Treatment of Post-bariatric Hypoglycaemia

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an investigator-initiated, proof-of-concept, randomised, double-blind, placebo-controlled, single-centre phase II study aiming to evaluate the efficacy, safety and tolerability of self-administered subcutaneous 120 µg dasiglucagon with an investigational trial device (i.e. a multi-dose reusable pen) for the treatment of postprandial hypoglycaemia after Roux-en-Y gastric bypass (RYGB) surgery. The study is divided into an in-patient and out-patient part.

The primary aim of the study is to compare the effects of self-administered 120 µg dasiglucagon versus placebo on continuous glucose monitoring (CGM)-assessed time spent in hypoglycaemia in RYGB-operated individuals in an out-patient setting.

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

Details

• Lead Sponsor: Filip Krag Knop
• Collaborator: Zealand Pharma

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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