The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Trial studied 9,795 adults with Type 2 diabetes to determine if a once daily blood fat improving tablet fenofibrate for at least 5 years could protect against diabetic cardiovascular disease, eye, kidney and nerve damage. Fenofibrate provided substantial protection against sight-threatening eye disease, kidney and nerve damage, foot amputations and some heart disease related events.  The FIELD trial continues annual observational follow-up. As a result of the FIELD trial fenofibrate has been approved for use in adults with Type 2 diabetes and existent (even mild) diabetic retinopathy in Australia and at least seven overseas countries.

Long-term follow-up of the FIELD cohort 

After post-trial central ethics approval, NZ participants were followed up by five rounds of questionnaires. We also used registry searches for data from the New Zealand Health Information Service (NZHIS) and the Australian Institute of Health and Welfare (AIHW) for mortality and morbidity data.

Other clinical research

FIELD data are being analysed to generate risk models of cardiovascular disease, microvascular disease including diabetic renal disease, retinopathy and amputations, and other clinical outcomes.

FIELD biomarkers and genetic study 

Blood samples from consenting patients are being analysed to identify biological and genetic markers for the risk of cardiovascular disease and other complications of type 2 diabetes.

 

See ISRCTN for full trial details >

 

Trial Summary:

FIELD was a double-blind placebo-controlled trial conducted in Australia, New Zealand and Finland. A feature of the trial was its wide entry criteria to 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. The results were published in The Lancet in November 2005 and results for secondary and tertiary endpoints planned in the protocol have also been published.

Supported By:

Laboratoires Fournier S.A.

Eligibility:

  • type 2 diabetes mellitus with onset after the age of 35 years
  • men and women aged 50 to 75 years of age average total cholesterol 3.0 to 6.5 mmol/L
  • triglycerides/high-density cholesterol ratio of 4.0 or higher, or triglycerides over 1.0 mmol/L

Registration ID:

ISRCTN 64783481

Participation:

9,795 participants in ANZ and Finland

Australian Lead Group:

NHMRC CTC

Status:

Long-term follow up

Activation Date:

 

Chairs:

Professor Anthony Keech

Contact:

FIELDTrial@ctc.usyd.edu.au