Comparison of Pharmacokinetic and Pharmacodynamic Profiles of G-Pump™ (Glucagon Infusion) vs. GlucaGen® Delivered Subcutaneously to Subjects With Type 1 Diabetes (T1DM)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early)
研究概览
简要总结
The purpose of the study is to assess the safety, speed of absorption, and onset of action of G-Pump™ (glucagon infusion) at three subcutaneous doses as compared to Novo GlucaGen®, all delivered via an OmniPod® infusion pump to patients with type 1 diabetes.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females diagnosed with type 1 diabetes mellitus for at least 24 months
- •Current usage of subcutaneous insulin pump treatment
- •Age 18-65 years
- •C-peptide level < 0.5 ng/ml
- •Willingness to follow all study procedures, including attending all clinic visits
- •Subject has provided informed consent and has signed and dated an informed consent form before any trial-related activities
排除标准
- •Pregnant and/ or Lactating: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study.
- •HbA1c >10.0%
- •Renal insufficiency (serum creatinine of 1.2 mg/dL or greater)
- •Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less than 3.0 g/dL; or serum bilirubin of over 2.
- •Hematocrit of less than or equal to 34%
- •Congestive heart failure, NYHA class II, III or IV
- •History of coronary artery disease
- •Active foot ulceration
- •History of a cerebrovascular accident
- •Active alcohol abuse or substance abuse
- •Active malignancy, except basal cell or squamous cell skin cancers
- •Major surgical operation within 30 days prior to screening
- •Seizure disorder
- •Current administration of oral or parenteral corticosteroids
- •Use of an investigational drug within 30 days prior to screening
- •Bleeding disorder, treatment with warfarin, or platelet count below 50,000
- •Proliferative or severe non-proliferative retinopathy
- •Gastroparesis
- •Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease)
- •Insulinoma
- •Allergies to glucagon or glucagon-like products, or any history of significant hypersensitivity to glucagon or any related products.
- •Glycogen storage disease
- •Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen
- •Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening.
- •Any reason the principal investigator deems exclusionary
研究组 & 干预措施
G-Pump™ (glucagon infusion)
G-Pump™ (glucagon infusion); single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
干预措施: Novo Nordisk GlucaGen® (Drug)
G-Pump™ (glucagon infusion)
G-Pump™ (glucagon infusion); single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
干预措施: G-Pump™ (glucagon infusion) (Drug)
Novo Nordisk GlucaGen®
Novo Nordisk GlucaGen®; single subcutaneous infusion doses 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
干预措施: Novo Nordisk GlucaGen® (Drug)
Novo Nordisk GlucaGen®
Novo Nordisk GlucaGen®; single subcutaneous infusion doses 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
干预措施: G-Pump™ (glucagon infusion) (Drug)
结局指标
主要结局
Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early)
时间窗: 0 to 150 minutes post-dosing
The onset of action was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucose following each dose of glucagon.
Time to Reach 50% of Maximum Glucagon Concentration (Glucagon T50%-Early)
时间窗: 0 to 150 minutes post-dosing
The speed of absorption was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucagon following each dose of glucagon.
次要结局
- Glucagon Cmax(From 0 to 150 minutes post-dosing)
- Glucose Cmax(From 0 to 150 minutes post-dosing)
- Glucagon Tmax(From 0 to 150 minutes post-dosing)
- Glucose Tmax(From 0 to 150 minutes post-dosing)
- Glucagon AUC(From 0 to 150 minutes post-dosing)
- Glucose AUC(From 0 to 150 minutes post-dosing)
- Infusion Site Discomfort Score at 10 Minutes(At 10 minutes post-dosing)
- Infusion Site Discomfort Score at 30 Minutes(At 30 minutes post-dosing)