Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass

• Status: Completed
• Trial end date: 2020-02-26
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is investigating the effect of a novel glucagon analogue administration in gastric bypass operated individuals, who are reactive hypoglycemic.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Criteria

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 CKN-DASI-RYGB protocol version 1.0 6

• Normal electrocardiogram (ECG)

• Negative urine human chorionic gonadotropin (hCG) (for fertile women)

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.