protocolSection identificationModule nctId: NCT06370715, orgStudyIdInfo id: 18269, secondaryIdInfos id: I8B-MC-ITTA, type: OTHER, domain: Eli Lilly and Company, briefTitle: A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, collaborators name: Cipla Ltd., descriptionModule briefSummary: The purpose of this study is to assess the safety of insulin lispro-aabc in adult participants with Type 2 diabetes mellitus in India.The study will last about 33 weeks for each participant, including screening (1 week), Lead-in period (4 weeks), treatment period (26 weeks) and follow up period (2 weeks)., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: Insulin Lispro-aabc, interventions name: Insulin Glargine, outcomesModule primaryOutcomes measure: Percentage of Participants with at least 1 Episode of Hypoglycemia, secondaryOutcomes measure: Percentage of Participants with Severe Hypoglycemic Events, secondaryOutcomes measure: Percentage of Participants with Nocturnal Hypoglycemia Events, secondaryOutcomes measure: Percentage of Participants with Nocturnal and All Documented Hypoglycemic Events, secondaryOutcomes measure: Change from Baseline to Week 26 in Body Weight, secondaryOutcomes measure: Change from Baseline to Week 26 in Insulin Treatment Satisfaction Questionnaire (ITSQ) Score, secondaryOutcomes measure: Change from Baseline to Week 26 in Hemoglobin A1c (HbA1c), secondaryOutcomes measure: Percentage of Participants Achieving HbA1c Less Than (<) 7%, secondaryOutcomes measure: Change from Baseline to Week 26 in 1- and 2-hour Postprandial Glucose (PPG) Values, secondaryOutcomes measure: Change from Baseline to Week 26 in Bolus Insulin Dose, Basal Insulin Dose, and Basal: Bolus Ratio, secondaryOutcomes measure: Change from Baseline to Week 26 in 9-Point Self-Monitored Blood Glucose (SMBG) Values, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: King George Hospital, Visakhapatnam, city: Vizag, state: Andhra Pradesh, zip: 530002, country: India, contacts name: Bongi Vivekanand, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 17.68009, lon: 83.20161, locations facility: Diabetes Research Centre, city: Royapuram, state: Chennai, zip: 600013, country: India, contacts name: VIJAY VISHWANATHAN, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 13.11405, lon: 80.29474, locations facility: Vijyaratna Dibetes Diagnosis Treatment Centre, city: Ahmedabad, state: Gujarat, zip: 380007, country: India, contacts name: Sanjeev Phatak, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.02579, lon: 72.58727, locations facility: Center for Diabetes and Endocrine Care, city: Bengaluru, state: Karnataka, zip: 560043, country: India, contacts name: K M Prasanna Kumar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 12.97194, lon: 77.59369, locations facility: Chellaram Diabetes Institute, city: Pune, state: Maharashtra, zip: 411021, country: India, contacts name: Unnikrishnan Gopalkrishnan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.51957, lon: 73.85535, locations facility: Sahyadri Super Speciality Hospital, city: Pune, state: Maharashtra, country: India, contacts name: Uday Phadke, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.51957, lon: 73.85535, locations facility: S. P. Medical College & A G Hospital, city: Bikaner, state: Rajasthan, zip: 334003, country: India, contacts name: Bal Kishan Gupta, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.01762, lon: 73.31495, locations facility: Rajasthan University of Health Sciences, city: Jaipur, state: Rajasthan, zip: 302033, country: India, contacts name: Sudhir Bhandari, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.91962, lon: 75.78781, locations facility: Kovai Diabetes Speciality Center and Hospital, city: Coimbatore, state: Tamil Nadu, zip: 641009, country: India, contacts name: Ramanathan Balamurugan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 11.00555, lon: 76.96612, locations facility: Osmania Medical College & Hospital, city: Hyderabad, state: Telangana, zip: 500012, country: India, contacts name: Rakesh Sahay, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 17.38405, lon: 78.45636, locations facility: Brij Medical Center Pvt. Ltd., city: Kanpur, state: Uttar Pradesh, zip: 208020, country: India, contacts name: brij mohan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.46523, lon: 80.34975, locations facility: Medical College & Hospital, Kolkata, city: Kolkata, state: West Bengal, zip: 700073, country: India, contacts name: Animesh Maiti, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.56263, lon: 88.36304, hasResults: False