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

Primary Purpose

Hyperinsulinemia Hypoglycemia

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Exendin (9-39)

About this trial

This is an interventional treatment trial for Hyperinsulinemia Hypoglycemia focused on measuring Post-bariatric hypoglycemia, Non-insulinoma pancreatogenous hypoglycemia syndrome, Late dumping syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Dose A

Dose B

Dose C

Dose D

Arm Description

Subcutaneous injection of Dose A of Exendin (9-39)

Subcutaneous injection of Dose B of Exendin (9-39)

Subcutaneous injection of Dose C of Exendin (9-39)

Subcutaneous injection of Dose D of Exendin (9-39)

Outcomes

Primary Outcome Measures

Treatment effect on plasma glucose

Magnitude of plasma glucose nadir during repeat OGTT after treatment

Secondary Outcome Measures

Treatment effect on symptoms of hypoglycemia

Response rate in symptom score during repeat OGTT after treatment.

Full Information

NCT ID

NCT02996812

First Posted

December 15, 2016

Last Updated

December 15, 2016

Sponsor

Tracey McLaughlin

1. Study Identification

Unique Protocol Identification Number

NCT02996812

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Unknown status

Study Start Date

April 2015 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Tracey McLaughlin

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperinsulinemia Hypoglycemia

Keywords

Post-bariatric hypoglycemia, Non-insulinoma pancreatogenous hypoglycemia syndrome, Late dumping syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose A

Arm Type

Active Comparator

Arm Description

Subcutaneous injection of Dose A of Exendin (9-39)

Arm Title

Dose B

Arm Type

Active Comparator

Arm Description

Subcutaneous injection of Dose B of Exendin (9-39)

Arm Title

Dose C

Arm Type

Active Comparator

Arm Description

Subcutaneous injection of Dose C of Exendin (9-39)

Arm Title

Dose D

Arm Type

Active Comparator

Arm Description

Subcutaneous injection of Dose D of Exendin (9-39)

Intervention Type

Drug

Intervention Name(s)

Exendin (9-39)

Primary Outcome Measure Information:

Title

Treatment effect on plasma glucose

Description

Magnitude of plasma glucose nadir during repeat OGTT after treatment

Time Frame

0-180 minutes following initiation of oral glucose tolerance test (OGTT) conducted after treatment.

Secondary Outcome Measure Information:

Title

Treatment effect on symptoms of hypoglycemia

Description

Response rate in symptom score during repeat OGTT after treatment.

Time Frame

0-180 minutes following initiation of OGTT

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tracey McLaughlin, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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