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

This study has been completed.
Sponsor:
Collaborator:
Servier
Information provided by (Responsible Party):
The George Institute
ClinicalTrials.gov Identifier:
NCT00949286
First received: July 28, 2009
Last updated: May 15, 2014
Last verified: April 2014
  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:


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 ]

Enrollment: 8494
Study Start Date: January 2010
Study Completion Date: February 2014
Primary Completion Date: February 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 172 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:
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: May 15, 2014
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 August 21, 2014