Contact information
Type
Scientific
Primary contact
Prof Patrick Bell
ORCID ID
Contact details
East Wing Office
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
+44 28 9063 3423
patrick.bell@belfasttrust.hscni.net
Additional identifiers
EudraCT number
2007-004935-44
ClinicalTrials.gov number
Protocol/serial number
RGHTCUR125
Study information
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
Acronym
Study hypothesis
The peroxisome proliferator-activated receptor alpha agonist fenofibrate may increase insulin sensitivity compared to atorvastatin in type 2 diabetes mellitus.
Ethics approval
Local Research and Ethics Committee of the Queen's University of Belfast. Date of approval: 29/10/2003 (ref: 175/03)
Study design
Randomised, double-blind, prospective, two-period cross-over trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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Previous lipid-lowering therapy was withdrawn for 4 weeks prior to assessment for entry eligibility criteria.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 names
Fenofibrate, atorvastatin
Primary outcome measures
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 outcome measures
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
Overall trial start date
01/06/2004
Overall trial end date
25/01/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
12
Participant 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)
Recruitment start date
01/06/2004
Recruitment end date
25/01/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
East Wing Office
Belfast
BT12 6BA
United Kingdom
Sponsor information
Organisation
Belfast Health and Social Care Trust (UK)
Sponsor details
The Royal Research Office
Education & Research Centre
The Royal Hospitals
Belfast Trust and Social Care Trust
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom
+44 28 9063 2224
frances.burns@belfasttrust.hscni.net
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Research Fellowship Award from the Research and Development Office of the Northern Ireland Department of Health and Social Services (ref: EAT/2197/02)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. European Association for the Study of Diabetes, 2007 Black RN, Ennis CN, Young IS, Hunter SJ, Atkinson AB, Bell PM. The PPARa agonist fenofibrate does not improve insulin sensitivity in type 2 diabetes in man; results of a randomised trial. Diabetologia 2007; 50(suppl 1): S320.
2. Diabtes UK, 2007 Black RNA, Ennis CN, Young IS, Hunter SJ, Atkinson AB, Bell PM. The effect of PPAR alpha agonist fenofibrate on insulin sensitivity in man: a randomised controlled trial. Diabetic Medicine 2007; 24(suppl 1): 44.