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临床试验/JPRN-jRCT1080225321
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

发起方
ippon Boehringer Ingelheim Co., Ltd.

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