Dasiglucagon in the treatment of postprandial hypoglycaemia after Roux-en-Y gastric bypass

Center for Clinical Metabolic Research at Herlev-Gentofte Hospital0 个研究点目标入组 10 人开始时间: 2019年6月26日最近更新: 2021年6月14日

适应症

试验速览

暂无简介。

•-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
•-Normal electrocardiogram (ECG)
•-Negative urine human chorionic gonadotropin (hCG) (for fertile women)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•-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.

发起方

Center for Clinical Metabolic Research at Herlev-Gentofte Hospital