NCT03339453已完成1 期
Comparison of Glucagon Administered by Either the Nasal (LY900018) or Intra-muscular (GlucaGen®) Routes in Adult Patients With Type 1 Diabetes Mellitus During Controlled Insulin-Induced Hypoglycemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia
研究概览
简要总结
The purpose of this study is to compare a needle-free treatment of hypoglycemia with nasal glucagon (study drug) to a marketed glucagon administered by the intramuscular (IM) route, in participants with type 1 diabetes mellitus (T1DM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Type 1 Diabetes Mellitus (T1DM) for at least 2 years and receiving daily insulin since the time of diagnosis
排除标准
- •Have a history of hypersensitivity to glucagon or any related products or severe hypersensitivity reactions (such as angioedema) to any drugs
- •Have a history of pheochromocytoma (that is, adrenal gland tumor) or insulinoma
- •Occurrence of an episode of severe hypoglycemia (defined as requiring the assistance of another person in the 1 month prior to enrolling in the study)
- •Have a history of epilepsy or seizure disorder
- •Are women who are pregnant or lactating
- •Have, except for the current regimen of insulin therapy and concomitant medication, regular use of or intended use of any over-the-counter or prescription medications or nutritional supplements that treat hyperglycemia or insulin resistance or that promote weight loss within 14 days before dosing
- •Daily use of systemic beta-blocker, indomethacin, warfarin or anticholinergic drugs
- •Require daily insulin treatment greater than (>)1.5 unit/kilograms (U/kg)/body weight
研究组 & 干预措施
Nasal Glucagon
Experimental
Single dose of Nasal Glucagon.
干预措施: Nasal Glucagon (Drug)
Intramuscular Glucagon
Active Comparator
Single intramuscular (IM) dose of Glucagon.
干预措施: Intramuscular Glucagon (Drug)
结局指标
主要结局
Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia
时间窗: Pre-dose up to 30 minutes post each glucagon administration
Treatment success is defined as an increase in plasma glucose to greater than or equal to (≥) 70 milligrams per deciliter (mg/dL) or an increase of ≥20 mg/dL from plasma glucose nadir, without receiving additional actions to increase the plasma glucose concentration. Nadir is defined as the minimum plasma glucose concentration at the time of or within 10 minutes following glucagon administration.
次要结局
- Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax)(Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration)
- PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose(Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Baseline Adjusted Glucagon(Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration)
- PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon(Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration)
- PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon(Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration)
研究者
研究点 (1)
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