Information de reference pour ce titreAccession Number: | 00003458-199801000-00016.
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Institution: | U.K. Prospective Diabetes Study Group. This paper was prepared by Alex D. Wright, FRCP, Carole A. Cull, PhD, Rury R. Holman, FRCP, and Robert C. Turner, FRCP. From the Radcliffe Infirmary, Oxford; Royal Infirmary, Aberdeen; General Hospital, Birmingham; St. George's Hospital and Hammersmith Hospital, London; City Hospital and Royal Victoria Hospital, Belfast; North Staffordshire Royal Infirmary, Stoke-on-Trent; St. Helier Hospital, Carshalton; Whittington Hospital, London; Norfolk and Norwich Hospital; Lister Hospital, Stevenage; Ipswich Hospital; Ninewells Hospital, Dundee; and Northampton General Hospital, Northampton, U.K. Address correspondence and reprint requests to U.K. Prospective Diabetes Study, Diabetes Research Laboratories, Radcliffe Infirmary, Oxford OX2 6HE, U.K. E-mail: [email protected]. Received for publication 19 March 1997 and accepted in revised form 27 August 1997.
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Title: | UKPDS 28: A Randomized Trial of Efficacy of Early Addition of Metformin in Sulfonylurea-Treated Type 2 Diabetes.[Article]
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Source: | Diabetes Care. 21(1):87-92, January 1998.
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Abstract: | OBJECTIVE -To assess the efficacy over 3 years of the addition of metformin to maximum sulfonylurea therapy in type 2 diabetes.
RESEARCH DESIGN AND METHODS -This multicenter randomized open-controlled trial was conducted in outpatient diabetes clinics in 15 U.K. hospitals. A total of 591 subjects who had already been randomly allocated to sulfonylurea therapy were taking maximum doses with suboptimal glycemic control, i.e., raised fasting plasma glucose (FPG) concentrations of 6-15 mmol/l but no significant hyperglycemic symptoms. The main outcome measures included FPG, glycated hemoglobin, protocol-defined marked hyperglycemia, body weight, blood pressure, fasting plasma lipids, compliance, and hypoglycemia and other side effects.
RESULTS -After the addition of metformin, FPG concentrations decreased by mean (95% CI) -0.47 (-0.82 to -0.13) mmol/l over 3 years compared with an increase of 0.44 (0.07-0.81) mmol/l in subjects on sulfonylurea alone (P < 0.00001). Median FPG concentrations at 3 years were 8.6 vs. 9.9 mmol/l, respectively (P < 0.00001), and HbA1c values were 7.5 and 8.1%, respectively (P = 0.006). Adjustment for baseline BMI or FPG concentration did not affect response to therapy. Only 7% of those allocated to sulfonylurea plus metformin developed protocol-defined marked hyperglycemia compared with 36% of those allocated to sulfonylurea alone (P < 0.0001). Fasting plasma lipids, body weight, and blood pressure did not change significantly. The incidence of hypoglycemic episodes did not differ between groups: 4% on sulfonylurea plus metformin and 2% on sulfonylurea alone (NS).
CONCLUSIONS -Early addition of metformin improved glycemic control in patients with suboptimal glycemic control while taking maximum sulfonylurea therapy, irrespective of obesity or baseline FPG concentrations.
(C) 1998 by the American Diabetes Association, Inc.
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Language: | English.
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Document Type: | Original Article: Emerging Treatments And Technologies.
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Journal Subset: | Clinical Medicine.
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ISSN: | 0149-5992
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NLM Journal Code: | eag, 7805975
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