UK Prospective Diabetes Study - post study monitoring (PSM) and cohort follow-up (CFU)

ISRCTN	ISRCTN75451837
DOI	https://doi.org/10.1186/ISRCTN75451837
Protocol serial number	G8109618 (now incorporates G8815630)
Sponsors	Medical Research Council (MRC) (UK), University of Oxford Diabetes Trials Unit
Funders	Medical Research Council (MRC) (UK), Several pharmaceutical companies, Other organisations, 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

Submission date: 17/10/2000
Registration date: 17/10/2000
Last edited: 22/05/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Rury R Holman
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Scientific title	-
Study acronym	UKPDS
Study objectives	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 effects10 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 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 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(s)	Ethics approval received from the South East Multi-centre Research Ethics Committee on the 20th September 2002 (MREC 02/01/85)
Health condition(s) or problem(s) studied	Diabetes
Intervention	Diet/insulin/sulphonylurea/metformin in preventing the complications of type 2 diabetes.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Insulin/sulphonylurea/metformin
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
Key secondary outcome measure(s)	Added 15/08/2008: 1. Quality of life 2. Health economic outcomes 3. Cognitive function
Completion date	30/09/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	25 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	5102
Key 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
Key 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
Date of first enrolment	01/03/1998
Date of final enrolment	30/09/2002

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Diabetes Trials Unit

Oxford
OX3 7LJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	UKPDS results:	12/09/1998		Yes	No
Results article	UKPDS results:	12/09/1998		Yes	No
Results article	UKPDS results:	12/09/1998		Yes	No
Results article	UKPDS results:	12/09/1998		Yes	No
Results article	results of 10-year follow-up of intensive glucose control:	09/10/2008		Yes	No
Results article	results of long-term follow-up after tight control of blood pressure:	09/10/2008		Yes	No
Results article	results	05/03/2013		Yes	No
Results article	UKPDS results	01/03/2020	10/02/2020	Yes	No
Results article	UKPDS 89 results	01/08/2021	04/10/2021	Yes	No
Results article	UKPDS 91 results	17/05/2024	22/05/2024	Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

22/05/2024: Publication reference added.
04/10/2021: Publication reference added.
10/02/2020: Publication reference added.