Treatment of Post-bariatric Hypoglycaemia (NCT04836273) | Clinical Trial Compass
CompletedPhase 2
Treatment of Post-bariatric Hypoglycaemia
Denmark24 participantsStarted 2021-08-20
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time spent in hypoglycaemia (IG < 3.9 mmol)
Timeframe: During the four weeks of placebo and dasiglucagon treatment.