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

Diabetes Mellitus, Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05260021
• Other study ID #: 17121
• Secondary ID: I8F-MC-GPGV
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 13, 2022
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99
• Est. completion date: February 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Endocrine System Diseases
• Glucose Metabolism Disorders
• Metabolic Disease
• Metabolic Diseases
• T2D
• T2DM (Type 2 Diabetes Mellitus)
• Type2 Diabetes

Intervention

Drug:
• Tirzepatide Dose 1
Administered SC
• Tirzepatide Dose 2
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Australia	Centre for Children's Health Research	Brisbane	Queensland
Australia	Perth Children's Hospital	Perth	Western Australia
Australia	The Children's Hospital at Westmead	Westmead	New South Wales
Brazil	Centro de Pesquisa Sao Lucas	Campinas	São Paulo
Brazil	Instituto de Pesquisa clinica de Campinas	Campinas	São Paulo
Brazil	Centro de Diabetes Curitiba	Curitiba	Paraná
Brazil	Instituto Méderi de Pesquisa e Saúde	Passo Fundo	Rio Grande Do Sul
Brazil	Instituto da Crianca com Diabetes	Porto Alegre	Rio Grande Do Sul
Brazil	Ruschel Medicina e Pesquisa Clínica	Rio De Janeiro
Brazil	Instituto da Crianca do Hospital das Clinicas da FMUSP	Sao Paulo	São Paulo
Brazil	Instituto de Pesquisa Clinica	Sao Paulo	São Paulo
Brazil	CEPIC - Centro Paulista de Investigação Clínica	São Paulo
Brazil	CPQuali Pesquisa Clínica	São Paulo
Brazil	CEDOES	Vitória	Espírito Santo
France	Centre Hospitalier Universitaire d'Angers	Angers	Maine-et-Loire
France	Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (CHU)	Paris
India	Clinical and Research department	Ahmedabad	Gujarat
India	M S Ramaiah Medical College and Hospitals	Bangalore	Karnataka
India	Postgraduate Institute of Medical Education & Research	Chandigarh
India	Kovai Diabetes Speciality Center and Hospital	Coimbatore	Tamil Nadu
India	All India Institute of Medical Sciences	New Delhi	Delhi
India	Bhakti Vedanta Hospital and Research Institute	Thane	Maharashtra
Israel	Soroka Medical Center	Be'er Sheva	HaDarom
Israel	Yitzhak Shamir Medical Center	Beer Yaacov	HaMerkaz
Israel	Rambam Health Care Campus	Haifa	HaTsafon
Israel	Shaare Zedek Medical Center	Jerusalem	Yerushalayim
Israel	Sheba Medical Center	Ramat Gan	HaMerkaz
Italy	Ospedale Pediatrico Salesi	Ancona
Italy	Universita degli Studi della Campania Luigi Vanvitelli	Napoli	Campania
Italy	Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento	Verona	Veneto
Mexico	Investigacion En Salud Y Metabolismo Sc	Chihuahua
Mexico	Consultorio Médico de Endocrinología y Pediatría	Puebla
Mexico	Unidad Médica para la Salud Integral	San Nicolás de los Garza	Nuevo León
Mexico	Clínica Cemain	Tampico	Tamaulipas
Mexico	Arké SMO S.A de C.V	Veracruz
United Kingdom	Hull and East Yorkshire Hospitals NHS Trust	Hull	Kingston Upon Hull
United Kingdom	Leicester General Hospital	Leicester	Leicestershire
United Kingdom	Leicester Royal Infirmary	Leicester	England
United States	Children's Hospital Colorado	Aurora	Colorado
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	SUNY Downstate Health Sciences University	Brooklyn	New York
United States	Qualmedica Research, LLC	Evansville	Indiana
United States	AA Medical Research Center	Flint	Michigan
United States	Indiana University Health University Hospital	Indianapolis	Indiana
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Children's Hospital of Philadelphia (CHOP)	Philadelphia	Pennsylvania
United States	Center Of Excellence in Diabetes and Endocrinology	Sacramento	California
United States	Washington University	Saint Louis	Missouri
United States	Rady Children's Hospital	San Diego	California
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Touro University California	Vallejo	California
United States	Nemours Children's Health - Delaware	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  France,  India,  Israel,  Italy,  Mexico,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1c (HbA1c)		Baseline, Week 30
Secondary	Change from Baseline in HbA1c (Individual Doses)		Baseline, Week 30
Secondary	Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (age and sex-matched)		Baseline, Week 30
Secondary	Change From Baseline in Fasting Serum Glucose (FSG)		Baseline, Week 30
Secondary	Percentage of Participants Who Achieve =6.5% of HbA1c		Week 30
Secondary	Percentage of Participants Who Achieve <7.0% of HbA1c		Week 30
Secondary	Percentage of Participants Who Achieve <5.7% of HbA1c		Week 30
Secondary	Change From Baseline for Serum Lipid Levels		Baseline, Week 30
Secondary	Change From Baseline in Height Standard Deviation Score (SDS)		Baseline, Week 30
Secondary	Change From Baseline in Weight SDS		Baseline, Week 30
Secondary	Pharmacokinetics (PK): Area Under the Concentration Curve (AUC), Steady State (ss) of Tirzepatide		Baseline to Week 30
Secondary	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
Secondary	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

External Links

•   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)