Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study (ADVANCE-ON)

May 15, 2014 updated by: The George Institute
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

8494

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All living participants who took part in the ADVANCE study

Description

Inclusion Criteria:

  • Participated in ADVANCE
  • Ability to provide informed consent

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major macrovascular events -a composite of non-fatal myocardial infarction, non-fatal stroke and death from any cardiovascular cause (based on investigator diagnosis)
Time Frame: 2014
2014
Death from any cause
Time Frame: 2014
2014

Secondary Outcome Measures

Outcome Measure
Time Frame
Death from any cardiovascular cause
Time Frame: 2014
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
Time Frame: 2014
2014
Composite of major macrovascular events and major clinical microvascular events
Time Frame: 2014
2014
Stroke (non-fatal and fatal)
Time Frame: 2014
2014
Requirement for renal replacement therapy (dialysis or transplantation)
Time Frame: 2014
2014
Death from renal disease
Time Frame: 2014
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
Time Frame: 2014
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
Time Frame: 2014
2014
Myocardial infarction (non-fatal and fatal)
Time Frame: 2014
2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The George Institute

Collaborators

Servier

Investigators

  • Principal Investigator: John P Chalmers, The George Institute
  • Principal Investigator: Stephen MacMahon, The George Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

July 28, 2009

First Submitted That Met QC Criteria

July 28, 2009

First Posted (Estimate)

July 30, 2009

Study Record Updates

Last Update Posted (Estimate)

May 19, 2014

Last Update Submitted That Met QC Criteria

May 15, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADVANCE-ON

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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