JPRN-jRCT1080225321已完成4 期
A randomised, double-blind, placebo-controlled, parallel group, 52 weeks phase IV trial to evaluate efficacy and safety of oral, once daily empagliflozin in elderly Japanese patients with type 2 diabetes mellitus and insufficient glycaemic control
ippon Boehringer Ingelheim Co., Ltd.0 个研究点目标入组 129 人开始时间: 2020年8月19日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
研究概览
简要总结
In elderly Japanese patients with T2DM and insufficient glycaemic control, treatment with empagliflozin (10 mg) as an add-on therapy to OADs and in treatment naive patients demonstrated a statistically significant and clinically meaningful improvement in the change from baseline in HbA1c after 52 weeks of treatment compared with placebo. Empagliflozin as an add-on therapy to OADs and in treatment naive patients was well tolerated and no new safety findings were observed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 65age old 至 ot applicable(—)
- 性别
- All
入选标准
- •1.Japanese patients with diagnosis of type 2 diabetes mellitus prior to informed consent
- •2. Age over 65 years at informed consent
- •3. B+G20MI over 22 kg/m2
排除标准
- •1. Treatment with insulin within 12 weeks prior to informed consent
- •2. Uncontrolled hyperglycaemia with a fasting glucose level >200 mg/dL (>11.1 mmol/L) during run-in period
研究者
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