Glycaemic separation and risk factor control in the Veterans Affairs Diabetes Trial: an interim report

Diabetes Obes Metab. 2009 Feb;11(2):150-6. doi: 10.1111/j.1463-1326.2008.00933.x. Epub 2008 Jul 29.

Abstract

Objective: The Veterans Affairs Diabetes Trial (VADT) will assess the effect of intensive (INT) vs improved standard (STD) glycaemic control on major cardiovascular (CV) events, treating other risk factors equally in both arms. Four-year results of main metabolic parameters are presented.

Research design and methods: VADT is a 7.5 years prospective randomized study of 1791 patients, 20 centres, of men and women of age 60.5 +/- 8.7 years, diagnosed for 11.5 +/- 7.5 years. Their body mass index (BMI) at baseline was 31 +/- 4 kg/m(2) and mean A1C 9.4 +/- 1.5% after maximum dose of oral agents or insulin treatment. Step treatment consists of glimepiride or metformin, rosiglitazone, insulin and other agents; A1C goals are 8-9% in STD and <6% in INT. Lifestyle, blood pressure and lipids are treated uniformly in both arms.

Results: A1C improved in both arms. INT kept median A1C <7% all years, A1C separation is 1.5-1.7%. From year 1 to 4, mean blood pressure is <129/74 mmHg, similar throughout. Median LDL-C was <97 mg/dl by year 1 and triglycerides 150 or less by 2 years. Triglycerides were lower in INT (12-16 mg/dl; p < 0.01). By 4 years, 88% are on lipid-lowering agents and 93% are on antiplatelet/anticoagulant agents. BMI is higher in INT every year (0.9-1.6 kg/m(2); p < 0.01).

Conclusion: VADT is maintaining the expected A1C in both STD and INT, and LDL-C, triglycerides and blood pressure are at target. The trial is continuing to June 2008. It will be the first long-term completed type 2 diabetes study of the role of glycaemia on CV disease with modern treatments.

Publication types

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

MeSH terms

  • Aged
  • Blood Glucose / physiology
  • Body Mass Index
  • Body Weight / physiology
  • Cardiovascular Diseases / blood
  • Cardiovascular Diseases / drug therapy*
  • Cardiovascular Diseases / mortality
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / mortality
  • Diabetic Angiopathies / blood
  • Diabetic Angiopathies / drug therapy*
  • Diabetic Angiopathies / mortality
  • Female
  • Glycated Hemoglobin A / metabolism*
  • Humans
  • Hypoglycemic Agents / therapeutic use*
  • Insulin / therapeutic use
  • Male
  • Middle Aged
  • Prospective Studies
  • Risk Factors
  • Veterans

Substances

  • Blood Glucose
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Insulin