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Advances in Therapy

, Volume 22, Issue 6, pp 621–635 | Cite as

Postmarketing study of nateglinide in Japan: treatment of medication-naïve patients with type 2 diabetes

  • Hiroto Taki
  • Toshio Maki
  • Takako Iso
  • Shintaro Tanabe
  • Taiichi Kajiura
Article

Abstract

Nateglinide is an oral antidiabetic medication (OAD) that acts through rapid, short-term stimulation of insulin production. This study was conducted to identify the nature of any adverse effects associated with nateglinide and to evaluate its clinical efficacy in patients with type 2 diabetes, with particular attention to hypoglycemia. Patients with type 2 diabetes who were OAD naïve (n=547), whose fasting blood glucose levels were 150 mg/dL or lower, and who had started to take nateglinide alone were recruited from 139 centers in Japan with a 12-week observation period. The incidence of adverse reactions was 7.62%. Hypoglycemia accompanied by hypoglycemic symptoms was the most prevalent adverse event (2.10%; 11/525). Nine of 11 episodes required no therapeutic intervention. Severe hypoglycemia was recognized in only 1 case of diabetes complicated by serious renal dysfunction, for which nateglinide has been contraindicated in Japan. No subject experienced symptoms of nocturnal or prolonged hypoglycemia. After 12 weeks of nateglinide treatment, decreases were noted in hemoglobin A1c (0.82%), postprandial glucose (reduced by 59.4 mg/dL to 158.0 mg/dL), and fasting glucose (reduced by 11.7 mg/dL to 122.4 mg/dL). Nateglinide, which demonstrates limited risk of hypoglycemia and effectively controls blood glucose level, is regarded as a useful drug for the treatment of patients with type 2 diabetes.

Keywords

postmarketing surveillance study nateglinide type 2 diabetes NIDDM hypoglycemia clinical efficacy adverse effects postprandial hyperglycemia 

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References

  1. 1.
    Taki H, Maki T, Iso T, Iwamoto K, Kajiura T. Postmarketing surveillance study of nateglinide in Japan.Adv Ther. 2005;22:513–526.PubMedGoogle Scholar
  2. 2.
    Saloranta C, Hershon K, Ball M, Dickinson S, Holmes D. Efficacy and safety of nateglinide in type 2 diabetic patients with modest fasting hyperglycemia.J Clin Endocrinol Metab. 2002;87: 4171–4176.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science and Business Media and LLC 2005

Authors and Affiliations

  • Hiroto Taki
    • 1
  • Toshio Maki
    • 1
  • Takako Iso
    • 2
  • Shintaro Tanabe
    • 2
  • Taiichi Kajiura
    • 2
  1. 1.Pharmaceutical Regulatory Affairs and Quality Assurance DepartmentPharmaceutical Company, Ajinomoto Co., Inc.Chuo-ku TokyoJapan
  2. 2.QA, RA, and Pharmacovigilance Division Astellas Pharma, Inc.TokyoJapan

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