ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00949286
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : May 19, 2014
Sponsor:
Collaborator:
Servier
Information provided by (Responsible Party):
The George Institute

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.

Condition or disease
Diabetes Mellitus, Type 2

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.

Study Type : Observational
Actual Enrollment : 8494 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study
Study Start Date : January 2010
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]
  2. Death from any cause [ Time Frame: 2014 ]

Secondary Outcome Measures :
  1. Death from any cardiovascular cause [ Time Frame: 2014 ]
  2. 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 ]
  3. Composite of major macrovascular events and major clinical microvascular events [ Time Frame: 2014 ]
  4. Stroke (non-fatal and fatal) [ Time Frame: 2014 ]
  5. Requirement for renal replacement therapy (dialysis or transplantation) [ Time Frame: 2014 ]
  6. Death from renal disease [ Time Frame: 2014 ]
  7. 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 ]
  8. 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 ]
  9. Myocardial infarction (non-fatal and fatal) [ Time Frame: 2014 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The George Institute
ClinicalTrials.gov Identifier: NCT00949286     History of Changes
Other Study ID Numbers: ADVANCE-ON
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: May 19, 2014
Last Verified: April 2014

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
Antihypertensive Agents