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A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes (PRONTO-Peds)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03740919
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) in children and adolescents with type 1 diabetes (T1D).

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: LY900014 Drug: Insulin Lispro Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 945 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog With an Open-Label Postprandial LY900014 Treatment Group in Children and Adolescents With Type 1 Diabetes
Actual Study Start Date : April 7, 2019
Estimated Primary Completion Date : January 2, 2021
Estimated Study Completion Date : January 2, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: LY900014
LY900014 administered subcutaneously (SC).
Drug: LY900014
Administered SC
Other Name: Ultra-Rapid Lispro

Active Comparator: Insulin Lispro
Insulin lispro (Humalog) administered SC.
Drug: Insulin Lispro
Administered SC
Other Names:
  • Humalog
  • LY275585

Experimental: LY900014 Open Label
LY900014 administered SC.
Drug: LY900014
Administered SC
Other Name: Ultra-Rapid Lispro




Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) (Prandial Dosing) [ Time Frame: Baseline, Week 26 ]
    Change from baseline in HbA1c (prandial dosing)


Secondary Outcome Measures :
  1. Change from Baseline in HbA1c (Postprandial) [ Time Frame: Baseline, Week 26 ]
    Change from baseline in HbA1c (postprandial)

  2. Rate of Documented Hypoglycemia [ Time Frame: Week 0 through Week 26 ]
    Rate of documented hypoglycemia

  3. Rate of Severe Hypoglycemia [ Time Frame: Week 0 through Week 26 ]
    Rate of severe hypoglycemia

  4. Change from Baseline in Insulin Dose [ Time Frame: Baseline, Week 26 ]
    Change from baseline in insulin dose

  5. Proportion of Participants with HbA1c <7.5% [ Time Frame: Week 26 ]
    Proportion of participants with HbA1c <7.5%

  6. Change from Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values [ Time Frame: Baseline, Week 26 ]
    Change from baseline in 7-point SMBG values



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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • T1D for at least 6 months at the screening visit.
  • 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 ≥6.5% and ≤9.5% at the screening visit.

Exclusion Criteria:

  • Have current hypoglycemic unawareness or have had more than 1 episode of severe hypoglycemia within 6 months prior to the screening visit.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740919


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com

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Locations
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United States, Alabama
University of Alabama Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact    2059969569      
Principal Investigator: Mary Lauren Scott         
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact    520-626-6077      
Principal Investigator: Mark Wheeler         
United States, California
Children's Hospital Los Angeles - Dept of Endocrinology Recruiting
Los Angeles, California, United States, 90027
Contact    323-631-7040      
Principal Investigator: Roshanak Monzavi         
Stanford University School of Medicine - Division of Pediatric Endocrinology & Diabetes Recruiting
Palo Alto, California, United States, 94304
Contact    650-725-6549      
Principal Investigator: BRUCE BUCKINGHAM         
Center of Excellence in Diabetes & Endocrinology Recruiting
Sacramento, California, United States, 95821
Contact    916-426-1902      
Principal Investigator: Gnanagurudasan Prakasam         
Rady Childrens Hospital - San Diego Recruiting
San Diego, California, United States, 92123
Contact    858-966-4032      
Principal Investigator: Michael E Gottschalk         
United States, Colorado
Barbara Davis Center Recruiting
Aurora, Colorado, United States, 80045
Contact    303-724-6719      
Principal Investigator: Raj P Wadwa         
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06511
Contact    203-737-5831      
Principal Investigator: Jennifer L Sherr         
United States, Florida
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact    407-896-2901      
Principal Investigator: Konda Reddy         
University of South Florida Diabetes & Endocrinology Center Recruiting
Tampa, Florida, United States, 33612
Contact    813-396-2580      
Principal Investigator: Henry Rodriguez         
United States, Georgia
VanMeter Pediatric Endocrinology, P.C. Recruiting
Atlanta, Georgia, United States, 30318
Contact    678-961-2100      
Principal Investigator: Quentin VanMeter         
United States, Idaho
ST. Luke's Children's Endocrinology Recruiting
Boise, Idaho, United States, 83704
Principal Investigator: Daniel Flynn         
Rocky Mountain Diabetes and Osteoporosis Center Recruiting
Idaho Falls, Idaho, United States, 83404
Contact    208-523-1122      
Principal Investigator: Joshua Smith         
United States, Indiana
Indiana University- Riley Children's Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact    317-944-3889      
Principal Investigator: Linda DiMeglio         
United States, Iowa
Iderc, P.L.C. Recruiting
West Des Moines, Iowa, United States, 50265
Contact    515-329-6800      
Principal Investigator: Anuj Bhargava         
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808-4124
Contact    225-763-2831      
Principal Investigator: Daniel Hsia         
United States, Maryland
Barry Reiner Clinic Recruiting
Baltimore, Maryland, United States, 21229
Contact    410-646-4009      
Principal Investigator: Barry Reiner         
United States, Massachusetts
Joslin Diabetes Center Recruiting
Boston, Massachusetts, United States, 02215
Contact    617-732-2603      
Principal Investigator: Lori M Laffel         
United States, Missouri
Children's Mercy Hospital Not yet recruiting
Kansas City, Missouri, United States, 64108
Contact    816-855-1769      
Principal Investigator: Mark A Clements         
United States, New York
UBMD Pediatrics Recruiting
Buffalo, New York, United States, 14203
Contact    716-323-0170      
Principal Investigator: Kathleen Bethin         
Suny Health Science Center at Syracuse Recruiting
Syracuse, New York, United States, 13210
Contact    315-464-9007      
Principal Investigator: Ruth S Weinstock         
United States, Pennsylvania
Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact    215-426-7037      
Principal Investigator: Steven Willi         
United States, Texas
Texas Institute for Kidney and Endocrine Disorders Recruiting
Lufkin, Texas, United States, 75904
Contact    936-632-4282      
Principal Investigator: Lance Sloan         
United States, Washington
MultiCare Institute for Research & Innovation Recruiting
Tacoma, Washington, United States, 98405
Contact    253-403-7250      
Principal Investigator: Gadi B. Kletter         
Austria
Universitätsklinikum Graz Recruiting
Graz, Steiermark, Austria, 8036
Contact    4331638580562      
Principal Investigator: Elke Fröhlich-Reiterer         
