Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study - Full Text View

Purpose

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.

Condition
Diabetes Mellitus, Type 2

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2 Heart Attack Vascular Diseases

U.S. FDA Resources

Further study details as provided by The George Institute:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Death from any cause [ Time Frame: 2014 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Death from any cardiovascular cause [ Time Frame: 2014 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Composite of major macrovascular events and major clinical microvascular events [ Time Frame: 2014 ] [ Designated as safety issue: No ]
Stroke (non-fatal and fatal) [ Time Frame: 2014 ] [ Designated as safety issue: No ]
Requirement for renal replacement therapy (dialysis or transplantation) [ Time Frame: 2014 ] [ Designated as safety issue: No ]
Death from renal disease [ Time Frame: 2014 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Myocardial infarction (non-fatal and fatal) [ Time Frame: 2014 ] [ Designated as safety issue: No ]

Estimated Enrollment:	10000
Study Start Date:	January 2010
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All living participants who took part in the ADVANCE study

Criteria

Inclusion Criteria:

Participated in ADVANCE
Ability to provide informed consent

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949286

Show 209 Study Locations

Sponsors and Collaborators

The George Institute

Servier

Investigators

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

More Information

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. Epub 2008 Jun 6.

Responsible Party:	The George Institute
ClinicalTrials.gov Identifier:	NCT00949286 History of Changes
Other Study ID Numbers:	ADVANCE-ON
Study First Received:	July 28, 2009
Last Updated:	November 14, 2012
Health Authority:	Australia: Human Research Ethics Committee Australia: National Health and Medical Research Council Canada: Ethics Review Committee China: Ethics Committee Czech Republic: Ethics Committee Estonia: The State Agency of Medicine France: Institutional Ethical Committee Germany: Ethics Commission Hungary: National Institute of Pharmacy India: Institutional Review Board Ireland: Medical Ethics Research Committee Italy: Ethics Committee Lithuania: Bioethics Committee Malaysia: Ministry of Health Netherlands: Independent Ethics Committee New Zealand: Institutional Review Board Philippines: Department of Health Poland: Ethics Committee Russia: Ethics Committee Slovakia: State Institute for Drug Control United Kingdom: Research Ethics Committee

Keywords provided by The George Institute:

Diabetes Mellitus, Type 2

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Gliclazide

Indapamide, perindopril drug combination
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013

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