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
EudraCT/CTIS number 2007-004935-44
Secondary identifying numbers RGHTCUR125
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

Study designRandomised, double-blind, prospective, two-period cross-over trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe 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 objectivesThe 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) studiedType 2 diabetes mellitus, insulin resistance
InterventionThis 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Previous lipid-lowering therapy was withdrawn for 4 weeks prior to assessment for entry eligibility criteria.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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Fenofibrate, atorvastatin
Primary outcome measureGlucose 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 measuresThe 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 study start date01/06/2004
Completion date25/01/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants12
Total final enrolment13
Key inclusion criteria1. 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 criteria1. 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 enrolment01/06/2004
Date of final enrolment25/01/2006

Locations

Countries of recruitment

  • Northern Ireland
  • United Kingdom

Study participating centre

East Wing Office
Belfast
BT12 6BA
United Kingdom

Sponsor information

Belfast Health and Social Care Trust (UK)
Hospital/treatment centre

The Royal Research Office
Education & Research Centre
The Royal Hospitals
Belfast Trust and Social Care Trust
Grosvenor Road
Belfast
BT12 6BJ
Northern Ireland
United Kingdom

Phone +44 28 9063 2224
Email frances.burns@belfasttrust.hscni.net
Website http://www.belfasttrust.hscni.net
ROR logo "ROR" https://ror.org/02tdmfk69

Funders

Funder type

Government

Research Fellowship Award from the Research and Development Office of the Northern Ireland Department of Health and Social Services (ref: EAT/2197/02)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

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.