Hyperinsulinemia Hypoglycemia Clinical Trial
Official title:
Subcutaneous Injection of Exendin (9-39) in Subjects With Hyperinsulinemic Hypoglycemia Post-Bariatric Surgery
This study is designed to evaluate the safety, efficacy, and pharmacokinetic profile of single ascending doses of exendin 9-39 administered by subcutaneous route in subjects with post-bariatric hypoglycemia.
Post-Bariatric Hypoglycemia (PBH) is a debilitating rare disease afflicting 0.2-6.9% of
post-bariatric patients, characterized by repeated severe hypoglycemic episodes with
neuroglycopenic symptoms and marked disability. There are no effective medical therapies.
While the cause is not known, exaggerated postprandial secretion of glucagon-like peptide-1
(GLP-1) as a result of altered nutrient transit likely plays a major role. GLP-1 is an
incretin hormone secreted primarily by the distal ileum that contributes to postprandial
glucose regulation. Exendin 9-39 (Ex9) is a specific GLP-1 receptor antagonist, that when
given via continuous IV infusion, has been shown to effectively prevent postprandial
hypoglycemia in patients with PBH. Subcutaneous (SC) injection of Ex9 may represent a safe,
effective and practical therapeutic approach to treating PBH.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment