Skip to main content


Table 1 Inclusion and exclusion criteria for the FIELD study

From: The need for a large-scale trial of fibrate therapy in diabetes: the rationale and design of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. [ISRCTN64783481]

Individuals were eligible for this study provided they had the following characteristics:
• male or female, aged 50–75 years inclusive
• non-insulin dependent diabetes mellitus (type 2) with age at diagnosis >35 years (currently using any of diet, tablets or insulin); for Maori, Pacific Islanders, Australian Aborigines and Torres Strait Islanders, the eligible age of diagnosis was >25 years, provided there had been at least 1 year of treatment without insulin
• on the basis of diabetes, considered to be at higher risk for coronary heart disease than the general population
• no clear indication for any cholesterol-lowering treatment: the patient was not already taking any cholesterol-lowering drug and neither the patient nor the patient's doctor considered there to be any definite need to do so
• total cholesterol level 3 to 6.5 mmol/L, plus either
   a total cholesterol-to-HDL cholesterol ratio of ≥ 4.0
   a blood triglyceride level >1.0 mmol/L
• no clear contraindication to study therapy in the view of the treating physician
• no other predominant medical problem that might limit compliance with 5 years of study treatment or compromise long-term participation and clinic attendance in the trial
Individuals were not eligible if they had any of the following characteristics:
• serum triglyceride >5 mmol/L in the baseline visit fasting blood sample
• concurrent treatment with any other lipid-lowering agent
• serum creatinine >130 μmol/L
• known chronic liver disease, transaminases >2 × upper limit of normal or symptomatic gall-bladder disease
• myocardial infarction or hospital admission for unstable angina within 3 months
• female, of child-bearing potential, unless sterilized 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, with the understanding that follow-up was planned to continue for more than 5 years