Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/08/2004
Date assigned
14/09/2004
Last edited
22/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Rury R Holman

ORCID ID

Contact details

Diabetes Trials Unit
Oxford Centre for Diabetes
Endocrinology and Metabolism (OCDEM)
Churchill Hospital
Old Road
Oxford
OX3 7LJ
United Kingdom

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

Sponsor information

Organisation

Pfizer Ltd

Sponsor details

IPC 2F
Walton Oaks
Dorking Road
Tadworth
KT20 7NS
United Kingdom

Sponsor type

Industry

Website

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes

22/08/2016: Publication reference added.