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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00145925




Registration number
NCT00145925
Ethics application status
Date submitted
2/09/2005
Date registered
5/09/2005
Date last updated
17/09/2008

Titles & IDs
Public title
Blood Pressure and Glucose Lowering for the Prevention of Vascular Disease in High Risk Patients With Type 2 Diabetes
Scientific title
ADVANCE - Action in Diabetes and Vascular Disease: Preterax and Diamicron - MR Controlled Evaluation
Secondary ID [1] 0 0
ADVANCE
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Perindopril-indapamide
Treatment: Drugs - Gliclazide MR-based glucose lowering

Placebo Comparator: Blood pressure - Perindopril indapamide vs placebo

Other: Glucose control - Standard versus intensive glucose control


Treatment: Drugs: Perindopril-indapamide


Treatment: Drugs: Gliclazide MR-based glucose lowering


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause
Timepoint [1] 0 0
July 2001 - December 2007
Primary outcome [2] 0 0
Composite of new or substantially worsening nephropathy or microvascular eye disease.
Timepoint [2] 0 0
July 2001 - December 2007
Secondary outcome [1] 0 0
Includes cerebrovascular disease, coronary heart disease, heart failure, peripheral vascular disease, cardiovascular and all-cause mortality, microalbuminuria, visual deterioration, new or worsening nephropathy, cognitive function, and dementia.
Timepoint [1] 0 0
July 2001 - December 2007

Eligibility
Key inclusion criteria
1. A diagnosis of type 2 diabetes mellitus first made at age 30 years or older

2. Age 55 years or older at entry

3. Ability to provide informed consent

4. A substantially elevated risk of cardiovascular disease, indicated by:

- A history of major macrovascular disease defined as any one of: stroke,
myocardial infarction, hospital admission for transient ischaemic attack,
hospital admission for unstable angina, coronary artery bypass graft,
percutaneous transluminal coronary angioplasty (with or without stenting),
peripheral revascularisation (angioplasty or surgery) or amputation secondary to
vascular disease or

- A history of major microvascular disease defined as any one of nephropathy
(albumin:creatinine ratio >300ug/mg), retinal photocoagulation therapy,
proliferative retinopathy (new blood vessels on the disc or elsewhere, vitreous
haemorrhage, pre-retinal haemorrhage, or fibrous proliferations on the disc or
elsewhere), macular oedema (retinal thickening within one disc diameter of the
macular centre) or blindness in either eye (corrected visual acuity 6/60 or
worse, persisting for three months or more) not known to be due to non-diabetic
causes or

- A first diagnosis of type 2 diabetes made 10 or more years prior to entry or

- Another major risk factor for vascular disease defined as any one of: current
daily cigarette smoking, total cholesterol greater than 6.0 mmol/l (with or
without cholesterol lowering treatment), HDL cholesterol <1.0 mmol/l,
microalbuminuria (albumin:creatinine ratio 30-300ug/mg) or

- Age 65 years or over
Minimum age
55 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A definite contraindication to treatment with an ACE inhibitor or a thiazide-like
diuretic

2. A specific indication for treatment with an ACE inhibitor other than perindopril 2-4
mg daily (see also section 5.2.3) or a thiazide-like diuretic

3. A definite and specific indication for treatment with gliclazide or a haemoglobin A1c
control target of 6.5% or less

4. A definite contra-indication to treatment with gliclazide or a haemoglobin A1c control
target of 6.5% or less

5. A definite indication for long-term full-dose or bed-time insulin therapy

6. Participation in a trial within the month prior to the Registration Visit or current
participation in another trial

Other potential reasons for ineligibility include:

- High probability of non-adherence to study treatment or follow-up

- Current clinical instability (e.g. a major cerebral or coronary event or
sight-threatening retinopathy or macular oedema within the previous few weeks)

- Life threatening non-vascular disease other than diabetes and its complications

- Moderate or severe dementia

- Major disability that is likely to prevent regular attendance at study clinics

Final decisions about eligibility were made at the discretion of the study investigator and
the potential study participant, in the light of any requirements or guidance from local
ethics committees and other regulatory bodies.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint(s)
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)
VIC
Recruitment hospital [1] 0 0
The University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3010 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Quebec
Country [2] 0 0
China
State/province [2] 0 0
Beijing
Country [3] 0 0
Netherlands
State/province [3] 0 0
Utrecht
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Institut de Recherches Internationales Servier
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Sydney
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
National Health and Medical Research Council, Australia
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to provide information on the risks and benefits of routine
blood pressure lowering (regardless of blood pressure level), and intensive lowering of blood
glucose levels, in patients with Type 2 diabetes at high risk of cardiovascular events. The
major outcomes of the study will be cardiovascular events (heart attack, stroke or dying as a
result of cardiovascular disease), as well as new or worsening diabetic eye and kidney
disease.
Trial website
https://clinicaltrials.gov/show/NCT00145925
Trial related presentations / publications
Rationale and design of the ADVANCE study: a randomised trial of blood pressure lowering and intensive glucose control in high-risk individuals with type 2 diabetes mellitus. Action in Diabetes and Vascular Disease: PreterAx and DiamicroN Modified-Release Controlled Evaluation. J Hypertens Suppl. 2001 Nov;19(4):S21-8.
ADVANCE Collaborative Group (Writing Committee - J Chalmers, S Colman, S Heller, S MacMahon, B Neal, C Pan, A Patel, M Woodward). ADVANCE - Action in Diabetes and Vascular Disease: characteristics of participants at baseline. Diabetic Medicine 2005;22:882-888.
ADVANCE Management Committee. Study rationale and design of ADVANCE: action in diabetes and vascular disease--preterax and diamicron MR controlled evaluation. Diabetologia. 2001 Sep;44(9):1118-20.
Public notes

Contacts
Principal investigator
Name 0 0
John Chalmers, MB BS PhD
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