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ISRCTN
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ISRCTN22144829
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ClinicalTrials.gov identifier
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Public title
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Lipids in Diabetes Study
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Scientific title
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Acronym
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LDS
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Serial number at source
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BAY w 6228/200016
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Study hypothesis
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The Lipids in Diabetes Study (LDS) was a prospective, randomised, placebo-controlled, clinical outcome trial which commenced recruitment in April 1999. The principal objective of the trial was to determine whether lipid reduction with a statin (cerivastatin) or a fibrate (fenofibrate) could substantially reduce cardiovascular related morbidity and mortality in subjects with type 2 diabetes (non-insulin dependent diabetes). 4191 people with type 2 diabetes but not known coronary heart disease (CHD) and who were not thought to require lipid lowering therapy were randomised to lipid-lowering therapy with cerivastatin (Lipobay) and fenofibrate (Lipantil) in a two-by-two factorial design in thirty UK clinical centres before cerivastatin was withdrawn. Secondary objectives were to assess the effects of the two study drugs on predefined major clinical events, progression of microalbuminuria, changes in digital electrocardiographic parameters and the lipid profile. The study ended prematurely when Bayer unexpectedly withdrew their cholesterol lowering drug, cerivastatin, in August 2001.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised, placebo-controlled, clinical outcome trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Type 2 diabetes
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Participants - inclusion criteria
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Established type 2 diabetics aged between 40 and 75
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/04/1999
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Anticipated end date
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31/08/2001
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Status of trial
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Completed
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Patient information material
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Target number of participants
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5000
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Interventions
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1. Cerivastatin and placebo
2. Fenofibrate and placebo
3. Cerivastatin and fenofibrate
4. Placebo
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Bayer plc
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Trial website
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http://www.dtu.ox.ac.uk/index.html?maindoc=/4-T/
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Publications
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Contact name
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Dr
Rury R
Holman
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Address
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Diabetes Trials Unit
OCDEM, Churchill Hospital
Old Road, Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 7LJ
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Country
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United Kingdom
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Sponsor
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Bayer plc
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Address
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Bayer House
Strawberry Hill
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City/town
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Newbury
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Zip/Postcode
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RG14 1JA
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Country
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United Kingdom
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Sponsor website:
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http://www.bayer.co.uk
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Date applied
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31/05/2002
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Last edited
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10/03/2006
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Date ISRCTN assigned
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31/05/2002
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