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

ISRCTN	ISRCTN70518596
DOI	https://doi.org/10.1186/ISRCTN70518596
Clinical Trials Information System (CTIS)	2007-004935-44
Protocol serial number	RGHTCUR125
Sponsor	Belfast Health and Social Care Trust (UK)
Funder	Research Fellowship Award from the Research and Development Office of the Northern Ireland Department of Health and Social Services (ref: EAT/2197/02)

Submission date: 25/04/2008
Registration date: 15/05/2008
Last edited: 12/04/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Patrick Bell
Scientific

East Wing Office
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom

Phone	+44 28 9063 3423
Email	patrick.bell@belfasttrust.hscni.net

Study information

Primary study design	Interventional
Study design	Randomised, double-blind, prospective, two-period cross-over trial.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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
Study objectives	The peroxisome proliferator-activated receptor alpha agonist fenofibrate may increase insulin sensitivity compared to atorvastatin in type 2 diabetes mellitus.
Ethics approval(s)	Local Research and Ethics Committee of the Queen's University of Belfast. Date of approval: 29/10/2003 (ref: 175/03)
Health condition(s) or problem(s) studied	Type 2 diabetes mellitus, insulin resistance
Intervention	This is a randomised, cross-over trial. Treatment 1: Micronised fenofibrate (oral) 267 mg once daily Treatment 2: Atorvastatin (oral) 10 mg once daily Intervention schedule: Previous lipid-lowering therapy was withdrawn for 4 weeks prior to assessment for entry eligibility criteria. Subjects then commenced a 4-week placebo run-in after which baseline assessments were carried out. The participants were then randomised to either fenofibrate or atorvastatin in a double-blinded manner and continued for 12 weeks, after which end-point assessments were carried out. A 4-week placebo-controlled washout period followed, and then subjects proceeded to 12 weeks therapy with the alternative blinded therapy (atorvastatin or fenofibrate). End-points were again assessed after this treatment period. The full period of follow-up of each individual volunteer was 36 weeks, and is broken down as follows: 1. 4 week washout period from previous therapy 2. 4 week placebo run-in period 3. 12 week treatment period 1 4. 4 week placebo wash-out period 5. 12 week treatment period 2
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Fenofibrate, atorvastatin
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	25/01/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	12
Total final enrolment	13
Key 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
Key exclusion criteria	1. Age <35 or >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 <50 mL/minute, urine spot albumin >200 mg/L, albumin-creatinine ratio >20 mg/mmol or 24-hour urine protein >300 mg) 13. Uncontrolled hypertension (>140/80 mmHg)
Date of first enrolment	01/06/2004
Date of final enrolment	25/01/2006

Locations

Countries of recruitment

United Kingdom
Northern Ireland

Study participating centre

East Wing Office

Belfast
BT12 6BA
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/05/2014	12/04/2021	Yes	No
Abstract results	p.44	20/02/2007		No	No
Abstract results		21/08/2007		No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

12/04/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.