Universitätsklinik Innsbruck Recruiting
Innsbruck, Tyrol, Austria, 6020
Contact    4351250482187      
Principal Investigator: Sabine Hofer         
Brazil
Hospital das Clinicas da FMRP Not yet recruiting
Ribeirao Preto, SP, Brazil, 14048-900
Contact    551636022479      
Principal Investigator: Raphael Liberatore         
CPQuali Pesquisa Clínica Ltda. Recruiting
São Paulo, SP, Brazil, 01228-000
Contact    551127766801      
Principal Investigator: Francisco Samuel Magalhães Lima         
Cpclin Centro de Pesquisas Clinicas Recruiting
São Paulo, SP, Brazil, 01228-200
Contact    551127110251      
Principal Investigator: Denise R Franco         
UNIFESP - Escola Paulista de Medicina Not yet recruiting
São Paulo, Brazil, 04022-001
Contact    551155764744      
Principal Investigator: Sérgio Dib         
China, Hunan
The Second Xiangya Hospital of Central South University Not yet recruiting
Changsha, Hunan, China, 410011
Contact    13873104348      
Principal Investigator: Zhiguang Zhou         
China, Jiangsu
Children's hospital of Nanjing Recruiting
Nanjing, Jiangsu, China, 210008
Contact    8618951769571      
Principal Investigator: Wei Gu         
Wuxi Children's Hospital Recruiting
Wuxi, Jiangsu, China
Contact    8613912389918      
Principal Investigator: Xu XU         
China, Nanjing
The First Affiliated Hospital with Nanjing Medical Universit Not yet recruiting
Nanjing, Nanjing, China, 210029
Contact    8613851498409      
Principal Investigator: Tao Yang         
China
Children's Hospital Capital Institute of Pediatrics Not yet recruiting
Beijing, China, 100020
Contact    13681094823      
Principal Investigator: Xiaobo Chen         
Jiangxi Provincial Children's Hospital Not yet recruiting
Nanchang, China, 330006
Contact    8613870982952      
Principal Investigator: Yu Yang         
Children's hospital of Fudan University Not yet recruiting
Shanghai, China, 201102
Contact    (86)13918294095      
Principal Investigator: Feihong LUO         
Children's Hospital of Shanxi Women Health Center Of Shanxi Not yet recruiting
Taiyuan, China, 030013
Contact    13546454239      
Principal Investigator: Gaixiu Zhang         
Tongji Medical College of Huazhong University of Science and Technology Not yet recruiting
Wuhan, China, 430030
Contact    8613387522645      
Principal Investigator: Xiaoping LUO         
Zhengzhou Children's Hospital Not yet recruiting
Zhengzhou, China, 450018
Contact    13838501183      
Principal Investigator: Haiyan Wei         
Czechia
Fakultni Nemocnice v Motole Recruiting
Praha 5, Motole, Czechia, 150 06
Contact    420224432254      
Principal Investigator: Zdenek Sumnik         
Fakultni nemocnice Hradec Kralove Recruiting
Hradec Kralove, Czechia, 500 05
Contact    00420495832813      
Principal Investigator: David Neumann         
Pediatricke odd. Nemocnice Jihlava Recruiting
Jihlava, Czechia, 58633
Contact    420567157736      
Principal Investigator: Pavel Vlachy         
Medica Iberia Recruiting
Opava, Czechia, 74601
Contact    420553821500      
Principal Investigator: Martina Honkova         
FN Ostrava Recruiting
Ostrava-Poruba, Czechia, 70852
Contact    420597373522      
Principal Investigator: Jiri Strnadel         
Pardubicka krajska nemocnice Recruiting
Pardubice, Czechia, 532 03
Contact    420466014101      
Principal Investigator: Barbora Cervickova         
Denmark
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact    452 3204896      
Principal Investigator: Birthe Olsen         
France
CHRU Lille - Hôpital Jeanne de Flandre Recruiting
Lille, France, 59037
Contact    33320445070      
Principal Investigator: Christine Lefevre         
CHU Hopital d'enfants de la Timone Recruiting
Marseille CEDEX 05, France, 13385
Contact    33491387563      
Principal Investigator: Rachel Reynaud         
Hopital Robert Debre Recruiting
Paris, France, 75019
Contact    33140034120      
Principal Investigator: Elise Bismuth-Reisman         
Hôpital Universitaire Necker enfants malades Recruiting
Paris, France, 75743
Contact    33144481545      
Principal Investigator: Jacques Beltrand         
Germany
InnoDiab Forschung GmbH Recruiting
Essen, Nordrhein-Westfalen, Germany, 45136
Contact    4920189942100      
Principal Investigator: Helga Zeller-Stefan         
Medizinisches Versorgungszentrum am Universitätsklinikum Leipzig GmbH Recruiting
Leipzig, Sachsen, Germany, 04103
Contact    00493419712320      
Principal Investigator: Thomas Kapellen         
RED-Institut GmbH Recruiting
Oldenburg, Schleswig-Holstein, Germany, 23758
