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Diabetes Mellitus, Type 2ADVANCE-ONNCT00949286

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

An observational study of Diabetes Mellitus, Type 2, run by The George Institute at 172 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Diabetes Mellitus, Type 2
How many people
8,494 participants
Where
172 sitesin 20 countries
Study dates
Jan 2010to Feb 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All living participants who took part in the ADVANCE study

Who may be able to join

  • Participated in ADVANCE
  • Ability to provide informed consent

Who cannot join

  • None

Trial locations and contacts

172 sites in 20 countries.

172 sites in 20 countries

China49 sites

  • LCC 643 - 2nd Aff Hospital of Baotou Medical College

    Baotou

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

    Baotou

  • LCC 600 - Center Hospital of Aviation

    Beijing

  • LCC 601 - 305 Hospital of Chinese PLA

    Beijing

  • LCC 602 - Chinese PLA General Hospital

    Beijing

  • LCC 623 - Beijing 306 Hospital

    Beijing

  • LCC 626 - First Hospital of Peking University

    Beijing

  • LCC 627 - Peking Union Medical College Hospital

    Beijing

  • LCC 628 - Capital Steel Hospital

    Beijing

  • LCC 629 - Aff Beijing Tongren Hospital

    Beijing

  • LCC 630 - Beijing Hypertension League Institute

    Beijing

  • LCC 631 - Beijing Jiuxianqiao Hospital

    Beijing

  • LCC 632 - Dept Endocrinology Beijing 306 Hospital

    Beijing

  • LCC 633 - Cardiovascular Institute & Fu Wai Hospital

    Beijing

  • LCC 634 - Beijing Anzhen Hospital

    Beijing

  • LCC 637 - Chinese Air Force General Hospital

    Beijing

  • LCC 661 - Institute of Gerontology of Benxi City

    Benxi

  • LCC 607 - People's Hospital of Binzhou City

    Binzhou

  • LCC 609 - Xiang-ya Hospital,

    Changsha

  • LCC 620 - Municipal Hospital of Chengdou

    Chengdu

  • LCC 657 - The 1st Aff Hospital

    Chengdu

  • LCC 610 - Second Affiliated Hospital of Dalian Medical University

    Dalian

  • LCC 624 - The First Affiliated Hospital of Fujian Medical University

    Fuzhou

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

    Guiyang

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

    Harbin

  • LCC 653 - Aff Hospital of Anhui Medical University

    Hefei

  • LCC 642 - The Institute of Aged Gerontology of Inner Mongolia

    Hohhot

  • LCC 606 - Shandong Academy of Medical Sciences,

    Jin’an

  • LCC 660 - Shandong Academy of Medical Sciences

    Jin’an

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

    Lianyungang

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

    Nanchang

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

    Nanchang

  • LCC 651 - Jiangsu Institute of Geriatrics,

    Nanjing

  • LCC 608 - Qingdao City Hospital

    Qingdao

  • LCC 603 - Rujin Hospital

    Shanghai

  • LCC 635 -Aff Ruijin Hospital of Shanghai Second Medical University

    Shanghai

  • LCC 636 - Chang Zheng Hospital of Shanghai

    Shanghai

  • LCC 638 - Shanghai 6th People's Hospital

    Shanghai

  • LCC 611 - Hua Tai Hospital

    Shenyang

  • LCC 618 - Hebei Academy of Medical Sciences

    Shijiazhuang

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

    Shijiazhuang

  • LCC 613 - Cardiovascular Institute of Shanxi Province

    Taiyuan

  • LCC 645 - Hospital of Kailuan

    Tangshan

  • LCC 639 - Metabolic Disease Hospital of Tianjin Medical University

    Tianjin

  • LCC 640 - 3rd Hospital of Tianjin City

    Tianjin

  • LCC 619 - The First Hospital of Ning Bo City Municipal

    Xinning

  • LCC 647 - First Hospital of Yang Quan City

    Yangquan

  • LCC 614 -The First Affiliated Hospital of Henan Medical University

    Zhengzhou

  • LCC 616 - Center Hospital of Zhumadian City

    Zhumadian

Other trials in China

Australia22 sites

  • LCC 24 - Mater Hospital

    Brisbane, Queensland

  • LCC 42 - Princess Alexandra Hospital

    Brisbane, Queensland

  • LCC 28 - Royal Prince Alfred Hospital

    Camperdown, New South Wales

  • LCC 65 - Dandenong Hospital

    Dandenong, Victoria

  • LCC 73 - Repatriation General Hospital

    Daw Park, South Australia

  • LCC 66 - Lyell McEwin Health

    Elizabeth Vale, South Australia

  • LCC 33 - The Northern Hospital

    Epping, Victoria

  • LCC 50 - Fremantle Hospital

    Fremantle, Western Australia

  • LCC 80 - Canberra Hospital

    Garran, Australian Capital Territory

  • LCC 48 - Gosford

    Gosford, New South Wales

  • LCC 32 - Austin & Repatriation Hospital

    Heidelburg, Victoria

  • LCC 61 - Launceston General Hospital

    Launceston, Tasmania

  • LCC 59 - Liverpool Hospital

    Liverpool, New South Wales

  • LCC 76 - The Alfred Hospital

    Melbourne, Victoria

  • LCC 78 - Wentworth Diabetes Centre

    Penrith, New South Wales

  • LCC 56 - Prince of Wales Hospital

    Randwick, New South Wales

  • LCC 74 - Redcliffe Hospital

    Redcliffe, Queensland

  • LCC 109 - Rural Clinical Trials Research Unit

    Shepparton, Victoria

  • LCC 43 - Gold Coast Hospital

    Southport, Queensland

  • LCC 55 - Royal North Shore Hospital

    St Leonards, New South Wales

  • LCC 114 - Townsville Mater Hospital

    Townsville, Queensland

  • LCC 23 - Wollongong Hospital

    Wollongong, New South Wales

Other trials in Australia

United Kingdom19 sites

  • LCC 517 - Aberdeen Royal Infirmary

    Aberdeen

  • LCC 813 - Monklands Hospital

    Airdrie

  • LCC 819 - Royal United Hospital

    Bath

  • LCC 815 - City Hospital

    Birmingham

  • LCC 821 - West Byfleet Health Centre

    Byfleet

  • LCC 594 - Glasgow Royal Infirmary

    Glasgow

  • LCC 826 - St Mary's Hospital

    Isle of Wight

  • LCC 533 - Leicester Royal Infirmary

    Leicester

  • LCC 809 - Royal Liverpool University Hospital

    Liverpool

  • LCC 543 - St Mary's

    London

  • LCC 511 - Manchester Royal Infirmary

    Manchester

  • LCC 829 - Northampton General Hospital

    Northampton

  • LCC 830 - George Eliot Hospital

    Nuneaton

  • LCC 812 - Royal Alexandra Hospital

    Paisley

  • LCC 816 - Peninsula Medical School Headquarters

    Plymouth

  • LCC 820 - The Diabetes Centre

    Reading

  • LCC 827 - Northern General Hospital

    Sheffield

  • Sheffield Hallamshire

    Sheffield

  • LCC 831 - Warwick General Hospital

    Warwick

Other trials in United Kingdom

Canada10 sites

  • LCC 468 - Calgary Metabolic Education and Research Centre

    Calgary, Alberta

  • LCC 467 - Queen Elizabeth II Health Science Centre

    Halifax, Nova Scotia

  • LCC 452 - Centre de recherche clinique de Laval

    Laval, Quebec

  • LCC 465 - St. Joseph's Health Centre

    London, Ontario

  • LCC 453 - Centre hospitalier de l'Universite de Montreal

    Montreal, Quebec

  • LCC 460 - Centre Hospitalier de L'universitaire de Sherbrooke

    Sherbrooke, Quebec

  • LCC 466 - Centre de recherche d'endocrinologie

    Sherbrooke, Quebec

  • LCC 470 - Hôpital Laval

    Ste-Foy, Quebec

