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Comparison of Pioglitazone and Gliclazide in Sustaining Glycemic Control Over 2 Years in Patients With Type 2 Diabetes

¹ Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana
² Isle of Wight Healthcare, National Health Service Trust, St. Mary’s Hospital, Newport, Isle of Wight, U.K
³ Second Department of Internal Medicine, Faculty Hospital, Comenius University, Mickiewiczona, Bratislava, Slovak Republic
⁴ NZOZ GCP Dobra Pratyka Lebarska, ul che-mi-ska, Grudzi-dz, Poland
⁵ Medyczyne Centrum, Diabetologiczno-Endokrynologia, Diabetologia Rusznikarska, Krakow, Poland
⁶ Takeda Europe Research and Development Centre, London, U.K

Address correspondence and reprint requests to Dr. Meng H. Tan, Lilly Corporate Center, Eli Lilly and Company, Indianapolis, IN 46285. E-mail: tan_meng{at}lilly.com

OBJECTIVE—The hypothesis that pioglitazone treatment is superior to gliclazide treatment in sustaining glycemic control for up to 2 years in patients with type 2 diabetes was tested.

RESEARCH DESIGN AND METHODS—This was a randomized, multicenter, double-blind, double-dummy, parallel-group, 2-year study. Approximately 600 patients from 98 centers participated. Eligible patients had completed a previous 12-month study and consented to continue treatment for a further year. To avoid selection bias, all patients from all centers were included in the primary analysis (a comparison of the time-to-failure distributions of the two groups by using a log-rank test) regardless of whether they continued treatment for a 2nd year. By using repeated-measures ANOVA, time course of least square means of HbA_1c and homeostasis model of assessment (HOMA) indexes (HOMA-%S and HOMA-%B) were analyzed.

RESULTS—A greater proportion of patients treated with pioglitazone maintained HbA_1c <8% over the 2-year period than those treated with gliclazide. A difference between the Kaplan-Meier curves was apparent as early as week 32 and widened at each time point thereafter, becoming statistically significant from week 52 onward. At week 104, 129 (47.8%) of 270 pioglitazone-treated patients and 110 (37.0%) of 297 gliclazide-treated patients maintained HbA_1c <8%. Compared with gliclazide treatment, pioglitazone treatment produced a larger decrease in HbA_1c, a larger increase in HOMA-%S, and a smaller increase in HOMA-%B during the 2nd year of treatment.

CONCLUSIONS—Pioglitazone is superior to gliclazide in sustaining glycemic control in patients with type 2 diabetes during the 2nd year of treatment.

Abbreviations: FPG, fasting plasma glucose • FSI, fasting serum insulin • HOMA, homeostasis model of assessment • IFG, impaired fasting glucose • IGT, impaired glucose tolerance • OAM, oral antihyperglycemic medication

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