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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00949286




Registration number
NCT00949286
Ethics application status
Date submitted
28/07/2009
Date registered
28/07/2009
Date last updated
15/05/2014

Titles & IDs
Public title
Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study
Scientific title
Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study
Secondary ID [1] 0 0
ADVANCE-ON
Universal Trial Number (UTN)
Trial acronym
ADVANCE-ON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Diabetes Mellitus, Type 2 0 0
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major macrovascular events -a composite of non-fatal myocardial infarction, non-fatal stroke and death from any cardiovascular cause (based on investigator diagnosis)
Timepoint [1] 0 0
2014
Primary outcome [2] 0 0
Death from any cause
Timepoint [2] 0 0
2014
Primary outcome [3] 0 0
Major macrovascular events -a composite of non-fatal myocardial infarction, non-fatal stroke and death from any cardiovascular cause (based on investigator diagnosis)
Timepoint [3] 0 0
2014
Primary outcome [4] 0 0
Death from any cause
Timepoint [4] 0 0
2014
Primary outcome [5] 0 0
Major macrovascular events -a composite of non-fatal myocardial infarction, non-fatal stroke and death from any cardiovascular cause (based on investigator diagnosis)
Timepoint [5] 0 0
2014
Primary outcome [6] 0 0
Death from any cause
Timepoint [6] 0 0
2014
Secondary outcome [1] 0 0
Death from any cardiovascular cause
Timepoint [1] 0 0
2014
Secondary outcome [2] 0 0
Major clinical microvascular events - a composite of requirement for renal replacement therapy, death from renal disease and development of severe diabetes-related eye disease
Timepoint [2] 0 0
2014
Secondary outcome [3] 0 0
Composite of major macrovascular events and major clinical microvascular events
Timepoint [3] 0 0
2014
Secondary outcome [4] 0 0
Stroke (non-fatal and fatal)
Timepoint [4] 0 0
2014
Secondary outcome [5] 0 0
Requirement for renal replacement therapy (dialysis or transplantation)
Timepoint [5] 0 0
2014
Secondary outcome [6] 0 0
Death from renal disease
Timepoint [6] 0 0
2014
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
2014
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
2014
Secondary outcome [9] 0 0
Myocardial infarction (non-fatal and fatal)
Timepoint [9] 0 0
2014
Secondary outcome [10] 0 0
Death from any cardiovascular cause
Timepoint [10] 0 0
2014
Secondary outcome [11] 0 0
Major clinical microvascular events - a composite of requirement for renal replacement therapy, death from renal disease and development of severe diabetes-related eye disease
Timepoint [11] 0 0
2014
Secondary outcome [12] 0 0
Composite of major macrovascular events and major clinical microvascular events
Timepoint [12] 0 0
2014
Secondary outcome [13] 0 0
Stroke (non-fatal and fatal)
Timepoint [13] 0 0
2014
Secondary outcome [14] 0 0
Requirement for renal replacement therapy (dialysis or transplantation)
Timepoint [14] 0 0
2014
Secondary outcome [15] 0 0
Death from renal disease
Timepoint [15] 0 0
2014
Secondary outcome [16] 0 0
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
Timepoint [16] 0 0
2014
Secondary outcome [17] 0 0
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
Timepoint [17] 0 0
2014
Secondary outcome [18] 0 0
Myocardial infarction (non-fatal and fatal)
Timepoint [18] 0 0
2014
Secondary outcome [19] 0 0
Death from any cardiovascular cause
Timepoint [19] 0 0
2014
Secondary outcome [20] 0 0
Major clinical microvascular events - a composite of requirement for renal replacement therapy, death from renal disease and development of severe diabetes-related eye disease
Timepoint [20] 0 0
2014
Secondary outcome [21] 0 0
Composite of major macrovascular events and major clinical microvascular events
Timepoint [21] 0 0
2014
Secondary outcome [22] 0 0
Stroke (non-fatal and fatal)
Timepoint [22] 0 0
2014
Secondary outcome [23] 0 0
Requirement for renal replacement therapy (dialysis or transplantation)
Timepoint [23] 0 0
2014
Secondary outcome [24] 0 0
Death from renal disease
Timepoint [24] 0 0
2014
Secondary outcome [25] 0 0
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
Timepoint [25] 0 0
2014
Secondary outcome [26] 0 0
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
Timepoint [26] 0 0
2014
Secondary outcome [27] 0 0
Myocardial infarction (non-fatal and fatal)
Timepoint [27] 0 0
2014

Eligibility
Key inclusion criteria
- Participated in ADVANCE

- Ability to provide informed consent
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- None

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
LCC 80 - Canberra Hospital - Garran
Recruitment hospital [2] 0 0
LCC 28 - Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
LCC 48 - Gosford - Gosford
Recruitment hospital [4] 0 0
LCC 59 - Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
LCC 78 - Wentworth Diabetes Centre - Penrith
Recruitment hospital [6] 0 0
LCC 56 - Prince of Wales Hospital - Randwick
Recruitment hospital [7] 0 0
LCC 55 - Royal North Shore Hospital - St Leonards
Recruitment hospital [8] 0 0
LCC 23 - Wollongong Hospital - Wollongong
Recruitment hospital [9] 0 0
LCC 24 - Mater Hospital - Brisbane
Recruitment hospital [10] 0 0
LCC 42 - Princess Alexandra Hospital - Brisbane
Recruitment hospital [11] 0 0
LCC 74 - Redcliffe Hospital - Redcliffe
Recruitment hospital [12] 0 0
LCC 43 - Gold Coast Hospital - Southport
Recruitment hospital [13] 0 0
LCC 114 - Townsville Mater Hospital - Townsville
Recruitment hospital [14] 0 0
LCC 73 - Repatriation General Hospital - Daw Park
Recruitment hospital [15] 0 0
LCC 66 - Lyell McEwin Health - Elizabeth Vale
Recruitment hospital [16] 0 0
LCC 61 - Launceston General Hospital - Launceston
Recruitment hospital [17] 0 0
LCC 65 - Dandenong Hospital - Dandenong
Recruitment hospital [18] 0 0
LCC 33 - The Northern Hospital - Epping
Recruitment hospital [19] 0 0
LCC 32 - Austin & Repatriation Hospital - Heidelburg
Recruitment hospital [20] 0 0
LCC 76 - The Alfred Hospital - Melbourne
Recruitment hospital [21] 0 0
LCC 109 - Rural Clinical Trials Research Unit - Shepparton
Recruitment hospital [22] 0 0
LCC 50 - Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
- Garran
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Gosford
Recruitment postcode(s) [4] 0 0
- Liverpool
Recruitment postcode(s) [5] 0 0
- Penrith
Recruitment postcode(s) [6] 0 0
- Randwick
Recruitment postcode(s) [7] 0 0
- St Leonards
Recruitment postcode(s) [8] 0 0
- Wollongong
Recruitment postcode(s) [9] 0 0
- Brisbane
Recruitment postcode(s) [10] 0 0
- Redcliffe
Recruitment postcode(s) [11] 0 0
- Southport
Recruitment postcode(s) [12] 0 0
- Townsville
Recruitment postcode(s) [13] 0 0
- Daw Park
Recruitment postcode(s) [14] 0 0
- Elizabeth Vale
Recruitment postcode(s) [15] 0 0
- Launceston
Recruitment postcode(s) [16] 0 0
- Dandenong
Recruitment postcode(s) [17] 0 0
- Epping
Recruitment postcode(s) [18] 0 0
- Heidelburg
Recruitment postcode(s) [19] 0 0
- Melbourne
Recruitment postcode(s) [20] 0 0
- Shepparton
Recruitment postcode(s) [21] 0 0
- Fremantle
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Nova Scotia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
China
State/province [6] 0 0
Baotou
Country [7] 0 0
China
State/province [7] 0 0
Beijing
Country [8] 0 0
China
State/province [8] 0 0
Benxi
Country [9] 0 0
China
State/province [9] 0 0
Binzhou
Country [10] 0 0
China
State/province [10] 0 0
Changsha
Country [11] 0 0
China
State/province [11] 0 0
Chengdu
Country [12] 0 0
China
State/province [12] 0 0
Dalian
Country [13] 0 0
China
State/province [13] 0 0
Fuzhou City
Country [14] 0 0
China
State/province [14] 0 0
Guiyang
Country [15] 0 0
China
State/province [15] 0 0
Harbin
Country [16] 0 0
China
State/province [16] 0 0
Hefei
Country [17] 0 0
China
State/province [17] 0 0
Huhehot
Country [18] 0 0
China
State/province [18] 0 0
Jin'an
Country [19] 0 0
China
State/province [19] 0 0
Lianyungang
Country [20] 0 0
China
State/province [20] 0 0
Nanchang City
Country [21] 0 0
China
State/province [21] 0 0
Nanjing City
Country [22] 0 0
China
State/province [22] 0 0
Ning
Country [23] 0 0
China
State/province [23] 0 0
Qingdao
Country [24] 0 0
China
State/province [24] 0 0
Shanghai
Country [25] 0 0
China
State/province [25] 0 0
Shenyang
Country [26] 0 0
China
State/province [26] 0 0
Shijiazhuang
Country [27] 0 0
China
State/province [27] 0 0
Taiyuan
Country [28] 0 0
China
State/province [28] 0 0
Tangshan
Country [29] 0 0
China
State/province [29] 0 0
Tianjin
Country [30] 0 0
China
State/province [30] 0 0
Yangquan
Country [31] 0 0
China
State/province [31] 0 0
Zhengzhou
Country [32] 0 0
China
State/province [32] 0 0
Zhumadian
Country [33] 0 0
Czech Republic
State/province [33] 0 0
Neratovice
Country [34] 0 0
Czech Republic
State/province [34] 0 0
Ostrava-Poruba
Country [35] 0 0
Czech Republic
State/province [35] 0 0
Pisek
Country [36] 0 0
Czech Republic
State/province [36] 0 0
Praha
Country [37] 0 0
Czech Republic
State/province [37] 0 0
Usti nad Labem
Country [38] 0 0
Estonia
State/province [38] 0 0
Tallinn
Country [39] 0 0
Estonia
State/province [39] 0 0
Tartu
Country [40] 0 0
France
State/province [40] 0 0
Angers
Country [41] 0 0
France
State/province [41] 0 0
