Status:
COMPLETED
Treatment of Post-bariatric Hypoglycaemia
Lead Sponsor:
Filip Krag Knop
Collaborating Sponsors:
Zealand Pharma
Conditions:
Hyperinsulinemic Hypoglycemia
Postprandial Hypoglycemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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-adminis...
Detailed Description
Study design: Before inclusion in the study, the participants will complete a screening visit and a blinded 14-day continuous glucose monitoring (CGM) run-in period to ascertain a regular occurrence ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04836273
Start Date
August 20 2021
End Date
December 15 2022
Last Update
February 2 2023
Active Locations (1)
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1
Center for Clinical Metabolic Research, Herlev-Gentofte Hospital
Hellerup, Denmark, 2900