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

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ClinicalTrials.gov Identifier: NCT02996812
Recruitment Status : Unknown
Verified December 2016 by Tracey McLaughlin, Stanford University.
Recruitment status was:  Active, not recruiting
First Posted : December 19, 2016
Last Update Posted : December 19, 2016
Sponsor:
Information provided by (Responsible Party):
Tracey McLaughlin, Stanford University

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.

Condition or disease Intervention/treatment Phase
Hyperinsulinemia Hypoglycemia Drug: Exendin (9-39) Phase 1

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Subcutaneous Injection of Exendin (9-39) in Subjects With Hyperinsulinemic Hypoglycemia Post-Bariatric Surgery
Study Start Date : April 2015
Actual Primary Completion Date : May 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arm Intervention/treatment
Active Comparator: Dose A
Subcutaneous injection of Dose A of Exendin (9-39)
Drug: Exendin (9-39)
Active Comparator: Dose B
Subcutaneous injection of Dose B of Exendin (9-39)
Drug: Exendin (9-39)
Active Comparator: Dose C
Subcutaneous injection of Dose C of Exendin (9-39)
Drug: Exendin (9-39)
Active Comparator: Dose D
Subcutaneous injection of Dose D of Exendin (9-39)
Drug: Exendin (9-39)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 blood glucose of ≤55 mg/dL, and resolution with glucose or carbohydrate administration.
  • Symptomatic hypoglycemia during the baseline/screening OGTT, as defined by the presence of plasma glucose ≤55 mg/dL with concomitant autonomic and/or neuroglycopenic symptoms.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996812


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Tracey McLaughlin
Investigators
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Principal Investigator: Tracey McLaughlin, MD Stanford University

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Responsible Party: Tracey McLaughlin, Associate Professor of Medicine (Endocrinology), Stanford University
ClinicalTrials.gov Identifier: NCT02996812     History of Changes
Other Study ID Numbers: 34054
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: December 19, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tracey McLaughlin, Stanford University:
Post-bariatric hypoglycemia
Non-insulinoma pancreatogenous hypoglycemia syndrome
Late dumping syndrome

Additional relevant MeSH terms:
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Hypoglycemia
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases