{"id":"humalog-kwikpen","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypoglycemia"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Lipodystrophy"},{"rate":null,"effect":"Weight gain"}]},"_chembl":{"chemblId":"CHEMBL1201538","moleculeType":"Protein"},"_dailymed":{"setId":"c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f","title":"HUMALOG (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG JUNIOR KWIKPEN (INSULIN LISPRO) INJECTION, SOLUTION HUMALOG TEMPO PEN (INSULIN LISPRO) INJECTION, SOLUTION STERILE DILUENT (DILUENT) INJECTION, SOLUTION HUMALOG TEMPO PEN (INSULIN LISPRO) INJECTION, SOLUTION [ELI LILLY AND COMPANY]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Humalog (insulin lispro) is a recombinant human insulin analog with a modified amino acid sequence that allows faster absorption and onset of action compared to regular human insulin. It mimics the body's natural insulin response by binding to insulin receptors on muscle, fat, and liver cells, promoting glucose uptake and storage while inhibiting gluconeogenesis. The Kwikpen is a prefilled injection device formulation of this insulin.","oneSentence":"Humalog is a rapid-acting insulin analog that binds to insulin receptors to facilitate glucose uptake and utilization in cells.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:36:56.609Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Type 1 diabetes mellitus"},{"name":"Type 2 diabetes mellitus"}]},"trialDetails":[{"nctId":"NCT02556840","phase":"NA","title":"Impact on Birth Weight of Two Therapeutic Strategies (Insulin Therapy From the Beginning of Pregnancy vs. Insulin Therapy Initiated According to Fetal Growth Evaluated by Ultrasonography Measurements) in Pregnant Women With Monogenic Diabetes","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2016-04-25","conditions":"Maturity-Onset Diabetes of the Young","enrollment":46},{"nctId":"NCT06948760","phase":"NA","title":"Testing a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System Among Adolescents With T1D","status":"COMPLETED","sponsor":"Mark D. DeBoer, MD, MSc., MCR","startDate":"2025-07-23","conditions":"Type 1 Diabetes","enrollment":11},{"nctId":"NCT07165652","phase":"PHASE1","title":"Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(L), US-Humalog®, and EU-Humalog®","status":"COMPLETED","sponsor":"Xentria, Inc.","startDate":"2025-10-13","conditions":"Healthy Male Adult Volunteers","enrollment":54},{"nctId":"NCT04416269","phase":"PHASE4","title":"Oral Anti Diabetic Agents in the Hospital","status":"ACTIVE_NOT_RECRUITING","sponsor":"Emory University","startDate":"2020-08-07","conditions":"Diabetes Mellitus","enrollment":255},{"nctId":"NCT05508061","phase":"NA","title":"Ultrarapid Insulin Administered by a Bihormonal Closed Loop System in Patients With Type 1 Diabetes","status":"COMPLETED","sponsor":"Inreda Diabetic B.V.","startDate":"2022-10-19","conditions":"Type 1 Diabetes","enrollment":12},{"nctId":"NCT06445946","phase":"PHASE4","title":"DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes","status":"RECRUITING","sponsor":"Ohio State University","startDate":"2024-08-01","conditions":"Gestational Diabetes Mellitus, Pregnancy, High Risk","enrollment":1572},{"nctId":"NCT07090824","phase":"PHASE1","title":"Subcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes","status":"RECRUITING","sponsor":"Stanford University","startDate":"2025-10-28","conditions":"Diabetes Mellitus, Type 1, Type 1 Diabetes Mellitus","enrollment":20},{"nctId":"NCT04124302","phase":"PHASE4","title":"The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal.","status":"COMPLETED","sponsor":"Medical University of Warsaw","startDate":"2019-10-01","conditions":"Diabetes Mellitus, Type 1","enrollment":76},{"nctId":"NCT05893797","phase":"NA","title":"A Study of LY8888AX in Participants Using a Connected Insulin Management Platform","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2023-10-05","conditions":"Type 1 Diabetes, Type 2 Diabetes, Type 2 Diabetes Treated With Insulin","enrollment":36},{"nctId":"NCT06370715","phase":"PHASE4","title":"A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2024-04-18","conditions":"Diabetes Mellitus, Type 2","enrollment":150},{"nctId":"NCT07109245","phase":"PHASE4","title":"Do Antipsychotics Block Insulin Action in the Brain: is it a Class Effect?","status":"NOT_YET_RECRUITING","sponsor":"Centre for Addiction and Mental Health","startDate":"2025-09-01","conditions":"Brain Insulin Sensitivity, Healthy Controls, Cognition","enrollment":35},{"nctId":"NCT05748990","phase":"NA","title":"Does Abnormal Insulin Action in the Brain Underlie Cognitive and Metabolic Dysfunction in Schizophrenia","status":"RECRUITING","sponsor":"Centre for Addiction and Mental Health","startDate":"2023-04-01","conditions":"Schizophrenia, Healthy","enrollment":20},{"nctId":"NCT04974528","phase":"PHASE3","title":"Afrezza® INHALE-1 Study in Pediatrics","status":"COMPLETED","sponsor":"Mannkind Corporation","startDate":"2021-09-29","conditions":"Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2","enrollment":319},{"nctId":"NCT05462756","phase":"PHASE3","title":"A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2022-08-11","conditions":"Type 2 Diabetes, Type 2 Diabetes Treated With Insulin","enrollment":730},{"nctId":"NCT05571878","phase":"NA","title":"Is Brain Insulin Resistance a Feature of the Biology of Depression in Adolescents","status":"ACTIVE_NOT_RECRUITING","sponsor":"Centre for Addiction and Mental Health","startDate":"2021-09-01","conditions":"Major Depressive Disorder, Depression","enrollment":24},{"nctId":"NCT06419803","phase":"NA","title":"Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2)","status":"RECRUITING","sponsor":"Thomas Jefferson University","startDate":"2024-09-01","conditions":"Gestational Diabetes, Pregnancy Related","enrollment":430},{"nctId":"NCT06419777","phase":"NA","title":"Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes","status":"RECRUITING","sponsor":"Thomas Jefferson University","startDate":"2024-09-01","conditions":"Gestational Diabetes, Pregnancy Related","enrollment":430},{"nctId":"NCT05262387","phase":"PHASE1","title":"A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2022-02-14","conditions":"Diabetes Mellitus, Type 1","enrollment":25},{"nctId":"NCT06532461","phase":"NA","title":"A Trial of Three- and Seven-days Insulin Infusions Set","status":"RECRUITING","sponsor":"Steno Diabetes Center Copenhagen","startDate":"2024-07-20","conditions":"Type 1 Diabetes","enrollment":80},{"nctId":"NCT06346366","phase":"PHASE3","title":"Glucose Control Through a Bihormonal Artificial Pancreas in Patients After Total Pancreatectomy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","startDate":"2023-04-25","conditions":"Pancreatic Neoplasms, Type 3c Diabetes, Total Pancreatectomy","enrollment":40},{"nctId":"NCT02518945","phase":"PHASE3","title":"Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes","status":"COMPLETED","sponsor":"University at Buffalo","startDate":"2015-08","conditions":"Type 1 Diabetes Mellitus","enrollment":26},{"nctId":"NCT06153329","phase":"PHASE1","title":"A Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of THDB0206 Injection in Healthy Chinese Subjects","status":"COMPLETED","sponsor":"Tonghua Dongbao Pharmaceutical Co.,Ltd","startDate":"2021-06-17","conditions":"Healthy","enrollment":39},{"nctId":"NCT04019821","phase":"PHASE4","title":"Super-Bolus: Effects on Postprandial Glycemia After High Glycemic Index Meal","status":"COMPLETED","sponsor":"Medical University of Warsaw","startDate":"2020-01-01","conditions":"Diabetes Mellitus, Type 1","enrollment":72},{"nctId":"NCT05660941","phase":"NA","title":"Automated Fully Closed-Loop Insulin Delivery in Type 1 Diabetes With Ultra-Rapid Lispro (ACOLYTE Study)","status":"UNKNOWN","sponsor":"Manchester University NHS Foundation Trust","startDate":"2023-07-21","conditions":"Diabetes Mellitus, Type 1","enrollment":26},{"nctId":"NCT05373186","phase":"PHASE1","title":"A Trial Investigating the Pharmacodynamics of BC Combo THDB0207 Compared With Humalog® Mix25 and Simultaneous Injections of Humalog® and Lantus® in Healthy Chinese Volunteers","status":"COMPLETED","sponsor":"Adocia","startDate":"2022-05-12","conditions":"Healthy","enrollment":27},{"nctId":"NCT05067270","phase":"PHASE1","title":"A Study of Infusion Site Pain After Infusion of Excipients in Participants With Type 1 Diabetes Mellitus","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2021-10-22","conditions":"Type 1 Diabetes Mellitus","enrollment":40},{"nctId":"NCT05579119","phase":"PHASE4","title":"SITAgliptin Plus GLARgine to Glycemic Control in the Hospital Setting (SITAGLAR-H)","status":"COMPLETED","sponsor":"Hospital de Especialidades, Centro Medico Nacional \"La Raza\", Instituto Mexicano del Seguro Social","startDate":"2022-07-06","conditions":"Type 2 Diabetes","enrollment":76},{"nctId":"NCT05373199","phase":"PHASE1","title":"A Trial Comparing the Pharmacodynamics and Pharmacokinetics of BC Combo THDB0207 and Lantus® and Humalog® in Subjects With Type 1 Diabetes","status":"COMPLETED","sponsor":"Adocia","startDate":"2022-05-12","conditions":"Type 1 Diabetes","enrollment":30},{"nctId":"NCT05373212","phase":"PHASE1","title":"A Trial Investigating the Dose Linearity and Safety of BC Combo THDB0207 in Subjects With Type 2 Diabetes","status":"COMPLETED","sponsor":"Adocia","startDate":"2022-05-12","conditions":"Type 2 Diabetes","enrollment":40},{"nctId":"NCT05543850","phase":"NA","title":"Portable Artificial Pancreas Applied for Youth and Adolescents","status":"COMPLETED","sponsor":"Inreda Diabetic B.V.","startDate":"2022-10-28","conditions":"Diabetes Mellitus, Type 1","enrollment":20},{"nctId":"NCT04243629","phase":"NA","title":"Co-administration of Pramlintide and Insulin Via an Automated Dual-hormone Artificial Pancreas System in Adults With Type 1 Diabetes","status":"UNKNOWN","sponsor":"McGill University","startDate":"2021-11-12","conditions":"Diabetes Mellitus, Type 1, Type 1 Diabetes, Postprandial Hyperglycemia","enrollment":26},{"nctId":"NCT03952130","phase":"PHASE3","title":"A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2019-05-29","conditions":"Type 1 Diabetes Mellitus","enrollment":354},{"nctId":"NCT03248271","phase":"","title":"Effects of Insulin on Hypotension and Sarcopenia","status":"WITHDRAWN","sponsor":"Kenneth Madden","startDate":"2017-10-01","conditions":"Diabetes, Sarcopenia, Hypotension, Orthostatic","enrollment":""},{"nctId":"NCT03262116","phase":"PHASE2, PHASE3","title":"Individualizing Automated Closed Loop Glucose Control Through Pharmacokinetic Profiling in an Insulin-Only Bionic Pancreas","status":"TERMINATED","sponsor":"Massachusetts General Hospital","startDate":"2019-03-19","conditions":"Type 1 Diabetes Mellitus","enrollment":20},{"nctId":"NCT04079881","phase":"PHASE1, PHASE2","title":"Glucagon Response to Prandial Insulin Administration in Persons With Type 1 Diabetes","status":"TERMINATED","sponsor":"Washington University School of Medicine","startDate":"2020-02-13","conditions":"Type 1 Diabetes, Hyperglycemia, Postprandial","enrollment":1},{"nctId":"NCT04816890","phase":"PHASE2","title":"A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM)","status":"COMPLETED","sponsor":"Adocia","startDate":"2021-03-23","conditions":"Type 1 Diabetes Mellitus","enrollment":80},{"nctId":"NCT01613807","phase":"PHASE4","title":"Humalog® Mix50/50(tm) as a Treatment for Gestational Diabetes","status":"COMPLETED","sponsor":"Sansum Diabetes Research Institute","startDate":"2008-10","conditions":"Gestational Diabetes Mellitus","enrollment":40},{"nctId":"NCT03260868","phase":"PHASE4","title":"Evaluation of Virtual Versus Traditional Study Conducted in a Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus (eStudy)","status":"TERMINATED","sponsor":"Sanofi","startDate":"2017-09-19","conditions":"Type 1 Diabetes Mellitus","enrollment":15},{"nctId":"NCT03952143","phase":"PHASE3","title":"A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2019-05-27","conditions":"Type 2 Diabetes Mellitus","enrollment":628},{"nctId":"NCT03740919","phase":"PHASE3","title":"A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2019-04-07","conditions":"Type 1 Diabetes Mellitus","enrollment":751},{"nctId":"NCT03328845","phase":"PHASE4","title":"Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. (Ineox Study)","status":"COMPLETED","sponsor":"Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud","startDate":"2017-01-20","conditions":"Type 1 Diabetes Mellitus","enrollment":300},{"nctId":"NCT04049123","phase":"PHASE1","title":"A Study of LY900014 in Healthy Chinese Participants","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2019-11-18","conditions":"Healthy","enrollment":15},{"nctId":"NCT03670641","phase":"PHASE4","title":"Remission Through Early Monitored Insulin Therapy - Duration Month","status":"COMPLETED","sponsor":"Sandra Sobel","startDate":"2019-03-26","conditions":"Type 2 Diabetes Mellitus","enrollment":10},{"nctId":"NCT02250794","phase":"PHASE4","title":"Metformin and Sitagliptin Therapy for Adult Patients With Type 2 Diabetes Admitted to the General Medical Unit","status":"WITHDRAWN","sponsor":"Rush University Medical Center","startDate":"2014-10","conditions":"Type 2 Diabetes Mellitus","enrollment":""},{"nctId":"NCT04276207","phase":"PHASE1","title":"A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2020-02-25","conditions":"Diabetes Mellitus, Type 1","enrollment":32},{"nctId":"NCT01269034","phase":"PHASE4","title":"New Onset Type 1 Diabetes: Role of Exenatide","status":"COMPLETED","sponsor":"Albert Einstein College of Medicine","startDate":"2010-12","conditions":"Type 1 Diabetes","enrollment":13},{"nctId":"NCT04965051","phase":"NA","title":"Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With T1DM","status":"UNKNOWN","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2021-08","conditions":"Type 1 Diabetes Mellitus With Diabetic Gastroparesis, HbA1c, Time in Range","enrollment":40},{"nctId":"NCT02971228","phase":"PHASE2","title":"Feasibility Trial Testing the Bionic Pancreas With ZP4207","status":"COMPLETED","sponsor":"Zealand Pharma","startDate":"2016-11","conditions":"Diabetes Mellitus, Type 1","enrollment":13},{"nctId":"NCT02432976","phase":"PHASE2, PHASE3","title":"Impact of Perioperative Exenatide Infusion on Quality of Life in Cardiac Surgery Patients","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de Besancon","startDate":"2015-05","conditions":"Quality of Life","enrollment":64},{"nctId":"NCT03495908","phase":"NA","title":"Regular Insulin vs Rapid Insulin Delivered by V-Go","status":"COMPLETED","sponsor":"East Coast Institute for Research","startDate":"2018-04-09","conditions":"Type 2 Diabetes, Type 2 Diabetes Mellitus","enrollment":136},{"nctId":"NCT03830281","phase":"PHASE3","title":"A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2019-02-14","conditions":"Type 1 Diabetes Mellitus","enrollment":471},{"nctId":"NCT00461331","phase":"PHASE4","title":"Comparison of Insulins Aspart and Lispro in Insulin Pumps","status":"COMPLETED","sponsor":"Tulane University Health Sciences Center","startDate":"2004-10","conditions":"Type 1 Diabetes Mellitus","enrollment":20},{"nctId":"NCT02417090","phase":"","title":"Late Metabolic Effects of Metformin Therapy in Gestational Diabetes","status":"COMPLETED","sponsor":"Turku University Hospital","startDate":"2015-05","conditions":"Gestational Diabetes","enrollment":173},{"nctId":"NCT04501107","phase":"PHASE1","title":"A Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus","status":"COMPLETED","sponsor":"Adocia","startDate":"2020-08-03","conditions":"Type 1 Diabetes","enrollment":32},{"nctId":"NCT03760640","phase":"PHASE2","title":"A Study of LY900014 in a Medtronic Pump","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2019-02-18","conditions":"Type1 Diabetes Mellitus","enrollment":42},{"nctId":"NCT04161976","phase":"PHASE1","title":"A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2019-12-27","conditions":"Diabetes Mellitus, Type 1","enrollment":20},{"nctId":"NCT03465878","phase":"PHASE1","title":"A Study of LY900014 in Participants With Type 1 Diabetes Mellitus","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2018-03-26","conditions":"Type 1 Diabetes Mellitus","enrollment":56},{"nctId":"NCT02846831","phase":"PHASE2","title":"Closed-loop Control of Glucose Levels (Artificial Pancreas) for 12 Days in Adults With Type 1 Diabetes","status":"COMPLETED","sponsor":"Institut de Recherches Cliniques de Montreal","startDate":"2019-01-24","conditions":"Type 1 Diabetes","enrollment":36},{"nctId":"NCT03341312","phase":"PHASE1","title":"A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM)","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2017-11-13","conditions":"Diabetes Mellitus, Type 2","enrollment":36},{"nctId":"NCT03305822","phase":"PHASE1","title":"A Study of LY900014 in Participants With Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2017-10-11","conditions":"Diabetes Mellitus, Type 2","enrollment":38},{"nctId":"NCT02525744","phase":"PHASE1","title":"A Study of a New LY900014 Formulation in Healthy Participants","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2015-08","conditions":"Healthy","enrollment":24},{"nctId":"NCT03341299","phase":"PHASE1","title":"A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 1 Diabetes Mellitus","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2017-11-13","conditions":"Diabetes Mellitus, Type 1","enrollment":36},{"nctId":"NCT02636361","phase":"PHASE1","title":"A Study of Various Formulations of LY900014 in Healthy Participants","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2015-12","conditions":"Healthy","enrollment":26},{"nctId":"NCT03056456","phase":"PHASE1","title":"A Study of LY900014 Administered in Participants With Type 1 Diabetes Using an Insulin Pump","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2017-02-23","conditions":"Diabetes Mellitus, Type 1","enrollment":24},{"nctId":"NCT03407118","phase":"PHASE1","title":"A Study of LY900014 in Japanese Participants With Type 1 Diabetes Mellitus","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2018-02-17","conditions":"Diabetes Mellitus, Type 1","enrollment":31},{"nctId":"NCT03286751","phase":"PHASE1","title":"A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2017-10-13","conditions":"Diabetes