Efficacy, Tolerability and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients With Post Bariatric Hypoglycemia

Trial ID or NCT#

NCT02771574

Status

not recruiting iconNOT RECRUITING

Purpose

This study is designed to evaluate the efficacy, safety and pharmacokinetics of subcutaneous exendin (9-39) in subjects with post-bariatric hypoglycemia. Development of this subcutaneous formulation of exendin (9-39) would represent a targeted therapeutic approach for this rare disease with unmet clinical need.

Official Title

A Phase 2 Multi-Ascending Dose Trial to Assess the Efficacy, Tolerability and Pharmacokinetic Profile of Exendin (9-39) in Patients With Post-bariatric Hyperinsulinemic Hypoglycemia

Eligibility Criteria

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Post-bariatric surgery more than 6 months prior to signing the informed consent - Reported history of Whipple's triad: the occurrence of hypoglycemic symptoms associated with a capillary blood glucose of ≤55 mg/dL, and resolution with glucose or carbohydrate administration. - Symptomatic hypoglycemia during the baseline/screening oral glucose tolerance test (OGTT), as defined by the presence of plasma glucose ≤55 mg/dL with concomitant autonomic and/or neuroglycopenic symptoms.
Exclusion Criteria:
  1. - Patients currently using sulfonylureas or other medications that may interfere with glucose metabolism within 5 half-lives of drug. - Participation in any clinical investigation within 4 weeks prior to dosing - History of or current insulinoma - Active infection or significant acute illness within 2 weeks prior to dosing - Female patients who are pregnant or lactating - Women of childbearing potential and not utilizing effective contraceptive methods - Inadequate end organ function
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Investigator(s)

Marilyn Tan
Marilyn Tan
Endocrinologist
Clinical Associate Professor, Medicine - Endocrinology, Gerontology, & Metabolism

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Contact

Cindy Lamendola, RN, MSN, NP
650-723-3141

View on ClinicalTrials.gov