ADVANCE--Action in Diabetes and Vascular Disease: patient recruitment and characteristics of the study population at baseline

Diabet Med. 2005 Jul;22(7):882-8. doi: 10.1111/j.1464-5491.2005.01596.x.


Aims: The primary aim of ADVANCE is to determine the effects on macrovascular and microvascular disease of blood pressure lowering (with an ACE inhibitor-diuretic combination), irrespective of initial blood pressure level; and of intensive glucose lowering, in high-risk individuals with Type 2 diabetes.

Methods: The study is a 2 x 2 factorial randomized controlled trial. Following 6 weeks on active perindopril-indapamide combination, eligible participants were randomized to perindopril/indapamide (initially 2.0/0.625 mg daily, increasing to 4.0/1.25 mg daily after 3 months) or matching placebo; and to an intensive gliclazide MR-based glucose control regimen aiming for a haemoglobin A1c (HbA1c) value of 6.5% or lower, or local standard therapy. The study is being conducted in 215 centres in 20 countries within Australasia, Asia, Europe and North America.

Results: Recruitment commenced in June 2001 and was completed in March 2003, with the inclusion of 11,140 randomized participants. Fifty-seven per cent of participants are male and the mean age at baseline was 66 years. On average, the diagnosis of diabetes was made 8 years before study entry. At baseline 32 and 10% of patients had a history of macrovascular and microvascular disease, respectively. The mean blood pressure at baseline was 145/81 mmHg; the mean HbA1c concentration was 7.5%. While blood pressure and HbA1c values were broadly similar, certain characteristics of randomized participants varied between countries.

Conclusions: With successful worldwide recruitment completed, ADVANCE should provide reliable and broadly generalizable results on the effects of routine blood pressure lowering and intensive glucose control in high-risk individuals with Type 2 diabetes.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antihypertensive Agents / therapeutic use
  • Blood Glucose / analysis
  • Blood Pressure / physiology
  • Body Mass Index
  • Cholesterol / blood
  • Diabetes Mellitus, Type 2 / drug therapy
  • Diabetes Mellitus, Type 2 / ethnology
  • Diabetes Mellitus, Type 2 / physiopathology*
  • Diabetic Angiopathies / drug therapy
  • Diabetic Angiopathies / ethnology
  • Diabetic Angiopathies / physiopathology*
  • Female
  • Humans
  • Hypertension / drug therapy
  • Hypoglycemic Agents / therapeutic use
  • Male
  • Patient Selection
  • Smoking / physiopathology


  • Antihypertensive Agents
  • Blood Glucose
  • Hypoglycemic Agents
  • Cholesterol