Phase II Study to Investigate the Safety and Efficacy of 2 Dose Levels of a Novel Glucagon Formulation Compared to Commercially Available Glucagon in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Percentage of Responders
研究概览
简要总结
In this study, participants with Type 1 diabetes received insulin through an infusion into a vein to reduce their blood glucose, and then received nasal glucagon (NG) or glucagon for injection under the skin, and their blood glucose was measured for 3 hours.
The main objective of this study was to evaluate the safety and efficacy of intranasal and subcutaneous glucagon (SC) in reversing insulin-induced hypoglycemia in participants with type 1 diabetes.
详细描述
In the study, up to four (4) treatments were administered as a single dose either intranasally or subcutaneously to eighteen (18) male or female participants under fasting conditions and following the use of insulin to lower blood glucose. The participants were assigned at random to a group that received one treatment for each of the 3 study periods. The glucagon administrations were separated by approximately 7 calendar days. For 2 participants, a single dose of 3 mg NG was administered at the 4th period that was separated by at least 21 calendar days from the 3rd period.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of type 1 diabetes between 2 and 30 years
- •Receiving daily insulin injections or insulin pump therapy for at least 2 years
- •If patient is taking Lantus, Levemir or equivalent once-daily in the evening as basal insulin, must be willing to transition to once-daily in the morning at least 48 hours prior to 1st dosing, and to follow this dosing regimen for the entire duration of the study
- •Body mass index (BMI) greater than or equal to 20.00 and below or equal to 33.00 kg/m2
- •Female patients must not be pregnant, and must be using effective contraception.
- •Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes or less per day for at least 3 months before day 1 of this study. An ex smoker is defined as someone who completely stopped smoking for at least 6 months before day 1 of this study
排除标准
- •History of an episode of severe hypoglycemia (as defined by an episode that required third party assistance for treatment) in the previous 6 months before day 1 of this study
- •Score ≥4 on the Clarke Hypoglycemia Awareness survey at screening
- •Presence or history of pheochromocytoma (i.e. adrenal gland tumor)
- •Presence or history of significant upper respiratory or allergic (i.e., seasonal rhinitis) disease
- •Presence of clinically significant findings on nasal examination and bilateral anterior rhinoscopy
- •Known presence of hereditary problems of galactose and /or lactose intolerance
- •History of significant hypersensitivity to glucagon or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs
研究组 & 干预措施
Nasal Glucagon 1 mg
Nasal glucagon (NG) administered as single dose of 1 milligram (mg).
干预措施: Nasal Glucagon 1 mg (Drug)
Nasal Glucagon 2 mg
NG administered as single dose of 2 mg.
干预措施: Nasal Glucagon 2 mg (Drug)
SC Glucagon
Glucagon solution dose of 1 mg administered as a single subcutaneous (SC) injection.
干预措施: SC Glucagon (Drug)
Nasal Glucagon 3 mg
NG administered as single dose of 3 mg (composed of one dose of 1 mg NG immediately followed by one dose of 2mg NG).
干预措施: Nasal Glucagon 3 mg (Drug)
结局指标
主要结局
Percentage of Responders
时间窗: Pre-dose; 30 minutes following glucagon administration
Participants with a blood glucose increment of ≥1.5 millimole per liter \[mmol/L) within 15 of nadir (5 minutes post dose) and for at least 10 minutes following nadir.
Number of Participants With at Least One Adverse Event
时间窗: Within 3 hours post glucagon administration
Safety and tolerability evaluated through the assessment of adverse events. An AE was defined as any untoward medical occurrence in a clinical investigation subject administered the investigational product and which did not necessarily have a causal relationship with this treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
次要结局
- Maximum Concentration (Cmax) of Baseline-Adjusted Glucose(Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration)
- Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose(Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration)
- Maximum Change From Baseline Concentration (Cmax) of Glucagon(Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration)
- Area Under the Curve (AUC0-last) of Baseline Adjusted Glucagon(Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration)
- Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon(Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration)