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Clinical Trial Details

Trial ID: L4506
Source ID: NCT03740919
Associated Drug: Ly900014
Title: A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes
Acronym: PRONTO-Peds
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03740919/results
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: LY900014|DRUG: Insulin Lispro|DRUG: Insulin Glargine|DRUG: Insulin Degludec
Outcome Measures: Primary: 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: 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., Baseline, 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., Baseline through Week 26|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., Baseline through Week 26|Percentage of Participants With Documented Hypoglycemic Events, Documented hypoglycemia is defined as \<54 mg/dL and ≤70 mg/dL, respectively., Baseline through Week 26|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., Week 0 through Week 26|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., Week 0 through Week 26|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., Baseline, Week 26|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., Week 26|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., Baseline, Week 26
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: CHILD
Phases: PHASE3
Enrollment: 751
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2019-04-07
Completion Date: 2021-07-02
Results First Posted: 2022-01-24
Last Update Posted: 2022-01-24
Locations: 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, Steiermark, 8036, Austria|Universitätsklinik Innsbruck, Innsbruck, Tyrol, 6020, Austria|Hospital das Clinicas da FMRP, Ribeirao Preto, SP, 14048-900, Brazil|CPCLIN, São Paulo, SP, 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, Praha 5, Motole, 150 06, Czechia|Fakultni nemocnice Hradec Kralove, Hradec Kralove, 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 CEDEX 05, 13385, France|Hopital Robert Debre, Paris, 75019, France|Hôpital Universitaire Necker enfants malades, Paris, 75743, France|InnoDiab Forschung Gmbh, Essen, Nordrhein-Westfalen, 45136, Germany|Diabetologische Schwerpunktpraxis Dr. Ziegler, Münster, North Rhine-Westphalia, 48155, Germany|Medizinisches Versorgungszentrum am Universitätsklinikum Leipzig GmbH, Leipzig, Sachsen, 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, Beer-Sheva, 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, Firenze, 50139, Italy|IRCCS Ospedale San Raffaele, Milano, 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, 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, 00927, Puerto Rico|San Jorge Children and Women's Hospital- Shipping Location, San Juan, 00912, Puerto Rico|Research Institute for Pediatric Endocrinology, Moscow, 117036, Russian Federation|Morozovsky Children's City Clinical Hospital, Moscow, 119049, Russian Federation|Samarskiy Regional Children's Clinical Hospital, Samara, 443079, Russian Federation|Saratov State Medical University, Saratov, 410054, Russian Federation|Smolensk Regional Children's Clinical Hospital, Smolensk, 214019, Russian Federation|St.Petersburg Children's City Polyclinic #44, St.Petersburg, 193144, Russian Federation|Siberian State Medical University of Roszdrav, Tomsk, 634055, Russian Federation|Tver Children's Clinical Hospital, Tver, 170023, Russian Federation|Voronezh State Medical University, Voronezh, 394024, Russian Federation|Hospital Universitario Central de Asturias, Oviedo, Asturias, 33011, Spain|Hospital Virgen del Camino, Pamplona, Navarra, 31008, 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|CHUS - Hospital Clinico Universitario, La Coruña, 15706, Spain|Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE), Sevilla, 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
URL: https://clinicaltrials.gov/show/NCT03740919

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress