Improved Control with Once-Daily Administration of Glimepiride for OHA Naive and Oral Monotherapy Japanese Patients without Clinically Significant Weight Gain

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  • Kobayashi Masashi
    First Department of Internal Medicine, Toyama Medical and Pharmaceutical University, Faculty of Medicine
  • Kaku Kohei
    Department of Internal Medicine, Kawasaki Medical School
  • Kawamori Ryuzo
    Department of Medicine, Juntendo University, School of Medicine
  • Iwamoto Yasuhiko
    Diabetes Center, Tokyo Women's Medical University School of Medicine
  • Seino Yutaka
    Department of Diabetes and Clinical Nutrition, Kyoto University, Graduate School of Medicine, Faculty of Medicine

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Other Title
  • ２型糖尿病患者に対するグリメピリド１日１回投与による臨床効果
  • 2ガタ トウニョウビョウ カンジャ ニ タイスル グリメピリド 1ニチ 1カイ トウヨ ニ ヨル リンショウ コウカ

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Abstract

This prospective observational study evaluated the efficacy and safety of once-daily glimepiride monotherapy, together with the effect on body weight, for 6 months in Japanese Type 2 diabetic patients.Subjects were 1, 236 Japanese type 2 diabetes mellitus patients (mean age: 62.7±10.7years), recruited from 183 study sites across Japan.Patients who were oral hypoglycemic agent (OHA) naive numbered 30%, and 61% had been switched from previous mono or combination therapy with other oral hypoglycemic agents (OHA).HbA1c improved significantly in the 293 OHA naive patients [median:(25%, 75%), 7.60:(7.10, 8.00)% to 6.50:(6.10, 7.00)%, p<0.0001], and a significant decrease in HbA1c was observed in patients switched from other oral monotherapy (nateglinide, α-GI, biguanide). In switching from other SU monotherapy to glimepiride, glycemic control improved significantly for patients with HbA1c>7 prior to treatment, while patients with already good control (HbA1c≤7) maintained control.Similar trends in improvement were also observed in FPG.Glimepiride did not result in any clinically relevant weight gain.Although initiating glimepiride in OHA naive patients resulted in a median BMI increase of+0.28kg/m2 [23.72:(21.77, 26.18) kg/m2 to 24.00 (22.20, 26.37) kg/m2, p<0.0001], no significant change in BMI was observed in subgroups previously treated with other OHA monotherapy (except nateglinide and α-GI).Adverse effects, including hypoglycemia, occurred in 8.54%(103/1206).This study confirmed that monotherapy with oncedaily administration of glimepiride is safe and improves glycemic control to a satisfactory level in OHA naive patients and in switching from most OHA monotherapy regimens.

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