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Fenofibrate Intervention and Event Lowering in Diabetes

Fenofibrate Intervention and Event Lowering in Diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN64783481
Enrollment
9795
Registered
2004-10-19
Start date
1998-01-01
Completion date
Unknown
Last updated
2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

200 mg daily comicronized fenofibrate or matching placebo.

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
First nonfatal myocardial infarction or coronary death

Secondary

MeasureTime frame
Not provided at time of registration

Countries

Australia, Finland, New Zealand

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 6, 2026