Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-29 @ 5:49 PM
Study NCT ID:
NCT04712266
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2021-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005934', 'term': 'Glucagon'}, {'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-14', 'studyFirstSubmitDate': '2021-01-12', 'studyFirstSubmitQcDate': '2021-01-14', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hypoglycemic excursions', 'timeFrame': '180-360 minutes post meal', 'description': '\\< 50mg/dl'}, {'measure': 'hyperglycemic excursions', 'timeFrame': '60-120 minutes post meal', 'description': '\\>150mg/dl'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus With Hypoglycemia']}, 'descriptionModule': {'briefSummary': 'This is a single center, double-blind, randomized trial in subjects with type 1 diabetes mellitus applying an adaptive design approach.', 'detailedDescription': 'Subjects were be studied on two occasions, in randomized sequence, whereby glycemic excursions are assessed following an oral mixed meal challenge while treated with either insulin alone or co-administered insulin and glucagon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients aged between 18 and 64 years (both inclusive)\n* Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to the screening visit\n* Treated with daily insulin for T1DM ≥ 12 months prior to the screening visit\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04712266', 'briefTitle': 'A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abvance Therapeutics'}, 'officialTitle': 'A Randomized, Double-blinded Trial to Investigate Glycemic Excursions Following an Oral Mixed Meal Challenge in Subjects With Type 1 Diabetes When Concomitantly Treated With Insulin Alone or Co-administered Insulin and Glucagon', 'orgStudyIdInfo': {'id': 'ABV201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin IV', 'description': 'calculated insulin rate', 'interventionNames': ['Drug: Insulin']}, {'type': 'EXPERIMENTAL', 'label': 'Insulin and Glucagon IV', 'description': 'calculated molar ratio insulin:glucagon', 'interventionNames': ['Drug: Glucagon', 'Drug: Insulin']}], 'interventions': [{'name': 'Glucagon', 'type': 'DRUG', 'otherNames': ['Glucagen Hypokit'], 'description': 'calculated IV insulin:Glucagon molar ratio', 'armGroupLabels': ['Insulin and Glucagon IV']}, {'name': 'Insulin', 'type': 'DRUG', 'otherNames': ['Human Insulin (Eli Lilly)'], 'description': 'calculated IV Insulin dose infused at a constant rate', 'armGroupLabels': ['Insulin IV', 'Insulin and Glucagon IV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30318', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Diabetes Associates', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Bruce Bode, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atlanta Diabetes Associates'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abvance Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'T1D Exchange, United States', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}