Hormone treatment of low blood sugar due to meal ingestion in individuals with a reduced stomach size

Phase 1

• Conditions: Postprandial hyperinsulinemic hypoglycaemia; MedDRA version: 20.1Level: LLTClassification code 10079748Term: Reactive hypoglycaemiaSystem Organ Class: 100000004861; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2019-001915-22-DK
• Lead Sponsor: Center for Clinical Metabolic Research at Herlev-Gentofte Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-26
• Study Completion: 2020-02-26
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

-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

Exclusion Criteria

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified