Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/10/2000
Date assigned
17/10/2000
Last edited
04/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.dtu.ox.ac.uk/ukpds

Contact information

Type

Scientific

Primary contact

Dr Rury R Holman

ORCID ID

Contact details

Diabetes Trials Unit
OCDEM
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom

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 patient’s 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

http://www.mrc.ac.uk

Funders

Funder type

Industry

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Additional files

Editorial Notes