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
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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