Title: Atorvastatin in Factorial with Omega-3 fatty acid Risk Reduction in Diabetes
1Atorvastatin in Factorial with Omega-3 fatty acid
Risk Reduction in Diabetes
2Trial Design
- Collaborative academic and pharmaceutical study
- Funded by Pfizer, with data owned, analysed and
reported by the University of Oxford Diabetes
Trials Unit (DTU) - Multi-centre primary prevention trial in 1,000
patients with type 2 diabetes - Double-blind, placebo-controlled
- 2 x 2 factorial randomisation to
- Atorvastatin (Lipitor 20 mg/day)
- Omega 3 PUFA (Omacor 2g/day)
- 70 UK clinical centres, one year follow-up
3Trial Organisation
Steering Committee Overall responsibility for
scientific, professionaland operational conduct
of the study
Diabetes Trials Unit Study Design and Protocol
Dev. Co-ordinating Centre Investigator
agreements Ethical/regulatory approval Data
collection and management Protocol/clinical
queries Statistical analysis/publication
Pfizer UK Protocol development Regulatory
aspects Study medication On-site Monitoring SAE
reporting
70 Clinical Centres
DTU CentralLaboratory
4Aims
- To determine the
- Range of estimated CHD risk levels typically seen
in people with type 2 diabetes in UK general
practice - Proportion whose estimated ten-year CHD risk can
be reduced below 15 with a 20 mg of atorvastatin
or 1.8 g omega-3 PUFA/day - Degree to which atorvastatin and omega-3 PUFA in
combination have additive effects - Extent to which therapy adherence can be enhanced
using a simple behavioural intervention
5Inclusion Criteria
- Aged 18 years and above
- Have had type 2 diabetes for at least 3 months
- Not known to have had a cardiovascular event
- Have provided written informed consent
6Exclusion Criteria
- Taking prescribed lipid lowering therapy
- Triglycerides 8.0 mmol/L
- Have specific contraindications toatorvastatin
or omega-3 PUFA - Have participated in a clinical trialwithin the
last 3 months - Are pregnant or lactating females
72 x 2 Factorial Randomisation
Atorvastatin (20 mg )
Atorvastatin Placebo 500 Omega-3 Omega-3
Omega-3 (250) (250) Atorvastatin
Placebo 500 Placebo Placebo
Placebo (250) (250) 500 500 1,000 Atorvastatin
Placebo patients in total
Omega-3PUFA (1.8 g)
8Primary Objectives
- Proportion of subjects whose LDL levels arelt2.6
mmol/L at four months - Proportion of subjects whose triglycerides
arelt1.5 mmol/L at four months
9Secondary Objectives
- Proportion of subjects with LDL levelslt2.6
mmol/L at one year - Proportion of subjects with triglycerideslt1.5
mmol/L at one year - Proportion () of subjects with estimated
ten-year CHD risk lt15 at 16 weeks and one year - Study medication adherenceat 16 weeks and at one
year - Health economic assessmentat 16 weeks and at one
year
10Visit Schedule
- Visit 1 week -2 Recruitment
- Visit 2 week 0 Randomisation
- Visit 3 week 16 Four month evaluation
- Visit 4 week 18 Additional medication Adherenc
e study - Visit 5 week 32 Routine Follow up
- Visit 6 week 52 One year evaluation End of
study - Patients whose estimated CHD risk remains
greater than 15 at four months will receive an
additional tablet containing 20 mg atorvastatin,
whilst the remainder will receive an additional
placebo tablet, in double-blind fashion.
11Trial Schedule
- Study commenced in November 2004
- One year recruitment in 70 UK practices
- One year follow-up for all subjects
- Results expected late 2006
- Contact
- Email aforrd_at_dtu.ox.ac.uk
- Phone 01865 857 246
- Fax 01865 857 256
- Web site www.dtu.ox.ac.uk/aforrd