Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Nadir plasma glucose concentration within two hundred forty minutes after MMT
研究概览
简要总结
The aim of this study is investigating the effect of a novel glucagon analogue administration in gastric bypass operated individuals, who are reactive hypoglycemic.
详细描述
The Roux-En-Y gastric bypass (RYGB) has major health-promoting effects - reversing type-2-diabetes, improving dyslipidemia and inducing robust weight loss. However, several RYGB-individuals, post surgery, suffers from dumping syndrome and postprandial hyperinsulinemic hypoglycemia (PHH) due to the anatomical rearrangement of the gastro-intestinal system. Dasiglugaon (also known as (ZP4207) has shown great pharmacokinetic- and dynamic effects, compared to other glucagon analogues on the market, when administrated to hypoglycemic type-1-diabetics.
Therefore we aim to examine the effects of two different doses of dasiglucagon on the postprandial nadir plasma glucose concentration in RYGB-operated individuals suffering from PHH by use of a mixed meal test (MMT).
The study is designed as a double-blinded, randomised, 3-period, 3-treatment, crossover study comprising 3 separate treatment days in which participants will undergo an MMT along with one of the following double-blinded interventions:
- Subcutaneous (sc) placebo (saline) injection
- Sc injection with 80 μg dasiglucagon
- Sc injection with 200 μg dasiglucagon
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Documented postprandial hypoglycaemia (<3.9 mmol/l) by 6-day CGM or during a MMT
- •Documented plasma glucose concentration excursions >5.0 mmol/l by 6-day CGM or a MMT
- •Haemoglobin levels for women >7.3 mmol/l and for men >8.3 mmol/l
- •Ferritin >10 μg/l
- •Cobalamin >150 pmol/l
- •Fasting plasma glucose concentration within the range of 4.0-6.0 mmol/l CKN-DASI-RYGB protocol version 1.0 6
- •Normal electrocardiogram (ECG)
- •Negative urine human chorionic gonadotropin (hCG) (for fertile women)
排除标准
- •Treatment with medication(s) affecting insulin secretion or any antidiabetic drugs
- •Treatment with antipsychotics
- •Current participation in another clinical trial with administration of investigational drug.
- •Previous exposure to dasiglucagon (otherwise known as ZP4207)
- •History of liver disease that is expected to interfere with the anti-hypoglycaemic action of glucagon (e.g. liver failure or cirrhosis).
- •Pregnancy
- •Breastfeeding
- •Any factors that, in the opinion of the site principal investigator or clinical protocol chair, would interfere with the safe completion of the study, including medical conditions that may require hospitalization during the trial or allergy to the ingredients in the study drug.
研究组 & 干预措施
80 ug of sc dasiglucagon
80 ug of dasiglucagon in a 0.4 mL fluid (saline) is injected abdominal subcutaneous postprandial prior to hypoglycemia.
干预措施: ZP4207 (Drug)
200 ug of sc dasiglucagon
200 ug of dasiglucagon in a 0.4 mL fluid (saline) is injected abdominal subcutaneous postprandial prior to hypoglycemia.
干预措施: ZP4207 (Drug)
0.4 mL of sc saline (placebo)
0.4 mL fluid (saline/placebo) is injected abdominal subcutaneous postprandial prior to hypoglycemia.
干预措施: Placebo (saline) (Other)
结局指标
主要结局
Nadir plasma glucose concentration within two hundred forty minutes after MMT
时间窗: Two hundred forty minutes
Nadir plasma glucose concentration within two hundred forty minutes after MMT
次要结局
- Frequency and severity of adverse events and serious adverse events recorded during the meal test(from t= minus thirty to t=Two hundred forty minutes)
- Time in hypoglycaemia (plasma glucose concentration <3.9 mmol/l) from study drug administration until 240 minutes(Two hundred forty minutes)
- Time below fasting plasma glucose level from study drug administration until two hundred forty minutes(Two hundred forty minutes)
- Time from dasiglucagon administration to recovery (first plasma glucose value above the fasting plasma glucose level(Two hundred forty minutes)
- Edinburgh Hypoglycaemia Symptom Scale (EHSS) responses of the Edinburgh Hypoglycaemia Symptom Scale (EHSS) and early dumping symptoms based on(t=zero to t=Two hundred forty minutes)
- The Dumping Severity Score (DSS).(t=zero to t=Two hundred forty minutes)
- Area 1: the area above the glucose curve and below the fasting level from the time of study drug administration until glucose values reach the fasting level.(Two hundred forty minutes)
- Area 2: the area below the glucose curve and above the fasting level from the time glucose values reach the fasting level until 240 minutes.(Two hundred forty minutes)
研究者
Filip Krag Knop
MD, professor
University Hospital, Gentofte, Copenhagen