FIELD -Fenofibrate Intervention and Event Lowering in Diabetes

The FIELD trial “Fenofibrate Intervention and Event Lowering in Diabetes” aims to determine whether treatment with fenofibrate, a potent modifier of blood lipid levels, will reduce the risk of fatal coronary heart disease in people with type 2 diabetes.

FIELD will determine whether strokes and deaths can be prevented in people with diabetes treated with fenofibrate.

Official Title

Conditions

Type 2 Diabetes Mellitus

Study Type

Study Design

Further Details

FIELD has been a double-blind placebo-controlled trial of prevention of coronary heart disease in people with type 2 diabetes. The trial was conducted in Australia, New Zealand and Finland. A feature of the trial is that its wide entry criteria allow the results to be generalised to a population of typical patients with diabetes consulting general practitioners. The trial began recruiting patients in early 1998, and randomly assigned the last of its 9795 participants in November 2000. Its five-year follow-up was completed in October 2005.FIELD is internationally managed by the NHMRC Clinical Trials Centre.The international Management Committee has representatives from the three participating countries: Australia, New Zealand and Finland.The sponsor is Solvay Pharma.

Study Start

November 2000 – October 2005

Eligibility & Criteria

INCLUSION CRITERIA

• Men and women aged 50 to 75 years
• Non-insulin-dependent diabetes mellitus (NIDDM) with age at diagnosis >35 years: for patients not currently on any hypoglycemic medication. Confirmation, by medical records or oral glucose tolerance test, that they meet WHO criteria for NIDDM must be obtained
• No clear indication for the study treatment or other cholesterol-lowering treatment: the patient is not already taking any cholesterol-lowering drug and neither the patient nor their doctor considers there to be any definite need to do so
• Total cholesterol level between 3 and 6.5 mmol/L plus any one of the 2 lipid criteria below:
  • total-to-HDL cholesterol ratio of >4.0
  • blood triglyceride level >1 mmol/L

EXCLUSION CRITERIA

• Triglyceride >5 mmol/L on the baseline visit fasting blood sample
• Concurrent treatment with any other lipidlowering agent
• Creatinine >130 micromol/L
• Transaminases >2 upper limit of normal or symptomatic gall-bladder disease
• Myocardial infarction or hospital admission for unstable angina within 3 months
• Women of child-bearing potential unless sterilised or on reliable approved methods of contraception, including oral contraceptives
• Concurrent cyclosporin treatment (or a condition likely to result in organ transplantation and the need for cyclosporin during the next 5 years)
• Known allergy to any fibrate drug or known photosensitivity
• Unwilling or unable to consent to enter the study, understanding that follow-up is planned to continue for more than 5 years
• Other predominant medical problems or evidence of poor compliance with 5 years of study treatment – major psychiatric illness or any other illness (e.g. recent history of drug or alcohol abuse, physical disability, severe heart failure or some importantly life-threatening illness other than vascular disease or known complications of diabetes, etc.) that is likely to compromise longterm participation and clinic attendance in the trial.

Total Enrolment

9795

Contact Details

Visit the Field Study Homepage for more information.Results publshed in The Lancet