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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
LY900014
Insulin Lispro
Insulin Glargine
Insulin Degludec
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring prandial insulin, multiple daily injections, pediatric patients, postmeal dosing

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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 ≤ 9.9% 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.

Sites / Locations

  • University of Alabama Birmingham
  • University of Arizona
  • Children's Hospital Los Angeles - Dept of Endocrinology
  • Stanford University School of Medicine - Division of Pediatric Endocrinology & Diabetes
  • Center of Excellence in Diabetes & Endocrinology
  • Rady Childrens Hospital - San Diego
  • Barbara Davis Center
  • Florida Hospital
  • Tallahassee Memorial HealthCare
  • University of South Florida Diabetes & Endocrinology Center
  • VanMeter Pediatric Endocrinology, P.C.
  • St. Luke's Children's Endocrinology
  • Rocky Mountain Diabetes and Osteoporosis Center
  • Indiana University- Riley Children's Hospital
  • Iowa Diabetes and Endocrinology Research Center
  • Pennington Biomedical Research Center
  • Barry Reiner Clinic
  • Joslin Diabetes Center
  • Children's Mercy Hospital
  • UBMD Pediatrics
  • Suny Health Science Center at Syracuse
  • Endocrinology Services NorthWest
  • Children's Hospital of Philadelphia
  • Texas Diabetes & Endocrinology, P.A.
  • Texas Institute for Kidney and Endocrine Disorders
  • Diabetes and Glandular Disease Research Associates PA
  • MultiCare Institute for Research & Innovation
  • Universitätsklinikum Graz
  • Universitätsklinik Innsbruck
  • Hospital das Clinicas da FMRP
  • CPCLIN
  • CPQuali Pesquisa Clínica
  • Children's hospital of Nanjing
  • Wuxi Children's Hospital
  • The Fourth Affiliated Hospital of Harbin Medical University
  • Children's Hospital Capital Institute of Pediatrics
  • Children's hospital of Fudan University
  • Zhengzhou Children's Hospital
  • Fakultni Nemocnice v Motole
  • Fakultni nemocnice Hradec Kralove
  • Pediatricke odd. Nemocnice Jihlava
  • Medica Iberia
  • FN Ostrava
  • Pardubicka krajska nemocnice
  • Herlev and Gentofte Hospital
  • CHRU Lille - Hôpital Jeanne de Flandre
  • CHU Hopital d'enfants de la Timone
  • Hopital Robert Debre
  • Hôpital Universitaire Necker enfants malades
  • InnoDiab Forschung Gmbh
  • Diabetologische Schwerpunktpraxis Dr. Ziegler
  • Medizinisches Versorgungszentrum am Universitätsklinikum Leipzig GmbH
  • RED-Institut GmbH
  • Shamir Medical Center (Asaf Harofe)-Pediatric Endocrinology Unit
  • Soroka Medical Center - Pediatric Outpatient Clinic
  • Rambam Medical Center - Department of Pediatrics A, Ruth Rappaport Children's Hospital
  • Schneider Children's Medical Center
  • Shiba Medical Center
  • Azienda Ospedaliera Umberto I
  • Azienda Ospedaliero Universitaria Meyer
  • IRCCS Ospedale San Raffaele
  • Azienda Ospedaliera Universitaria Federico II
  • Ospedale Bambino Gesu
  • Ospedale Civile Maggiore Borgo Trento
  • Saitama Children's Medical Center
  • Nihon University Hospital
  • Tokyo Women's Medical University Hospital
  • Hiroshima Prefectural Hospital
  • Niigata University Medical & Dental Hospital
  • Osaka City University Hospital
  • Unidad de Investigacion Clinica Cardiometabolica de Occidente
  • Centro de Inv. Medica de Occidente, SC
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Cli-nica Hospital Cemain
  • Hospital Angeles Puebla
  • Gdanski Uniwersytet Medyczny
  • Uniwersytecki Szpital Kliniczny
  • Instytut Diabetologii Sp. z o.o
  • Pediatric Endocrine Research Associates
  • San Jorge Children and Women's Hospital- Shipping Location
  • Research Institute for Pediatric Endocrinology
  • Morozovsky Children's City Clinical Hospital
  • Samarskiy Regional Children's Clinical Hospital
  • Saratov State Medical University
  • Smolensk Regional Children's Clinical Hospital
  • St.Petersburg Children's City Polyclinic #44
  • Siberian State Medical University of Roszdrav
  • Tver Children's Clinical Hospital
  • Voronezh State Medical University
  • Hospital Universitario Central de Asturias
  • Hospital Virgen del Camino
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario HM Monteprincipe
  • Hospital Sant Joan de Déu
  • CHUS - Hospital Clinico Universitario
  • Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
  • Hospital Universitario La Fe de Valencia
  • Hospital Txagorritxu
  • Ivano-Frankivsk regional clinical children hospital
  • Institute of the Health Care of Children & Adolescents
  • V.P. Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine
  • Odesa regional children's clinical hospital
  • Vinnytsia Regional Clinical Highly Specialized Endocrinology Center
  • Zaporizhzhia regional clinical children hospital
  • Stepping Hill Hospital
  • Norfolk and Norwich Hospital
  • King's Mill Hospital
  • Worthing Hospital
  • St Richards Hospital
  • St James's University Hospital
  • St. George's University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Insulin Lispro (Humalog)

