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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
First received
Last updated
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
Health authority
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.

Study Design


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
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