Status:
WITHDRAWN
Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults
Lead Sponsor:
Zealand Pharma
Conditions:
Hypoglycemia
Glucose Metabolism Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The objective of the trial is to assess the effect of single subcutaneous doses of dasiglucagon versus placebo on post-prandial plasma glucose nadir following a Mixed Meal Test in Roux-en-Y Gastric By...
Eligibility Criteria
Inclusion
- Previously undergone Roux-en-Y gastric bypass (RYGB) surgery at least 6 months prior to screening
- Previous diagnosis of post-bariatric hypoglycemia (PBH), requiring intake of oral carbohydrates.
- Body mass index (BMI) ≤ 40 kg/m2
- Fasting plasma glucose between 72-106 mg/dL (4.0-6.0 mmol/l)
Exclusion
- History of hypersensitivity reactions to glucagon or dasiglucagon or any of the excipients
- History of insulinoma, pheochromocytoma, MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease.
- Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m2 or end-stage renal disease at screening
- Hepatic disease, including serum alanine aminotransferase or aspartate aminotransferase ≥ 2.5 times the upper limit of normal (ULN)
- Active malignancy, except for basal or squamous cell skin cancers
- History of a cerebrovascular accident within 6 months prior to screening
- History of myocardial infarction, unstable angina, or revascularization within 6 months prior to screening.
- Congestive heart failure, New York Heart Association Class III or IV
- Concurrent administration of β-blocker therapy
- Clinically significant ECG abnormalities at screening
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04824872
Start Date
February 1 2023
End Date
February 1 2023
Last Update
February 21 2023
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