Lipids in Diabetes Study
| ISRCTN | ISRCTN22144829 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22144829 |
| Protocol serial number | BAY w 6228/200016 |
| Sponsor | Bayer PLC (UK) |
| Funder | Bayer PLC (UK) |
- Submission date
- 31/05/2002
- Registration date
- 31/05/2002
- Last edited
- 18/02/2010
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Rury R Holman
Scientific
Scientific
Diabetes Trials Unit
OCDEM, Churchill Hospital
Old Road, Headington
Oxford
OX3 7LJ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, placebo-controlled, clinical outcome trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | LDS |
| Study objectives | 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and fenofibrate (Lipantil) in a two-by-two factorial design in thirty UK clinical centres before cerivastatin was withdrawn.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 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | cerivastatin |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/08/2001 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 5000 |
| Key inclusion criteria | Established type 2 diabetics aged between 40 and 75 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/1999 |
| Date of final enrolment | 31/08/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Diabetes Trials Unit
Oxford
OX3 7LJ
United Kingdom
OX3 7LJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