Avignon
Country [42] 0 0
France
State/province [42] 0 0
Nevers
Country [43] 0 0
France
State/province [43] 0 0
Nimes
Country [44] 0 0
France
State/province [44] 0 0
Paris
Country [45] 0 0
France
State/province [45] 0 0
Poitiers
Country [46] 0 0
France
State/province [46] 0 0
Rennes
Country [47] 0 0
France
State/province [47] 0 0
Strasbourg
Country [48] 0 0
France
State/province [48] 0 0
Toul
Country [49] 0 0
Germany
State/province [49] 0 0
Dresden
Country [50] 0 0
Germany
State/province [50] 0 0
Munich
Country [51] 0 0
Hungary
State/province [51] 0 0
Balatonfured
Country [52] 0 0
Hungary
State/province [52] 0 0
Budapest
Country [53] 0 0
India
State/province [53] 0 0
Delhi
Country [54] 0 0
India
State/province [54] 0 0
Hyderabad
Country [55] 0 0
India
State/province [55] 0 0
Madras
Country [56] 0 0
Ireland
State/province [56] 0 0
Ballinasloe
Country [57] 0 0
Ireland
State/province [57] 0 0
Dublin
Country [58] 0 0
Ireland
State/province [58] 0 0
Tallaght
Country [59] 0 0
Italy
State/province [59] 0 0
Milan
Country [60] 0 0
Lithuania
State/province [60] 0 0
Kaunas
Country [61] 0 0
Lithuania
State/province [61] 0 0
Palanga
Country [62] 0 0
Malaysia
State/province [62] 0 0
Ipoh
Country [63] 0 0
Malaysia
State/province [63] 0 0
Kota Bharu
Country [64] 0 0
Malaysia
State/province [64] 0 0
Kuala Lumpur
Country [65] 0 0
Malaysia
State/province [65] 0 0
Penang
Country [66] 0 0
Malaysia
State/province [66] 0 0
Putrajaya
Country [67] 0 0
Netherlands
State/province [67] 0 0
Eindhoven
Country [68] 0 0
Netherlands
State/province [68] 0 0
Etten-Leur
Country [69] 0 0
Netherlands
State/province [69] 0 0
Groningen
Country [70] 0 0
Netherlands
State/province [70] 0 0
Rotterdam
Country [71] 0 0
Netherlands
State/province [71] 0 0
Velp
Country [72] 0 0
Netherlands
State/province [72] 0 0
Zeist
Country [73] 0 0
New Zealand
State/province [73] 0 0
Auckland
Country [74] 0 0
New Zealand
State/province [74] 0 0
Christchurch
Country [75] 0 0
New Zealand
State/province [75] 0 0
Hastings
Country [76] 0 0
New Zealand
State/province [76] 0 0
Palmerston North
Country [77] 0 0
New Zealand
State/province [77] 0 0
Timaru
Country [78] 0 0
New Zealand
State/province [78] 0 0
Waikato
Country [79] 0 0
New Zealand
State/province [79] 0 0
Wellington
Country [80] 0 0
Philippines
State/province [80] 0 0
Manila
Country [81] 0 0
Philippines
State/province [81] 0 0
Quezon City
Country [82] 0 0
Poland
State/province [82] 0 0
Elblag
Country [83] 0 0
Poland
State/province [83] 0 0
Katowice
Country [84] 0 0
Poland
State/province [84] 0 0
Krakow
Country [85] 0 0
Poland
State/province [85] 0 0
Kutno
Country [86] 0 0
Poland
State/province [86] 0 0
Olsztyn
Country [87] 0 0
Poland
State/province [87] 0 0
Poznan
Country [88] 0 0
Poland
State/province [88] 0 0
Radom
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Moscow
Country [90] 0 0
Russian Federation
State/province [90] 0 0
St Petersburg
Country [91] 0 0
Slovakia
State/province [91] 0 0
Kosice
Country [92] 0 0
Slovakia
State/province [92] 0 0
Levice
Country [93] 0 0
Slovakia
State/province [93] 0 0
Lucenec
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Aberdeen
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Airdrie
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Bath
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Birmingham
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Byfleet
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Glasgow
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Isle of Wight
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Leicester
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Liverpool
Country [103] 0 0
United Kingdom
State/province [103] 0 0
London
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Manchester
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Northampton
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Nuneaton
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Paisley
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Plymouth
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Reading
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Sheffield
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Warwick

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Servier
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Servier
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Servier
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00949286
Trial related presentations / 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.
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
John P Chalmers
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications