Ready-to-use dasiglucagon for the treatment of postprandial hypoglycaemia in Roux-en-Y gastric bypass operated patients

Center for Clinical Metabolic Research at Herlev-Gentofte Hospital0 个研究点目标入组 24 人开始时间: 2021年2月5日最近更新: 2021年4月12日

适应症

试验速览

暂无简介。

•-Documented postprandial hypoglycaemia (IG <3.9 mmol/l, =3 times/week) assessed by 14-days of blinded CGM recording
•-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 24
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Treatment with medication(s) affecting insulin secretion, glucose metabolism or any antidiabetic drugs
•-Treatment with antipsychotics
•-Current participation in another clinical trial with administration of investigational drug
•-Previous exposure to dasiglucagon (also known as ZP4207) within the last 30 days prior screening
•-History of liver disease that is expected to interfere with the anti-hypoglycaemic action of glucagon (e.g. liver failure or cirrhosis)
•-Pregnancy
•-Breastfeeding
•-Major surgery within 30 days before screening
•-Alcohol abuse (per investigator assessment)
•-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
•-History of pheochromocytoma or insulinoma
•-History of hypersensitivity or allergic reaction to dasiglucagon or any of the excipients
•-Known or suspected allergies to glucagon or related products

发起方

Center for Clinical Metabolic Research at Herlev-Gentofte Hospital