  • LCC 459 - University of Toronto

    Toronto, Ontario

  • LCC 454 University of British Columbia

    Vancouver, British Columbia

Other trials in Canada

Poland10 sites

  • LCC 426 - NZOZ Specjalistyczna Poradnia Endokrynologii

    Elblag

  • LCC 382 - Puls Med

    Katowice

  • LCC 381 - I Klinika Kardiologii

    Krakow

  • LCC 383 - Klinika Chorob Metabolicznych

    Krakow

  • LCC 389 - Zakład Angiologii

    Krakow

  • LCC 390 - Klinika Choroby Wiencowej

    Krakow

  • LCC 380 - I Oddzial Chorob Wewnetrznych

    Kutno

  • LCC 392 - Osrodek Diabetologii

    Olsztyn

  • LCC 378 - Klinika Nefrologii

    Poznan

  • LCC 394 - II Oddzial Chorob Wewnetrznvch

    Radom

Other trials in Poland

France9 sites

  • LCC 320 - CHU Angers

    Angers

  • LCC 376 - CH Avignon - Hôpital Henri Duffaut

    Avignon

  • LCC 375 - CH Nevers

    Nevers

  • LCC 373 - CHU Hopital Caremeau

    Nîmes

  • LCC 329 - CHU Bichat

    Paris

  • LCC 315 - Hôpital Jean Bernard la Miletrie

    Poitiers

  • LCC 310 - Hôpital Sud

    Rennes

  • LCC 304 - CHU Hôpital Civil

    Strasbourg

  • LCC 374 - CHU Hôpital Jeanne d' Arc

    Toul

Other trials in France

Netherlands8 sites

  • LCC 352 - Justus Medical Research

    Eindhoven

  • LCC 354 - Stichting Huisartsen Laboratorium

    Etten-Leur

  • LCC 347 - Martini Ziekenhuis

    Groningen

  • LCC 850 - Andromed Groningen

    Groningen

  • LCC 351 - Andromed Rotterdam

    Rotterdam

  • LCC 852 - Andromed Baarn

    Rotterdam

  • LCC 851 - Andromed Oost

    Velp

  • LCC 356 - Huisartsenpraktijk Tollenslaan

    Zeist

Other trials in Netherlands

New Zealand8 sites

  • LCC 11 - Middlemore Hospital

    Auckland

  • LCC 14 - North Shore Hospital

    Auckland

  • LCC 12 - Christchurch Hospital

    Christchurch

  • LCC 5 - Hawkes Bay Hospital

    Hastings

  • LCC 2 - Palmerston North Hospital

    Palmerston North

  • LCC 91 - Timaru Hospital

    Timaru

  • LCC 6 Waikato Hospital

    Waikato

  • LCC 1 - Wellington Hospital

    Wellington

Other trials in New Zealand

Czechia5 sites

  • LCC 437 - Metabolicke Centrum

    Neratovice

  • LCC 372- Fakultni Nemocnice

    Ostrava-Poruba

  • LCC 438 - Diabetologicka ambulance

    Písek

  • Lcc 435 - Ikem

    Prague

  • LCC 369- Masarykova Nemocnice

    Ústí nad Labem

Other trials in Czechia

Ireland5 sites

  • LCC 832 - Portincula Hospital

    Ballinasloe

  • LCC 514 - Beaumont Hospital

    Dublin

  • LCC 810 - Mater Hospital

    Dublin

  • LCC 817 - St James Hospital

    Dublin

  • LCC 806 - Adelaide & Meadth Hospital

    Tallaght

Other trials in Ireland

Malaysia5 sites

  • LCC 901 - Penang Medical College

    George Town

  • LCC 903 - Hospital Ipoh

    Ipoh

  • LCC 904 - Universiti Sains Malaysia

    Kota Bharu

  • LCC 902 - University of Malaya Medical Centre

    Kuala Lumpur

  • Universiti Kebangsaan Malaysia & Universiti Teknologi MARA

    Putrajaya

Other trials in Malaysia

Philippines4 sites

  • LCC 909 - Makati Medical Center

    Makati City, Manila

  • LCC 906 - Philippine General Hospital

    Manila

  • LCC 907 - East Avenue Medical Centre

    Quezon City

  • LCC 908 - Diabetes Foundation

    Quezon City

Other trials in Philippines

India3 sites

  • Lcc 740 - Aiims

    Delhi

  • LCC 744 - Care Hospital

    Hyderabad

  • LCC 741 - Madras Diabetic Research Foundation

    Madras

Other trials in India

Russia3 sites

  • LCC 420 - Russian Peoples Friendship University

    Moscow

  • LCC 421 - St Petersburg State Medical University

