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1 January 1996 | Volume 124 Issue 1 Part 2 | Pages 136-145
Purpose: To report the progress (after 9-year follow-up) of a study designed to determine whether improved glucose control in patients with newly diagnosed non–insulin-dependent diabetes mellitus (NIDDM) is effective in reducing the incidence of clinical complications.
Data Source: A multicenter, randomized, controlled trial of different therapies for NIDDM. After initial diet therapy, 4209 asymptomatic patients who remained hyperglycemic (fasting plasma glucose levels, 6.0 to 15.0 mmol/L) were assigned to either a conventional therapy policy, primarily with diet alone, or to an intensive therapy policy, aiming for fasting plasma glucose levels of less than 6.0 mmol/L, with assignment to primary therapy with sulfonylurea or insulin (which increased insulin supply) or metformin (which enhanced insulin sensitivity).
Results: All three modes of pharmacologic therapy in the intensively treated group—sulfonylurea, insulin, and metformin—had similar efficacy in reducing the fasting plasma glucose and glycated hemoglobin levels. Over 9 years, patients assigned to intensive therapy with sulfonylurea or insulin had lower fasting plasma glucose levels (median, 7.3 and 9.0 mmol/L, respectively) and lower hemoglobin A1c levels (6.7% and 7.5%, respectively) than patients assigned to conventional therapy. Regardless of the assigned therapy, however, the fasting plasma glucose and hemoglobin A1c levels increased, and maintaining near-normal glycemia was, in general, not feasible. Even insulin therapy did not achieve the therapeutic goal of near-normal glycemia because of the difficulty in treating marked hyperglycemia and the risk for hypoglycemic episodes. Nine years after the diagnosis of diabetes, 29% of the patients had had a diabetes-related clinical end point, 20% had had a macrovascular complication, and 9% had had a microvascular complication.
Conclusions: A report will be published in 1998 after a median duration from randomization of 11 years (range, 6 to 20 years) with an 81% power at a 1% level of significance of detecting whether the obtained improvement in glucose control causes a 15% decrease or increase in the incidence of major complications and whether any specific therapy is advantageous or disadvantageous.
Author and Article Information
From the Radcliffe Infirmary, Oxford; Royal Infirmary, Aberdeen; General Hospital, Birmingham; St. George's Hospital and Hammersmith Hospital, London; City Hospital, Belfast; North Staffordshire Royal Infirmary, Stoke-on-Trent; Royal Victoria Hospital, Belfast; St. Helier Hospital, Carshalton; Whittington Hospital, London; Norfolk and Norwich Hospital, Norwich; Lister Hospital, Stevenage; Ipswich Hospital, Ipswich; Ninewells Hospital, Dundee; Northampton Hospital, Northampton; Torbay Hospital, Torquay; Peterborough General Hospital, Peterborough; Scarborough Hospital, Scarborough; Derbyshire Royal Infirmary, Derby; Manchester Royal Infirmary, Manchester; Hope Hospital, Salford; Leicester General Hospital, Leicester; and Royal Devon and Exeter Hospital, Exeter, United Kingdom.
ONGOING AND PROPOSED TRIALS
United Kingdom Prospective Diabetes Study 17: A 9-Year Update of a Randomized, Controlled Trial on the Effect of Improved Metabolic Control on Complications in Non-Insulin-dependent Diabetes Mellitus
Note: This article is one of a series of articles comprising an Annals of Internal Medicine supplement entitled "Risks and Benefits of Intensive Management in Non-Insulin-dependent Diabetes Mellitus: The Fifth Regenstrief Conference." To view a complete list of the articles included in this supplement, please view its Table of Contents.
Acknowledgments: The authors thank the patients and many National Health Service (NHS) and non-NHS staff at the centers for their cooperation. They also thank Mrs. Irene Stratton, Professor Eva Kohner, and Drs. Sue Manley, David Matthews, Andrew Neil, and Jonathan Levy for their collaboration and advice and Ms. Ivy Samuel and Mrs. Caroline Wood for assistance with the manuscript.
Grant Support: From the United Kingdom Medical Research Council; British Diabetic Association; United Kingdom Department of Health; National Eye Institute and National Institute of Digestive and Diabetes and Kidney Disease, National Institutes of Health; British Heart Foundation; Health Promotion Research Trust; Charles Wolfson Charitable Trust; Alan and Babette Sainsbury Trust; Oxford University Medical Research Fund Committee; various pharmaceutical companies, including Novo-Nordisk; Bayer Corporation; Bristol-Myers Squibb Company; Hoechst; Eli Lilly and Company; Lipha; and Farmitalia Carlo Erba; and other companies, including Boehringer-Mannheim, Becton Dickinson and Company, Owen Mumford, Securicor, Kodak, and Cortecs Diagnostics.
Requests for Reprints: United Kingdom Prospective Diabetes Study Group, Diabetes Research Laboratories, Radcliffe Infirmary, Woodstock Road, Oxford OX2 6HE, United Kingdom.
Current Author Addresses: Drs. Turner, Cull, and Holman: United Kingdom Prospective Diabetes Study Group, Diabetes Research Laboratories, Radcliffe Infirmary, Woodstock Road, Oxford OX2 6HE, United Kingdom.
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