Post-trial monitoring of a randomised controlled trial of intensive glycaemic control in type 2 diabetes extended from 10 years to 24 years (UKPDS 91).
Open accessAbstract
Background The 20-year UK Prospective Diabetes Study showed major clinical benefits for people with newly diagnosed type 2 diabetes randomly allocated to intensive glycaemic control with sulfonylurea or insulin therapy or metformin therapy, compared with conventional glycaemic control. 10-year post-trial follow-up identified enduring and emerging glycaemic and metformin legacy treatment effects. We aimed to determine whether these effects would wane by extending follow-up for another 14 years. Methods 5102 patients enrolled between 1977 and 1991, of whom 4209 (82·5%) participants were originally randomly allocated to receive either intensive glycaemic control (sulfonylurea or insulin, or if overweight, metformin) or conventional glycaemic control (primarily diet). At the end of the 20-year interventional trial, 3277 surviving participants entered a 10-year post-trial monitoring period, which ran until Sept 30, 2007. Eligible participants for this study were all surviving participants at the end of the 10-year post-trial monitoring period. An extended follow-up of these participants was done by linking them to their routinely collected National Health Service (NHS) data for another 14 years. Clinical outcomes were derived from records of deaths, hospital admissions, outpatient visits, and accident and emergency unit attendances. We examined seven prespecified aggregate clinical outcomes (ie, any diabetes-related endpoint, diabetes-related death, death from any cause, myocardia…
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An observational study with median 17.5 years follow-up on 1489 of 1525 surviving participants reported reductions in all-cause mortality (2.7%-4.9%), myocardial infarction (3.3%-6.2%), and microvascular disease (3.5%) in those previously randomized to receive intensive treatment vs conventional therapy (P < .05 for all comparisons).
“An observational study that published follow-up data (median of 17.5 years [range, 0–42 years]) on 1489 (97.6%) of the 1525 surviving participants reported reductions in all-cause mortality (2.7%–4.9%), myocardial infarction (3.3%–6.2%), and microvascular disease defined as vitreous hemorrhage, retinal photocoagulation, death due to kidney disease, or kidney failure (3.5%) in those previously”
From Diagnosis and Treatment of Type 2 Diabetes in Adults (2025) · cites this paper as [38]
Sulfonylureas are inexpensive and have high HbA1C-lowering efficacy.
“Sulfonylureas are inexpensive and have high HbA1C-lowering efficacy.38,81”
From Diagnosis and Treatment of Type 2 Diabetes in Adults (2025) · cites this paper as [38]
Metformin is inexpensive and widely available.
“Metformin is effective and safe, is inexpensive and widely available, and reduces risks of microvascular complications, cardiovascular events, and death (92,94,95).”
From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [92]
Metformin is effective and safe.
“Metformin is effective and safe, is inexpensive and widely available, and reduces risks of microvascular complications, cardiovascular events, and death (92,94,95).”
From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [92]
Metformin reduces risk of death.
“Metformin is effective and safe, is inexpensive and widely available, and reduces risks of microvascular complications, cardiovascular events, and death (92,94,95).”
From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [92]
Metformin reduces risk of microvascular complications.
“Metformin is effective and safe, is inexpensive and widely available, and reduces risks of microvascular complications, cardiovascular events, and death (92,94,95).”
From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [92]
Metformin reduces risk of cardiovascular events.
“Metformin is effective and safe, is inexpensive and widely available, and reduces risks of microvascular complications, cardiovascular events, and death (92,94,95).”
From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [92]
For people who already have diabetes, lifestyle modification and pharmacological treatment, as well as blood pressure and cholesterol control, can delay progression to complications and reduce mortality, or even help with remission, especially if started early.
“For people who already have diabetes, lifestyle modification and pharmacological treatment, as well as blood pressure and cholesterol control, can delay progression to complications and reduce mortality, or even help with remission, especially if started early.1,2,58–62”
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“19 Modern management of type 2 diabetes includes the use of newer glucose-lowering agents that have been shown to reduce the risk of diabetes-related complications such as GLP-1 receptor agonists 20 and SGLT2 inhibitors.”
BackgroundLong-term follow-up after tight control of blood pressure in type 2 diabetes
Holman, R. R., Paul, S. K., Bethel, M. A., Neil, H. A. W., & Matthews, D. R. (2008) · New England Journal of Medicine · doi:10.1056/nejmoa0806359 · Cited by 762 · see citing works
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Diagnosis and Treatment of Type 2 Diabetes in Adults
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- Authors
- Adler, A. I., Coleman, R. L., Leal, J., Whiteley, W. N., Clarke, P., & Holman, R. R.
- Affiliations
- University of Oxford (GB)
- British Heart Foundation (GB)
- Churchill Hospital (GB)
- Corresponding author
- Holman, Rury R
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2024-07
- Volume
- 404
- Issue
- 10448
- Pages
- 145-155
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W4397039731
- Cited by
- 166
- References
- 7
- Citations by year
- 2026: 61 · 2025: 81 · 2024: 24
- FWCI
- 54.38
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- The Lancet (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, cc-by)
- Funders
- University of Oxford
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- type 2 diabetes, tight glycemic control, post-trial follow-up, long-term outcomes, sulfonylureas, insulin therapy, diabetes mortality, myocardial infarction, stroke, peripheral vascular disease, microangiopathy, long-term follow-up, hospitalization, accident and emergency attendances
- MeSH terms
- Glycemic Control, Adult, Aged, Blood Glucose, Diabetes Mellitus, Type 2, Female, Follow-Up Studies, United Kingdom, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Male, Metformin, Middle Aged, Sulfonylurea Compounds, Treatment Outcome
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