A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes
PRONTO-Peds
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
3 other identifiers
interventional
751
18 countries
111
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2019
111 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2018
CompletedFirst Posted
Study publicly available on registry
November 14, 2018
CompletedStudy Start
First participant enrolled
April 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2021
CompletedResults Posted
Study results publicly available
January 24, 2022
CompletedJanuary 24, 2022
December 1, 2021
2.2 years
November 12, 2018
December 23, 2021
December 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
Change from baseline in HbA1c was analyzed using mixed model repeated measures (MMRM) and includes fixed class effects of treatment, strata (pooled country, type of basal insulin, and age group), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. An unstructured covariance structure will be used to model the within-participant errors. The Efficacy estimand included data collected prior to permanent discontinuation of study drug through Week 26.
Baseline, Week 26
Secondary Outcomes (9)
Change From Baseline in HbA1c (Postprandial) at Week 26
Baseline, Week 26
Percentage of Participants With Documented Post-dose Hypoglycemic Events Within 1 and 2 Hours After the Prandial Dose
Baseline through Week 26
Rate of Documented Post-dose Hypoglycemic Events Within 1 and 2 Hours After the Prandial Dose
Baseline through Week 26
Percentage of Participants With Documented Hypoglycemic Events
Baseline through Week 26
Rate of Documented Hypoglycemia Events
Week 0 through Week 26
- +4 more secondary outcomes
Study Arms (3)
Insulin Lispro (Humalog)
ACTIVE COMPARATORParticipants 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.
LY900014
EXPERIMENTALParticipants received 100 U/mL LY900014 administered SC, 0 to 2 minutes before start of the meal.
LY900014 Postmeal
EXPERIMENTALParticipants received 100 U/mL LY900014 administered SC, up to 20 minutes after the start of the meal.
Interventions
Eligibility Criteria
You may qualify if:
- 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 ≤ 9.9% at the screening visit.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (111)
University of Alabama Birmingham
Birmingham, Alabama, 35233, United States
University of Arizona
Tucson, Arizona, 85724, United States
Children's Hospital Los Angeles - Dept of Endocrinology
Los Angeles, California, 90027, United States
Stanford University School of Medicine - Division of Pediatric Endocrinology & Diabetes
Palo Alto, California, 94304, United States
Center of Excellence in Diabetes & Endocrinology
Sacramento, California, 95821, United States
Rady Childrens Hospital - San Diego
San Diego, California, 92123, United States
Barbara Davis Center
Aurora, Colorado, 80045, United States
Florida Hospital
Orlando, Florida, 32803, United States
Tallahassee Memorial HealthCare
Tallahassee, Florida, 32308, United States
University of South Florida Diabetes & Endocrinology Center
Tampa, Florida, 33612, United States
VanMeter Pediatric Endocrinology, P.C.
Atlanta, Georgia, 30318, United States
St. Luke's Children's Endocrinology
Boise, Idaho, 83704, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404, United States
Indiana University- Riley Children's Hospital
Indianapolis, Indiana, 46202, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808-4124, United States
Barry Reiner Clinic
Baltimore, Maryland, 21229, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
UBMD Pediatrics
Buffalo, New York, 14203, United States
Suny Health Science Center at Syracuse
Syracuse, New York, 13210, United States
Endocrinology Services NorthWest
Bend, Oregon, 97702, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78731-4309, United States
Texas Institute for Kidney and Endocrine Disorders
Lufkin, Texas, 75904, United States
Diabetes and Glandular Disease Research Associates PA
San Antonio, Texas, 78229, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405, United States
Universitätsklinikum Graz
Graz, Styria, 8036, Austria
Universitätsklinik Innsbruck
Innsbruck, Tyrol, 6020, Austria
Hospital das Clinicas da FMRP
Ribeirão Preto, São Paulo, 14048-900, Brazil
CPCLIN
São Paulo, São Paulo, 01228-200, Brazil
CPQuali Pesquisa Clínica
São Paulo, 01228-000, Brazil
Children's hospital of Nanjing
Nanjing, Jiangsu, 210008, China
Wuxi Children's Hospital
Wuxi, Jiangsu, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Nangang District, 150001, China
Children's Hospital Capital Institute of Pediatrics
Beijing, 100020, China
Children's hospital of Fudan University
Shanghai, 201102, China
Zhengzhou Children's Hospital
Zhengzhou, 450018, China
Fakultni Nemocnice v Motole
Prague, Motole, 150 06, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Pediatricke odd. Nemocnice Jihlava
Jihlava, 58633, Czechia
Medica Iberia
Opava, 74601, Czechia
FN Ostrava
Ostrava-Poruba, 70852, Czechia
Pardubicka krajska nemocnice
Pardubice, 532 03, Czechia
Herlev and Gentofte Hospital
Herlev, 2730, Denmark
CHRU Lille - Hôpital Jeanne de Flandre
Lille, 59037, France
CHU Hopital d'enfants de la Timone
Marseille, 13385, France
Hopital Robert Debre
Paris, 75019, France
Hôpital Universitaire Necker enfants malades
Paris, 75743, France
InnoDiab Forschung Gmbh
Essen, North Rhine-Westphalia, 45136, Germany
Diabetologische Schwerpunktpraxis Dr. Ziegler
Münster, North Rhine-Westphalia, 48155, Germany
Medizinisches Versorgungszentrum am Universitätsklinikum Leipzig GmbH
Leipzig, Saxony, 04103, Germany
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany
Shamir Medical Center (Asaf Harofe)-Pediatric Endocrinology Unit
Beer Yaakov, 7033001, Israel
Soroka Medical Center - Pediatric Outpatient Clinic
Beersheba, 8410101, Israel
Rambam Medical Center - Department of Pediatrics A, Ruth Rappaport Children's Hospital
Haifa, 3109601, Israel
Schneider Children's Medical Center
Petah Tikva, 4920235, Israel
Shiba Medical Center
Ramat Gan, 5265601, Israel
Azienda Ospedaliera Umberto I
Ancona, 60100, Italy
Azienda Ospedaliero Universitaria Meyer
Florence, 50139, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, 80131, Italy
Ospedale Bambino Gesu
Roma, 00165, Italy
Ospedale Civile Maggiore Borgo Trento
Verona, 37126, Italy
Saitama Children's Medical Center
Saitama-shi, Saitama, 330 8777, Japan
Nihon University Hospital
Chiyoda-ku, Tokyo, 101 8309, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666, Japan
Hiroshima Prefectural Hospital
Hiroshima, 734-8530, Japan
Niigata University Medical & Dental Hospital
Niigata, 951-8520, Japan
Osaka City University Hospital
Osaka, 545-8586, Japan
Unidad de Investigacion Clinica Cardiometabolica de Occidente
Guadalajara, Jalisco, 44150, Mexico
Centro de Inv. Medica de Occidente, SC
Zapopan, Jalisco, 45116, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, N.L., 64460, Mexico
Cli-nica Hospital Cemain
Tampico, Tamaulipas, 89170, Mexico
Hospital Angeles Puebla
Puebla City, 72190, Mexico
Gdanski Uniwersytet Medyczny
Gdansk, 80-211, Poland
Uniwersytecki Szpital Kliniczny
Lodz, 91-738, Poland
Instytut Diabetologii Sp. z o.o
Warsaw, 04-376, Poland
Pediatric Endocrine Research Associates
Rio Piedras, PR, 00927, Puerto Rico
San Jorge Children and Women's Hospital- Shipping Location
San Juan, PR, 00912, Puerto Rico
Research Institute for Pediatric Endocrinology
Moscow, 117036, Russia
Morozovsky Children's City Clinical Hospital
Moscow, 119049, Russia
St.Petersburg Children's City Polyclinic #44
Saint Petersburg, 193144, Russia
Samarskiy Regional Children's Clinical Hospital
Samara, 443079, Russia
Saratov State Medical University
Saratov, 410054, Russia
Smolensk Regional Children's Clinical Hospital
Smolensk, 214019, Russia
Siberian State Medical University of Roszdrav
Tomsk, 634055, Russia
Tver Children's Clinical Hospital
Tver', 170023, Russia
Voronezh State Medical University
Voronezh, 394024, Russia
Hospital Virgen del Camino
Pamplona, Navarre, 31008, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
CHUS - Hospital Clinico Universitario
A Coruña, 15706, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario HM Monteprincipe
Boadilla del Monte, 28660, Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, 08950, Spain
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
Seville, 41003, Spain
Hospital Universitario La Fe de Valencia
Valencia, 46026, Spain
Hospital Txagorritxu
Vitoria-Gasteiz, 01009, Spain
Ivano-Frankivsk regional clinical children hospital
Ivano-Frankivsk, 76018, Ukraine
Institute of the Health Care of Children & Adolescents
Kharkiv, 61153, Ukraine
V.P. Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine
Kyiv, 04114, Ukraine
Odesa regional children's clinical hospital
Odesa, 65031, Ukraine
Vinnytsia Regional Clinical Highly Specialized Endocrinology Center
Vinnytsia, 21000, Ukraine
Zaporizhzhia regional clinical children hospital
Zaporizhzhia, 69063, Ukraine
Stepping Hill Hospital
Stockport, Cheshire, SK2 7JE, United Kingdom
Norfolk and Norwich Hospital
Norwich, Norfolk, NR4 7UY, United Kingdom
King's Mill Hospital
Sutton in Ashfield, Nottinghamshire, NG17 4JL, United Kingdom
Worthing Hospital
Worthing, West Sessex, BN11 2DH, United Kingdom
St Richards Hospital
Chichester, West Sussex, PO19 6SE, United Kingdom
St James's University Hospital
Leeds, West Yorkshire, LS9 7TF, United Kingdom
St. George's University Hospitals NHS Foundation Trust
London, SW17 0QT, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2018
First Posted
November 14, 2018
Study Start
April 7, 2019
Primary Completion
July 2, 2021
Study Completion
July 2, 2021
Last Updated
January 24, 2022
Results First Posted
January 24, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.