Condition category
Nutritional, Metabolic, Endocrine
Date applied
31/05/2002
Date assigned
31/05/2002
Last edited
18/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rury R Holman

ORCID ID

Contact details

Diabetes Trials Unit
OCDEM
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom

Additional identifiers

EudraCT 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and fenofibrate (Lipantil) in a two-by-two factorial design in thirty UK clinical centres before cerivastatin was withdrawn.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

Not provided at time of registration

Study design

Randomised, placebo-controlled, clinical outcome trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial 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

Phase

Not Specified

Drug names

cerivastatin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/1999

Overall trial end date

31/08/2001

Reason abandoned

Objectives no longer viable

Eligibility

Participant inclusion criteria

Established type 2 diabetics aged between 40 and 75

Participant type

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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

http://www.bayer.co.uk

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes