Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G8109618 (now incorporates G8815630)
Study information
Scientific title
Acronym
UKPDS
Study hypothesis
Please note that as of 15/08/2008 this record has been extensively updated and now includes a follow-up study. All details pertaining to these updates can be found in the relevant field under the above update date. At this time, the title of this trial was changed to the above; the previous title was: UK prospective diabetes study - post-study monitoring (PSM). Please also note that the anticipated end-date of this trial was extended to 31/12/2007; the previous anticipated end date was 30/09/2002.
Current hypothesis as of 15/08/2008:
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 and the cohort follow-up phases, to track any changes in the incidence of complications. There is no further intervention in these phases. Physicians are responsible for each patients care. The PSM and CFU phases of the study are examining possible legacy effects 10 years post-trial of earlier randomised allocation to more intensive blood glucose and/or blood pressure control.
Previous hypothesis:
To determine whether improved blood glucose control will prevent the complications of type two 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 two 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.
Ethics approval
Added 15/08/2008:
Ethics approval received from the South East Multi-centre Research Ethics Committee on the 20th September 2002 (MREC 02/01/85)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Diabetes
Intervention
Diet/insulin/sulphonylurea/metformin in preventing the complications of type 2 diabetes.
Added 15/08/2008:
Sponsor details for the cohort follow-up:
University of Oxford Diabetes Trials Unit
OCDEM, Churchill Hospital
Old Road, Headington
Oxford OX3 7LJ
United Kingdom
Tel: +44 (0)1865 857242
Fax: +44 (0)1865 857241
Email: dtu@dtu.ox.ac.uk
Intervention type
Drug
Phase
Not Specified
Drug names
insulin/sulphonylurea/metformin
Primary outcome measures
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 measures
Added 15/08/2008:
1. Quality of life
2. Health economic outcomes
3. Cognitive function
Overall trial start date
01/03/1998
Overall trial end date
30/09/2002
Reason abandoned
Eligibility
Participant inclusion criteria
1. Newly diagnosed type 2 diabetic patients
2. Aged 25 - 65 years inclusive (median age 52 years)
3. Two fasting plasma glucose concentrations more than 6 mmol/l
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
5102
Participant exclusion criteria
1. Severe vascular disease
2. Accelerated hypertension
3. Proliferative or pre-proliferative retinopathy
4. Renal failure
5. Other life threatening diseases an illness requiring systematic steroids
6. An occupation that precluded insulin therapy
7. Language difficulties
8. Ketouric greater than 3 millimols per litre suggestive of insulin dependent diabetes
Recruitment start date
01/03/1998
Recruitment end date
30/09/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Diabetes Trials Unit
Oxford
OX3 7LJ
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Industry
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
Several pharmaceutical companies
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Other organisations
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
For a full list of sources of funding for this trial, please visit the trial website at http://www.dtu.ox.ac.uk/ukpds/funding.php
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
Results of the main trial:
1. UKPDS 33 results: http://www.ncbi.nlm.nih.gov/pubmed/9742976
2. UKPDS 34 results: http://www.ncbi.nlm.nih.gov/pubmed/9742977
3. UKPDS 38 results: http://www.ncbi.nlm.nih.gov/pubmed/9732337
4. UKPDS 39 results: http://www.ncbi.nlm.nih.gov/pubmed/9732338
5. 2008 results of long-term follow-up after tight control of blood pressure: http://www.ncbi.nlm.nih.gov/pubmed/18784091
6. 2008 results of 10-year follow-up of intensive glucose control: http://www.ncbi.nlm.nih.gov/pubmed/18784090
7. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23362315
Publication citations
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Results
Davis TM, Coleman RL, Holman RR, , Prognostic significance of silent myocardial infarction in newly diagnosed type 2 diabetes mellitus: United Kingdom Prospective Diabetes Study (UKPDS) 79., Circulation, 2013, 127, 9, 980-987, doi: 10.1161/CIRCULATIONAHA.112.000908.
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Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group., Lancet, 1998, 352, 9131, 837-853.
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Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group., Lancet, 1998, 352, 9131, 854-865.
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Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. UK Prospective Diabetes Study Group., BMJ, 1998, 317, 7160, 703-713.
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Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 39. UK Prospective Diabetes Study Group., BMJ, 1998, 317, 7160, 713-720.
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Holman RR, Paul SK, Bethel MA, Neil HA, Matthews DR, Long-term follow-up after tight control of blood pressure in type 2 diabetes., N. Engl. J. Med., 2008, 359, 15, 1565-1576, doi: 10.1056/NEJMoa0806359.
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Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA, 10-year follow-up of intensive glucose control in type 2 diabetes., N. Engl. J. Med., 2008, 359, 15, 1577-1589, doi: 10.1056/NEJMoa0806470.