| Source of record | UK Trials |
| ISRCTN | ISRCTN22144829 |
| Date ISRCTN assigned | 31/05/2002 |
| Local reference number(s) | BAY w 6228/200016 |
| Public title | Lipids in Diabetes Study |
| Scientific title |
|
| Acronym | LDS |
| Disease/condition/study domain | Type 2 diabetes |
| 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and fenofibrate (Lipantil) in a two-by-two factorial design in thirty UK clinical centres before cerivastatin was withdrawn.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.
|
| Design/methodology | Randomised, placebo-controlled, clinical outcome trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Established type 2 diabetics aged between 40 and 75 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/04/1999 |
| Anticipated end date | 31/08/2001 |
| Status of trial | Completed |
| Target number of participants | 5000 |
| Interventions | 1. Cerivastatin and placebo
2. Fenofibrate and placebo
3. Cerivastatin and fenofibrate
4. Placebo |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Trial website | http://www.dtu.ox.ac.uk/index.html?maindoc=/4-T/ |
| Sources of funding | Bayer plc |
| Sponsor name | Bayer plc |
| Sponsor details | Bayer House
Strawberry Hill
Newbury
United Kingdom
RG14 1JA |
| Sponsor website | http://www.bayer.co.uk |
| Contact name | Professor Rury R Holman |
| Contact details | Diabetes Trials Unit
Block 11-2
Radcliffe Infirmary
Woodstock Road
Oxford
United Kingdom
OX2 6HE |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN22144829 |
| Date last extracted from ISRCTN register | 17/04/2008 |
