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Type 1 Diabetes MellitusPhase 3PRONTO-PedsNCT03740919

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

A Phase 3 study testing LY900014, Insulin Lispro and Insulin Glargine in people with Type 1 Diabetes Mellitus, run by Eli Lilly and Company at 111 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 1 year to 17 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
LY900014, Insulin Lispro and Insulin Glargine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
751 participants
Where
111 sitesin 18 countries
Study dates
7 Apr 2019to 2 Jul 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

111 sites in 18 countries.

111 sites in 18 countries

United States27 sites

  • VanMeter Pediatric Endocrinology, P.C.

    Atlanta, Georgia, 30318

  • Barbara Davis Center

    Aurora, Colorado, 80045

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas, 78731-4309

  • Barry Reiner Clinic

    Baltimore, Maryland, 21229

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808-4124

  • Endocrinology Services NorthWest

    Bend, Oregon, 97702

  • University of Alabama Birmingham

    Birmingham, Alabama, 35233

  • St. Luke's Children's Endocrinology

    Boise, Idaho, 83704

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • UBMD Pediatrics

    Buffalo, New York, 14203

  • Rocky Mountain Diabetes and Osteoporosis Center

    Idaho Falls, Idaho, 83404

  • Indiana University- Riley Children's Hospital

    Indianapolis, Indiana, 46202

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • Children's Hospital Los Angeles - Dept of Endocrinology

    Los Angeles, California, 90027

  • Texas Institute for Kidney and Endocrine Disorders

    Lufkin, Texas, 75904

  • Florida Hospital

    Orlando, Florida, 32803

  • Stanford University School of Medicine - Division of Pediatric Endocrinology & Diabetes

    Palo Alto, California, 94304

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Center of Excellence in Diabetes & Endocrinology

    Sacramento, California, 95821

  • Diabetes and Glandular Disease Research Associates PA

    San Antonio, Texas, 78229

  • Rady Childrens Hospital - San Diego

    San Diego, California, 92123

  • Suny Health Science Center at Syracuse

    Syracuse, New York, 13210

  • MultiCare Institute for Research & Innovation

    Tacoma, Washington, 98405

  • Tallahassee Memorial HealthCare

    Tallahassee, Florida, 32308

  • University of South Florida Diabetes & Endocrinology Center

    Tampa, Florida, 33612

  • University of Arizona

    Tucson, Arizona, 85724

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50265

Other trials in United States

Russia9 sites

  • Research Institute for Pediatric Endocrinology

    Moscow, 117036

  • Morozovsky Children's City Clinical Hospital

    Moscow, 119049

  • St.Petersburg Children's City Polyclinic #44

    Saint Petersburg, 193144

  • Samarskiy Regional Children's Clinical Hospital

    Samara, 443079

  • Saratov State Medical University

    Saratov, 410054

  • Smolensk Regional Children's Clinical Hospital

    Smolensk, 214019

  • Siberian State Medical University of Roszdrav

    Tomsk, 634055

  • Tver Children's Clinical Hospital

    Tver', 170023

  • Voronezh State Medical University

    Voronezh, 394024

Other trials in Russia

Spain9 sites

  • CHUS - Hospital Clinico Universitario

    A Coruña, 15706

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario HM Monteprincipe

    Boadilla del Monte, 28660

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, 08950

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Virgen del Camino

    Pamplona, Navarre, 31008

  • Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

    Seville, 41003

  • Hospital Universitario La Fe de Valencia

    Valencia, 46026

  • Hospital Txagorritxu

    Vitoria-Gasteiz, 01009

Other trials in Spain

United Kingdom7 sites

  • St Richards Hospital

    Chichester, West Sussex, PO19 6SE

  • St James's University Hospital

    Leeds, West Yorkshire, LS9 7TF

  • St. George's University Hospitals NHS Foundation Trust

    London, SW17 0QT

  • Norfolk and Norwich Hospital

    Norwich, Norfolk, NR4 7UY

  • Stepping Hill Hospital

    Stockport, Cheshire, SK2 7JE

  • King's Mill Hospital

    Sutton in Ashfield, Nottinghamshire, NG17 4JL

  • Worthing Hospital

    Worthing, West Sessex, BN11 2DH

Other trials in United Kingdom

China6 sites

  • Children's Hospital Capital Institute of Pediatrics

    Beijing, 100020

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Nangang District, 150001

  • Children's hospital of Nanjing

    Nanjing, Jiangsu, 210008

  • Children's hospital of Fudan University

    Shanghai, 201102

  • Wuxi Children's Hospital

    Wuxi, Jiangsu

  • Zhengzhou Children's Hospital

    Zhengzhou, 450018

Other trials in China

Czechia6 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Pediatricke odd. Nemocnice Jihlava

    Jihlava, 58633

  • Medica Iberia

    Opava, 74601

  • FN Ostrava

    Ostrava-Poruba, 70852

  • Pardubicka krajska nemocnice

    Pardubice, 532 03

  • Fakultni Nemocnice v Motole

    Prague, Motole, 150 06

Other trials in Czechia

Italy6 sites

  • Azienda Ospedaliera Umberto I

    Ancona, 60100

  • Azienda Ospedaliero Universitaria Meyer

    Florence, 50139

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

  • Ospedale Bambino Gesu

    Roma, 00165

  • Ospedale Civile Maggiore Borgo Trento

    Verona, 37126

Other trials in Italy

Japan6 sites

  • Nihon University Hospital

    Chiyoda-ku, Tokyo, 101 8309

  • Hiroshima Prefectural Hospital

    Hiroshima, 734-8530

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520

  • Osaka City University Hospital

    Osaka, 545-8586

  • Saitama Children's Medical Center

    Saitama-shi, Saitama, 330 8777

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, Tokyo, 162-8666

Other trials in Japan

Ukraine6 sites

  • Ivano-Frankivsk regional clinical children hospital

    Ivano-Frankivsk, 76018

  • Institute of the Health Care of Children & Adolescents

    Kharkiv, 61153

  • V.P. Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine

    Kyiv, 04114

  • Odesa regional children's clinical hospital

    Odesa, 65031

  • Vinnytsia Regional Clinical Highly Specialized Endocrinology Center

    Vinnytsia, 21000

  • Zaporizhzhia regional clinical children hospital

    Zaporizhzhya, 69063

Other trials in Ukraine

Israel5 sites

  • Shamir Medical Center (Asaf Harofe)-Pediatric Endocrinology Unit

    Beer Yaakov, 7033001

  • Soroka Medical Center - Pediatric Outpatient Clinic

    Beersheba, 8410101

  • Rambam Medical Center - Department of Pediatrics A, Ruth Rappaport Children's Hospital

    Haifa, 3109601

  • Schneider Children's Medical Center

    Petah Tikva, 4920235

  • Shiba Medical Center

    Ramat Gan, 5265601

Other trials in Israel

Mexico5 sites

  • Unidad de Investigacion Clinica Cardiometabolica de Occidente

    Guadalajara, Jalisco, 44150

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, N.L., 64460

  • Hospital Angeles Puebla

    Puebla City, 72190

  • Cli-nica Hospital Cemain

    Tampico, Tamaulipas, 89170

  • Centro de Inv. Medica de Occidente, SC

    Zapopan, Jalisco, 45116

Other trials in Mexico

France4 sites

  • CHRU Lille - Hôpital Jeanne de Flandre

    Lille, 59037

  • CHU Hopital d'enfants de la Timone

    Marseille, 13385

  • Hopital Robert Debre

    Paris, 75019

  • Hôpital Universitaire Necker enfants malades

    Paris, 75743

Other trials in France

Germany4 sites

  • InnoDiab Forschung Gmbh

    Essen, North Rhine-Westphalia, 45136

  • Medizinisches Versorgungszentrum am Universitätsklinikum Leipzig GmbH

    Leipzig, Saxony, 04103

  • Diabetologische Schwerpunktpraxis Dr. Ziegler

    Münster, North Rhine-Westphalia, 48155

  • RED-Institut GmbH

    Oldenburg in Holstein, Schleswig-Holstein, 23758

Other trials in Germany

Brazil3 sites

  • Hospital das Clinicas da FMRP

    Ribeirão Preto, São Paulo, 14048-900

  • CPCLIN

    São Paulo, São Paulo, 01228-200

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000

Other trials in Brazil

Poland3 sites

  • Gdanski Uniwersytet Medyczny

    Gdansk, 80-211

  • Uniwersytecki Szpital Kliniczny

    Lodz, 91-738

  • Instytut Diabetologii Sp. z o.o

    Warsaw, 04-376

Other trials in Poland

Austria2 sites

  • Universitätsklinikum Graz

    Graz, Styria, 8036

  • Universitätsklinik Innsbruck

    Innsbruck, Tyrol, 6020

Other trials in Austria

Puerto Rico2 sites

  • Pediatric Endocrine Research Associates

    Rio Piedras, PR, 00927

  • San Jorge Children and Women's Hospital- Shipping Location

    San Juan, PR, 00912

Other trials in Puerto Rico

Denmark1 site

  • Herlev and Gentofte Hospital

    Herlev, 2730

Other trials in Denmark

About this study

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

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).

Being tested
LY900014, Insulin Lispro, Insulin Glargine, Insulin Degludec
Keywords
prandial insulin, multiple daily injections, pediatric patients, postmeal dosing
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY900014Drug

    Also called Ultra-Rapid Lispro

    Administered SC

  • Insulin LisproDrug

    Also called Humalog, LY275585

    Administered SC

  • Insulin GlargineDrug

    Administered SC

  • Insulin DegludecDrug

    Administered SC

Study groups in NCT03740919
Study groupRoleWhat they receive
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.
Receives: Drug: Insulin Lispro; Drug: Insulin Glargine; Drug: Insulin Degludec
LY900014ExperimentalParticipants received 100 U/mL LY900014 administered SC, 0 to 2 minutes before start of the meal.
Receives: Drug: LY900014
LY900014 PostmealExperimentalParticipants received 100 U/mL LY900014 administered SC, up to 20 minutes after the start of the meal.
Receives: Drug: LY900014

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 26

Secondary outcomes (9)

  1. 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.

    Measured: Baseline, Week 26

  2. 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.

    Measured: Baseline through Week 26

  3. 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.

    Measured: Baseline through Week 26

  4. Percentage of Participants With Documented Hypoglycemic Events

    Documented hypoglycemia is defined as <54 mg/dL and ≤70 mg/dL, respectively.

    Measured: Baseline through Week 26

  5. 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.

    Measured: Week 0 through Week 26

  6. 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.

    Measured: Week 0 through Week 26

  7. 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.

    Measured: Baseline, Week 26

  8. 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.

    Measured: Week 26

  9. 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.

    Measured: Baseline, Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2018
  2. Study start7 Apr 2019
  3. Primary completion2 Jul 2021
  4. Study completion2 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
751 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03740919
Sponsor's protocol ID
16698
Other IDs
I8B-MC-ITSB, 2018-002371-18, 2018
Acronym
PRONTO-Peds
Status last verified
Dec 2021
First submitted
12 Nov 2018
Last updated
24 Jan 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LY900014, Insulin Lispro and Insulin Glargine in people with Type 1 Diabetes Mellitus, run by Eli Lilly and Company at 111 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 111 sites in United States, Russia, Spain, United Kingdom, China and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26 (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03740919.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.

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