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

NCT00949286 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8494

Last updated 2014-05-19

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Sponsors & Collaborators

  • Servier

    collaborator INDUSTRY

  • The George Institute

    lead OTHER

Principal Investigators

  • John P Chalmers · The George Institute

  • Stephen MacMahon · The George Institute

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Australia
  • Canada
  • China
  • Czechia
  • Estonia
  • France
  • Germany
  • Hungary
  • India
  • Ireland
  • Italy
  • Lithuania
  • Malaysia
  • Netherlands
  • New Zealand
  • Philippines
  • Poland
  • Russia
  • Slovakia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00949286 on ClinicalTrials.gov