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

ISRCTN	ISRCTN76737502
DOI	https://doi.org/10.1186/ISRCTN76737502
ClinicalTrials.gov number	NCT00141232
Secondary identifying numbers	A2581114

Submission date: 04/08/2004
Registration date: 14/09/2004
Last edited: 22/08/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Atorvastatin in Factorial with Omega-3 fatty acid Risk Reduction in Diabetes
Study acronym	AFORRD
Study hypothesis	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
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
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/11/2004
Overall study end date	31/07/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	1000 patients in 70 UK clinical centres
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 exclusion criteria	Not provided at time of registration
Recruitment start date	01/11/2004
Recruitment end date	31/07/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Churchill Hospital

Oxford
OX3 7LJ
United Kingdom

Sponsor information

Pfizer Ltd
Industry

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

"ROR"	https://ror.org/04x4v8p40

Funders

Funder type

Industry

Pfizer UK
Private sector organisation / For-profit companies (industry)

Alternative name(s): Pfizer Ltd, Pfizer Limited
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	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

Editorial Notes

22/08/2016: Publication reference added.