LY900014

LY900014 Postmeal

Arm Description

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.

Participants received 100 U/mL LY900014 administered SC, 0 to 2 minutes before start of the meal.

Participants received 100 U/mL LY900014 administered SC, up to 20 minutes after the start of the meal.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline in HbA1c (Postprandial) at Week 26
Change from baseline in HbA1c postprandial was analyzed using (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.
Percentage of Participants With Documented Post-dose Hypoglycemic Events Within 1 and 2 Hours After the Prandial Dose
Documented post-dose hypoglycemia <54 milligrams per deciliter (mg/dL) and ≤ 70 mg/dL that occurred 1 and 2 hours after prandial dose.
Rate of Documented Post-dose Hypoglycemic Events Within 1 and 2 Hours After the Prandial Dose
Documented post-dose hypoglycemia event is an event of blood glucose of < 54 mg/dL and ≤70 mg/dL that occurred within 1 and 2 hours after the prandial dose. The rate of documented hypoglycemia was estimated by a negative binomial regression including treatment and age group as independent variable and number of episodes as dependent variables with log (exposure/365.25 days) as the offset in the model.
Percentage of Participants With Documented Hypoglycemic Events
Documented hypoglycemia is defined as <54 mg/dL and ≤70 mg/dL, respectively.
Rate of Documented Hypoglycemia Events
Documented hypoglycemia is defined as a hypoglycemic event of blood glucose of ≤70 mg/dL or <54 mg/dL. The rate of documented hypoglycemia was estimated by negative binomial regression including treatment and age group as independent variables and number of episodes as dependent variable with log (exposure/365.25 days) as the offset in the model.
Rate of Severe Hypoglycemia
Severe hypoglycemia: during these episodes, participants have an altered mental status and cannot assist in their own care, may be semiconscious or unconscious, or experience coma with or without seizures, and require assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. The rate of severe hypoglycemia per 100 years was calculated as: 100 times the total number of severe hypoglycemia episodes within the period divided by total exposure (in year) for all participants within the treatment group.
Change From Baseline in Insulin Dose at Week 26
Change from baseline in insulin dose was analyzed using mixed model repeated measures (MMRM) and includes fixed class effects of treatment, strata (pooled country, type of basal insulin, age group, and HbA1c stratum (≤8.0%, >8.0%)), baseline value, visit and treatment-by-visit interaction. An unstructured covariance structure was used to model the within-participant errors.
Percentage of Participants With HbA1c < 7.0% and <7.5%
Percentage of participants with HbA1c < 7.0% and <7.5% was analyzed using a longitudinal logistic regression with repeated measurements conducted by a generalized linear mixed model including independent variables of treatment, baseline HbA1c value, visit, baseline HbA1c-by-visit interaction, and treatment-by-visit interaction. An unstructured covariance structure was used.
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values at Week 26
Change from baseline in 7-point SMBG values were analyzed using MMRM and includes fixed class effects of treatment, strata (pooled country, type of basal insulin, and age group, and HbA1c stratum (≤8.0%, >8.0%)) baseline value, visit, and treatment-by-visit interaction. An unstructured covariance structure was used to model the within-participant errors.

Full Information

First Posted
November 12, 2018
Last Updated
December 23, 2021
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03740919
Brief Title
A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes
Acronym
PRONTO-Peds
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 7, 2019 (Actual)
Primary Completion Date
July 2, 2021 (Actual)
Study Completion Date
July 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
prandial insulin, multiple daily injections, pediatric patients, postmeal dosing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
751 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin Lispro (Humalog)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
LY900014
Arm Type
Experimental
Arm Description
Participants received 100 U/mL LY900014 administered SC, 0 to 2 minutes before start of the meal.
Arm Title
LY900014 Postmeal
Arm Type
Experimental
Arm Description
Participants received 100 U/mL LY900014 administered SC, up to 20 minutes after the start of the meal.
Intervention Type
Drug
Intervention Name(s)
LY900014
Other Intervention Name(s)
Ultra-Rapid Lispro
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Insulin Lispro
Other Intervention Name(s)
Humalog, LY275585
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Insulin Degludec
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
Description
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.
Time Frame
Baseline, Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline in HbA1c (Postprandial) at Week 26
Description
Change from baseline in HbA1c postprandial was analyzed using (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.
Time Frame
Baseline, Week 26
Title
Percentage of Participants With Documented Post-dose Hypoglycemic Events Within 1 and 2 Hours After the Prandial Dose
Description
Documented post-dose hypoglycemia <54 milligrams per deciliter (mg/dL) and ≤ 70 mg/dL that occurred 1 and 2 hours after prandial dose.
Time Frame
Baseline through Week 26
Title
Rate of Documented Post-dose Hypoglycemic Events Within 1 and 2 Hours After the Prandial Dose
Description
Documented post-dose hypoglycemia event is an event of blood glucose of < 54 mg/dL and ≤70 mg/dL that occurred within 1 and 2 hours after the prandial dose. The rate of documented hypoglycemia was estimated by a negative binomial regression including treatment and age group as independent variable and number of episodes as dependent variables with log (exposure/365.25 days) as the offset in the model.
Time Frame
Baseline through Week 26
Title
Percentage of Participants With Documented Hypoglycemic Events
Description
Documented hypoglycemia is defined as <54 mg/dL and ≤70 mg/dL, respectively.
Time Frame
Baseline through Week 26
Title
Rate of Documented Hypoglycemia Events
Description
Documented hypoglycemia is defined as a hypoglycemic event of blood glucose of ≤70 mg/dL or <54 mg/dL. The rate of documented hypoglycemia was estimated by negative binomial regression including treatment and age group as independent variables and number of episodes as dependent variable with log (exposure/365.25 days) as the offset in the model.
Time Frame
Week 0 through Week 26
Title
Rate of Severe Hypoglycemia
Description
Severe hypoglycemia: during these episodes, participants have an altered mental status and cannot assist in their own care, may be semiconscious or unconscious, or experience coma with or without seizures, and require assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. The rate of severe hypoglycemia per 100 years was calculated as: 100 times the total number of severe hypoglycemia episodes within the period divided by total exposure (in year) for all participants within the treatment group.
Time Frame
Week 0 through Week 26
Title
Change From Baseline in Insulin Dose at Week 26
Description
Change from baseline in insulin dose was analyzed using mixed model repeated measures (MMRM) and includes fixed class effects of treatment, strata (pooled country, type of basal insulin, age group, and HbA1c stratum (≤8.0%, >8.0%)), baseline value, visit and treatment-by-visit interaction. An unstructured covariance structure was used to model the within-participant errors.
Time Frame
Baseline, Week 26
Title
Percentage of Participants With HbA1c < 7.0% and <7.5%
Description
Percentage of participants with HbA1c < 7.0% and <7.5% was analyzed using a longitudinal logistic regression with repeated measurements conducted by a generalized linear mixed model including independent variables of treatment, baseline HbA1c value, visit, baseline HbA1c-by-visit interaction, and treatment-by-visit interaction. An unstructured covariance structure was used.
Time Frame
Week 26
Title
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values at Week 26
Description
Change from baseline in 7-point SMBG values were analyzed using MMRM and includes fixed class effects of treatment, strata (pooled country, type of basal insulin, and age group, and HbA1c stratum (≤8.0%, >8.0%)) baseline value, visit, and treatment-by-visit interaction. An unstructured covariance structure was used to model the within-participant errors.
Time Frame
Baseline, Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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 ≤ 9.9% 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Children's Hospital Los Angeles - Dept of Endocrinology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Stanford University School of Medicine - Division of Pediatric Endocrinology & Diabetes
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Center of Excellence in Diabetes & Endocrinology
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Rady Childrens Hospital - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Barbara Davis Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Tallahassee Memorial HealthCare
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
University of South Florida Diabetes & Endocrinology Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
VanMeter Pediatric Endocrinology, P.C.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
St. Luke's Children's Endocrinology
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Rocky Mountain Diabetes and Osteoporosis Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Indiana University- Riley Children's Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Iowa Diabetes and Endocrinology Research Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808-4124
Country
United States
Facility Name
Barry Reiner Clinic
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
UBMD Pediatrics
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Suny Health Science Center at Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Endocrinology Services NorthWest
City
Bend
State/Province
Oregon
ZIP/Postal Code
97702
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Texas Diabetes & Endocrinology, P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78731-4309
Country
United States
Facility Name
Texas Institute for Kidney and Endocrine Disorders
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904
Country
United States
Facility Name
Diabetes and Glandular Disease Research Associates PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
MultiCare Institute for Research & Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Universitätsklinikum Graz
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Universitätsklinik Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Hospital das Clinicas da FMRP
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
CPCLIN
City
São Paulo
State/Province
SP
ZIP/Postal Code
01228-200
Country
Brazil
Facility Name
CPQuali Pesquisa Clínica
City
São Paulo
ZIP/Postal Code
01228-000
Country
Brazil
Facility Name
Children's hospital of Nanjing
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Wuxi Children's Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
The Fourth Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Nangang District
ZIP/Postal Code
150001
Country
China
Facility Name
Children's Hospital Capital Institute of Pediatrics
City
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Children's hospital of Fudan University
City
Shanghai
ZIP/Postal Code
201102
Country
China
Facility Name
Zhengzhou Children's Hospital
City
Zhengzhou
ZIP/Postal Code
450018
Country
China
Facility Name
Fakultni Nemocnice v Motole
City
Praha 5
State/Province
Motole
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Pediatricke odd. Nemocnice Jihlava
City
Jihlava
ZIP/Postal Code
58633
Country
Czechia
Facility Name
Medica Iberia
City
Opava
ZIP/Postal Code
74601
Country
Czechia
Facility Name
FN Ostrava
City
Ostrava-Poruba
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Pardubicka krajska nemocnice
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
Herlev and Gentofte Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
CHRU Lille - Hôpital Jeanne de Flandre
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Hopital d'enfants de la Timone
City
Marseille CEDEX 05
ZIP/Postal Code
13385
Country
France
Facility Name
Hopital Robert Debre
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Hôpital Universitaire Necker enfants malades
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
InnoDiab Forschung Gmbh
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Diabetologische Schwerpunktpraxis Dr. Ziegler
City
Münster
State/Province
North Rhine-Westphalia
ZIP/Postal Code
48155
Country
Germany
Facility Name
Medizinisches Versorgungszentrum am Universitätsklinikum Leipzig GmbH
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
RED-Institut GmbH
City
Oldenburg in Holstein
State/Province
Schleswig Holstein
ZIP/Postal Code
23758
Country
Germany
Facility Name
Shamir Medical Center (Asaf Harofe)-Pediatric Endocrinology Unit
City
Beer Yaakov
ZIP/Postal Code
7033001
Country
Israel
Facility Name
Soroka Medical Center - Pediatric Outpatient Clinic
City
Beer-Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Rambam Medical Center - Department of Pediatrics A, Ruth Rappaport Children's Hospital
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Schneider Children's Medical Center
City
Petah Tikva
ZIP/Postal Code
4920235
Country
Israel
Facility Name
Shiba Medical Center
City
Ramat-gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Azienda Ospedaliera Umberto I
City
Ancona
ZIP/Postal Code
60100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Meyer
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale Bambino Gesu
City
Roma
ZIP/Postal Code
00165
Country
Italy
Facility Name
Ospedale Civile Maggiore Borgo Trento
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Saitama Children's Medical Center
City
Saitama-shi
State/Province
Saitama
ZIP/Postal Code
330 8777
Country
Japan
Facility Name
Nihon University Hospital
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101 8309
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Hiroshima Prefectural Hospital
City
Hiroshima
ZIP/Postal Code
734-8530
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Unidad de Investigacion Clinica Cardiometabolica de Occidente
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44150
Country
Mexico
Facility Name
Centro de Inv. Medica de Occidente, SC
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45116
Country
Mexico
Facility Name
Hospital Universitario Dr. Jose Eleuterio Gonzalez
City
Monterrey
State/Province
N.l.
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Cli-nica Hospital Cemain
City
Tampico
State/Province
Tamaulipas
ZIP/Postal Code
89170
Country
Mexico
Facility Name
Hospital Angeles Puebla
City
Puebla
ZIP/Postal Code
72190
Country
Mexico
Facility Name
Gdanski Uniwersytet Medyczny
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny
City
Lodz
ZIP/Postal Code
91-738
Country
Poland
Facility Name
Instytut Diabetologii Sp. z o.o
City
Warsaw
ZIP/Postal Code
04-376
Country
Poland
Facility Name
Pediatric Endocrine Research Associates
City
Rio Piedras
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
San Jorge Children and Women's Hospital- Shipping Location
City
San Juan
ZIP/Postal Code
00912
Country
Puerto Rico
Facility Name
Research Institute for Pediatric Endocrinology
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Morozovsky Children's City Clinical Hospital
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
Samarskiy Regional Children's Clinical Hospital
City
Samara
ZIP/Postal Code
443079
Country
Russian Federation
Facility Name
Saratov State Medical University
City
Saratov
ZIP/Postal Code
410054
Country
Russian Federation
Facility Name
Smolensk Regional Children's Clinical Hospital
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
St.Petersburg Children's City Polyclinic #44
City
St.Petersburg
ZIP/Postal Code
193144
Country
Russian Federation
Facility Name
Siberian State Medical University of Roszdrav
City
Tomsk
ZIP/Postal Code
634055
Country
Russian Federation
Facility Name
Tver Children's Clinical Hospital
City
Tver
ZIP/Postal Code
170023
Country
Russian Federation
Facility Name
Voronezh State Medical University
City
Voronezh
ZIP/Postal Code
394024
Country
Russian Federation
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Virgen del Camino
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario HM Monteprincipe
City
Boadilla del Monte
ZIP/Postal Code
28660
Country
Spain
Facility Name
Hospital Sant Joan de Déu
City
Esplugues de Llobregat
ZIP/Postal Code
08950
Country
Spain
Facility Name
CHUS - Hospital Clinico Universitario
City
La Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
City
Sevilla
ZIP/Postal Code
41003
Country
Spain
Facility Name
Hospital Universitario La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Txagorritxu
City
Vitoria-Gasteiz
ZIP/Postal Code
01009
Country
Spain
Facility Name
Ivano-Frankivsk regional clinical children hospital
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Institute of the Health Care of Children & Adolescents
City
Kharkiv
ZIP/Postal Code
61153
Country
Ukraine
Facility Name
V.P. Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine
City
Kyiv
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Odesa regional children's clinical hospital
City
Odesa
ZIP/Postal Code
65031
Country
Ukraine
Facility Name
Vinnytsia Regional Clinical Highly Specialized Endocrinology Center
City
Vinnytsia
ZIP/Postal Code
21000
Country
Ukraine
Facility Name
Zaporizhzhia regional clinical children hospital
City
Zaporizhzhia
ZIP/Postal Code
69063
Country
Ukraine
Facility Name
Stepping Hill Hospital
City
Stockport
State/Province
Cheshire
ZIP/Postal Code
SK2 7JE
Country
United Kingdom
Facility Name
Norfolk and Norwich Hospital
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
King's Mill Hospital
City
Sutton In Ashfield
State/Province
Nottinghamshire
ZIP/Postal Code
NG17 4JL
Country
United Kingdom
Facility Name
Worthing Hospital
City
Worthing
State/Province
West Sessex
ZIP/Postal Code
BN11 2DH
Country
United Kingdom
Facility Name
St Richards Hospital
City
Chichester
State/Province
West Sussex
ZIP/Postal Code
PO19 6SE
Country
United Kingdom
Facility Name
St James's University Hospital
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
St. George's University Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/3msKrLw2I0WuYqosKQw22Q
Description
A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes

Learn more about this trial

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

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