Fenofibrate Intervention and Event Lowering in Diabetes

ISRCTN	ISRCTN64783481
DOI	https://doi.org/10.1186/ISRCTN64783481
Protocol serial number	N/A
Sponsor	Australian National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Funders	Fournier Pharma (France), National Health and Medical Research Council (Australia)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Anthony Keech
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Fenofibrate Intervention and Event Lowering in Diabetes
Study acronym	FIELD
Study objectives	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(s)	Added 10/09/2007: The study has been approved by local ethics committees at each participating institution.
Health condition(s) or problem(s) studied	Type 2 diabetes
Intervention	200 mg daily comicronized fenofibrate or matching placebo.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Fenofibrate
Primary outcome measure(s)	First nonfatal myocardial infarction or coronary death
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	9795
Total final enrolment	9795
Key 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
Key exclusion criteria	Added 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
Date of first enrolment	01/01/1998
Date of final enrolment	31/12/2005

NHMRC Clinical Trials Centre

Camperdown
2040
Australia

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	22/08/2005		Yes	No
Results article	results	26/11/2005		Yes	No
Results article	results	17/11/2007		Yes	No
Results article	results	08/01/2010		Yes	No
Results article	results	01/02/2011		Yes	No
Results article	results	01/02/2012		Yes	No
Results article	results	01/03/2012		Yes	No
Results article	results	01/03/2015		Yes	No
Protocol article	protocol	01/12/2004		Yes	No
Other publications	post-hoc analysis	01/04/2018		Yes	No
Other publications	Post-hoc analysis	09/03/2023	10/03/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

10/03/2023: Publication reference and total final enrolment added.
07/03/2018: Publication reference added.
23/12/2015: Publication reference added.