Lipids in Diabetes Study
| ISRCTN | ISRCTN22144829 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22144829 |
| Secondary identifying numbers | BAY w 6228/200016 |
- 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
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
| 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 |
| Scientific title | |
| Study 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and fenofibrate (Lipantil) in a two-by-two factorial design in thirty UK clinical centres before cerivastatin was withdrawn.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 |
| 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 type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 5000 |
| Participant inclusion criteria | Established type 2 diabetics aged between 40 and 75 |
| 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
OX3 7LJ
United Kingdom
Sponsor information
Bayer PLC (UK)
Industry
Industry
Bayer House
Strawberry Hill
Newbury
RG14 1JA
United Kingdom
| Website | http://www.bayer.co.uk |
|---|---|
"ROR" |
https://ror.org/05emrqw14 |
Funders
Funder type
Industry
Bayer PLC (UK)
No information available
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 |
