Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gas… (NCT04824872) | Clinical Trial Compass
WithdrawnPhase 2
Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults
Stopped: Never started
0Started 2023-02
Plain-language 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 Bypass (RYGB) subjects
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Nadir plasma glucose concentration
Timeframe: From trial drug administration to 240 minutes after initiation of Mixed Meal Test