Efficacy, Tolerability and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients With Post Bariatric Hypoglycemia
Completed · Phase 2
Conditions studied: Post Bariatric Hypoglycemia
In brief
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.
Key facts
- Study ID
- NCT02771574
- Run by
- Tracey McLaughlin
- People needed
- 19
- Starts
- 2016-05-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2020-11-13
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Stanford University School of Medicine — Stanford, California, United States
Full record on ClinicalTrials.gov
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