To see if fenofibrate has any advantage over atorvastatin in effects on insulin sensitivity in volunteers with type 2 diabetes

The effect of the peroxisome proliferator-activated receptor alpha agonist fenofibrate on insulin sensitivity compared to atorvastatin in type 2 diabetes mellitus: A randomised, double-blind controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN70518596

Enrollment

Registered

2008-05-15

Start date

2004-06-01

Completion date

Unknown

Last updated

2021-04-26

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

Conditions

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

Interventions

This is a randomised, cross-over trial. Treatment 1: Micronised fenofibrate (oral) 267 mg once daily Treatment 2: Atorvastatin (oral) 10 mg once daily

Eligibility

Inclusion criteria

Inclusion criteria: 1. Males and post-menopausal females 2. Aged 35-70 years old 3. Type 2 diabetes mellitus, clinically well 4. On diet or oral anti-diabetic therapy 5. Fasting total triglyceride <4.5 mmol/L

Exclusion criteria

Exclusion criteria: 1. Age 70 years 2. Total fasting triglycerides pre-treatment or after withdrawal of previous therapy >= 4.5mmol/L 3. Total cholesterol >6.5 mmol/L 4. Excess alcohol consumption 5. Ischaemic heart, peripheral vascular or cerebrovascular disease 6. Hepatic disease 7. Epilepsy 8. Body mass index >35 kg/m^2 9. Pre-menopausal females 10. HbA1c >8% 11. Current insulin or thiazolidinedione therapy within 6 months 12. Significant renal impairment or overt proteinuria (serum creatinine >150 µmol/L, estimated glomerular filtration rate (eGFR) by the Modification of Diet in Renal Disease (MDRD) formula 200 mg/L, albumin-creatinine ratio >20 mg/mmol or 24-hour urine protein >300 mg) 13. Uncontrolled hypertension (>140/80 mmHg)

Design outcomes

Primary

Measure	Time frame
Glucose infusion rate required to maintain isoglycaemia in the last 30 minutes of a 2-hour insulin infusion at a rate of 2 mU/kg/minute. This was assessed within three days of the end of each treatment period.	—

Secondary

Measure	Time frame
The following were assessed within three days of the end of each treatment period: 1. Isotopically-determined total body glucose disposal rate and suppression of endogenous glucose production in the last 30 minutes of a 2-hour insulin infusion at a rate of 2 mU/kg/minute 2. Serum total, low-density and high density cholesterol and fasting total triglyceride	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026