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Clinical Trial Details

Trial ID: L4698
Source ID: NCT05260021
Associated Drug: Tirzepatide Dose 1
Title: A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both
Acronym: SURPASS-PEDS
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type2 Diabetes|Diabetes Mellitus|Diabetes Mellitus, Type 2|T2D|T2DM (Type 2 Diabetes Mellitus)|Glucose Metabolism Disorders|Endocrine System Diseases|Metabolic Disease
Interventions: DRUG: Tirzepatide Dose 1|DRUG: Tirzepatide Dose 2|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1c (HbA1c), Baseline, Week 30 | Secondary: Change from Baseline in HbA1c (Individual Doses), Baseline, Week 30|Percent Change from Baseline in BMI, Baseline, Week 30|Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (age and sex-matched), Baseline, Week 30|Change From Baseline in Fasting Serum Glucose (FSG), Baseline, Week 30|Percentage of Participants Who Achieve ≤6.5% of HbA1c, Week 30|Percentage of Participants Who Achieve <7.0% of HbA1c, Week 30|Percentage of Participants Who Achieve <5.7% of HbA1c, Week 30|Change From Baseline for Serum Lipid Levels, Baseline, Week 30|Change From Baseline in Height Standard Deviation Score (SDS), Baseline, Week 30|Change From Baseline in Weight SDS, Baseline, Week 30|Pharmacokinetics (PK): Area Under the Concentration Curve (AUC), Steady State (ss) of Tirzepatide, Baseline to Week 30|Change From Baseline in PedsQL Generic Core Scale, The PedsQL Generic Core Scale has 23 items that measure the core dimensions of health: physical, emotional, and social and school functioning. Scores range from 0 to 100. Higher scores indicate better health related quality of life., Baseline, Week 52|Change From Baseline PedsQL (3.2) Diabetic Module, The PedsQL 3.2 Diabetes Module has 33 items for ages 13 to 45 years, and 32 items (1 less item for the Worry Scale) for ages 2 to 12 years. The 5 dimensions consist of diabetes symptoms, treatment barriers, treatment adherence, worry and communication. Scores range from 0 to 100. Higher scores indicate less problems., Baseline, Week 52
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE3
Enrollment: 99
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-04-13
Completion Date: 2025-01-28
Results First Posted:
Last Update Posted: 2025-02-26
Locations: Children's Hospital Los Angeles, Los Angeles, California, 90027, United States|Center Of Excellence in Diabetes and Endocrinology, Sacramento, California, 95821, United States|Rady Children's Hospital, San Diego, California, 92123, United States|Touro University California, Vallejo, California, 94592, United States|Children's Hospital Colorado, Aurora, Colorado, 80045, United States|Nemours Children's Health - Delaware, Wilmington, Delaware, 19803, United States|Qualmedica Research, LLC, Evansville, Indiana, 47715, United States|Indiana University Health University Hospital, Indianapolis, Indiana, 46202, United States|AA Medical Research Center, Flint, Michigan, 48504, United States|Washington University School of Medicine, Saint Louis, Missouri, 63110, United States|SUNY Upstate Medical University, Syracuse, New York, 13210, United States|Children's Hospital of Philadelphia (CHOP), Philadelphia, Pennsylvania, 19104, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|The Children's Hospital at Westmead, Westmead, New South Wales, 2145, Australia|Centre for Children's Health Research, Brisbane, Queensland, 4101, Australia|Perth Children's Hospital, Perth, Western Australia, 6009, Australia|CEDOES, Vitória, Espírito Santo, 29055450, Brazil|Centro de Diabetes Curitiba, Curitiba, Paraná, 80810-040, Brazil|Instituto Méderi de Pesquisa e Saúde, Passo Fundo, Rio Grande Do Sul, 99010-120, Brazil|Instituto da Crianca com Diabetes, Porto Alegre, Rio Grande Do Sul, 91350-250, Brazil|Centro de Pesquisa Sao Lucas, Campinas, São Paulo, 13034-685, Brazil|Instituto de Pesquisa clinica de Campinas, Campinas, São Paulo, 13060-080, Brazil|Instituto de Pesquisa Clinica, Sao Paulo, São Paulo, 01223-001, Brazil|Instituto da Crianca do Hospital das Clinicas da FMUSP, Sao Paulo, São Paulo, 05403-000, Brazil|Ruschel Medicina e Pesquisa Clínica, Rio De Janeiro, 22270-060, Brazil|CPQuali Pesquisa Clínica, São Paulo, 01228-000, Brazil|CEPIC - Centro Paulista de Investigação Clínica, São Paulo, 04266-010, Brazil|Centre Hospitalier Universitaire d'Angers, Angers, Maine-et-Loire, 49933, France|Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T, Paris, 75019, France|All India Institute of Medical Sciences, New Delhi, Delhi, 110029, India|Gujarat Endocrin Pvt Ltd, Ahmedabad, Gujarat, 380052, India|M S Ramaiah Medical College and Hospitals, Bangalore, Karnataka, 560054, India|Bhakti Vedanta Hospital and Research Institute, Thane, Maharashtra, 401107, India|Kovai Diabetes Speciality Center and Hospital, Coimbatore, Tamil Nadu, 641009, India|Postgraduate Institute of Medical Education & Research, Chandigarh, 160012, India|Soroka Medical Center, Be'er Sheva, HaDarom, 8410101, Israel|Yitzhak Shamir Medical Center, Be'er Ya'aqov, HaMerkaz, 70300, Israel|Sheba Medical Center, Ramat Gan, HaMerkaz, 5262100, Israel|Rambam Health Care Campus, Haifa, HaTsafon, 3109601, Israel|Shaare Zedek Medical Center, Jerusalem, Yerushalayim, 9013102, Israel|Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" Piazza Luigi Miraglia, 2 Napoli Campa -T, Napoli, Campania, 80138, Italy|Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento, Verona, Veneto, 37126, Italy|Ospedale Pediatrico Salesi, Ancona, 60123, Italy|Unidad Médica para la Salud Integral, San Nicolás de los Garza, Nuevo León, 66465, Mexico|Clínica Cemain, Tampico, Tamaulipas, 89170, Mexico|Investigacion En Salud Y Metabolismo Sc, Chihuahua, 31217, Mexico|Consultorio Médico de Endocrinología y Pediatría, Puebla, 72190, Mexico|Arké SMO S.A de C.V, Veracruz, 91910, Mexico|Leicester Royal Infirmary, Leicester, England, LE1 5WW, United Kingdom|Hull Royal Infirmary, Hull, Kingston Upon Hull, HU3 2JZ, United Kingdom|Leicester General Hospital, Leicester, Leicestershire, LE5 4PW, United Kingdom
URL: https://clinicaltrials.gov/show/NCT05260021

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