G-Pen (Glucagon Injection) Compared to Lilly Glucagon (Glucagon for Injection [RDNA Origin]) for Induced Hypoglycemia Rescue in Adult Patients With T1DM: A Phase 3, Multi-center, Randomized, Blinded, 2-Way Crossover Study to Evaluate Efficacy and Safety
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 7
- 主要终点
- Hypoglycemia Rescue: Per Protocol Population
研究概览
简要总结
This is a blinded, randomized crossover study to compare the safety and efficacy of G-Pen (glucagon injection) to Lilly Glucagon (glucagon for injection [rDNA origin]) for hypoglycemia rescue of adult patients with type 1 diabetes.
详细描述
This is a blinded, randomized, Phase 3 comparative efficacy and safety study in adults with type 1 diabetes. Patients will complete screening procedures up to 60 days before randomization to determine eligibility before enrollment to the treatment phase.
The procedure for evaluating the efficacy of the G-Pen (glucagon injection) consists of inducing hypoglycemia by intravenous administration of regular insulin diluted in normal saline. Each participant will undergo two episodes of insulin-induced hypoglycemia, and in random order will receive 1 mg G-Pen (glucagon injection) during one episode and 1 mg Lilly Glucagon during the other episode. There will be wash out period of 7-28 days between treatment visits.
Blood glucose levels will be monitored post-dosing, with a return of plasma glucose to a concentration > 70 mg/dL within 30 minutes signifying successful hypoglycemia rescue. As a confirmation of efficacy, subjects will complete a questionnaire concerning changes in symptoms of hypoglycemia following treatment with glucagon.
Subjects will return for a follow-up safety visit 3-14 days following administration of the final dose of glucagon.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with type 1 diabetes mellitus for at least 24 months
- •usage of daily insulin treatment
- •random serum C-peptide concentration < 0.5 ng/mL
排除标准
- •pregnant or nursing
- •HbA1c >9.0%
- •renal insufficiency
- •hepatic synthetic insufficiency
- •aspartate or alanine aminotransferase > 3 times the upper limit of normal
- •hematocrit less than or equal to 30%
- •use of > 2.0 U/kg total insulin dose per day
- •inadequate bilateral venous access in both arms
- •congestive heart failure, New York Heart Association class II, III or IV
- •active malignancy within 5 years, except basal cell or squamous cell skin cancers
- •history of breast cancer or malignant melanoma
- •major surgical operation within 30 days
- •current seizure disorder.
- •current bleeding disorder, treatment with warfarin, or platelet count below 50,000
- •history of pheochromocytoma or disorder with increased risk of pheochromocytoma
- •history of insulinoma
- •history of glycogen storage disease.
- •positive for HIV, hepatitis C virus or active hepatitis B virus infection
- •whole blood donation of 1 pint (500 mL) within 8 weeks
- •active substance or alcohol abuse
- •administration of glucagon within 28 days
- •participation in other studies involving an investigational drug or device within 30 days
研究组 & 干预措施
G-Pen first, then Lilly Glucagon
A single 1 mg subcutaneous (SC) injection of G-Pen (glucagon injection) with a 7-28 day wash-out, followed by a single 1 mg SC injection of Lilly Glucagon (glucagon injection [rDNA origin])
干预措施: G-Pen (glucagon injection) (Drug)
G-Pen first, then Lilly Glucagon
A single 1 mg subcutaneous (SC) injection of G-Pen (glucagon injection) with a 7-28 day wash-out, followed by a single 1 mg SC injection of Lilly Glucagon (glucagon injection [rDNA origin])
干预措施: Lilly Glucagon (glucagon injection [rDNA origin]) (Drug)
Lilly Glucagon first, then G-Pen
A single 1 mg SC injection of Lilly Glucagon (glucagon injection [rDNA origin]) with a 7-28 day wash-out, followed by a single 1 mg SC injection of G-Pen (glucagon injection)
干预措施: G-Pen (glucagon injection) (Drug)
Lilly Glucagon first, then G-Pen
A single 1 mg SC injection of Lilly Glucagon (glucagon injection [rDNA origin]) with a 7-28 day wash-out, followed by a single 1 mg SC injection of G-Pen (glucagon injection)
干预措施: Lilly Glucagon (glucagon injection [rDNA origin]) (Drug)
结局指标
主要结局
Hypoglycemia Rescue: Per Protocol Population
时间窗: At 30 minutes following administration of study drug
Number of subjects with an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL within 30 minutes after administration of glucagon
Hypoglycemia Rescue: Alternate Glucose Response Definition
时间窗: At 30 minutes following administration of study drug
Number of subjects with either an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL or an increase in from baseline in plasma glucose concentration of at least 20 mg/dL within 30 minutes after administration of glucagon
Hypoglycemia Rescue: Intent-to-Treat Population
时间窗: At 30 minutes following administration of study drug
Number of subjects with an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL within 30 minutes after administration of glucagon
次要结局
- Plasma Glucose Area Under the Curve (AUC)(At -5, 0, 10, 20, 30, 45, 60, and 90 minutes following administration of glucagon)
- Time to Resolution of Hypoglycemia Symptoms(At 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 minutes following administration of glucagon)
- Plasma Glucose Maximum Concentration (Cmax)(At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon)
- Plasma Glucose Time to Maximum Concentration (Tmax)(At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon)
- Plasma Glucose Time to Concentration > 70 mg/dL(At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon)
- Global Assessment of Hypoglycemia(At 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 minutes following administration of glucagon)