Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Anthony Keech


Contact details

NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Fenofibrate Intervention and Event Lowering in Diabetes



Study hypothesis

The trial 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.

Ethics approval

Added as of 10/09/2007: The study has been approved by local ethics committees at each participating institution.

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Type 2 diabetes


200 mg daily comicronized fenofibrate or matching placebo.

Intervention type



Not Specified

Drug names


Primary outcome measures

First nonfatal myocardial infarction or coronary death.

Secondary outcome measures

Not provided at time of registration

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Type 2 diabetes mellitus with onset after the age of 35 years
2. Men and women aged 50-75 years of age
3. Average total cholesterol 3.0-6.5 mmol/L
4. Triglycerides/high-density cholesterol ratio of 4.0 or higher, or triglycerides over 1.0 mmol/L

Participant type


Age group




Target number of participants


Participant exclusion criteria

Added as of 21/04/2008:
1. Triglyceride levels over 5.0 mmol/L
2. Participants could not be taking any lipid-modifying therapy at the start of the dietary run-in period. However, the protocol allows for statin or other lipid-lowering therapy to be added at any time after randomisation and recommends continuing study medication

Recruitment start date


Recruitment end date



Countries of recruitment

Australia, Finland, New Zealand

Trial participating centre

NHMRC Clinical Trials Centre

Sponsor information


Australian National Health and Medical Research Council (NHMRC) Clinical Trials Centre

Sponsor details

Locked Bag 77
Camperdown NSW

Sponsor type

Research council



Funder type


Funder name

Fournier Pharma (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

National Health and Medical Research Council (Australia)

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government



Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2004 protocol in
2. 2005 results in
3. 2005 results in
4. 2007 results in
5. 2010 results in
6. 2011 results in
7. 2012 results in
8. 2012 results in
9. 2015 results in

Publication citations

  1. Results

    Simes J, Voysey M, O'Connell R, Glasziou P, Best JD, Scott R, Pardy C, Byth K, Sullivan DR, Ehnholm C, Keech A, , A novel method to adjust efficacy estimates for uptake of other active treatments in long-term clinical trials., PLoS ONE, 2010, 5, 1, e8580, doi: 10.1371/journal.pone.0008580.

  2. Results

    Davis TM, Ting R, Best JD, Donoghoe MW, Drury PL, Sullivan DR, Jenkins AJ, O'Connell RL, Whiting MJ, Glasziou PP, Simes RJ, Kesäniemi YA, Gebski VJ, Scott RS, Keech AC, , Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study., Diabetologia, 2011, 54, 2, 280-290, doi: 10.1007/s00125-010-1951-1.

  3. Results

    Tonkin A, Hunt D, Voysey M, Kesäniemi A, Hamer A, Waites J, Mahar L, Mann S, Glasziou P, Forder P, Simes J, Keech AC, , Effects of fenofibrate on cardiovascular events in patients with diabetes, with and without prior cardiovascular disease: The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study., Am. Heart J., 2012, 163, 3, 508-514, doi: 10.1016/j.ahj.2011.12.004.

  4. Results

    Ting RD, Keech AC, Drury PL, Donoghoe MW, Hedley J, Jenkins AJ, Davis TM, Lehto S, Celermajer D, Simes RJ, Rajamani K, Stanton K, , Benefits and safety of long-term fenofibrate therapy in people with type 2 diabetes and renal impairment: the FIELD Study., Diabetes Care, 2012, 35, 2, 218-225, doi: 10.2337/dc11-1109.

  5. 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]., Cardiovasc Diabetol, 2004, 3, 9, doi: 10.1186/1475-2840-3-9.

  6. Scott R, Best J, Forder P, Taskinen MR, Simes J, Barter P, Keech A, , Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study: baseline characteristics and short-term effects of fenofibrate [ISRCTN64783481]., Cardiovasc Diabetol, 2005, 4, 13, doi: 10.1186/1475-2840-4-13.

  7. Keech A, Simes RJ, Barter P, Best J, Scott R, Taskinen MR, Forder P, Pillai A, Davis T, Glasziou P, Drury P, Kesäniemi YA, Sullivan D, Hunt D, Colman P, d'Emden M, Whiting M, Ehnholm C, Laakso M, , Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial., Lancet, 2005, 366, 9500, 1849-1861, doi: 10.1016/S0140-6736(05)67667-2.

  8. Keech AC, Mitchell P, Summanen PA, O'Day J, Davis TM, Moffitt MS, Taskinen MR, Simes RJ, Tse D, Williamson E, Merrifield A, Laatikainen LT, d'Emden MC, Crimet DC, O'Connell RL, Colman PG, , Effect of fenofibrate on the need for laser treatment for diabetic retinopathy (FIELD study): a randomised controlled trial., Lancet, 2007, 370, 9600, 1687-1697, doi: 10.1016/S0140-6736(07)61607-9.

Additional files

Editorial Notes

23/12/2015: Publication reference added.