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Diabetes Care 25:330-336, 2002
© 2002 by the American Diabetes Association, Inc.

Emerging Treatments and Technologies
Original Article

Sulfonylurea Inadequacy

Efficacy of addition of insulin over 6 years in patients with type 2 diabetes in the U.K. Prospective Diabetes Study (UKPDS 57)

Alex Wright, FRCP1, A.C. Felix Burden, FRCP2, Richard B. Paisey, FRCP3, Carole A. Cull, PHD4 and Rury R. Holman, FRCP4 for the U.K. Prospective Diabetes Study Group

1 University Hospital, Birmingham, U.K.
2 University Hospitals of Leicester, Leicester, U.K.
3 Torbay Hospital, Torquay, Devon, U.K.
4 Diabetes Trials Unit, OCDEM, University of Oxford, Oxford, U.K.

OBJECTIVE—To evaluate the efficacy of the addition of insulin when maximal sulfonylurea therapy is inadequate in individuals with type 2 diabetes.

RESEARCH DESIGN AND METHODS—Glycemic control, hypoglycemia, and body weight were monitored over 6 years in 826 patients with newly diagnosed type 2 diabetes in 8 of 23 U.K. Prospective Diabetes Study (UKPDS) centers that used a modified protocol. Patients were randomly allocated to a conventional glucose control policy, primarily with diet (n = 242) or an intensive policy with insulin alone (n = 245), as in the main study. However, for patients randomized to an intensive policy with sulfonylurea (n = 339), insulin was added automatically if the fasting plasma glucose remained >108 mg/dl (6.0 mmol/l) despite maximal sulfonylurea doses.

RESULTS—Over 6 years, ~53% of patients allocated to treatment with sulfonylurea required additional insulin therapy. Median HbA1c in the sulfonylurea ± insulin group was significantly lower (6.6%, interquartile range [IQR] 6.0–7.6) than in the group taking insulin alone (7.1%, IQR 6.2–8.0; P = 0.0066), and significantly more patients in the sulfonylurea ± insulin group had an HbA1c <7% (47 vs. 35%, respectively; P = 0.011). Weight gain was similar in the intensive therapy groups, but major hypoglycemia occurred less frequently over all in the sulfonylurea (± insulin) group compared with the insulin alone group (1.6 vs. 3.2% per annum, respectively; P = 0.017).

CONCLUSIONS—Early addition of insulin when maximal sulfonylurea therapy is inadequate can significantly improve glycemic control without promoting increased hypoglycemia or weight gain.

Abbreviations: C, conventional glucose control policy • CI, chlorpropamide ± insulin • FPG, fasting plasma glucose • GI, glipizide ± insulin • IQR, interquartile range • SI, sulfonylurea ± insulin • UKPDS, U.K. Prospective Diabetes Study


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