Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-01 @ 9:59 AM
Study NCT ID:
NCT01871493
Status:
COMPLETED
Last Update Posted:
2014-10-21
First Post:
2013-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY2605541 and Insulin Lispro Mixture in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C587357', 'term': 'LY2605541'}, {'id': 'D061268', 'term': 'Insulin Lispro'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-20', 'studyFirstSubmitDate': '2013-06-04', 'studyFirstSubmitQcDate': '2013-06-04', 'lastUpdatePostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Time to Reach Peak Concentration (tmax) of LY2605541 and Insulin Lispro', 'timeFrame': 'Pre-dose up to 216 hours post-dose'}, {'measure': 'Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY2605541 and Insulin Lispro', 'timeFrame': 'Pre-dose up to 216 hours post-dose'}, {'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-∞) of LY2605541 and Insulin Lispro', 'timeFrame': 'Pre-dose up to 216 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'Maximum Glucose Infusion Rate (Rmax)', 'timeFrame': 'Predose up to 32 hours post clamp procedure in all treatment periods'}, {'measure': 'Total Glucose Infused Over Clamp Duration (Gtot)', 'timeFrame': 'Predose up to 32 hours post clamp procedure in all treatment periods'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate how the body absorbs and removes LY2605541, insulin lispro, and a mixture of both from the blood. The study has two parts. Participants may enroll in only one part. Each part has four treatment periods in a fixed order. The study will last approximately 8 weeks, not including screening. Screening is required within 28 days prior to the start of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are not of child-bearing potential\n* Have a body mass index (BMI) between 18 and 29.9 kilograms per meter squared (kg/m\\^2), inclusive\n* Are nonsmokers or have not smoked for at least 2 months prior to entering the study\n\nExclusion Criteria:\n\n* Have known allergies to insulin or its excipients, or related drugs, or history of relevant allergic reactions of any origin\n* Have a history of first-degree relatives known to have diabetes mellitus\n* Have used systemic glucocorticoids within 3 months prior to entry into the study\n* Have donated blood or had a blood loss of 450 milliliter (mL) within 1 month prior to study enrollment'}, 'identificationModule': {'nctId': 'NCT01871493', 'briefTitle': 'A Study of LY2605541 and Insulin Lispro Mixture in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1 Study to Evaluate the Pharmacokinetics of LY2605541 Injection and Insulin Lispro Injection Administered as Mixture or as Individual Components in Healthy Subjects', 'orgStudyIdInfo': {'id': '14833'}, 'secondaryIdInfos': [{'id': 'I6O-FW-BHBA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY2605541-Part A', 'description': '1.42 units per kilogram (U/kg) of LY2605541 given once daily (QD) for 1 day, subcutaneously (SQ) in 1 of 4 treatment periods.', 'interventionNames': ['Drug: LY2605541']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Lispro-Part A', 'description': 'Single dose 0.36 U/kg of insulin lispro given QD for 1 day, SQ in 1 of 4 treatment periods.', 'interventionNames': ['Drug: Insulin Lispro']}, {'type': 'EXPERIMENTAL', 'label': 'LY2605541/Lispro Mix 1-Part A', 'description': 'Single dose 0.54 U/kg of LY2605541 and 0.36 U/kg insulin lispro mixture given QD for 1 day, SQ in 1 of 4 treatment periods.', 'interventionNames': ['Drug: LY2605541', 'Drug: Insulin Lispro']}, {'type': 'EXPERIMENTAL', 'label': 'LY2605541/Lispro Mix 2-Part A', 'description': 'Single dose 1.42 U/kg of LY2605541 and 0.36 insulin lispro mixture given QD for 1 day, SQ in 1 of 4 treatment periods.', 'interventionNames': ['Drug: LY2605541', 'Drug: Insulin Lispro']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Lispro-Part B', 'description': '0.18 U/kg insulin lispro given twice daily (BID) for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.', 'interventionNames': ['Drug: Insulin Lispro']}, {'type': 'EXPERIMENTAL', 'label': 'LY2605541/Lispro Mix-Part B', 'description': '0.71 U/kg LY2605541 and 0.18 U/kg insulin lispro mixture given BID for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.', 'interventionNames': ['Drug: LY2605541', 'Drug: Insulin Lispro']}, {'type': 'EXPERIMENTAL', 'label': 'LY2605541 QD-Part B', 'description': '0.54 U/kg of LY2605541 given QD for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.', 'interventionNames': ['Drug: LY2605541']}, {'type': 'EXPERIMENTAL', 'label': 'LY2605541 BID-Part B', 'description': '0.71 U/kg of LY2605541 given BID for 1 day SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.', 'interventionNames': ['Drug: LY2605541']}], 'interventions': [{'name': 'LY2605541', 'type': 'DRUG', 'description': 'Administered subcutaneous (SQ)', 'armGroupLabels': ['LY2605541 BID-Part B', 'LY2605541 QD-Part B', 'LY2605541-Part A', 'LY2605541/Lispro Mix 1-Part A', 'LY2605541/Lispro Mix 2-Part A', 'LY2605541/Lispro Mix-Part B']}, {'name': 'Insulin Lispro', 'type': 'DRUG', 'otherNames': ['Humalog'], 'description': 'Administered SQ', 'armGroupLabels': ['Insulin Lispro-Part A', 'Insulin Lispro-Part B', 'LY2605541/Lispro Mix 1-Part A', 'LY2605541/Lispro Mix 2-Part A', 'LY2605541/Lispro Mix-Part B']}]}, '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'}}}}