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

  1. Meng H. Tan, MD1,
  2. Arun Baksi, FRCP2,
  3. Boris Krahulec, MD3,
  4. Piotr Kubalski, MD4,
  5. Andrzej Stankiewicz, MD5,
  6. Richard Urquhart, MD6,
  7. Gareth Edwards, BS6,
  8. Don Johns, PHD1 and
  9. for the GLAL Study Group
  1. 1Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana
  2. 2Isle of Wight Healthcare, National Health Service Trust, St. Mary’s Hospital, Newport, Isle of Wight, U.K
  3. 3Second Department of Internal Medicine, Faculty Hospital, Comenius University, Mickiewiczona, Bratislava, Slovak Republic
  4. 4NZOZ GCP Dobra Pratyka Lebarska, ul che-mi-ska, Grudzi-dz, Poland
  5. 5Medyczyne Centrum, Diabetologiczno-Endokrynologia, Diabetologia Rusznikarska, Krakow, Poland
  6. 6Takeda Europe Research and Development Centre, London, U.K
  1. 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

Abstract

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 HbA1c and homeostasis model of assessment (HOMA) indexes (HOMA-%S and HOMA-%B) were analyzed.

RESULTS—A greater proportion of patients treated with pioglitazone maintained HbA1c <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 HbA1c <8%. Compared with gliclazide treatment, pioglitazone treatment produced a larger decrease in HbA1c, 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.

Footnotes

  • A.B. has received grant/research support from Quintiles.

    A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.

    • Accepted December 12, 2004.
    • Received August 30, 2004.
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  1. doi: 10.2337/diacare.28.3.544 Diabetes Care March 2005 vol. 28 no. 3 544-550
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