Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00141232
Protocol/serial number
A2581114
Study information
Scientific title
Atorvastatin in Factorial with Omega-3 fatty acid Risk Reduction in Diabetes
Acronym
AFORRD
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled 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 contact details to request a participant information sheet
Condition
Type 2 diabetes
Intervention
Placebo-controlled double-blind, 2 x 2 factorial randomisation - it is a one year treatment trial of 1000 participants, 250 randomised to each receive either:
1. Atorvastatin (Lipitor 20mg/day) and comparator (olive oil) (250 participants)
2. Omega-3 polyunsaturated fatty acids (PUFA) (Omacor 2g/day) and placebo (250 participants)
3. Atorvastatin and Omega-3 PUFA (250 participants)
4. Placebo and comparator (olive oil) (250 participants)
In addition, according to their cardiovascular disease (CVD) risk which is assessed at the start of the trial, all participants at greater than or equal to 20% 10-year CVD risk will be allocated (single blind) to the Atorvastatin treatment arm of the study at 16 weeks. If already in the treatment arm, their dose of Atorvastatin will be doubled.
Intervention type
Mixed
Phase
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2004
Overall trial end date
31/07/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18 years or above
2. Have had Type 2 diabetes for at least 3 months
3. Not known to have had a cardiovascular event
4. Have provided written informed consent
5. In UK general practice
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1000 patients in 70 UK clinical centres
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/11/2004
Recruitment end date
31/07/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Churchill Hospital
Oxford
OX3 7LJ
United Kingdom
Funders
Funder type
Industry
Funder name
Pfizer UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
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
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19002433
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/21036355
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27522034
Publication citations
-
Results
Holman RR, Paul S, Farmer A, Tucker L, Stratton IM, Neil HA, , Atorvastatin in Factorial with Omega-3 EE90 Risk Reduction in Diabetes (AFORRD): a randomised controlled trial., Diabetologia, 2009, 52, 1, 50-59, doi: 10.1007/s00125-008-1179-5.
-
Results
Neil HA, Ceglarek U, Thiery J, Paul S, Farmer A, Holman RR, Impact of atorvastatin and omega-3 ethyl esters 90 on plasma plant sterol concentrations and cholesterol synthesis in type 2 diabetes: a randomised placebo controlled factorial trial., Atherosclerosis, 2010, 213, 2, 512-517, doi: 10.1016/j.atherosclerosis.2010.09.013.
-
Results
Farmer AJ, Oke J, Hardeman W, Tucker L, Sutton S, Kinmonth AL, Griffin S, Holman RR, The effect of a brief action planning intervention on adherence to double-blind study medication, compared to a standard trial protocol, in the Atorvastatin in Factorial with Omega EE90 Risk Reduction in Diabetes (AFORRD) clinical trial: A cluster randomised sub-study, Diabetes Res Clin Pract, 2016 , 120, 56-64, doi: 10.1016/j.diabres.2016.07.004.