Fenofibrate Intervention and Event Lowering in Diabetes

ISRCTN	ISRCTN64783481
DOI	https://doi.org/10.1186/ISRCTN64783481
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Prof Anthony Keech
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Fenofibrate Intervention and Event Lowering in Diabetes
Study 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(s)	Added 10/09/2007: The study has been approved by local ethics committees at each participating institution.
Condition	Type 2 diabetes
Intervention	200 mg daily comicronized fenofibrate or matching placebo.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Fenofibrate
Primary outcome measure	First nonfatal myocardial infarction or coronary death
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1998
Overall study end date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	9,795
Total final enrolment	9795
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 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
Recruitment start date	01/01/1998
Recruitment end date	31/12/2005

NHMRC Clinical Trials Centre

Camperdown
2040
Australia

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

Locked Bag 77
Camperdown NSW
1450
Australia

"ROR"	https://ror.org/011kf5r70

Industry

Fournier Pharma (France)

No information available

National Health and Medical Research Council (Australia)
Government organisation / National government

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/12/2004		Yes	No
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
Other publications	post-hoc analysis	01/04/2018		Yes	No
Other publications	Post-hoc analysis	09/03/2023	10/03/2023	Yes	No

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