Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2026-03-04 @ 11:19 PM
Study NCT ID:
NCT02996812
Status:
COMPLETED
Last Update Posted:
2024-12-04
First Post:
2016-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Single Ascending Doses of Subcutaneous Exendin 9-39 in Patients With Post-Bariatric Hypoglycemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044903', 'term': 'Congenital Hyperinsulinism'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007003', 'term': 'Hypoglycemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C083773', 'term': 'exendin (9-39)'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2016-12-15', 'studyFirstSubmitQcDate': '2016-12-15', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment effect on plasma glucose', 'timeFrame': '0-180 minutes following initiation of oral glucose tolerance test (OGTT) conducted after treatment.', 'description': 'Magnitude of plasma glucose nadir during repeat OGTT after treatment'}], 'secondaryOutcomes': [{'measure': 'Treatment effect on symptoms of hypoglycemia', 'timeFrame': '0-180 minutes following initiation of OGTT', 'description': 'Response rate in symptom score during repeat OGTT after treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Post-bariatric hypoglycemia', 'Non-insulinoma pancreatogenous hypoglycemia syndrome', 'Late dumping syndrome'], 'conditions': ['Hyperinsulinemia Hypoglycemia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nWhile 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Post-bariatric surgery more than 6 months prior to signing the informed consent\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* Patients currently using sulfonylureas or other medications that may interfere with glucose metabolism within 5 half-lives of drug.\n* Participation in any clinical investigation within 4 weeks prior to dosing\n* History of or current insulinoma\n* Active infection or significant acute illness within 2 weeks prior to dosing\n* Female patients who are pregnant or lactating\n* Women of childbearing potential and not utilizing effective contraceptive methods\n* Inadequate end organ function"}, 'identificationModule': {'nctId': 'NCT02996812', 'briefTitle': 'Evaluation of Single Ascending Doses of Subcutaneous Exendin 9-39 in Patients With Post-Bariatric Hypoglycemia', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Subcutaneous Injection of Exendin (9-39) in Subjects With Hyperinsulinemic Hypoglycemia Post-Bariatric Surgery', 'orgStudyIdInfo': {'id': '34054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dose A', 'description': 'Subcutaneous injection of Dose A of Exendin (9-39)', 'interventionNames': ['Drug: Exendin (9-39)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dose B', 'description': 'Subcutaneous injection of Dose B of Exendin (9-39)', 'interventionNames': ['Drug: Exendin (9-39)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dose C', 'description': 'Subcutaneous injection of Dose C of Exendin (9-39)', 'interventionNames': ['Drug: Exendin (9-39)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dose D', 'description': 'Subcutaneous injection of Dose D of Exendin (9-39)', 'interventionNames': ['Drug: Exendin (9-39)']}], 'interventions': [{'name': 'Exendin (9-39)', 'type': 'DRUG', 'armGroupLabels': ['Dose A', 'Dose B', 'Dose C', 'Dose D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Tracey McLaughlin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tracey McLaughlin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine (Endocrinology)', 'investigatorFullName': 'Tracey McLaughlin', 'investigatorAffiliation': 'Stanford University'}}}}