Contact    494361513130      
Principal Investigator: Thomas Schaum         
Israel
Soroka Medical Center - Pediatric Outpatient Clinic Recruiting
Beer-Sheva, Israel, 8410101
Contact    972522629025      
Principal Investigator: Eli Hershkovitz         
Rambam Medical Center - Department of Pediatrics A, Ruth Rappaport Children's Hospital Recruiting
Haifa, Israel, 3109601
Contact    97249016300      
Principal Investigator: Naim Shehadeh         
Schneider Medical Center Recruiting
Petah Tikva, Israel, 4920235
Contact    97239253830      
Principal Investigator: Moshe Philip         
Shiba Medical Center Recruiting
Ramat-gan, Israel, 5265601
Contact    +972-3-5305015      
Principal Investigator: Orit Pinhas-Hamiel         
Italy
Azienda Ospedaliera Umberto I Recruiting
Ancona, Italy, 60100
Contact    390715962367      
Principal Investigator: Valentino Cherubini         
A.O.Universitaria Meyer Recruiting
Firenze, Italy, 50139
Contact    390555662486      
Principal Investigator: Sonia Toni         
IRCCS Ospedale San Raffaele Recruiting
Milano, Italy, 20132
Contact    39022643176      
Principal Investigator: Riccardo Bonfanti         
Azienda Ospedaliera Universitaria Federico II Recruiting
Napoli, Italy, 80131
Contact    390817464234      
Principal Investigator: Enza Mozzillo         
Ospedale Bambino Gesu Recruiting
Roma, Italy, 00165
Contact    390668592935      
Principal Investigator: Riccardo Schiaffini         
Ospedale Civile Maggiore Borgo Trento Recruiting
Verona, Italy, 37126
Contact    390458127664      
Principal Investigator: Claudio Maffeis         
Japan
Saitama Children's Medical Center Recruiting
Saitama-shi, Saitama, Japan, 330 8777
Contact    81120023812      
Principal Investigator: Katsuya Aizu         
Nihon University Hospital Not yet recruiting
Chiyoda-ku, Tokyo, Japan, 101 8309
Contact    81120023812      
Principal Investigator: Tatsuhiko Urakami         
Tokyo Women's Medical University Hospital Not yet recruiting
Shinjuku-ku, Tokyo, Japan, 162-8666
Contact    81120023812      
Principal Investigator: Junnosuke Miura         
Hiroshima Prefectural Hospital Recruiting
Hiroshima, Japan, 734-8530
Contact    81120023812      
Principal Investigator: Kazuhiko Jinno         
Niigata University Medical & Dental Hospital Recruiting
Niigata, Japan, 951-8520
Contact    81120023812      
Principal Investigator: Yohei Ogawa         
Osaka City University Hospital Recruiting
Osaka, Japan, 545-8586
Contact    81120023812      
Principal Investigator: Tomoyuki Kawamura         
Mexico
Health Pharma Professional Research, S.A. de C.V. Recruiting
Mexico, Federal District, Mexico, 03810
Contact    525563814282      
Principal Investigator: Diego Gaytan Saracho         
Unidad de Investigacion Clinica Recruiting
Guadalajara, Jalisco, Mexico, 44150
Contact    523336152650      
Principal Investigator: Maricela Vidrio         
Centro de Inv. Medica de Occidente, SC Recruiting
Zapopan, Jalisco, Mexico, 45116
Contact    523312044280      
Principal Investigator: Susana Emilia Pelayo         
Hospital Universitario Dr. Jose Eleuterio Gonzalez Recruiting
Monterrey, N.l., Mexico, 64460
Contact    018183485764      
Principal Investigator: Pedro Alberto Garcia Hernandez         
Cli-nica Hospital Cemain Recruiting
Tampico, Tamaulipas, Mexico, 89170
Contact    528332412800      
Principal Investigator: Ricardo Salas         
Hospital Angeles Puebla Recruiting
Puebla, Mexico, 72190
Contact    522223038350      
Principal Investigator: Margarita Barrientos         
Poland
Gdanski Uniwersytet Medyczny Recruiting
Gdansk, Poland, 80-211
Contact    48583492898      
Principal Investigator: Malgorzata Szmigiero-Kawko         
Uniwersytecki Szpital Kliniczny Recruiting
Lodz, Poland, 91-738
Contact    48607145644      
Principal Investigator: Agnieszka Szadkowska         
Instytut Diabetologii Sp. z o.o Recruiting
Warsaw, Poland, 04-376
Contact    48505795484      
Principal Investigator: Ewa Pankowska         
Puerto Rico
Pediatric Endocrine Research Associates Recruiting
Rio Piedras, Puerto Rico, 00927
Contact    7876142159      
Principal Investigator: Francisco Nieves-Rivera         
San Jorge Children and Women's Hospital- Shipping Location Recruiting
San Juan, Puerto Rico, 00912
Contact    7879999453      
Principal Investigator: Luis Font-Aponte         
Russian Federation
Ivanovo Regional Clinical Hospital Not yet recruiting
Ivanovo, Russian Federation, 153040
Contact    74932560589      
Principal Investigator: Olga Votyakova         
Research Institute for Pediatric Endocrinology Not yet recruiting
Moscow, Russian Federation, 117036
Contact    74955000090      
Principal Investigator: VALENTINA PETERKOVA         
Morozov Children's City Hospital Not yet recruiting
Moscow, Russian Federation, 119049
Contact    74959598800      
Principal Investigator: Elena Petryaikina         
Samarskiy Regional Children's Clinical Hospital Recruiting
Samara, Russian Federation, 443079
Contact    78462073098      
Principal Investigator: Evgenia Mikhailova         
Saratov State Medical University Recruiting
Saratov, Russian Federation, 410054
Contact    78452525227      
Principal Investigator: Nina Bolotova         
Smolensk Regional Children's Clinical Hospital Not yet recruiting
Smolensk, Russian Federation, 214019
Contact    74812555494      
Principal Investigator: Irina Alimova         
St.Petersburg Children's City Polyclinic #44 Recruiting
St.Petersburg, Russian Federation, 193144
Contact    78127107706      
Principal Investigator: Elena Bashnina         
Tver Children's Clinical Hospital Not yet recruiting
Tver, Russian Federation, 170023
Contact    74822421534      
Principal Investigator: Oleg Dianov         
Voronezh State Medical University Not yet recruiting
Voronezh, Russian Federation, 394024
Contact    74732656636      
Principal Investigator: Timofei Chubarov         
Yaroslavl Regional Children's Clinical Hospital Not yet recruiting
Yaroslavl, Russian Federation, 150042
Contact    74852552265      
Principal Investigator: Valentina Tuz         
Spain
Hospital Virgen del Camino Recruiting
Pamplona, Navarra, Spain, 31008
Contact    34848422790      
Principal Investigator: Maria Jesus Chueca         
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact    34934893100      
Principal Investigator: Maria Clemente León         
Hospital Universitario HM Monteprincipe Recruiting
Boadilla del Monte, Spain, 28660
Contact    34917089900      
Principal Investigator: Amparo Rodriguez         
Hospital Sant Joan de Déu Recruiting
Esplugues de Llobregat, Spain, 08950
Contact    34936009731      
Principal Investigator: Larisa Suarez Ortega         
Hospital Clinico Universitario de Santiago Recruiting
La Coruña, Spain, 15706
Contact    34981951108      
Principal Investigator: Jesus Barreiro Conde         
Hospital Txagorritxu Recruiting
Vitoria-Gasteiz, Spain, 01009
Contact    34619845144      
Principal Investigator: Ignacio Diez Lopez         
Ukraine
Institute of the Health Care of Children & Adolescents Recruiting
Kharkiv, Ukraine, 61153
Contact    380572626046      
Principal Investigator: Svitlana Chumak         
V.P. Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine Recruiting
Kyiv, Ukraine, 04114
Contact    380672365464      
Principal Investigator: Olena Bolshova         
Vinnytsia Regional Clinical Highly Specialized Endocrinology Center Recruiting
Vinnytsia, Ukraine, 21000
Contact    380432611743      
Principal Investigator: Maryna Vlasenko         
United Kingdom
Stepping Hill Hospital Recruiting
Stockport, Cheshire, United Kingdom, SK2 7JE
Contact    441614192132      
Principal Investigator: Christopher Cooper         
Norfolk and Norwich Hospital Recruiting
Norwich, Norfolk, United Kingdom, NR4 7UY
Contact    01603286286      
Principal Investigator: Vipan Datta         
Kings Mill Hospital Recruiting
Mansfield, Nottinghamshire, United Kingdom, NG17 4JT
Contact    00441623622515      
Principal Investigator: Ursula Ngwu         
Worthing Hospital Recruiting
Worthing, West Sessex, United Kingdom, BN11 2DH
Contact    4401903205111      
Principal Investigator: Sue Coldwell         
St Richards Hospital Recruiting
Chichester, West Sussex, United Kingdom, PO19 6SE
Contact    00441903205111      
Principal Investigator: Sue Coldwell         
St James's University Hospital Recruiting
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Contact    01132066897      
Principal Investigator: fiona Campbell         
St. George'S Healthcare Nhs Trust Recruiting
London, United Kingdom, SW17 0QT
Contact    00442087254803      
Principal Investigator: Christina Wei         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03740919     History of Changes
Other Study ID Numbers: 16698
I8B-MC-ITSB ( Other Identifier: Eli Lilly and Company )
2018-002371-18 ( EudraCT Number )
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
prandial insulin
multiple daily injections
pediatric patients
postmeal dosing
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs