A Randomized Open-label Crossover Study to Compare the Safety and Efficacy of ZP-Glucagon to Injectable Glucagon in the Treatment of Insulin-induced Hypoglycemia in Subjects With Type-1 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Percentage of subjects achieving normoglycemia
研究概览
简要总结
The purpose of this study is to determine whether glucagon administered by microneedle patch is comparable to glucagon administered by injection pen in the treatment of insulin-induced hypoglycemia.
详细描述
The purpose of this study is to compare ZP-Glucagon transdermal patch system at doses of 0.5 mg and 1 mg to glucagon by injection at doses of 0.5 mg and 1 mg by means of a 4 way crossover open label design. Eligible subjects giving informed consent will be randomised to a treatment sequence of each of the four treatments in one week intervals. At each treatment visit, subjects will undergo an insulin induction procedure designed to safely induce hypoglycemia, and then have a treatment applied, either by injection or by patch, and then monitored for return to normoglycemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women or men 18 to 60 years with type-1 diabetes on daily insulin treatment (basal-bolus injection regimen or insulin pump) for at least two years, on a total daily dose that has been stable for the last 3 months preceding enrollment (no more than 20% variation), and with a current level of glycated hemoglobin between 6.5% and 10%
排除标准
- •Any history of hypoglycemic coma or hypoglycemic seizures.
- •Any episode of severe hypoglycemia (requiring treatment) within one month prior to study start.
- •Any history of pheochromocytoma or insulinoma
研究组 & 干预措施
ZP-Glucagon 0.5 mg
glucagon applied to the ZP transdermal microneedle patch system at a dose of 0.5 mg applied by means of a purpose built reusable applicator and worn for 30 minutes
干预措施: Glucagon (ZP-Glucagon) (Drug)
ZP-Glucagon 1.0 mg
glucagon applied to the ZP transdermal microneedle patch system at a dose of 1.0 mg applied by means of a purpose built reusable applicator and worn for 30 minutes
干预措施: Glucagon (ZP-Glucagon) (Drug)
Glucagon by injection, 0.5 mg
glucagon applied as GlucaGen (NovoNordisk) injector system at a dose of 0.5 mg
干预措施: Glucagon (GlucaGen) (Drug)
Glucagon by injection, 1.0 mg
glucagon applied as GlucaGen (NovoNordisk) injector system at a dose of 0.5 mg
干预措施: Glucagon (GlucaGen) (Drug)
结局指标
主要结局
Percentage of subjects achieving normoglycemia
时间窗: 30 minutes
次要结局
- Time at which maximal glucose levels are reached(3 hours)
- Increases in blood glucose by 15 minute intervals(3 hours)
- Peak Plasma Concentration (Cmax)(3 hours)
- Time at which normoglycemia is first reached(3 hours)
- Area under the plasma concentration versus time curve (AUC)(3 hours)