Mellitus, Type 2","enrollment":42},{"nctId":"NCT03214367","phase":"PHASE3","title":"A Study of LY900014 in Participants With Type 1 Diabetes","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2017-07-17","conditions":"Type 1 Diabetes Mellitus","enrollment":1392},{"nctId":"NCT03449433","phase":"PHASE1","title":"A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2018-03-15","conditions":"Diabetes Mellitus, Type 1","enrollment":80},{"nctId":"NCT03166124","phase":"PHASE1","title":"A Study of LY900014 in Elderly and Younger Adult Participants With Type 1 Diabetes Mellitus","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2017-05-24","conditions":"Diabetes Mellitus, Type 1","enrollment":80},{"nctId":"NCT03214380","phase":"PHASE3","title":"A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2017-07-14","conditions":"Type 2 Diabetes Mellitus","enrollment":933},{"nctId":"NCT02690883","phase":"PHASE4","title":"Effect of Exenatide on 24h-UAER in Patients With Diabetic Nephropathy","status":"COMPLETED","sponsor":"Nanfang Hospital, Southern Medical University","startDate":"2016-04-08","conditions":"Diabetic Nephropathies","enrollment":92},{"nctId":"NCT04235439","phase":"PHASE1","title":"PK/PD Biosimilarity Study of Gan & Lee Insulin Lispro Injection vs. EU and US Humalog® in Healthy Males","status":"COMPLETED","sponsor":"Gan and Lee Pharmaceuticals, USA","startDate":"2019-04-23","conditions":"Diabetes Mellitus","enrollment":36},{"nctId":"NCT04112069","phase":"NA","title":"The Insulin-Only Bionic Pancreas Bridging Study- Pediatric Transitional Study","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2018-07-09","conditions":"Type1 Diabetes Mellitus","enrollment":20},{"nctId":"NCT04254380","phase":"PHASE3","title":"Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro","status":"WITHDRAWN","sponsor":"Gan and Lee Pharmaceuticals, USA","startDate":"2019-12-04","conditions":"Diabetes Mellitus, Type 1","enrollment":""},{"nctId":"NCT02556918","phase":"PHASE4","title":"Sitagliptin for Hyperglycemia in Patients With T2DM Undergoing Cardiac Surgery","status":"COMPLETED","sponsor":"Emory University","startDate":"2016-01","conditions":"Hyperglycemia","enrollment":202},{"nctId":"NCT03170544","phase":"PHASE1","title":"Single Ascending Dose Study of MK-1092 in Healthy Participants and in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-1092-001)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2017-08-16","conditions":"Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus","enrollment":69},{"nctId":"NCT03433677","phase":"PHASE3","title":"A Study of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Participants With Type 1 Diabetes","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2018-02-21","conditions":"Diabetes Type 1","enrollment":49},{"nctId":"NCT04100473","phase":"PHASE2","title":"Dose Response of Dance 501 in Subjects With Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"Dance Biopharm Inc.","startDate":"2018-04-23","conditions":"Type 2 Diabetes Mellitus","enrollment":24},{"nctId":"NCT03307512","phase":"PHASE2","title":"PK and PD Profile of Dance 501 in Healthy, Non-diabetic Subjects With Mild to Moderate Asthma or COPD","status":"TERMINATED","sponsor":"Dance Biopharm Inc.","startDate":"2018-02-06","conditions":"Safety and Tolerability","enrollment":40},{"nctId":"NCT03565666","phase":"PHASE2, PHASE3","title":"The Insulin-Only Bionic Pancreas Bridging Study","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2018-07-09","conditions":"Type1 Diabetes Mellitus","enrollment":36},{"nctId":"NCT02846857","phase":"PHASE2","title":"Closed-loop Control of Glucose Levels (Artificial Pancreas) for 