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Completed

NCT Number: NCT00949286

Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study

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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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

LCC 80 - Canberra Hospital, Garran, Australian Capital Territory, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participated in ADVANCE
  • Ability to provide informed consent

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The George Institute

Other

Collaborators

  • Servier

Registry information

Acronym: ADVANCE-ON

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2009
Registry last updated
May 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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