Clinical Trial: Evaluation of Single Ascending Doses of Subcutaneous Exendin 9-39 in Patients With Post-Bariatric Hypoglycemia

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Subcutaneous Injection of Exendin (9-39) in Subjects With Hyperinsulinemic Hypoglycemia Post-Bariatric Surgery

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Tracey McLaughlin

Current Primary Outcome: Treatment effect on plasma glucose [ Time Frame: 0-180 minutes following initiation of oral glucose tolerance test (OGTT) conducted after treatment. ]

Magnitude of plasma glucose nadir during repeat OGTT after treatment


Original Primary Outcome: Same as current

Current Secondary Outcome: Treatment effect on symptoms of hypoglycemia [ Time Frame: 0-180 minutes following initiation of OGTT ]

Response rate in symptom score during repeat OGTT after treatment.


Original Secondary Outcome: Same as current

Information By: Stanford University

Dates:
Date Received: December 15, 2016
Date Started: April 2015
Date Completion: May 2017
Last Updated: December 15, 2016
Last Verified: December 2016