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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)

Primary Purpose

Type2 Diabetes, Diabetes Mellitus, Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tirzepatide Dose 1
Tirzepatide Dose 2
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes focused on measuring GLP-1 RA, Glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), GIP/GLP-1 dual receptor agonist, Incretins

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Center Of Excellence in Diabetes and EndocrinologyRecruiting
  • Rady Children's HospitalRecruiting
  • Touro University CaliforniaRecruiting
  • Children's Hospital ColoradoRecruiting
  • Nemours Children's Health - DelawareRecruiting
  • Indiana University Health University HospitalRecruiting
  • AA Medical Research CenterRecruiting
  • SUNY Downstate Health Sciences UniversityRecruiting
  • SUNY Upstate Medical UniversityRecruiting
  • Children's Hospital of Philadelphia (CHOP)Recruiting
  • The Children's Hospital at WestmeadRecruiting
  • Centre for Children's Health ResearchRecruiting
  • Perth Children's HospitalRecruiting
  • CEDOESRecruiting
  • Centro de Diabetes CuritibaRecruiting
  • Instituto Méderi de Pesquisa e SaúdeRecruiting
  • Instituto da Crianca com DiabetesRecruiting
  • Instituto de Pesquisa clinica de CampinasRecruiting
  • Centro de Pesquisa Sao LucasRecruiting
  • Instituto de Pesquisa ClinicaRecruiting
  • Instituto da Crianca do Hospital das Clinicas da FMUSPRecruiting
  • Ruschel Medicina e Pesquisa ClínicaRecruiting
  • CPQuali Pesquisa ClínicaRecruiting
  • Hospital das Clinicas FMUSPRecruiting
  • Centre Hospitalier Universitaire d'AngersRecruiting
  • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (CHU)Recruiting
  • All India Institute of Medical SciencesRecruiting
  • M S Ramaiah Medical College and HospitalsRecruiting
  • Bhakti Vedanta Hospital and Research InstituteRecruiting
  • Kovai Diabetes Speciality Center and HospitalRecruiting
  • Postgraduate Institute of Medical Education & ResearchRecruiting
  • Soroka Medical CenterRecruiting
  • Yitzhak Shamir Medical CenterRecruiting
  • Rambam Health Care CampusRecruiting
  • Shaare Zedek Medical CenterRecruiting
  • Universita degli Studi della Campania Luigi VanvitelliRecruiting
  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo TrentoRecruiting
  • Ospedale Pediatrico SalesiRecruiting
  • Azienda Ospedaliera di Perugia
  • Unidad Médica para la Salud IntegralRecruiting
  • Clínica CemainRecruiting
  • Investigacion En Salud Y Metabolismo ScRecruiting
  • Consultorio Médico de Endocrinología y PediatríaRecruiting
  • Arké SMO S.A de C.VRecruiting
  • Leicester Royal InfirmaryRecruiting
  • Hereford County Hospital
  • Leicester General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Tirzepatide Dose 1

Tirzepatide Dose 2

Placebo

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Hemoglobin A1c (HbA1c)

Secondary Outcome Measures

Change from Baseline in HbA1c (Individual Doses)
Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (age and sex-matched)
Change From Baseline in Fasting Serum Glucose (FSG)
Percentage of Participants Who Achieve ≤6.5% of HbA1c
Percentage of Participants Who Achieve <7.0% of HbA1c
Percentage of Participants Who Achieve <5.7% of HbA1c
Change From Baseline for Serum Lipid Levels
Change From Baseline in Height Standard Deviation Score (SDS)
Change From Baseline in Weight SDS
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC), Steady State (ss) of Tirzepatide
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.
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.

Full Information

First Posted
February 25, 2022
Last Updated
October 16, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05260021
Brief 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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes, Diabetes Mellitus, Diabetes Mellitus, Type 2, T2D, T2DM (Type 2 Diabetes Mellitus), Glucose Metabolism Disorders, Endocrine System Diseases, Metabolic Disease
Keywords
GLP-1 RA, Glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), GIP/GLP-1 dual receptor agonist, Incretins

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tirzepatide Dose 1
Arm Type
Experimental
Arm Description
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
Arm Title
Tirzepatide Dose 2
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tirzepatide Dose 1
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Tirzepatide Dose 2
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin A1c (HbA1c)
Time Frame
Baseline, Week 30
Secondary Outcome Measure Information:
Title
Change from Baseline in HbA1c (Individual Doses)
Time Frame
Baseline, Week 30
Title
Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (age and sex-matched)
Time Frame
Baseline, Week 30
Title
Change From Baseline in Fasting Serum Glucose (FSG)
Time Frame
Baseline, Week 30
Title
Percentage of Participants Who Achieve ≤6.5% of HbA1c
Time Frame
Week 30
Title
Percentage of Participants Who Achieve <7.0% of HbA1c
Time Frame
Week 30
Title
Percentage of Participants Who Achieve <5.7% of HbA1c
Time Frame
Week 30
Title
Change From Baseline for Serum Lipid Levels
Time Frame
Baseline, Week 30
Title
Change From Baseline in Height Standard Deviation Score (SDS)
Time Frame
Baseline, Week 30
Title
Change From Baseline in Weight SDS
Time Frame
Baseline, Week 30
Title
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC), Steady State (ss) of Tirzepatide
Time Frame
Baseline to Week 30
Title
Change From Baseline in PedsQL Generic Core Scale
Description
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.
Time Frame
Baseline, Week 52
Title
Change From Baseline PedsQL (3.2) Diabetic Module
Description
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.
Time Frame
Baseline, Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
1-877-CTLilly (1877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
2056389107
First Name & Middle Initial & Last Name & Degree
Christy Anne Foster
Facility Name
Center Of Excellence in Diabetes and Endocrinology
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
916-426-1902
First Name & Middle Initial & Last Name & Degree
Gnanagurudasan Prakasam
Facility Name
Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
8589664032
First Name & Middle Initial & Last Name & Degree
Michael Everett Gottschalk
Facility Name
Touro University California
City
Vallejo
State/Province
California
ZIP/Postal Code
94592
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
707-638-5999
First Name & Middle Initial & Last Name & Degree
jay h shubrook
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
720-777-6128
First Name & Middle Initial & Last Name & Degree
Philip Zeitler
Facility Name
Nemours Children's Health - Delaware
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chijioke Ikomi
Facility Name
Indiana University Health University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamara Hannon
Facility Name
AA Medical Research Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
810-237-1125
First Name & Middle Initial & Last Name & Degree
Ahmed Arif
Facility Name
SUNY Downstate Health Sciences University
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
718-270-4714
First Name & Middle Initial & Last Name & Degree
Vivian Chin
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
315-464-9006
First Name & Middle Initial & Last Name & Degree
David Hansen
Facility Name
Children's Hospital of Philadelphia (CHOP)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven M. Willi
Facility Name
The Children's Hospital at Westmead
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
0298453171
First Name & Middle Initial & Last Name & Degree
Ann Maguire
Facility Name
Centre for Children's Health Research
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tony Huynh
Facility Name
Perth Children's Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
6165462222
First Name & Middle Initial & Last Name & Degree
Jacqueline Anne Curran
Facility Name
CEDOES
City
Vitória
State/Province
Espírito Santo
ZIP/Postal Code
29055450
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
55279993333
First Name & Middle Initial & Last Name & Degree
queulla garret santos
Facility Name
Centro de Diabetes Curitiba
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80810-040
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
554130231252
First Name & Middle Initial & Last Name & Degree
LUCIANA muniz PECHMANN
Facility Name
Instituto Méderi de Pesquisa e Saúde
City
Passo Fundo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
99010-120
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
555435811831
First Name & Middle Initial & Last Name & Degree
Hugo Roberto Kurtz Lisboa
Facility Name
Instituto da Crianca com Diabetes
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-250
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
55133372215
First Name & Middle Initial & Last Name & Degree
Balduino Tschiedel
Facility Name
Instituto de Pesquisa clinica de Campinas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13060-080
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
551932670023
First Name & Middle Initial & Last Name & Degree
Sylka Rodovalho
Facility Name
Centro de Pesquisa Sao Lucas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13060-803
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
551933438688
First Name & Middle Initial & Last Name & Degree
Mila Pontes Ramos Cunha
Facility Name
Instituto de Pesquisa Clinica
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01223-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
551127370277
First Name & Middle Initial & Last Name & Degree
Joao Eduardo Nunes Salles
Facility Name
Instituto da Crianca do Hospital das Clinicas da FMUSP
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
1126618833
First Name & Middle Initial & Last Name & Degree
Louise Cominato
Facility Name
Ruschel Medicina e Pesquisa Clínica
City
Rio De Janeiro
ZIP/Postal Code
22270-060
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
552135979708
First Name & Middle Initial & Last Name & Degree
Luiza Siffert
Facility Name
CPQuali Pesquisa Clínica
City
São Paulo
ZIP/Postal Code
01228-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
55112776680
First Name & Middle Initial & Last Name & Degree
Francisco Samuel Magalhães Lima
Facility Name
Hospital das Clinicas FMUSP
City
São Paulo
ZIP/Postal Code
04266-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Breno Balabem Alves
Facility Name
Centre Hospitalier Universitaire d'Angers
City
Angers
State/Province
Maine-et-Loire
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0241355655
First Name & Middle Initial & Last Name & Degree
Jessica Amsellem-Jager
Facility Name
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (CHU)
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise Bismuth
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Contact:
Phone
911126593237
First Name & Middle Initial & Last Name & Degree
Rajesh Khadgawat
Facility Name
M S Ramaiah Medical College and Hospitals
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Individual Site Status
Recruiting
Facility Contact:
Phone
918197132111
First Name & Middle Initial & Last Name & Degree
Dr Chitra Selvan
Facility Name
Bhakti Vedanta Hospital and Research Institute
City
Thane
State/Province
Maharashtra
ZIP/Postal Code
401107
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ameya Sudhakar Joshi
Facility Name
Kovai Diabetes Speciality Center and Hospital
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641009
Country
India
Individual Site Status
Recruiting
Facility Contact:
Phone
9842244881
First Name & Middle Initial & Last Name & Degree
Balamurugan Ramanathan
Facility Name
Postgraduate Institute of Medical Education & Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Individual Site Status
Recruiting
Facility Contact:
Phone
07740073634
First Name & Middle Initial & Last Name & Degree
Soham Mukerjee
Facility Name
Soroka Medical Center
City
Be'er Sheva
State/Province
HaDarom
ZIP/Postal Code
8410101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
97286244150
First Name & Middle Initial & Last Name & Degree
Alon Haim
Facility Name
Yitzhak Shamir Medical Center
City
Beer Yaacov
State/Province
HaMerkaz
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
972537346636
First Name & Middle Initial & Last Name & Degree
Marianna Rachmiel
Facility Name
Rambam Health Care Campus
City
Haifa
State/Province
HaTsafon
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
97247774807
First Name & Middle Initial & Last Name & Degree
Nehama Zuckerman-Levin
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
9013102
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
97226666062
First Name & Middle Initial & Last Name & Degree
Floris Levy-Khademi
Facility Name
Universita degli Studi della Campania Luigi Vanvitelli
City
Napoli
State/Province
Campania
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
00390815665434
First Name & Middle Initial & Last Name & Degree
Angela Zanfardino
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
City
Verona
State/Province
Veneto
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
0458127662
First Name & Middle Initial & Last Name & Degree
Claudio Maffeis
Facility Name
Ospedale Pediatrico Salesi
City
Ancona
ZIP/Postal Code
60123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
390715962011
First Name & Middle Initial & Last Name & Degree
Valentino Cherubini
Facility Name
Azienda Ospedaliera di Perugia
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
390755783990
First Name & Middle Initial & Last Name & Degree
Paolo Sportoletti
Facility Name
Unidad Médica para la Salud Integral
City
San Nicolás de los Garza
State/Province
Nuevo León
ZIP/Postal Code
66465
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
52818348897
First Name & Middle Initial & Last Name & Degree
Ramiro Guadalupe Banda Elizondo
Facility Name
Clínica Cemain
City
Tampico
State/Province
Tamaulipas
ZIP/Postal Code
89170
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RICARDO SALAS
Facility Name
Investigacion En Salud Y Metabolismo Sc
City
Chihuahua
ZIP/Postal Code
31217
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
526144398618
First Name & Middle Initial & Last Name & Degree
Luis Alejandro Nevarez
Facility Name
Consultorio Médico de Endocrinología y Pediatría
City
Puebla
ZIP/Postal Code
72190
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
522222657319
First Name & Middle Initial & Last Name & Degree
Margarita Barrientos
Facility Name
Arké SMO S.A de C.V
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
2299314102
First Name & Middle Initial & Last Name & Degree
Maria del Carmen Ramon Ramirez
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anbezhil Subbarayan
Facility Name
Hereford County Hospital
City
Hereford
State/Province
Herefordshire
ZIP/Postal Code
HR1 2ER
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
01432355444 ext2225
First Name & Middle Initial & Last Name & Degree
Fergus Jack
Facility Name
Leicester General Hospital
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anbezhil Subbarayan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/WoqX8k1IVNPugq1V1yyyL
Description
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)

Learn more about this trial

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

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