    Saint Petersburg

  • LCC 424 - Research Institute of Cardiology

    Saint Petersburg

Other trials in Russia

Slovakia3 sites

  • LCC 254 - Poliklinikou Vychod

    Košice

  • LCC 252 - Nemocnica s poliklinikou

    Levice

  • LCC 253 - Nemocnica s poliklinikou

    Lučenec

Other trials in Slovakia

Estonia2 sites

  • LCC 280 - Tallinn Central

    Tallinn

  • LCC 281 - Dept of Medicine

    Tartu

Other trials in Estonia

Germany2 sites

  • LCC 377 - Zentrum fur Klinische Studien

    Dresden

  • LCC 330 - Klinikyum der Universitat Munchen

    Munich

Other trials in Germany

Hungary2 sites

  • LCC 336 - Heart Center Foundation-DRC Ltd

    Balatonfüred

  • LCC 335 - Bajcsy Zsilinszky Kórház

    Budapest

Other trials in Hungary

Lithuania2 sites

  • LCC 270 - Institute of Cardiology

    Kaunas

  • LCC 273 - Institute Psychophysiology and Rehabilitation

    Palanga

Other trials in Lithuania

Italy1 site

  • LCC 418 - Ospedale San Gerado

    Milan

Other trials in Italy

About this study

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.

Read the 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.

Keywords
Diabetes Mellitus, Type 2
Medical subject headings
Diabetes Mellitus, Type 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major macrovascular events -a composite of non-fatal myocardial infarction, non-fatal stroke and death from any cardiovascular cause (based on investigator diagnosis)

    Measured: 2014

  2. Death from any cause

    Measured: 2014

Secondary outcomes (9)

  1. Death from any cardiovascular cause

    Measured: 2014

  2. Major clinical microvascular events - a composite of requirement for renal replacement therapy, death from renal disease and development of severe diabetes-related eye disease

    Measured: 2014

  3. Composite of major macrovascular events and major clinical microvascular events

    Measured: 2014

  4. Stroke (non-fatal and fatal)

    Measured: 2014

  5. Requirement for renal replacement therapy (dialysis or transplantation)

    Measured: 2014

  6. Death from renal disease

    Measured: 2014

  7. 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

    Measured: 2014

  8. 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

    Measured: 2014

  9. Myocardial infarction (non-fatal and fatal)

    Measured: 2014

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
8,494 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00949286
Sponsor's protocol ID
ADVANCE-ON
Acronym
ADVANCE-ON
Status last verified
Apr 2014
First submitted
28 Jul 2009
Last updated
19 May 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17765963

  • 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.

    PubMed 18539916

  • 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.

    PubMed 36109108

  • 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.

    PubMed 31302707

  • 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.

    PubMed 27590190

  • 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.

    PubMed 27006512

  • 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.

    PubMed 25234206

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by The George Institute at 172 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 172 sites in China, Australia, United Kingdom, Canada, Poland and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00949286, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2014.

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