Treatment with a hormone that increases blood sugar levels of individuals that suffers from meal-induced low blow sugar due to bariatric surgery.
- Conditions
- Postprandial hyperinsulinemic hypoglycaemiaMedDRA version: 20.1Level: LLTClassification code 10079748Term: Reactive hypoglycaemiaSystem Organ Class: 100000004861Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2020-005241-16-DK
- Lead Sponsor
- Center for Clinical Metabolic Research at Herlev-Gentofte Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 24
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method