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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00949286
Registration number
NCT00949286
Ethics application status
Date submitted
28/07/2009
Date registered
30/07/2009
Date last updated
19/05/2014
Titles & IDs
Public title
Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study
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Scientific title
Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study
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Secondary ID [1]
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ADVANCE-ON
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Universal Trial Number (UTN)
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Trial acronym
ADVANCE-ON
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Metabolic and Endocrine
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0
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Diabetes
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Major macrovascular events -a composite of non-fatal myocardial infarction, non-fatal stroke and death from any cardiovascular cause (based on investigator diagnosis)
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Assessment method [1]
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0
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Timepoint [1]
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2014
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Primary outcome [2]
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Death from any cause
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Assessment method [2]
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0
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Timepoint [2]
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2014
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Secondary outcome [1]
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Death from any cardiovascular cause
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Assessment method [1]
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0
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Timepoint [1]
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2014
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Secondary outcome [2]
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Major clinical microvascular events - a composite of requirement for renal replacement therapy, death from renal disease and development of severe diabetes-related eye disease
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Assessment method [2]
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0
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Timepoint [2]
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2014
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Secondary outcome [3]
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Composite of major macrovascular events and major clinical microvascular events
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Assessment method [3]
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0
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Timepoint [3]
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2014
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Secondary outcome [4]
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Stroke (non-fatal and fatal)
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Assessment method [4]
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0
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Timepoint [4]
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2014
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Secondary outcome [5]
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Requirement for renal replacement therapy (dialysis or transplantation)
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Assessment method [5]
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0
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Timepoint [5]
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2014
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Secondary outcome [6]
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Death from renal disease
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Assessment method [6]
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0
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Timepoint [6]
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2014
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Secondary outcome [7]
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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
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Assessment method [7]
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Timepoint [7]
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2014
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Secondary outcome [8]
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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
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Assessment method [8]
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0
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Timepoint [8]
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2014
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Secondary outcome [9]
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Myocardial infarction (non-fatal and fatal)
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Assessment method [9]
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0
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Timepoint [9]
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2014
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Eligibility
Key inclusion criteria
- Participated in ADVANCE
- Ability to provide informed consent
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- None
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2014
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Sample size
Target
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Accrual to date
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Final
8494
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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LCC 80 - Canberra Hospital - Garran
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LCC 28 - Royal Prince Alfred Hospital - Camperdown
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LCC 48 - Gosford - Gosford
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LCC 59 - Liverpool Hospital - Liverpool
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LCC 78 - Wentworth Diabetes Centre - Penrith
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LCC 56 - Prince of Wales Hospital - Randwick
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LCC 55 - Royal North Shore Hospital - St Leonards
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LCC 23 - Wollongong Hospital - Wollongong
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LCC 24 - Mater Hospital - Brisbane
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LCC 42 - Princess Alexandra Hospital - Brisbane
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LCC 74 - Redcliffe Hospital - Redcliffe
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LCC 43 - Gold Coast Hospital - Southport
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LCC 114 - Townsville Mater Hospital - Townsville
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LCC 73 - Repatriation General Hospital - Daw Park
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LCC 66 - Lyell McEwin Health - Elizabeth Vale
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LCC 61 - Launceston General Hospital - Launceston
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LCC 65 - Dandenong Hospital - Dandenong
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LCC 33 - The Northern Hospital - Epping
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LCC 32 - Austin & Repatriation Hospital - Heidelburg
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LCC 76 - The Alfred Hospital - Melbourne
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LCC 109 - Rural Clinical Trials Research Unit - Shepparton
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LCC 50 - Fremantle Hospital - Fremantle
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- Garran
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- Camperdown
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- St Leonards
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- Wollongong
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- Brisbane
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- Redcliffe
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- Southport
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- Townsville
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Recruitment postcode(s) [13]
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- Daw Park
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- Elizabeth Vale
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- Launceston
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- Dandenong
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- Epping
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- Heidelburg
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- Melbourne
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- Shepparton
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- Fremantle
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Recruitment outside Australia
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Binzhou
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Chengdu
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Dalian
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Guiyang
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Harbin
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Hefei
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Moscow
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Russian Federation
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Manchester
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Northampton
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United Kingdom
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Plymouth
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United Kingdom
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Reading
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Sheffield
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United Kingdom
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Warwick
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Funding & Sponsors
Primary sponsor type
Other
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Name
The George Institute
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Servier
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00949286
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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. doi: 10.1016/S0140-6736(07)61303-8.
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.
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Contacts
Principal investigator
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John P Chalmers
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The George Institute
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00949286
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