Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/09/2004
Date assigned
19/10/2004
Last edited
23/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ctc.usyd.edu.au/trials/cardiovascular/field.htm

Contact information

Type

Scientific

Primary contact

Prof Anthony Keech

ORCID ID

Contact details

NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77
Camperdown
2040
Australia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Fenofibrate Intervention and Event Lowering in Diabetes

Acronym

FIELD

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Type 2 diabetes

Intervention

200 mg daily comicronized fenofibrate or matching placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Fenofibrate

Primary outcome measures

First nonfatal myocardial infarction or coronary death.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1998

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

9,795

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

01/01/1998

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Australia, Finland, New Zealand

Trial participating centre

NHMRC Clinical Trials Centre
Camperdown
2040
Australia

Sponsor information

Organisation

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

Sponsor details

Locked Bag 77
Camperdown NSW
1450
Australia

Sponsor type

Research council

Website

Funders

Funder type

Industry

Funder name

Fournier Pharma (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Health and Medical Research Council (Australia)

Alternative name(s)

NHMRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Australia

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 http://www.ncbi.nlm.nih.gov/pubmed/15571637
2. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16111499
3. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16310551
4. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17988728
5. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20072614
6. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21052978
7. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22424024
8. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22210576
9. 2015 results in http://www.ncbi.nlm.nih.gov/pubmed/25425220

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.