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Atorvastatin in Factorial with Omega-3 fatty acid Risk Reduction in Diabetes
…in an academic collaboration with
Trial DesignTrial 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
Steering CommitteeOverall responsibility for scientific, professional
and operational conduct of the study
Diabetes Trials UnitStudy Design and Protocol Dev.Co-ordinating CentreInvestigator agreementsEthical/regulatory approvalData collection and managementProtocol/clinical queriesStatistical analysis/publication
Pfizer UKProtocol development Regulatory aspectsStudy medication On-site MonitoringSAE reporting
DTU CentralLaboratory
70 Clinical Centres
Trial Organisation
AimsAimsTo 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
Inclusion CriteriaInclusion 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
Exclusion CriteriaExclusion 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
Atorvastatin Placebo 500Omega-3 Omega-3 Omega-3
(250) (250)
Atorvastatin Placebo 500
Placebo Placebo Placebo(250) (250)
500 500 1,000Atorvastatin Placebo patients
in total
Atorvastatin (20 mg )
Omega-3PUFA (1.8 g)
2 x 2 Factorial Randomisation2 x 2 Factorial Randomisation
Primary ObjectivesPrimary Objectives
Proportion of subjects whose LDL levels are<2.6 mmol/L at four months
Proportion of subjects whose triglycerides are<1.5 mmol/L at four months
Secondary ObjectivesSecondary Objectives Proportion of subjects with LDL levels
<2.6 mmol/L at one year
Proportion of subjects with triglycerides<1.5 mmol/L at one year
Proportion (%) of subjects with estimated ten-year CHD risk <15% at 16 weeks and one year
Study medication adherenceat 16 weeks and at one year
Health economic assessmentat 16 weeks and at one year
Visit ScheduleVisit ScheduleVisit 1: week -2 Recruitment
Visit 2: week 0 Randomisation
Visit 3: week 16 Four month evaluation
Visit 4: week 18 Additional medication*Adherence study
Visit 5: week 32 Routine Follow up
Visit 6: week 52 One year evaluationEnd of study
* Patients whose estimated CHD risk remains greater than 20% 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.
Study will commence in 2004
One year recruitment in 70 UK practices
One year follow-up for all subjects
Results expected 2006
Contact:
• Email: [email protected]
• Phone: 01865 857 246
• Fax: 01865 857 256
• Web site:www.dtu.ox.ac.uk/aforrd
Trial ScheduleTrial Schedule