CompletedPhase 2

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

Lead sponsor

University Hospital, Gentofte, Copenhagen

Asset

Dasiglucagon

Subcutaneous · Glucagon receptor agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Prediabetes / glucose intolerance

Eligibility highlights

Primary endpoint

•Nadir plasma glucose concentration within two hundred forty minutes after MMT

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03984370

Org study IDCKN-DASI-RYGB

Secondary ID2019

Secondary ID2019-001915-22

Timeline

Milestones

Study first posted2019-06-13actual

Study start2019-09-18actual

Primary completion2020-02-26actual

Study completion2020-02-26actual

Last update posted2020-03-31actual

Assets

Investigational agents

Dasiglucagon

Who this study enrolls

Prediabetes / glucose intolerance

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

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.

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK

Other (unclassified)