Equivalence of A Stable Liquid Glucagon Formulation With Freshly Reconstituted Lyophilized Glucagon
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Tmax
研究概览
简要总结
This study will test the hypothesis that micro-doses of Xerisol Glucagon (Xeris Pharmaceuticals) will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of Glucagon for Injection (Eli Lilly).
详细描述
This study will test the hypothesis that micro-doses of a new formulation of stable glucagon, Xerisol Glucagon (Xeris Pharmaceuticals), will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of a freshly reconstituted formulation of glucagon that has poor stability in solution, Glucagon for Injection (Eli Lilly).
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 to 80 years old with type 1 diabetes for at least one year.
- •Diabetes managed using an insulin infusion pump using rapid-acting insulin such as insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra) for at least one week prior to enrollment.
排除标准
- •Unable to provide informed consent.
- •Unable to comply with study procedures.
- •Current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the clamp study or the safety of the subject.
- •Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception.
- •End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
- •Hemoglobin < 11.5 gm/dl.
- •History of pheochromocytoma. Fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor (paroxysms of tachycardia, pallor, or headache; personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease; episodic or treatment of refractory hypertension, defined as requiring 4 or more medications to achieve normotension).
- •History of adverse reaction to glucagon (including allergy) besides nausea, vomiting, or headache.
- •Inadequate venous access as determined by study nurse or physician at time of screening.
- •Liver failure or cirrhosis.
- •Any other factors that, in the judgment of the principal investigator, would interfere with the safe completion of the study procedures.
研究组 & 干预措施
Xeris glucagon
Xeris glucagon 50 micrograms, subcutaneous injection
干预措施: Xeris glucagon (Drug)
Lilly glucagon
Lilly glucagon 30 micrograms, subcutaneous injection
干预措施: Lilly glucagon (Drug)
结局指标
主要结局
Tmax
时间窗: every 2 minutes for 1 hour post-dose of each glucagon
tmax for Xeris vs. Lilly (non-inferiority)
次要结局
- GIRmin(every 2 minutes for 1 hour post-dose of each glucagon)
- Injection Pain(immediately after injection)
- Maximal Nausea(within 1 hour of injection)
- AOCGIR(every 2 minutes for 1 hour post-dose of each glucagon)
- t½Max(every 2 minutes for 1 hour post-dose of each glucagon)
- Injection Site Erythema(within 1 hour of injection)
- Dermal Response (Draize Scale Grade for Edema Formation)(within 1 hour of injection)
- Dermal Response (Draize Scale for Erythema and Eschar Formation)(within 1 hour of injection)
研究者
Steven J. Russell, MD, PhD
Assistant Professor of Medicine
Massachusetts General Hospital