Study of nateglinide in Japan: long-term treatment of patients with type 2 diabetes.

Nateglinide is an oral antidiabetic medication that acts through rapid, short-term stimulation of insulin production. This study undertook to identify the nature of any adverse effects of nateglinide and to assess its clinical efficacy in long-term use in clinical practice. Patients (n=1014) were recruited from centers in Japan and were followed over a 15-month treatment period. Pretreatment and posttreatment values were obtained for fasting blood glucose, postprandial blood glucose, hemoglobin A1c (HbA1c), triglycerides, and total cholesterol. All adverse reactions were noted, along with standard laboratory blood variables. The efficacy value was rated as 78.76% by the treating physicians; this was indicated by a postprandial glucose decrease of 53.2 mg/dL (from 223.8+/-61.1 mg/dL to 170.6+/-40.7 mg/dL), a fasting glucose decrease of 9.3 mg/dL (from 155.1+/- 40.0 mg/dL to 145.4+/-35.1 mg/dL), and an HbA1c decrease of 0.68% (from 7.51+/- 1.36% to 6.83+/-1.09%). In patients previously treated with sulfonylurea, a decrease in HbA1c was not observed. Changes in HbA1c had no association with age, body mass index (BMI), duration of diabetes, or concomitant disease. No change in BMI was noted after 15 months of nateglinide treatment. Adverse reactions occurred at an incidence of 10.07% (100/993 cases), with hypoglycemic symptoms being the most prevalent (1.91%). Adverse reactions were sometimes associated with extant renal dysfunction, a condition about which the physician had to be aware. No problems such as increased incidences of adverse reactions or deterioration in severity were detected in this long-term study. This study showed the efficacy and safety of long-term treatment with nateglinide of patients with diabetes from various backgrounds.

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

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.

Postmarketing surveillance study of nateglinide in Japan.

Nateglinide is an oral antidiabetic medication that acts through rapid, short-term stimulation of insulin production. This study was undertaken to identify the incidence and nature of adverse effects of nateglinide and to assess its efficacy in clinical practice. Patients (n = 3254) were recruited from 606 centers in Japan with a 12-week observation period. Pretreatment and posttreatment values were obtained for fasting blood glucose, postprandial blood glucose, hemoglobin A1c (HbA1c), triglycerides, cholesterol, and body mass index. All adverse events were reported, along with standard laboratory blood variables. The incidence of adverse events was 7.40%; hypoglycemia, including hypoglycemic symptoms, was reported as the most prevalent (1.62%). Adverse events were observed more frequently in patients with hepatic or renal dysfunction; no significant findings were noted in the remaining patient population. The efficacy rating determined by the treating physicians was 76.40%. HbA1c decreased by 0.81% from 7.70+/-1.53% to 6.89+/-1.22%, postprandial glucose decreased by 54.05 mg/dL from 228.91+/-73.69 mg/dL to 174.86+/-62.86 mg/dL, and fasting glucose decreased by 23.73 mg/dL from 164.15+/-51.42 mg/dL to 140.43+/-42.63 mg/dL. These effects were most marked in patients who were previously medication naïve or who had been diagnosed with diabetes for a short period. Mean body mass index decreased, and nateglinide was equally effective in obese patients. Nateglinide showed good therapeutic effect when used as the first choice in patients with a short duration of diabetes, and in those with no history of previous treatment. Moreover, nateglinide seemed to be useful for the treatment of elderly patients and obese patients.