New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naive people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3)
New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naive people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3)
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DOI：
10.1111/dom.12438
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发表时间：
2015-04-01
影响因子：
5.8
通讯作者：
Home, P. D.
中科院分区：
文献类型：
--
作者：
Bolli, G. B.;Riddle, M. C.;Home, P. D.
目的：比较新型甘精胰岛素300 U/ml （Gla-300）与100 U/ml甘精胰岛素（Gla-100）在胰岛素初治2型糖尿病患者口服降糖药物治疗中的疗效和安全性。方法：EDITION 3研究是一项多中心、开放标签、平行组研究。受试者每天随机服用一次Gla-300或Gla-100，持续6个月，停用磺脲类药物和格列尼德，剂量滴定旨在使早餐前血浆葡萄糖浓度达到4.4-5.6 mmol/l （80-100mg/dl）。主要终点是糖化血红蛋白（HbA1c）从基线到第6个月的变化。主要次要终点是夜间确认>= 1的参与者的百分比[
Aims: To compare the efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with that of glargine 100 U/ml (Gla-100) in insulin-naive people with type 2 diabetes using oral glucose-lowering drugs.Methods: The EDITION 3 study was a multicentre, open-label, parallel-group study. Participants were randomized to Gla-300 or Gla-100 once daily for 6 months, discontinuing sulphonylureas and glinides, with a dose titration aimed at achieving pre-breakfast plasma glucose concentrations of 4.4-5.6 mmol/l (80-100mg/dl). The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline to month 6. The main secondary endpoint was percentage of participants with >= 1 nocturnal confirmed [