Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-03 @ 1:24 PM
Study NCT ID:
NCT01995656
Status:
COMPLETED
Last Update Posted:
2014-07-15
First Post:
2013-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY3108743 in Healthy Participants and Participants With Type 2 Diabetes
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-11', 'studyFirstSubmitDate': '2013-11-20', 'studyFirstSubmitQcDate': '2013-11-20', 'lastUpdatePostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', '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': 'Pre-dose up to Day 6 (5 days post-dose)'}], 'secondaryOutcomes': [{'measure': 'Maximum Change from Baseline up to 24 Hours in Level of Blood Glucose Before and After a Standard Meal', 'timeFrame': 'Baseline up to 24 hours'}, {'measure': 'Pharmacokinetics: Maximum Concentration (Cmax) of LY3108743', 'timeFrame': 'Baseline up to 48 hours'}, {'measure': 'Pharmacokinetics: Area Under the Curve (AUC) of LY3108743', 'timeFrame': 'Baseline up to 48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3108743 in healthy participants and in participants with type 2 diabetes.\n\nThe study will also investigate how LY3108743 affects the levels of blood sugar and other naturally occurring substances (e.g. hormones that control the way sugar is used) in the body, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it.\n\nInformation about any side effects that may occur will be collected. The study is expected to last approximately 7 to 8 weeks for each participant.\n\nThe study will have up to 3 parts. Participants may enroll in only one part.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes\n* Have a body mass index (BMI) of 18.5 to 40.0 kilogram per square meter (kg/m\\^2), inclusive, at screening\n* Have normal blood pressure\n* Participants with diabetes must not be taking any anti-hyperglycemic medications with the exception of metformin. If on metformin, participants must be on a stable treatment regimen for at least for 4 weeks prior to screening\n* Participants with diabetes must have a hemoglobin A1c (HbA1c) level between 6 to 11%, inclusive, at screening\n\nExclusion Criteria:\n\n* Have previously completed or withdrawn from this study\n* Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study'}, 'identificationModule': {'nctId': 'NCT01995656', 'briefTitle': 'A Study of LY3108743 in Healthy Participants and Participants With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of LY3108743 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '15197'}, 'secondaryIdInfos': [{'id': 'I7D-FW-SGAA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo - Healthy', 'description': 'Part A. Healthy participants will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods.', 'interventionNames': ['Drug: Placebo - Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'LY3108743 - Healthy', 'description': 'Part A. Healthy participants will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods.', 'interventionNames': ['Drug: LY3108743 - Capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo - Diabetes', 'description': 'Part B. Participants with diabetes mellitus will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods.', 'interventionNames': ['Drug: Placebo - Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'LY3108743 - Diabetes', 'description': 'Part B. Participants with diabetes mellitus will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods.', 'interventionNames': ['Drug: LY3108743 - Capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo - Solution', 'description': 'Part C. Contingent on results from Parts A and B. Healthy participants will receive a single oral dose of placebo matching LY3108743 in 1 of 2 study periods.', 'interventionNames': ['Drug: Placebo - Solution']}, {'type': 'EXPERIMENTAL', 'label': 'LY3108743 - Solution', 'description': 'Part C. Contingent on results from Parts A and B. Healthy participants will receive a single oral dose of LY3108743 in 1 of 2 study periods.', 'interventionNames': ['Drug: LY3108743 - Solution']}], 'interventions': [{'name': 'Placebo - Capsule', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo - Diabetes', 'Placebo - Healthy']}, {'name': 'LY3108743 - Capsule', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY3108743 - Diabetes', 'LY3108743 - Healthy']}, {'name': 'Placebo - Solution', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo - Solution']}, {'name': 'LY3108743 - Solution', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY3108743 - Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '117597', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], '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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}