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Cited by 478Diabetes Treatment and ManagementDiabetes Management and ResearchDiabetes, Cardiovascular Risks, and Lipoproteins

United Kingdom prospective diabetes study (UKPDS) 13: relative efficacy of randomly allocated diet, sulphonylurea, insulin, or metformin in patients with newly diagnosed non-insulin dependent diabetes followed for three years

Open access
·1995·BMJ
DOI 10.1136/bmj.310.6972.83PMC PMC2548496
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Abstract

Objective : To assess the relative efficacy of treatments for non-insulin dependent diabetes over three years from diagnosis. Design : Multicentre, randomised, controlled trial allocating patients to treatment with diet alone or additional chlorpropamide, glibenclamide, insulin, or metformin (if obese) to achieve fasting plasma glucose concentrations </=6 mmol/l. Setting : Outpatient diabetic clinics in 15 British hospitals. Subjects : 2520 subjects who, after a three month dietary run in period, had fasting plasma glucose concentrations of 6.1-14.9 mmol/l but no hyperglycaemic symptoms. Main outcome measures : Fasting plasma glucose, glycated haemoglobin, and fasting plasma insulin concentrations; body weight; compliance; and hypoglycaemia. Results : Median fasting plasma glucose concentrations were significantly lower at three years in patients allocated to chlorpropamide, glibenclamide, or insulin rather than diet alone (7.0, 7.6, 7.4, and 9.0 mmol/l respectively; P<0.001) with lower mean glycated haemoglobin values (6.8%, 6.9%, 7.0%, and 7.6% respectively; P<0.001). Mean body weight increased significantly with chlorpropamide, glibenclamide, and insulin but not diet (by 3.5, 4.8, 4.8, and 1.7 kg; P<0.001). A similar pattern was seen for mean fasting plasma insulin concentration (by 0.9, 1.2, 2.4, and −0.1 mU/l; P<0.001). In obese subjects metformin was as effective as the other drugs with no change in mean body weight and significant reduction in mean fasting plasma insulin concentration (−2.5 mU/l; P<0.001). More hypoglycaemic episodes occurred with sulphonylurea or insulin than with diet or metformin. Conclusion : The drugs had similar glucose lowering efficacy, although most patients remained hyperglycaemic. Long term follow up is required to determine the risk-benefit ratio of the glycaemic improvement, side effects, changes in body weight, and plasma insulin concentration. Key messages: Key messages In this study after three years chlorpropamide, glibenclamide, insulin, and metformin were all more effective than diet alone with no differences in efficacy in reducing glycaemia Sulphonylureas and insulin tended to increase body weight, plasma insulin, and the risk of hypoglycaemia, whereas metformin did not affect weight, reduced insulin, and was associated with less frequent hypoglycaemia Long term follow up is required to determine the risk benefit ratio for each of these treatments

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  • The 1993 Diabetes Control and Complications Trial and 1998 United Kingdom Prospective Diabetes Study demonstrated definitive relationships between glycemic control and microvascular complications and showed that lower A1cs were associated with higher rates of severe hypoglycemia.

    “The 1993 publication of the Diabetes Control and Complications Trial112 and 1998 United Kingdom Prospective Diabetes Study113–115 demonstrated definitive relationships between glycemic control and microvascular complications and showed that lower A1cs were associated with higher rates of severe hypoglycemia.”

    From 100 years of insulin: celebrating the past, present and future of diabetes therapy (2021) · cites this paper as [115]

  • A 0.5% reduction in HbA1c is similar to that achieved with medication.

    “with a reduction of 0.5% that was similar to that achieved by using medication (44,45)”

    From Systematic review and meta-analysis of different dietary approaches to the management of type 2 diabetes (2013) · cites this paper as [45]

  • Hypoglycemia is very uncommon with metformin monotherapy but has been reported in combination regimens, likely due to metformin potentiating other therapeutic agents.

    “Hypoglycemia is very uncommon with metformin monotherapy [173] but has been reported in combination regimens [174], likely due to metformin potentiating other therapeutic agents.”

    From Metformin: An Old But Still the Best Treatment for Type 2 Diabetes (2013) · cites this paper as [174]

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Venue
BMJ
Publisher
BMJ
Published
1995-01-14
Volume
310
Issue
6972
Pages
83-88
ISSN
  • 0007-1447 (ISSN-L)
  • 0959-8138
  • 1468-5833
DOI
10.1136/bmj.310.6972.83
PMC
PMC2548496
OpenAlex
W4250413101
Cited by
478
References
2
Citations by year
2026: 2 · 2025: 8 · 2024: 10 · 2023: 6 · 2022: 6 · 2021: 8 · 2020: 14 · 2019: 7 · 2018: 15 · 2017: 14 · 2016: 21 · 2015: 22 · 2014: 28 · 2013: 20 · 2012: 12
FWCI
13.96
Type
journal article
Language
en
Open access
Licence
www.bmj.com/company/legal-information/terms-conditions/legal-information/tdm-licencepolicy (tdm)
Locations
  • BMJ (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
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, sulfonylureas, chlorpropamide, glibenclamide, insulin therapy, metformin, dietary therapy, fasting blood glucose, HbA1c, fasting insulin, body weight, hypoglycemia, obesity, treatment efficacy, newly diagnosed diabetes, long-term follow-up
MeSH terms
Adult, Aged, Blood Glucose, Body Weight, Chlorpropamide, Diabetes Mellitus, Diabetes Mellitus, Type 2, Female, Follow-Up Studies, Glyburide, Glycated Hemoglobin, Humans, Insulin, Male, Metformin, Middle Aged, Obesity, Patient Compliance, Sulfonylurea Compounds

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