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

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ClinicalTrials.gov Identifier: NCT02771574
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Tracey McLaughlin, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Post Bariatric Hypoglycemia Drug: Exendin (9-39) Phase 2

Detailed Description:
Post-Bariatric Hypoglycemia (PBH) is a rare, but increasingly reported disease occurring after bariatric surgery, characterized by severe hypoglycemic episodes accompanied by symptoms of hypoglycemia. At the moment, no medical therapies have been developed for this disorder, but the clinical need is great. The major contributory factor is thought to be an exaggerated secretion of glucagon-like peptide-1 (GLP-1) due to altered nutrient transit after bariatric surgery. GLP-1 is an incretin hormone secreted primarily by the distal ileum that contributes to postprandial glucose regulation. Exendin (9-39) is a specific GLP-1 receptor antagonist, that when given via continuous IV infusion, has been shown to effectively prevent postprandial hypoglycemia and reduce symptoms of hypoglycemia in patients with PBH. This study is designed to assess the efficacy, safety and pharmacokinetic profile of a novel subcutaneous formulation of exendin (9-39).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Study Start Date : May 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 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. ]
    Response rate in 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.


Other Outcome Measures:
  1. Pharmacokinetics of subcutaneous exendin (9-39) [ Time Frame: 0-720 minutes following each subcutaneous injection of exendin (9-39) over 4 days. ]
    Plasma concentrations of exendin (9-39)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 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 a capillary 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): NCT02771574


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: Marilyn Tan, MD Clinical Assistant Professor

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Responsible Party: Tracey McLaughlin, Associate Professor of Medicine (Endocrinology), Stanford University
ClinicalTrials.gov Identifier: NCT02771574     History of Changes
Other Study ID Numbers: 36673
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tracey McLaughlin, Stanford University:
Bariatric surgery complications
Glucose Metabolism Disorders
Exendin (9-39)
GLP-1
Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases