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

NCT02996812 | Completed Phase 1 DMC

• 1 other identifier: 34054
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperinsulinemia Hypoglycemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Treatment effect on plasma glucose

  Magnitude of plasma glucose nadir during repeat OGTT after treatment

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

Secondary Outcomes (1)

• Treatment effect on symptoms of hypoglycemia

  0-180 minutes following initiation of OGTT

Study Arms (4)

Dose A

ACTIVE COMPARATOR

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

Drug: Exendin (9-39)

Dose B

ACTIVE COMPARATOR

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

Drug: Exendin (9-39)

Dose C

ACTIVE COMPARATOR

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

Drug: Exendin (9-39)

Dose D

ACTIVE COMPARATOR

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

Drug: Exendin (9-39)

Interventions

Exendin (9-39) DRUG

Dose A; Dose B; Dose C; Dose D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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.

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

Sponsors & Collaborators

• Tracey McLaughlin: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Congenital Hyperinsulinism

Interventions

exendin (9-39)

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hypoglycemia

Study Officials

• Tracey McLaughlin, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine (Endocrinology)

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 19, 2016
• Study Start: April 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)