Clinical trial NCT03740919: A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes Mellitus
Keywords: prandial insulin
multiple daily injections
pediatric patients
postmeal dosing
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-11-14
Enrollment: 751
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Change From Baseline in HbA1c (Postprandial) at Week 26
timeFrame: Baseline, Week 26
measure: Percentage of Participants With Documented Post-dose Hypoglycemic Events Within 1 and 2 Hours After the Prandial Dose
timeFrame: Baseline through Week 26
measure: Rate of Documented Post-dose Hypoglycemic Events Within 1 and 2 Hours After the Prandial Dose
timeFrame: Baseline through Week 26
measure: Percentage of Participants With Documented Hypoglycemic Events
timeFrame: Baseline through Week 26
measure: Rate of Documented Hypoglycemia Events
timeFrame: Week 0 through Week 26
measure: Rate of Severe Hypoglycemia
timeFrame: Week 0 through Week 26
measure: Change From Baseline in Insulin Dose at Week 26
timeFrame: Baseline, Week 26
measure: Percentage of Participants With HbA1c < 7.0% and <7.5%
timeFrame: Week 26
measure: Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values at Week 26
timeFrame: Baseline, Week 26
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles - Dept of Endocrinology
state: California
city: Palo Alto
country: United States
facility: Stanford University School of Medicine - Division of Pediatric Endocrinology & Diabetes
state: California
city: Sacramento
country: United States
facility: Center of Excellence in Diabetes & Endocrinology
state: California
city: San Diego
country: United States
facility: Rady Childrens Hospital - San Diego
state: California
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial HealthCare
state: Florida
city: Tampa
country: United States
facility: University of South Florida Diabetes & Endocrinology Center
state: Florida
city: Atlanta
country: United States
facility: VanMeter Pediatric Endocrinology, P.C.
state: Georgia
city: Boise
country: United States
facility: St. Luke's Children's Endocrinology
state: Idaho
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center
state: Idaho
city: Indianapolis
country: United States
facility: Indiana University- Riley Children's Hospital
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Baltimore
country: United States
facility: Barry Reiner Clinic
state: Maryland
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Buffalo
country: United States
facility: UBMD Pediatrics
state: New York
city: Syracuse
country: United States
facility: Suny Health Science Center at Syracuse
state: New York
city: Bend
country: United States
facility: Endocrinology Services NorthWest
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Lufkin
country: United States
facility: Texas Institute for Kidney and Endocrine Disorders
state: Texas
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease Research Associates PA
state: Texas
city: Tacoma
country: United States
facility: MultiCare Institute for Research & Innovation
state: Washington
city: Graz
country: Austria
facility: Universitätsklinikum Graz
state: Steiermark
city: Innsbruck
country: Austria
facility: Universitätsklinik Innsbruck
state: Tyrol
city: Ribeirao Preto
country: Brazil
facility: Hospital das Clinicas da FMRP
state: SP
city: São Paulo
country: Brazil
facility: CPCLIN
state: SP
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica
city: Nanjing
country: China
facility: Children's hospital of Nanjing
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Children's Hospital
state: Jiangsu
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Nangang District
city: Beijing
country: China
facility: Children's Hospital Capital Institute of Pediatrics
city: Shanghai
country: China
facility: Children's hospital of Fudan University
city: Zhengzhou
country: China
facility: Zhengzhou Children's Hospital
city: Praha 5
country: Czechia
facility: Fakultni Nemocnice v Motole
state: Motole
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Jihlava
country: Czechia
facility: Pediatricke odd. Nemocnice Jihlava
city: Opava
country: Czechia
facility: Medica Iberia
city: Ostrava-Poruba
country: Czechia
facility: FN Ostrava
city: Pardubice
country: Czechia
facility: Pardubicka krajska nemocnice
city: Herlev
country: Denmark
facility: Herlev and Gentofte Hospital
city: Lille
country: France
facility: CHRU Lille - Hôpital Jeanne de Flandre
city: Marseille CEDEX 05
country: France
facility: CHU Hopital d'enfants de la Timone
city: Paris
country: France
facility: Hopital Robert Debre
city: Paris
country: France
facility: Hôpital Universitaire Necker enfants malades
city: Essen
country: Germany
facility: InnoDiab Forschung Gmbh
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Diabetologische Schwerpunktpraxis Dr. Ziegler
state: North Rhine-Westphalia
city: Leipzig
country: Germany
facility: Medizinisches Versorgungszentrum am Universitätsklinikum Leipzig GmbH
state: Sachsen
city: Oldenburg in Holstein
country: Germany
facility: RED-Institut GmbH
state: Schleswig Holstein
city: Beer Yaakov
country: Israel
facility: Shamir Medical Center (Asaf Harofe)-Pediatric Endocrinology Unit
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center - Pediatric Outpatient Clinic
city: Haifa
country: Israel
facility: Rambam Medical Center - Department of Pediatrics A, Ruth Rappaport Children's Hospital
city: Petah Tikva
country: Israel
facility: Schneider Children's Medical Center
city: Ramat-gan
country: Israel
facility: Shiba Medical Center
city: Ancona
country: Italy
facility: Azienda Ospedaliera Umberto I
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Meyer
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Roma
country: Italy
facility: Ospedale Bambino Gesu
city: Verona
country: Italy
facility: Ospedale Civile Maggiore Borgo Trento
city: Saitama-shi
country: Japan
facility: Saitama Children's Medical Center
state: Saitama
city: Chiyoda-ku
country: Japan
facility: Nihon University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Hiroshima
country: Japan
facility: Hiroshima Prefectural Hospital
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Guadalajara
country: Mexico
facility: Unidad de Investigacion Clinica Cardiometabolica de Occidente
state: Jalisco
city: Zapopan
country: Mexico
facility: Centro de Inv. Medica de Occidente, SC
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez
state: N.l.
city: Tampico
country: Mexico
facility: Cli-nica Hospital Cemain
state: Tamaulipas
city: Puebla
country: Mexico
facility: Hospital Angeles Puebla
city: Gdansk
country: Poland
facility: Gdanski Uniwersytet Medyczny
city: Lodz
country: Poland
facility: Uniwersytecki Szpital Kliniczny
city: Warsaw
country: Poland
facility: Instytut Diabetologii Sp. z o.o
city: Rio Piedras
country: Puerto Rico
facility: Pediatric Endocrine Research Associates
city: San Juan
country: Puerto Rico
facility: San Jorge Children and Women's Hospital- Shipping Location
city: Moscow
country: Russian Federation
facility: Research Institute for Pediatric Endocrinology
city: Moscow
country: Russian Federation
facility: Morozovsky Children's City Clinical Hospital
city: Samara
country: Russian Federation
facility: Samarskiy Regional Children's Clinical Hospital
city: Saratov
country: Russian Federation
facility: Saratov State Medical University
city: Smolensk
country: Russian Federation
facility: Smolensk Regional Children's Clinical Hospital
city: St.Petersburg
country: Russian Federation
facility: St.Petersburg Children's City Polyclinic #44
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University of Roszdrav
city: Tver
country: Russian Federation
facility: Tver Children's Clinical Hospital
city: Voronezh
country: Russian Federation
facility: Voronezh State Medical University
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Pamplona
country: Spain
facility: Hospital Virgen del Camino
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Boadilla del Monte
country: Spain
facility: Hospital Universitario HM Monteprincipe
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
city: La Coruña
country: Spain
facility: CHUS - Hospital Clinico Universitario
city: Sevilla
country: Spain
facility: Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
city: Valencia
country: Spain
facility: Hospital Universitario La Fe de Valencia
city: Vitoria-Gasteiz
country: Spain
facility: Hospital Txagorritxu
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk regional clinical children hospital
city: Kharkiv
country: Ukraine
facility: Institute of the Health Care of Children & Adolescents
city: Kyiv
country: Ukraine
facility: V.P. Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine
city: Odesa
country: Ukraine
facility: Odesa regional children's clinical hospital
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Highly Specialized Endocrinology Center
city: Zaporizhzhia
country: Ukraine
facility: Zaporizhzhia regional clinical children hospital
city: Stockport
country: United Kingdom
facility: Stepping Hill Hospital
state: Cheshire
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich Hospital
state: Norfolk
city: Sutton In Ashfield
country: United Kingdom
facility: King's Mill Hospital
state: Nottinghamshire
city: Worthing
country: United Kingdom
facility: Worthing Hospital
state: West Sessex
city: Chichester
country: United Kingdom
facility: St Richards Hospital
state: West Sussex
city: Leeds
country: United Kingdom
facility: St James's University Hospital
state: West Yorkshire
city: London
country: United Kingdom
facility: St. George's University Hospitals NHS Foundation Trust
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: