groningen, , Netherlands

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LCC 850 - Andromed Groningen

Groningen, , Netherlands

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LCC 351 - Andromed Rotterdam

Rotterdam, , Netherlands

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LCC 852 - Andromed Baarn

Rotterdam, , Netherlands

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LCC 851 - Andromed Oost

Velp, , Netherlands

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LCC 356 - Huisartsenpraktijk Tollenslaan

Zeist, , Netherlands

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LCC 11 - Middlemore Hospital

Auckland, , New Zealand

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LCC 14 - North Shore Hospital

Auckland, , New Zealand

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LCC 12 - Christchurch Hospital

Christchurch, , New Zealand

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LCC 5 - Hawkes Bay Hospital

Hastings, , New Zealand

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LCC 2 - Palmerston North Hospital

Palmerston North, , New Zealand

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LCC 91 - Timaru Hospital

Timaru, , New Zealand

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LCC 6 Waikato Hospital

Waikato, , New Zealand

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LCC 1 - Wellington Hospital

Wellington, , New Zealand

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LCC 909 - Makati Medical Center

Makati City, Manila, Philippines

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LCC 906 - Philippine General Hospital

Manila, , Philippines

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LCC 907 - East Avenue Medical Centre

Quezon City, , Philippines

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LCC 908 - Diabetes Foundation

Quezon City, , Philippines

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LCC 426 - NZOZ Specjalistyczna Poradnia Endokrynologii

Elblag, , Poland

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LCC 382 - Puls Med

Katowice, , Poland

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LCC 381 - I Klinika Kardiologii

Krakow, , Poland

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LCC 383 - Klinika Chorob Metabolicznych

Krakow, , Poland

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LCC 389 - Zakład Angiologii

Krakow, , Poland

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LCC 390 - Klinika Choroby Wiencowej

Krakow, , Poland

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LCC 380 - I Oddzial Chorob Wewnetrznych

Kutno, , Poland

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LCC 392 - Osrodek Diabetologii

Olsztyn, , Poland

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LCC 378 - Klinika Nefrologii

Poznan, , Poland

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LCC 394 - II Oddzial Chorob Wewnetrznvch

Radom, , Poland

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LCC 420 - Russian Peoples Friendship University

Moscow, , Russia

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LCC 421 - St Petersburg State Medical University

Saint Petersburg, , Russia

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LCC 424 - Research Institute of Cardiology

Saint Petersburg, , Russia

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LCC 254 - Poliklinikou Vychod

Košice, , Slovakia

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LCC 252 - Nemocnica s poliklinikou

Levice, , Slovakia

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LCC 253 - Nemocnica s poliklinikou

Lučenec, , Slovakia

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LCC 517 - Aberdeen Royal Infirmary

Aberdeen, , United Kingdom

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LCC 813 - Monklands Hospital

Airdrie, , United Kingdom

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LCC 819 - Royal United Hospital

Bath, , United Kingdom

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LCC 815 - City Hospital

Birmingham, , United Kingdom

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LCC 821 - West Byfleet Health Centre

Byfleet, , United Kingdom

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LCC 594 - Glasgow Royal Infirmary

Glasgow, , United Kingdom

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LCC 826 - St Mary's Hospital

Isle of Wight, , United Kingdom

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LCC 533 - Leicester Royal Infirmary

Leicester, , United Kingdom

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LCC 809 - Royal Liverpool University Hospital

Liverpool, , United Kingdom

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LCC 543 - St Mary's

London, , United Kingdom

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LCC 511 - Manchester Royal Infirmary

Manchester, , United Kingdom

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LCC 829 - Northampton General Hospital

Northampton, , United Kingdom

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LCC 830 - George Eliot Hospital

Nuneaton, , United Kingdom

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LCC 812 - Royal Alexandra Hospital

Paisley, , United Kingdom

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LCC 816 - Peninsula Medical School Headquarters

Plymouth, , United Kingdom

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LCC 820 - The Diabetes Centre

Reading, , United Kingdom

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LCC 827 - Northern General Hospital

Sheffield, , United Kingdom

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Sheffield Hallamshire

Sheffield, , United Kingdom

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LCC 831 - Warwick General Hospital

Warwick, , United Kingdom

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Countries

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Australia Canada China Czechia Estonia France Germany Hungary India Ireland Italy Lithuania Malaysia Netherlands New Zealand Philippines Poland Russia Slovakia United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 17765963 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18539916 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36109108 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31302707 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27590190 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27006512 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25234206 (View on PubMed)

Other Identifiers

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ADVANCE-ON

Identifier Type: -

Identifier Source: org_study_id

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