Atorvastatin in factorial with omega-3 fatty acid risk reduction in diabetes

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Rury R Holman
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Atorvastatin in Factorial with Omega-3 fatty acid Risk Reduction in Diabetes
Study acronym	AFORRD
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/07/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	1000
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/11/2004
Date of final enrolment	31/07/2006

Churchill Hospital

Oxford
OX3 7LJ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2009		Yes	No
Results article	results	01/12/2010		Yes	No
Results article	results	01/10/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

22/08/2016: Publication reference added.