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Glycemic Control Continues to Deteriorate After Sulfonylureas Are Added to Metformin Among Patients With Type 2 Diabetes

¹ Department of Epidemiology, Merck Research Laboratories, Merck, West Point, Pennsylvania
² Department of Clinical Research-Metabolism, Merck Research Laboratories, Merck, Rahway, New Jersey
³ Department of Outcomes Research and Management, Merck, West Point, Pennsylvania
⁴ Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, U.K

Address correspondence and reprint requests to Michael N. Cook, PhD, Department of Epidemiology, Merck Research Laboratories, Merck, BL 1-7, P.O. Box 4, West Point, PA 19486-0004. E-mail: michael_cook{at}merck.com

OBJECTIVE—To describe the course and predictors of glycemic control among patients with type 2 diabetes after sulfonylureas (SUs) are added to metformin (MF).

RESEARCH DESIGN AND METHODS—Patients (n = 2,220) treated with MF monotherapy for >90 days before initiating MF plus SU combination therapy between January 1998 and March 2004 were studied in a retrospective analysis of electronic medical records from U.K. primary care practices using the General Practice Research Database. Median glycoslyated hemoglobin A_1c (A1C) before and after SU initiation was described, and patient characteristics were evaluated as predictors of time until A1C 8.0% or glucose-lowering therapy was intensified (by starting insulin or adding a third oral agent).

RESULTS—At 6 months post-SU initiation, median A1C resumed deteriorating at a somewhat comparable rate to that observed on MF monotherapy. Higher pre-SU A1C, younger age, female sex, shorter diabetes duration, higher serum creatinine, and being an ex-smoker predicted time until A1C 8.0% or glucose-lowering therapy was intensified in various analyses. Median A1C was 9.5% when therapy was intensified. A1C 8.0% was estimated to occur in 85% of patients 4 years after SU initiation and in 68% 4 years after initially achieving A1C <7% on MF plus SU therapy.

CONCLUSIONS—In this population, glycemic control is improved following the addition of SUs to MF, but deterioration resumes as early as 6 months. The high proportion of patients remaining on MF plus SU therapy despite having A1C 8.0% suggests that there are significant barriers to starting insulin or adding a third agent when treatment goals are not achieved with this combination.

Abbreviations: GPRD, General Practice Research Database • IQR, interquartile range • MF, metformin • OHA, oral hypoglycemic agent • SU, sulfonylurea • UKPDS, U.K. Prospective Diabetes Study

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