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題名 | A Randomized, Open-Labeled and Controlled Study of the Efficacy and Safety of Kludone Modified Release in the Treatment of Chinese Type 2 Diabetic Patients=隨機,開放性和對照研究Kludone修飾釋出劑型在治療第2型糖尿病患者的療效與安全性 |
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作者 | 孫銘聰; 石光中; 呂介華; 何志聰; 謝昌勳; 吳令怡; 周雨青; | 書刊名 | Journal of Medical Sciences |
卷期 | 30:1 2010.02[民99.02] |
頁次 | 頁21-27 |
分類號 | 418.271 |
關鍵詞 | 糖尿病; 療效; 安全性; Kludone-modified release; Type 2 diabetic mellitus; Diamicron-modified release; Sulfonylurea; Gliclazide-modified release; |
語文 | 英文(English) |
英文摘要 | Background: The aim of this study was to evaluate the efficacy and safety profile of Kludone modified release (MR) in Chinese patients with type 2 diabetes. Methods: Thirty-three Chinese patients with type 2 diabetes on diet control and low-dose sulfonylurea were randomized to Kludone MR or Diamicron MR once daily. Drug doses were increased at 4 week intervals from 30 mg to 120 mg until metabolic control was achieved or the maximum dose reached. Efficacy was evaluated by the fasting plasma glucose and hemoglobin A1c (HbA1c) levels. Results: Fasting plasma glucose significantly decreased from 178.4±38.7 mg/dL to 157.1±39.4 mg/dL (p<0.01) in the Diamicron MR group, but was not significant in the Kludone MR group after 4 weeks (p=0.084). After 12 weeks of treatment, fasting plasma glucose decreased from 178.4±38.7 mg/dL to 156.0±42.1 mg/dL (p<0.01) in the Diamicron MR group and from 156.2±45.1 mg/dL to 145.3±45.6 mg/dL (p=0.163) in the Kludone MR group. Hemoglobin A1c between groups was not statistically different (p=0.687), indicating the efficacy of treatment was similar. No adverse event led to withdrawal of the medication. No major episodes were reported in either treatment groups. Conclusion: Once-daily Diamicron MR showed a better trend in improving fasting plasma glucose control compared to Kludone MR regardless of the initial diabetes treatment. However, neither Kludone MR nor Diamicron MR significantly decreased HbA1c levels in this study with limited case numbers. Both drugs were well tolerated with a very small number of patients reporting hypoglycemic episodes. |
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