| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN75451837 |
| Date ISRCTN assigned | 17/10/2000 |
| Local reference number(s) | G8109618 (now incorporates G8815630) |
| Public title | UK prospective diabetes study - post-study monitoring (PSM) |
| Scientific title |
|
| Acronym | UKPDS |
| Disease/condition/study domain | Diabetes |
| Study hypothesis | To determine whether improved blood glucose control will prevent the complications of Type 2 diabetes, and whether any mode of therapy, diet, insulin, sulphonylurea or metformin, has specific advantages or disadvantages. The trial showed that improved blood glucose and blood pressure control did lead to a reduction in the incidence of complications of type 2 diabetes. All contactable surviving patients from the trial are being followed up during the post-study monitoring phase, to track any changes in the incidence of complications. There is no further intervention in this phase. Physicians responsible for each patient's care. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Newly diagnosed Type 2 diabetic patients, age 25-65 years inclusive (median age 52 years), with two fasting plasma glucose concentrations more than 6 mmol/l |
| Participants - exclusion criteria | Severe vascular disease; accelerated hypertension, proliferative or pre-proliferative retinopathy, renal failure, other life threatening diseases an illness requiring systematic steroids, an occupation that precluded insulin therapy, language difficulties, ketouric greater than 3 millimoles per litre suggestive of insulin dependent diabetes |
| Patient information material |
|
| Anticipated start date | 01/03/1998 |
| Anticipated end date | 30/09/2002 |
| Status of trial | Completed |
| Target number of participants | 5102 |
| Interventions | Diet/insulin/sulphonylurea/metformin in preventing the complications of Type 2 diabetes |
| Primary outcome measure(s) | 1. Diabetes related mortality: deaths from heart attacks, sudden death, stroke, complications from peripheral vascular disease or amputations, renal failure, hyperglycaemic or hypoglycaemic coma.
2. Total mortality
3. Diabetes related mortality and major clinical endpoints, including non-fatal myocardial infarct, clinical angina with confirmatory abnormal ECG, heart failure, major stroke, retinal photocoagulation, vitreous haemorrhage, blindness, renal failure |
| Secondary outcome measure(s) | Not provided at time of registration |
| Trial website | http://www.dtu.ox.ac.uk/index.html?maindoc=/4-T/ |
| Publications | Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17070446 |
| Sources of funding | Medical Research Council + several pharmaceutical companies + other organisations - see website |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent
London
United Kingdom
W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.ac.uk |
| Contact name | Professor Rury R Holman |
| Contact details | Diabetes Trials Unit
Block 11-2
Radcliffe Infirmary
Woodstock Road
Oxford
United Kingdom
OX2 6HE |
| Contact telephone | +44 (0)1865 224271 |
| Contact fax | +44 (0)1865 224858 |
| Contact email | rury.holman@dtu.ox.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN75451837 |
| Date last extracted from ISRCTN register | 17/04/2008 |
