Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-31 @ 11:55 PM
Study NCT ID:
NCT07215312
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal Insulin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571886', 'term': 'insulin degludec'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-10-09', 'studyFirstSubmitQcDate': '2025-10-09', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Non-Inferiority Analysis)', 'timeFrame': 'Baseline through Week 20'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Superiority Analysis)', 'timeFrame': 'Baseline through Week 20'}, {'measure': 'Change from Baseline in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline, Week 20'}, {'measure': 'Pharmacokinetics (PK): Average Concentration of LY3938577', 'timeFrame': 'Baseline through Week 20'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glycemic control', 'Hypoglycemia', 'Hyperglycemia'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/659897', 'label': 'A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal Insulin'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see how well LY3938577 works and how safe it is compared to degludec in people with type 2 diabetes. Participation in the study will last about 26 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have type 2 diabetes\n* Are receiving ≥20 units of basal insulin per day and ≤55 units/day and ≤1.5 units/kg/day at screening\n* Have hemoglobin A1c (HbA1c) 7.5% to 10.5% inclusive\n* Have a body mass index (BMI) of 20 or higher and less than 35 kilograms per square meter (kg/m2)\n\nExclusion Criteria:\n\n* Have type 1 diabetes'}, 'identificationModule': {'nctId': 'NCT07215312', 'briefTitle': 'A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal Insulin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 2, Randomized, Open-Label, Comparator-Controlled Trial to Evaluate the Efficacy and Safety of LY3938577 in Study Participants, With Type 2 Diabetes Previously Treated With Basal Insulin', 'orgStudyIdInfo': {'id': '27409'}, 'secondaryIdInfos': [{'id': 'J4P-MC-IYAC', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3938577', 'description': 'Participants will receive LY3938577 subcutaneously (SC)', 'interventionNames': ['Drug: LY3938577']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Degludec', 'description': 'Participants will receive degludec SC', 'interventionNames': ['Drug: Degludec']}], 'interventions': [{'name': 'LY3938577', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['LY3938577']}, {'name': 'Degludec', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Degludec']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Girish Karamchandani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tucson Clinical Research Institute', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91978', 'city': 'Spring Valley', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '619-660-9068'}, {'name': 'Hanid Audish', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Encompass Clinical Research', 'geoPoint': {'lat': 32.74477, 'lon': -116.99892}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '714-734-7944'}, {'name': 'Joanna Van', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Clinical Investigators, Inc.', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '33761', 'city': 'Clearwater', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '727-724-3316'}, {'name': 'Sureka Bollepalli', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tampa Bay Medical Research', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '954-400-1725'}, {'name': 'Rodolfo Perez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Encore Medical Research', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33805', 'city': 'Lakeland', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '863-853-5400'}, {'name': 'Michael Paul Gimness', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinical Research of Central Florida', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '954-777-8827'}, {'name': 'Sandro Bacchelli', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Encore Medical Research - Weston', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '515-329-6800'}, {'name': 'Robert Burr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Iowa Diabetes and Endocrinology Research Center', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '314-712-1765'}, {'name': 'Janet McGill', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '910-815-6108'}, {'name': 'John Parker', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Accellacare - Wilmington', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '73069', 'city': 'Norman', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '405-701-8999'}, {'name': 'Lisa Connery', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AMR Clinical', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}, {'zip': '29607', 'city': 'Greenville', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '864-334-0141'}, {'name': 'Ronald Mayfield', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tribe Clinical Research, LLC', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37620', 'city': 'Bristol', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '423-990-2478'}, {'name': 'Rick Whiles', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Holston Medical Group', 'geoPoint': {'lat': 36.59511, 'lon': -82.18874}}, {'zip': '78749', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '512-334-3505'}, {'name': 'Jean Chen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Texas Diabetes & Endocrinology, P.A.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dan Lender', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Velocity Clinical Research, Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77040', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '713-779-5494'}, {'name': 'Damaris Vega', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Juno Research', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75149', 'city': 'Mesquite', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '214-693-0904'}, {'name': 'Sumana Gangi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southern Endocrinology Associates', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'zip': '78231', 'city': 'Shavano Park', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '210-545-4900'}, {'name': 'Michelle Welch', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Consano Clinical Research, LLC', 'geoPoint': {'lat': 29.58495, 'lon': -98.55252}}, {'zip': '78596', 'city': 'Weslaco', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '956-431-8090'}, {'name': 'Eduardo Luna', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Texas Valley Clinical Research', 'geoPoint': {'lat': 26.15952, 'lon': -97.99084}}, {'zip': '84790', 'city': 'St. George', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '435-656-1704'}, {'name': 'Joseph Woolley', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chrysalis Clinical Research', 'geoPoint': {'lat': 37.10415, 'lon': -113.58412}}, {'zip': 'C1119ACN', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '5491165496764'}, {'name': 'Angela Romero Zarante', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CIPREC', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1128AAF', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '541145143400'}, {'name': 'Jose Fretes', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mautalen Salud e Investigación', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1405BUB', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '5491157417654'}, {'name': 'Pablo Costanzo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Consultorio de Investigación Clínica EMO SRL', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1425AGC', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '01148019001'}, {'name': 'Antonela Mainardi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '1204', 'city': 'CABA', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '5491121559419'}, {'name': 'SUSANA SALZBERG', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instituto Centenario'}, {'zip': '2000', 'city': 'Rosario', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '3416176661'}, {'name': 'Natacha Maldonado', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instituto Médico Catamarca IMEC', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}], 'centralContacts': [{'name': 'Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or', 'role': 'CONTACT', 'email': 'LillyTrials@Lilly.com', 'phone': '317-615-4559'}, {'name': 'Physicians interested in becoming principal investigators please contact', 'role': 'CONTACT', 'email': 'clinical_inquiry_hub@lilly.com'}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}