A Double-Blind, Placebo-Controlled, Cross-over Trial, Evaluating Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Nadir plasma glucose concentration
研究概览
简要总结
The objective of the trial is to assess the effect of single subcutaneous doses of dasiglucagon versus placebo on post-prandial plasma glucose nadir following a Mixed Meal Test in Roux-en-Y Gastric Bypass (RYGB) subjects
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Previously undergone Roux-en-Y gastric bypass (RYGB) surgery at least 6 months prior to screening
- •Previous diagnosis of post-bariatric hypoglycemia (PBH), requiring intake of oral carbohydrates.
- •Body mass index (BMI) ≤ 40 kg/m2
- •Fasting plasma glucose between 72-106 mg/dL (4.0-6.0 mmol/l)
排除标准
- •History of hypersensitivity reactions to glucagon or dasiglucagon or any of the excipients
- •History of insulinoma, pheochromocytoma, MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease.
- •Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m2 or end-stage renal disease at screening
- •Hepatic disease, including serum alanine aminotransferase or aspartate aminotransferase ≥ 2.5 times the upper limit of normal (ULN)
- •Active malignancy, except for basal or squamous cell skin cancers
- •History of a cerebrovascular accident within 6 months prior to screening
- •History of myocardial infarction, unstable angina, or revascularization within 6 months prior to screening.
- •Congestive heart failure, New York Heart Association Class III or IV
- •Concurrent administration of β-blocker therapy
- •Clinically significant ECG abnormalities at screening
研究组 & 干预措施
Sequence 4
Dasiglucagon high dose, followed by dasiglucagon low dose, followed by placebo
干预措施: Placebo (Drug)
Sequence 1
Dasiglucagon high dose, followed by placebo, followed by dasiglucagon low dose
干预措施: Dasiglucagon (Drug)
Sequence 1
Dasiglucagon high dose, followed by placebo, followed by dasiglucagon low dose
干预措施: Placebo (Drug)
Sequence 2
Dasiglucagn low dose, followed by dasiglucagon high dose, followed by placebo
干预措施: Dasiglucagon (Drug)
Sequence 2
Dasiglucagn low dose, followed by dasiglucagon high dose, followed by placebo
干预措施: Placebo (Drug)
Sequence 3
Placebo, followed by dasiglucagon low dose, followed by dasiglucagon high dose
干预措施: Dasiglucagon (Drug)
Sequence 3
Placebo, followed by dasiglucagon low dose, followed by dasiglucagon high dose
干预措施: Placebo (Drug)
Sequence 4
Dasiglucagon high dose, followed by dasiglucagon low dose, followed by placebo
干预措施: Dasiglucagon (Drug)
Sequence 5
Placebo, followed by dasiglucagon high dose, followed by dasiglucagn low dose
干预措施: Dasiglucagon (Drug)
Sequence 5
Placebo, followed by dasiglucagon high dose, followed by dasiglucagn low dose
干预措施: Placebo (Drug)
Sequence 6
Dasiglucagon low dose, followed by placebo, followed by dasiglucagon high dose
干预措施: Dasiglucagon (Drug)
Sequence 6
Dasiglucagon low dose, followed by placebo, followed by dasiglucagon high dose
干预措施: Placebo (Drug)
结局指标
主要结局
Nadir plasma glucose concentration
时间窗: From trial drug administration to 240 minutes after initiation of Mixed Meal Test
次要结局
- Percent time spent in hyperglycemia(From trial drug administration to 240 minutes after initiation of Mixed Meal Test)
- Percent time spent in hypoglycemia(From trial drug administration to 240 minutes after initiation of Mixed Meal Test)
- Percent time spent in clinical significant hypoglycemia(From trial drug administration to 240 minutes after initiation of Mixed Meal Test)
- Percent time spent in target range(From trial drug administration to 240 minutes after initiation of Mixed Meal Test)