A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes
NCT ID: NCT03740919
Last Updated: 2022-01-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
751 participants
INTERVENTIONAL
2019-04-07
2021-07-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Insulin Lispro (Humalog)
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) administered subcutaneously (SC), 0 to 2 minutes before each meal with once or twice daily basal insulin. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
Insulin Lispro
Administered SC
Insulin Glargine
Administered SC
Insulin Degludec
Administered SC
LY900014
Participants received 100 U/mL LY900014 administered SC, 0 to 2 minutes before start of the meal.
LY900014
Administered SC
LY900014 Postmeal
Participants received 100 U/mL LY900014 administered SC, up to 20 minutes after the start of the meal.
LY900014
Administered SC
Interventions
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LY900014
Administered SC
Insulin Lispro
Administered SC
Insulin Glargine
Administered SC
Insulin Degludec
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have been treated with only one of the following rapid-acting insulin analogs as part of an multiple daily injection regimen for at least the last 90 days prior to the screening visit:
* insulin lispro U-100, or
* insulin aspart
* insulin glulisine or
* fast acting insulin aspart
* Have been treated with only one of the following basal insulins for at least the last 90 days prior to the screening visit:
* insulin glargine U-100 (once a day \[QD\] or twice a day \[BID\]), or
* insulin detemir U-100 (QD or BID), or
* insulin degludec U-100 (QD)
* Have a HbA1c value ≤ 9.9% at the screening visit.
Exclusion Criteria
* Have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to the screening visit.
* Have been on a treatment regimen that includes regular human insulin, neutral protamine Hagedorn (NPH), Afrezza® (insulin human) inhalation powder, any premixed insulins or use of diluted insulins within 90 days prior to the screening visit.
1 Year
17 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
University of Arizona
Tucson, Arizona, United States
Children's Hospital Los Angeles - Dept of Endocrinology
Los Angeles, California, United States
Stanford University School of Medicine - Division of Pediatric Endocrinology & Diabetes
Palo Alto, California, United States
Center of Excellence in Diabetes & Endocrinology
Sacramento, California, United States
Rady Childrens Hospital - San Diego
San Diego, California, United States
Barbara Davis Center
Aurora, Colorado, United States
Florida Hospital
Orlando, Florida, United States
Tallahassee Memorial HealthCare
Tallahassee, Florida, United States
University of South Florida Diabetes & Endocrinology Center
Tampa, Florida, United States
VanMeter Pediatric Endocrinology, P.C.
Atlanta, Georgia, United States
St. Luke's Children's Endocrinology
Boise, Idaho, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States
Indiana University- Riley Children's Hospital
Indianapolis, Indiana, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Barry Reiner Clinic
Baltimore, Maryland, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
UBMD Pediatrics
Buffalo, New York, United States
Suny Health Science Center at Syracuse
Syracuse, New York, United States
Endocrinology Services NorthWest
Bend, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, United States
Texas Institute for Kidney and Endocrine Disorders
Lufkin, Texas, United States
Diabetes and Glandular Disease Research Associates PA
San Antonio, Texas, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, United States
Universitätsklinikum Graz
Graz, Styria, Austria
Universitätsklinik Innsbruck
Innsbruck, Tyrol, Austria
Hospital das Clinicas da FMRP
Ribeirão Preto, São Paulo, Brazil
CPCLIN
São Paulo, São Paulo, Brazil
CPQuali Pesquisa Clínica
São Paulo, , Brazil
Children's hospital of Nanjing
Nanjing, Jiangsu, China
Wuxi Children's Hospital
Wuxi, Jiangsu, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Nangang District, China
Children's Hospital Capital Institute of Pediatrics
Beijing, , China
Children's hospital of Fudan University
Shanghai, , China
Zhengzhou Children's Hospital
Zhengzhou, , China
Fakultni Nemocnice v Motole
Prague, Motole, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Pediatricke odd. Nemocnice Jihlava
Jihlava, , Czechia
Medica Iberia
Opava, , Czechia
FN Ostrava
Ostrava-Poruba, , Czechia
Pardubicka krajska nemocnice
Pardubice, , Czechia
Herlev and Gentofte Hospital
Herlev, , Denmark
CHRU Lille - Hôpital Jeanne de Flandre
Lille, , France
CHU Hopital d'enfants de la Timone
Marseille, , France
Hopital Robert Debre
Paris, , France
Hôpital Universitaire Necker enfants malades
Paris, , France
InnoDiab Forschung Gmbh
Essen, North Rhine-Westphalia, Germany
Diabetologische Schwerpunktpraxis Dr. Ziegler
Münster, North Rhine-Westphalia, Germany
Medizinisches Versorgungszentrum am Universitätsklinikum Leipzig GmbH
Leipzig, Saxony, Germany
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, Germany
Shamir Medical Center (Asaf Harofe)-Pediatric Endocrinology Unit
Beer Yaakov, , Israel
Soroka Medical Center - Pediatric Outpatient Clinic
Beersheba, , Israel
Rambam Medical Center - Department of Pediatrics A, Ruth Rappaport Children's Hospital
Haifa, , Israel
Schneider Children's Medical Center
Petah Tikva, , Israel
Shiba Medical Center
Ramat Gan, , Israel
Azienda Ospedaliera Umberto I
Ancona, , Italy
Azienda Ospedaliero Universitaria Meyer
Florence, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Ospedale Bambino Gesu
Roma, , Italy
Ospedale Civile Maggiore Borgo Trento
Verona, , Italy
Saitama Children's Medical Center
Saitama-shi, Saitama, Japan
Nihon University Hospital
Chiyoda-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Hiroshima Prefectural Hospital
Hiroshima, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Osaka City University Hospital
Osaka, , Japan
Unidad de Investigacion Clinica Cardiometabolica de Occidente
Guadalajara, Jalisco, Mexico
Centro de Inv. Medica de Occidente, SC
Zapopan, Jalisco, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, N.L., Mexico
Cli-nica Hospital Cemain
Tampico, Tamaulipas, Mexico
Hospital Angeles Puebla
Puebla City, , Mexico
Gdanski Uniwersytet Medyczny
Gdansk, , Poland
Uniwersytecki Szpital Kliniczny
Lodz, , Poland
Instytut Diabetologii Sp. z o.o
Warsaw, , Poland
Pediatric Endocrine Research Associates
Rio Piedras, PR, Puerto Rico
San Jorge Children and Women's Hospital- Shipping Location
San Juan, PR, Puerto Rico
Research Institute for Pediatric Endocrinology
Moscow, , Russia
Morozovsky Children's City Clinical Hospital
Moscow, , Russia
St.Petersburg Children's City Polyclinic #44
Saint Petersburg, , Russia
Samarskiy Regional Children's Clinical Hospital
Samara, , Russia
Saratov State Medical University
Saratov, , Russia
Smolensk Regional Children's Clinical Hospital
Smolensk, , Russia
Siberian State Medical University of Roszdrav
Tomsk, , Russia
Tver Children's Clinical Hospital
Tver', , Russia
Voronezh State Medical University
Voronezh, , Russia
Hospital Virgen del Camino
Pamplona, Navarre, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
CHUS - Hospital Clinico Universitario
A Coruña, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario HM Monteprincipe
Boadilla del Monte, , Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, , Spain
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
Seville, , Spain
Hospital Universitario La Fe de Valencia
Valencia, , Spain
Hospital Txagorritxu
Vitoria-Gasteiz, , Spain
Ivano-Frankivsk regional clinical children hospital
Ivano-Frankivsk, , Ukraine
Institute of the Health Care of Children & Adolescents
Kharkiv, , Ukraine
V.P. Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine
Kyiv, , Ukraine
Odesa regional children's clinical hospital
Odesa, , Ukraine
Vinnytsia Regional Clinical Highly Specialized Endocrinology Center
Vinnytsia, , Ukraine
Zaporizhzhia regional clinical children hospital
Zaporizhzhia, , Ukraine
Stepping Hill Hospital
Stockport, Cheshire, United Kingdom
Norfolk and Norwich Hospital
Norwich, Norfolk, United Kingdom
King's Mill Hospital
Sutton in Ashfield, Nottinghamshire, United Kingdom
Worthing Hospital
Worthing, West Sessex, United Kingdom
St Richards Hospital
Chichester, West Sussex, United Kingdom
St James's University Hospital
Leeds, West Yorkshire, United Kingdom
St. George's University Hospitals NHS Foundation Trust
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes
Other Identifiers
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I8B-MC-ITSB
Identifier Type: OTHER
Identifier Source: secondary_id
2018-002371-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16698
Identifier Type: -
Identifier Source: org_study_id
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