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首页> 外文期刊>American journal of therapeutics >Evaluation of efficacy and tolerability of gliclazide and metformin combination: a multicentric study in patients with type 2 diabetes mellitus uncontrolled on monotherapy with sulfonylurea or metformin.
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Evaluation of efficacy and tolerability of gliclazide and metformin combination: a multicentric study in patients with type 2 diabetes mellitus uncontrolled on monotherapy with sulfonylurea or metformin.

机译：格列齐特和二甲双胍联合用药的疗效和耐受性评估：一项多中心研究，对磺脲类或二甲双胍单药治疗无法控制的2型糖尿病患者。

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The objective of this study was to compare the effects of gliclazide/metformin on glycemic control in patients with Type 2 diabetes mellitus uncontrolled on monotherapy with sulfonylurea or metformin. This was a prospective, open-labeled, multicentric study over 12 weeks. Patients who were diagnosed of Type 2 diabetes and were uncontrolled on monotherapy with oral hypoglycemic agents, including gliclazide and metformin, characterized by HbA1c 7% or greater and 10% or less and fasting plasma glucose (FPG) 140 mg/dL or greater were enrolled in this study. The treatment regimen was started at 80 mg gliclazide plus 500 mg metformin once a day and was titrated to the next dose level depending on the clinician's judgment, not exceeding a total daily dose of 320 mg gliclazide and 2000 mg metformin. Changes from baseline HbA1c, FPG, and postprandial glucose were examined. After 12-weeks treatment, the gliclazide + metformin combination showed improvement in metabolic control as assessed by changes in HbA1c, FPG, and postprandial glucose. The primary efficacy parameter, HbA1c, was significantly reduced to 7.35 +/- 1.10 at the end of treatment from the baseline value (8.51 +/- 0.77) (P < 0.001). A total of 84.35% of patients showed a 0.5% or greater reduction in HbA1c and 37.39% of patients reported less than 7% HbA1c at the end of therapy. FPG and postprandial glucose were significantly reduced at the end of therapy as compared with baseline values (P < 0.001). Moreover, the lipid profile was also improved during the treatment period. The addition of gliclazide to metformin is an effective treatment for patients inadequately controlled on sulfonylurea or metformin alone. A combination of gliclazide with metformin achieves good glycemic control and improves lipid levels with better tolerability profile.
机译：这项研究的目的是比较格列齐特/二甲双胍对磺脲类或二甲双胍单药治疗无法控制的2型糖尿病患者血糖控制的影响。这是一项为期12周的前瞻性，开放标签，多中心研究。纳入被诊断为2型糖尿病且未经口服降糖药（包括格列齐特和二甲双胍）单药治疗无法控制的患者，其特征在于HbA1c为7％以上且10％以下且空腹血糖（FPG）为140 mg / dL在这个研究中。每天从80 mg格列齐特加500 mg二甲双胍开始治疗，并根据临床医生的判断将其调整至下一个剂量水平，每天总剂量不超过320 mg格列齐特和2000 mg二甲双胍。检查基线HbA1c，FPG和餐后血糖的变化。经过12周的治疗后，格列齐特+二甲双胍的组合显示通过HbA1c，FPG和餐后葡萄糖的变化评估了代谢控制的改善。治疗结束时，主要功效参数HbA1c从基线值（8.51 +/- 0.77）显着降低至7.35 +/- 1.10（P <0.001）。共有84.35％的患者显示HbA1c降低了0.5％或更多，并且37.39％的患者在治疗结束时报告的HbA1c低于7％。与基线值相比，治疗结束时FPG和餐后葡萄糖显着降低（P <0.001）。此外，在治疗期间脂质分布也得到改善。在二甲双胍中加用格列齐特是对磺脲类药物或单独使用二甲双胍治疗效果不佳的患者的有效治疗。格列齐特与二甲双胍的组合可实现良好的血糖控制，并以更好的耐受性改善脂质水平。

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