Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
BAY w 6228/200016
Study information
Scientific title
Acronym
LDS
Study hypothesis
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and fenofibrate (Lipantil) in a two-by-two factorial design in thirty UK clinical centres before cerivastatin was withdrawn.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.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised, placebo-controlled, clinical outcome trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Not Specified
Patient information sheet
Condition
Type 2 diabetes
Intervention
1. Cerivastatin and placebo
2. Fenofibrate and placebo
3. Cerivastatin and fenofibrate
4. Placebo
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
cerivastatin
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/04/1999
Overall study end date
31/08/2001
Reason abandoned (if study stopped)
Objectives no longer viable
Eligibility
Participant inclusion criteria
Established type 2 diabetics aged between 40 and 75
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
5000
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/04/1999
Recruitment end date
31/08/2001
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Diabetes Trials Unit
Oxford
OX3 7LJ
United Kingdom
Sponsor information
Organisation
Bayer PLC (UK)
Sponsor details
Bayer House
Strawberry Hill
Newbury
RG14 1JA
United Kingdom
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Bayer PLC (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|