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首页> 外文期刊>Diabetes, obesity & metabolism >Gliclazide modified release*: results of a 2-year study in patients with type 2 diabetes.
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Gliclazide modified release*: results of a 2-year study in patients with type 2 diabetes.

机译：格列齐特缓释*：2型糖尿病患者为期2年的研究结果。

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Aim: To evaluate the efficacy and safety of gliclazide modified release (MR), alone or combined with other oral antidiabetic drug(s) over 2 years in type 2 diabetic patients. Methods: Two consecutive periods: (i) a 10-month, double-blind comparative study, where 800 type 2 diabetic patients were randomized either to gliclazide MR (30-120 mg) once daily or to gliclazide (80-320 mg) twice daily. All the patients were then treated with gliclazide MR for a 2-month switch period; (ii) 549 patients were subsequently enrolled in a 12-month, open-label period on gliclazide MR alone or in combination according to glycaemic control, 507 of whom completed the study. Results: Glycated haemoglobin (HbA1c) significantly decreased from baseline over 2 years by -0.46 +/- 1.08% in the whole cohort of 2-year completed patients, -0.95% in the subgroup of diet-failed patients and by -0.34% in the subgroup of patients pretreated with one oral antidiabetic drug. HbA1c was reduced by -0.43 +/- 1.02% and by -0.51 +/- 1.16%, when gliclazide MR was used in monotherapy and in combination therapy, respectively. The overall incidence of symptoms suggestive of hypoglycaemia was 4.8 episodes/100 patient-year, with no severe episode. This incidence was similarly low in elderly patients and patients with impaired renal function. Conclusion: Gliclazide MR alone or in combination with another oral antidiabetic drug significantly improved glycaemic control in type 2 diabetic patients over 2 years with a very good safety profile, notably in the elderly and in patients with impaired renal function.
机译：目的：评估格列齐特缓释（MR）单独或与其他口服抗糖尿病药联合使用在2年糖尿病患者中的疗效和安全性，持续2年以上。方法：连续两个时期：（i）一项为期10个月的双盲比较研究，其中800例2型糖尿病患者被随机分配每天一次格列齐特MR（30-120 mg）或两次格列齐特（80-320 mg）日常。然后所有患者均接受格列齐特MR治疗，疗程为2个月。 （ii）549名患者随后在12个月的开放标签期内纳入了格列齐特MR单独治疗或根据血糖控制合并治疗，其中507名患者完成了研究。结果：糖化血红蛋白（HbA1c）在2年完成的整个队列中均比基线在两年内显着下降了-0.46 +/- 1.08％，在饮食不良患者的亚组中下降了-0.95％，而在饮食失败的患者中下降了-0.34％使用一种口服降糖药预治疗的患者亚组。当格列齐特MR分别用于单一疗法和联合疗法时，HbA1c降低-0.43 +/- 1.02％和-0.51 +/- 1.16％。提示低血糖症状的总发生率为4.8次/每百病人年，无严重发作。在老年患者和肾功能受损的患者中，该发病率同样较低。结论：格列齐特MR单独或与另一种口服降糖药联合使用可显着改善2年期2型糖尿病患者的血糖控制，并具有非常好的安全性，特别是在老年人和肾功能受损的患者中。

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