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 start-ed 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.