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临床试验/JPRN-jRCT2080223805
JPRN-jRCT2080223805已完成3 期

A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients with Diabetes Mellitus

Eli Lilly Japan K.K.0 个研究点目标入组 75 人开始时间: 2018年2月9日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
75

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 18age old 至 <= 70age old(—)
性别
All

入选标准

  • Type 1 diabetes
  • Age of 18 to 64 years old
  • Have been on multiple daily injection of insulin or continuous subcutaneous insulin infusion therapy for at least one year
  • Body mass Index (BMI) of 18.5 to 30.0 kilograms per meter squared (kg/m2)
  • Hemoglobin A1c (HbA1c) 10% or less
  • Type 2 diabetes
  • Age of 20 to 70 years old
  • Have been on multiple daily injection of insulin or continuous subcutaneous insulin infusion therapy with/ without oral anti hyperglycemic medications for at least 1 year
  • BMI of 18.5 to 35.0 kg/m2
  • HbA1c 10% or less

排除标准

  • Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month
  • Have received a total daily dose of insulin >1.2 units per kilogram (U/kg)
  • Have a history of an episode of severe hypoglycemia in the 1 month prior to screening or have a history of loss of consciousness within the last 2 years induced other than by hypoglycemia
  • Have known allergies or sensitivity to LY900018, glucagon, related compounds, or any components of the formulation, or history of significant atopy

研究者

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