- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05260021
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 (SURPASS-PEDS)
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study With an Open-Label Extension Assessing the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of Tirzepatide in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, or Basal Insulin, or Both
The purpose of this study is to learn more about the safety and efficacy of tirzepatide compared to placebo in children or teenagers with type 2 diabetes taking metformin, or basal insulin, or both.
The overall study will last about 60 weeks with up to 14 clinic visits and 6 phone visits. Clinic visits will include blood sample collection, physical exam and questionnaire.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Phone Number: 1-317-615-4559
- Email: clinicaltrials.gov@lilly.com
Study Locations
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New South Wales
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Westmead, New South Wales, Australia, 2145
- The Children's Hospital at Westmead
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Queensland
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Brisbane, Queensland, Australia, 4101
- Centre for Children's Health Research
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Western Australia
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Perth, Western Australia, Australia, 6009
- Perth Children's Hospital
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Rio De Janeiro, Brazil, 22270-060
- Ruschel Medicina e Pesquisa Clínica
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São Paulo, Brazil, 01228-000
- CPQuali Pesquisa Clínica
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São Paulo, Brazil, 04266-010
- CEPIC - Centro Paulista de Investigação Clínica
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Espírito Santo
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Vitória, Espírito Santo, Brazil, 29055450
- CEDOES
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Paraná
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Curitiba, Paraná, Brazil, 80810-040
- Centro de Diabetes Curitiba
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Rio Grande Do Sul
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Passo Fundo, Rio Grande Do Sul, Brazil, 99010-120
- Instituto Méderi de Pesquisa e Saúde
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Porto Alegre, Rio Grande Do Sul, Brazil, 91350-250
- Instituto da Crianca com Diabetes
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São Paulo
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Campinas, São Paulo, Brazil, 13060-080
- Instituto de Pesquisa clinica de Campinas
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Campinas, São Paulo, Brazil, 13060-803
- Centro de Pesquisa Sao Lucas
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Sao Paulo, São Paulo, Brazil, 01223-001
- Instituto de Pesquisa Clinica
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Sao Paulo, São Paulo, Brazil, 05403-000
- Instituto da Crianca do Hospital das Clinicas da FMUSP
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Paris, France, 75019
- Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (CHU)
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Maine-et-Loire
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Angers, Maine-et-Loire, France, 49933
- Centre Hospitalier Universitaire D'Angers
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Chandigarh, India, 160012
- Postgraduate Institute of Medical Education & Research
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Delhi
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New Delhi, Delhi, India, 110029
- All India Institute of Medical Sciences
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Gujarat
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Ahmedabad, Gujarat, India, 380052
- Clinical and Research department
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Karnataka
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Bangalore, Karnataka, India, 560054
- M S Ramaiah Medical College and Hospitals
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Maharashtra
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Thane, Maharashtra, India, 401107
- Bhakti Vedanta Hospital and Research Institute
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Tamil Nadu
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Coimbatore, Tamil Nadu, India, 641009
- Kovai Diabetes Speciality Center and Hospital
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HaDarom
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Be'er Sheva, HaDarom, Israel, 8410101
- Soroka Medical Center
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HaMerkaz
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Beer Yaacov, HaMerkaz, Israel, 70300
- Yitzhak Shamir Medical Center
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Ramat Gan, HaMerkaz, Israel, 5262100
- Sheba Medical Center
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HaTsafon
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Haifa, HaTsafon, Israel, 3109601
- Rambam Health Care Campus
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Yerushalayim
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Jerusalem, Yerushalayim, Israel, 9013102
- Shaare Zedek Medical Center
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Ancona, Italy, 60123
- Ospedale Pediatrico Salesi
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Campania
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Napoli, Campania, Italy, 80138
- Università degli Studi della Campania Luigi Vanvitelli
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Veneto
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Verona, Veneto, Italy, 37126
- Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
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Chihuahua, Mexico, 31217
- Investigacion En Salud Y Metabolismo Sc
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Puebla, Mexico, 72190
- Consultorio Médico de Endocrinología y Pediatría
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Veracruz, Mexico, 91910
- Arké SMO S.A de C.V
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Nuevo León
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San Nicolás de los Garza, Nuevo León, Mexico, 66465
- Unidad Médica para la Salud Integral
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Tamaulipas
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Tampico, Tamaulipas, Mexico, 89170
- Clínica Cemain
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England
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Leicester, England, United Kingdom, LE1 5WW
- Leicester Royal Infirmary
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Kingston Upon Hull
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Hull, Kingston Upon Hull, United Kingdom, HU3 2JZ
- Hull and East Yorkshire Hospitals NHS Trust
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Leicestershire
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Leicester, Leicestershire, United Kingdom, LE5 4PW
- Leicester General Hospital
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham
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California
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Los Angeles, California, United States, 90027
- Children's Hospital Los Angeles
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Sacramento, California, United States, 95821
- Center Of Excellence in Diabetes and Endocrinology
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San Diego, California, United States, 92123
- Rady Children's Hospital
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Vallejo, California, United States, 94592
- Touro University California
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Colorado
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Aurora, Colorado, United States, 80045
- Children's Hospital Colorado
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Connecticut
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New Haven, Connecticut, United States, 06519
- Yale University School of Medicine
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Delaware
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Wilmington, Delaware, United States, 19803
- Nemours Children's Health - Delaware
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Indiana
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Evansville, Indiana, United States, 47715
- Qualmedica Research, LLC
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Indianapolis, Indiana, United States, 46202
- Indiana University Health University Hospital
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Michigan
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Flint, Michigan, United States, 48504
- AA Medical Research Center
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University
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New York
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Brooklyn, New York, United States, 11203
- SUNY Downstate Health Sciences University
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Syracuse, New York, United States, 13210
- SUNY Upstate Medical University
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia (CHOP)
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Texas
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Shavano Park, Texas, United States, 78231
- Consano Clinical Research, LLC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female, aged 10 to below 18 years at screening visit
- Have type 2 diabetes, treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 90 days prior to study screening.
- Have HbA1c >6.5% to ≤11% at screening
- Have body weight ≥50 kilogram (kg) 110 pounds and BMI of >85th percentile of the general age and gender-matched population for that country or region.
Exclusion Criteria:
- Have Type 1 diabetes mellitus (T1DM), or positive GAD65 or IA2 antibodies
- After the T2DM diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
- Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months.
- Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
- Had chronic or acute pancreatitis any time prior to study entry
- Female participants who are pregnant or breast feeding or intending to become pregnant.
- Using prescription or over the counter medications for weight loss within 90 days of the screening visit.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tirzepatide Dose 1
Double-Blind: Participants receive Tirzepatide by weekly subcutaneous (SC) injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 1 is reached. Open-Label: Participants will continue to receive Tirzepatide at the last dose level |
Administered SC
|
Experimental: Tirzepatide Dose 2
Double-Blind: Participants receive Tirzepatide by weekly SC injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 2 is reached. Open-Label: Participants will continue to receive Tirzepatide at the last dose level |
Administered SC
|
Placebo Comparator: Placebo
Double-Blind: Participants receive placebo during the 30-week double-blind period. Open-Label: Participants will switch to Tirzepatide by weekly SC injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 1 is reached. |
Administered SC
Administered SC
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change From Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 30
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Baseline, Week 30
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in HbA1c (Individual Doses)
Time Frame: Baseline, Week 30
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Baseline, Week 30
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Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (age and sex-matched)
Time Frame: Baseline, Week 30
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Baseline, Week 30
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Change From Baseline in Fasting Serum Glucose (FSG)
Time Frame: Baseline, Week 30
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Baseline, Week 30
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Percentage of Participants Who Achieve ≤6.5% of HbA1c
Time Frame: Week 30
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Week 30
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Percentage of Participants Who Achieve <7.0% of HbA1c
Time Frame: Week 30
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Week 30
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Percentage of Participants Who Achieve <5.7% of HbA1c
Time Frame: Week 30
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Week 30
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Change From Baseline for Serum Lipid Levels
Time Frame: Baseline, Week 30
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Baseline, Week 30
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Change From Baseline in Height Standard Deviation Score (SDS)
Time Frame: Baseline, Week 30
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Baseline, Week 30
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Change From Baseline in Weight SDS
Time Frame: Baseline, Week 30
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Baseline, Week 30
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Pharmacokinetics (PK): Area Under the Concentration Curve (AUC), Steady State (ss) of Tirzepatide
Time Frame: Baseline to Week 30
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Baseline to Week 30
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Change From Baseline in PedsQL Generic Core Scale
Time Frame: Baseline, Week 52
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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.
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Baseline, Week 52
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Change From Baseline PedsQL (3.2) Diabetic Module
Time Frame: Baseline, Week 52
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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
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: 1-877-CTLilly (1877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17121
- I8F-MC-GPGV (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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