Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 2:19 PM
Study NCT ID:
NCT04276428
Status:
COMPLETED
Last Update Posted:
2020-12-03
First Post:
2020-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY3209590 in Japanese Participants With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-02', 'studyFirstSubmitDate': '2020-02-18', 'studyFirstSubmitQcDate': '2020-02-18', 'lastUpdatePostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration', 'timeFrame': 'Baseline through Day 85', 'description': 'A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area Under the Drug-Plasma-Concentration-Versus-Time Curve from Time Zero to 168 Hours Postdose (AUC[0-168]) of LY3209590', 'timeFrame': 'Predose on Day 1 through Day 85', 'description': 'PK: AUC(0-168) of LY3209590'}, {'measure': 'Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose', 'timeFrame': 'Day 1 through Day 85', 'description': 'PD: Change from Baseline in Fasting Plasma Glucose'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '39928225', 'type': 'DERIVED', 'citation': 'Nasu R, Oura T, Ohwaki K, Imori M, Furihata K. Pharmacokinetic and Pharmacodynamic Properties of Once-Weekly Insulin Efsitora Alfa in Japanese Patients with Type 2 Diabetes. Diabetes Ther. 2025 Mar;16(3):513-526. doi: 10.1007/s13300-025-01695-x. Epub 2025 Feb 10.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Japanese participants with type 2 diabetes. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug and how it affects blood sugar levels. The study will last almost five months for each participant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have type 2 diabetes mellitus (T2DM) for at least 1 year\n* Have received a stable daily dose of basal insulin at screening\n* Have hemoglobin A1c (HbA1c) greater than or equal to (≥)6.5 percent (%) and less than or equal to (≤)10.0% at screening\n* Have a body mass index greater than (\\>)18.5 and ≤40.0 kilograms per square meter (kg/m²) at screening\n\nExclusion Criteria:\n\n* Have received a total daily dose of insulin \\>1.2 units per kilogram (U/kg) of body weight at screening\n* Have received insulins except for basal insulins\n* Have received sulfonylurea at more than half of the maximum approved dose level\n* Have a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction or history of significant atopy\n* Have had more than 1 episode of severe hypoglycemia within 6 months before entry'}, 'identificationModule': {'nctId': 'NCT04276428', 'briefTitle': 'A Study of LY3209590 in Japanese Participants With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Multiple-Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 in Japanese Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '16983'}, 'secondaryIdInfos': [{'id': 'I8H-JE-BDCK', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3209590', 'description': 'LY3209590 administered subcutaneously (SC).', 'interventionNames': ['Drug: LY3209590']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Degludec', 'description': 'Insulin degludec administered SC.', 'interventionNames': ['Drug: Insulin Degludec']}], 'interventions': [{'name': 'LY3209590', 'type': 'DRUG', 'description': 'Administered SC.', 'armGroupLabels': ['LY3209590']}, {'name': 'Insulin Degludec', 'type': 'DRUG', 'description': 'Administered SC.', 'armGroupLabels': ['Insulin Degludec']}]}, 'contactsLocationsModule': {'locations': [{'zip': '162-0053', 'city': 'Shinjuku-ku', 'state': 'Jp-13', 'country': 'Japan', 'facility': 'Clinical Research Hospital Tokyo'}, {'zip': '192-0071', 'city': 'Hachiōji', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'P-one clinic', 'geoPoint': {'lat': 35.65583, 'lon': 139.32389}}, {'zip': '232-0064', 'city': 'Yokohama', 'country': 'Japan', 'facility': 'Yokohama Minoru Clinic', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}