Improvement of Glycemic Control in Subjects With Poorly Controlled Type 2 Diabetes

• Published in: Diabetes care Vol. 28; no. 6; pp. 1282 - 1288
• Main Authors: Davies, Melanie, Storms, Fred, Shutler, Simon, Bianchi-Biscay, Monique, Gomis, Ramon
• Format: Journal Article
• Language: English
• Published: American Diabetes Association 01.06.2005
• ISSN: 0149-5992; 1935-5548
• DOI: 10.2337/diacare.28.6.1282

Improvement of Glycemic Control in Subjects With Poorly Controlled Type 2 Diabetes Comparison of two treatment algorithms using insulin glargine Melanie Davies , MD 1 , Fred Storms , MD 2 , Simon Shutler , BSC 3 , Monique Bianchi-Biscay , MD 4 , Ramon Gomis , MD, PHD 5 and for the AT.LANTUS Study Group 1 University Hospitals of Leicester, Leicester, U.K. 2 Mesos Diabetes Centrum, Bilthoven, the Netherlands 3 Sanofi-Aventis, Guildford, U.K. 4 Medical Department, Sanofi-Aventis Intercontinental, Paris, France 5 Hospital Clínic Universitari, Barcelona, Spain Address correspondence and reprint requests to Dr. Melanie Davies, University Hospitals of Leicester, Leicester Royal Infirmary, Infirmary Close, Leicester LE1 5WW, U.K. E-mail: melanie.davies{at}uhl-tr.nhs.uk Abstract OBJECTIVE —Large prospective studies have demonstrated that optimum glycemic control is not routinely achieved in clinical practice. Barriers to optimal insulin therapy include hypoglycemia, weight gain, and suboptimal initiation and dose titration. This study compared two treatment algorithms for insulin glargine initiation and titration: algorithm 1 (investigator led) versus algorithm 2 (performed by study subjects). RESEARCH DESIGN AND METHODS —A prospective, multicenter ( n = 611), multinational ( n = 59), open-label, 24-week randomized trial in 4,961 (algorithm 1, n = 2,493; algorithm 2, n = 2,468) suboptimally controlled type 2 diabetic subjects. RESULTS —At baseline, mean diabetes duration was 12.3 ± 7.2 years, and 72% of subjects were pretreated with insulin. At end point, there was no significant difference in the incidence of severe hypoglycemia between algorithms 1 and 2 (0.9 vs. 1.1%). There was a significant reduction in HbA 1c from 8.9 ± 1.3 to 7.8 ± 1.2%, with a greater decrease ( P < 0.001) with algorithm 2 (−1.22%) versus algorithm 1 (−1.08%). Fasting blood glucose decreased from 170 to 110 mg/dl, with a greater decrease ( P < 0.001) with algorithm 2 (−62 mg/dl) versus algorithm 1 (−57 mg/dl). Mean basal insulin dose increased from 22.9 ± 15.5 to 43.0 ± 25.5 IU, with a significant difference ( P < 0.003) between algorithm 2 (21.6 IU) and algorithm 1 (18.7 IU). CONCLUSIONS —Glargine is safe and effective in improving glycemic control in a large, diverse population with longstanding type 2 diabetes. A simple subject-administered titration algorithm conferred significantly improved glycemic control with a low incidence of severe hypoglycemia compared with physician-managed titration. AE, adverse event DCCT, Diabetes Control and Complications Trial FBG, fasting blood glucose UKPDS, U.K. Prospective Diabetes Study Footnotes M.D. serves on advisory boards for and has received honoraria from Sanofi-Aventis. F.S. serves on an advisory board for Sanofi-Aventis. A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances. DIABETES CARE