15 Weeks in Adolescents and Adults With Type 1 Diabetes","status":"WITHDRAWN","sponsor":"Institut de Recherches Cliniques de Montreal","startDate":"","conditions":"Type 1 Diabetes","enrollment":""},{"nctId":"NCT04023344","phase":"PHASE3","title":"Efficacy and Safety of Insulin Lispro Biphasic 25 Compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients","status":"COMPLETED","sponsor":"Geropharm","startDate":"2018-03-14","conditions":"Diabetes Mellitus, Type 2, Diabetes Mellitus","enrollment":210},{"nctId":"NCT03916640","phase":"PHASE1","title":"A Trial to Assess a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus","status":"COMPLETED","sponsor":"Adocia","startDate":"2019-01-04","conditions":"Type 1 Diabetes Mellitus","enrollment":24},{"nctId":"NCT01109316","phase":"PHASE3","title":"Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2010-04","conditions":"Diabetes Mellitus, Type 1","enrollment":132},{"nctId":"NCT01526733","phase":"PHASE4","title":"Randomized, Double Blind, 2 Way Crossover Study of CSII With, Versus Without, Pretreatment With Human Hyaluronidase","status":"COMPLETED","sponsor":"Halozyme Therapeutics","startDate":"2011-12","conditions":"Type 1 Diabetes Mellitus","enrollment":25},{"nctId":"NCT00705536","phase":"PHASE1","title":"Pharmacokinetic (PK), Pharmacodynamic (PD), and Safety Study of Subcutaneously Administered Humalog® With and Without Recombinant Human Hyaluronidase (rHuPH20)and Humulin-R® With and Without rHuPH20","status":"COMPLETED","sponsor":"Halozyme Therapeutics","startDate":"2007-12","conditions":"Diabetes Mellitus","enrollment":26},{"nctId":"NCT01194245","phase":"PHASE2","title":"Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus","status":"COMPLETED","sponsor":"Halozyme Therapeutics","startDate":"2010-08","conditions":"Diabetes Mellitus, Type 1","enrollment":135},{"nctId":"NCT00774800","phase":"PHASE2","title":"Phase II Pharmacokinetics Study of Humalog and Humulin-R With and Without rHuPH20 in Type 1 Diabetes Mellitus","status":"COMPLETED","sponsor":"Halozyme Therapeutics","startDate":"2008-10","conditions":"Type 1 Diabetes Mellitus","enrollment":22},{"nctId":"NCT03512236","phase":"PHASE1","title":"A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus","status":"COMPLETED","sponsor":"Adocia","startDate":"2018-04-25","conditions":"Type 1 Diabetes Mellitus","enrollment":24},{"nctId":"NCT02004366","phase":"PHASE4","title":"Linagliptin Inpatient Trial","status":"COMPLETED","sponsor":"Emory University","startDate":"2014-01","conditions":"Type 2 Diabetes","enrollment":295},{"nctId":"NCT03507829","phase":"PHASE3","title":"Insulin Therapy for the Prevention of New Onset Diabetes After Transplantation Prospective Study in Non-Diabetic De Novo Kidney Transplant Recipients","status":"COMPLETED","sponsor":"Medical University of Vienna","startDate":"2012-11-21","conditions":"Hyperglycemia","enrollment":263},{"nctId":"NCT03662334","phase":"PHASE4","title":"A Study of Continuous Subcutaneous Insulin Infusion (CSII) Pump Function in Subjects With Type 1 Diabetes With Recombinant Human Hyaluronidase (rHuPH20)","status":"COMPLETED","sponsor":"Halozyme Therapeutics","startDate":"2013-10-03","conditions":"Type 1 Diabetes Mellitus","enrollment":14},{"nctId":"NCT00505882","phase":"PHASE4","title":"Efficacy of Pramlintide on Prevention of Weight Gain Early Onset of Type 1 Diabetes","status":"WITHDRAWN","sponsor":"University of Texas Southwestern Medical Center","startDate":"2007-07","conditions":"Type 1 Diabetes","enrollment":""},{"nctId":"NCT01378117","phase":"PHASE4","title":"Dipeptidyl Peptidase-4 Inhibitor (Sitagliptin) Therapy in the Inpatients With Type 2 Diabetes","status":"COMPLETED","sponsor":"Emory University","startDate":"2011-08","conditions":"Type 2 Diabetes Mellitus, Hospitalization, Hyperglycemia","enrollment":90},{"nctId":"NCT01848990","phase":"PHASE4","title":"CONSISTENT 1: Metabolic and Safety Outcomes of Hylenex Recombinant (Hyaluronidase Human Injection) Preadministered at CSII Infusion Site in Participants With Type 1 Diabetes Mellitus (T1DM)","status":"COMPLETED","sponsor":"Halozyme Therapeutics","startDate":"2013-03","conditions":"Type 1 Diabetes Mellitus","enrollment":456},{"nctId":"NCT02500979","phase":"PHASE1","title":"Effect of a Fixed Pramlintide: Insulin Dose Ratio on Postprandial Glucose in Type 1 Diabetes Mellitus","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2015-08-17","conditions":"Type 1 Diabetes Mellitus","enrollment":34},{"nctId":"NCT03102476","phase":"NA","title":"Environmental Effects Type 1 Diabetes Mellitus","status":"COMPLETED","sponsor":"University of Hull","startDate":"2016-06","conditions":"Type1diabetes","enrollment":10},{"nctId":"NCT01756105","phase":"PHASE2","title":"Efficacy of Metformin in Achieving Glycaemia Goals as Recommended for the Treatment of Gestational Diabetes in Non Obese Women","status":"TERMINATED","sponsor":"University Hospital, Strasbourg, France","startDate":"2012-06","conditions":"Gestational Diabetes, Metformin, Treatment","enrollment":84},{"nctId":"NCT00803972","phase":"PHASE1","title":"Dose-Ranging, Pharmacokinetic (PK), Glucodynamic (GD), Safety and Tolerability Study of Subcutaneously (SC) Administered Humulin R and Humalog With or Without rHuPH20","status":"COMPLETED","sponsor":"Halozyme Therapeutics","startDate":"2008-11","conditions":"Healthy Volunteers","enrollment":42},{"nctId":"NCT03156361","phase":"PHASE2","title":"21 Day Comparison of Continuous Insulin Infusion Using HDV Insulin to Standard Insulin in Type 1 Diabetes Mellitus","status":"COMPLETED","sponsor":"Diasome Pharmaceuticals","startDate":"2017-05-18","conditions":"Type1 Diabetes Mellitus","enrollment":24}],"_emaApprovals":[],"_faersSignals":[{"count":1446,"reaction":"BLOOD GLUCOSE INCREASED"},{"count":529,"reaction":"INCORRECT DOSE ADMINISTERED"},{"count":265,"reaction":"VISUAL IMPAIRMENT"},{"count":260,"reaction":"BLOOD GLUCOSE DECREASED"},{"count":251,"reaction":"WRONG TECHNIQUE IN PRODUCT USAGE PROCESS"},{"count":198,"reaction":"DRUG INEFFECTIVE"},{"count":154,"reaction":"GLYCOSYLATED HAEMOGLOBIN INCREASED"},{"count":143,"reaction":"ACCIDENTAL UNDERDOSE"},{"count":127,"reaction":"BLOOD GLUCOSE ABNORMAL"},{"count":121,"reaction":"PRODUCT DOSE OMISSION ISSUE"}],"_approvalHistory":[],"publicationCount":8,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Lispro insulin"],"phase":"marketed","status":"active","brandName":"Humalog Kwikpen","genericName":"Humalog Kwikpen","companyName":"Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud","companyId":"fundaci-n-p-blica-andaluza-para-la-investigaci-n-de-m-laga-en-biomedicina-y-salu","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Humalog Kwikpen is a subcutaneously delivered insulin used to treat type 1 and type 2 diabetes, with onset of effects typically occurring within 30 minutes and lasting about 5 hours. It is an insulin receptor agonist, classified as an AGONIST, and works by binding to the insulin receptor.","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1996-06-14T00:00:00.000Z","mah":"LILLY","brand_name_local":"HUMALOG KWIKPEN","application_number":"BLA020563"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2015-05-26T00:00:00.000Z","mah":"ELI LILLY AND CO","brand_name_local":"HUMALOG KWIKPEN","application_number":"BLA205747"}],"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}