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
- Conditions
- Diabetes MellitusT2DGlucose Metabolism DisordersT2DM (Type 2 Diabetes Mellitus)Endocrine System DiseasesMetabolic DiseaseType2 DiabetesDiabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT05260021
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tirzepatide Dose 2 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 Tirzepatide Dose 1 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 Placebo 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. Placebo Tirzepatide Dose 1 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 30
- Secondary Outcome Measures
Name Time Method 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 Baseline, Week 52 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 Baseline, Week 52 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.
Trial Locations
- Locations (51)
Ruschel Medicina e Pesquisa Clínica
🇧🇷Rio De Janeiro, Brazil
CPQuali Pesquisa Clínica
🇧🇷São Paulo, Brazil
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Center Of Excellence in Diabetes and Endocrinology
🇺🇸Sacramento, California, United States
Rady Children's Hospital
🇺🇸San Diego, California, United States
Touro University California
🇺🇸Vallejo, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Nemours Children's Health - Delaware
🇺🇸Wilmington, Delaware, United States
Qualmedica Research, LLC
🇺🇸Evansville, Indiana, United States
Indiana University Health University Hospital
🇺🇸Indianapolis, Indiana, United States
AA Medical Research Center
🇺🇸Flint, Michigan, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Children's Hospital of Philadelphia (CHOP)
🇺🇸Philadelphia, Pennsylvania, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
The Children's Hospital at Westmead
🇦🇺Westmead, New South Wales, Australia
Centre for Children's Health Research
🇦🇺Brisbane, Queensland, Australia
Perth Children's Hospital
🇦🇺Perth, Western Australia, Australia
CEDOES
🇧🇷Vitória, Espírito Santo, 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
Centro de Pesquisa Sao Lucas
🇧🇷Campinas, São Paulo, Brazil
Instituto de Pesquisa clinica de Campinas
🇧🇷Campinas, São Paulo, Brazil
Instituto de Pesquisa Clinica
🇧🇷Sao Paulo, São Paulo, Brazil
Instituto da Crianca do Hospital das Clinicas da FMUSP
🇧🇷Sao Paulo, São Paulo, Brazil
CEPIC - Centro Paulista de Investigação Clínica
🇧🇷São Paulo, Brazil
Centre Hospitalier Universitaire d'Angers
🇫🇷Angers, Maine-et-Loire, France
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T
🇫🇷Paris, France
All India Institute of Medical Sciences
🇮🇳New Delhi, Delhi, India
Gujarat Endocrin Pvt Ltd
🇮🇳Ahmedabad, Gujarat, India
M S Ramaiah Medical College and Hospitals
🇮🇳Bangalore, Karnataka, India
Bhakti Vedanta Hospital and Research Institute
🇮🇳Thane, Maharashtra, India
Kovai Diabetes Speciality Center and Hospital
🇮🇳Coimbatore, Tamil Nadu, India
Postgraduate Institute of Medical Education & Research
🇮🇳Chandigarh, India
Soroka Medical Center
🇮🇱Be'er Sheva, HaDarom, Israel
Yitzhak Shamir Medical Center
🇮🇱Be'er Ya'aqov, HaMerkaz, Israel
Sheba Medical Center
🇮🇱Ramat Gan, HaMerkaz, Israel
Rambam Health Care Campus
🇮🇱Haifa, HaTsafon, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Yerushalayim, Israel
Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" Piazza Luigi Miraglia, 2 Napoli Campa -T
🇮🇹Napoli, Campania, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
🇮🇹Verona, Veneto, Italy
Ospedale Pediatrico Salesi
🇮🇹Ancona, Italy
Unidad Médica para la Salud Integral
🇲🇽San Nicolás de los Garza, Nuevo León, Mexico
Clínica Cemain
🇲🇽Tampico, Tamaulipas, Mexico
Investigacion En Salud Y Metabolismo Sc
🇲🇽Chihuahua, Mexico
Consultorio Médico de Endocrinología y Pediatría
🇲🇽Puebla, Mexico
Arké SMO S.A de C.V
🇲🇽Veracruz, Mexico
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Hull Royal Infirmary
🇬🇧Hull, Kingston Upon Hull, United Kingdom
Leicester General Hospital
🇬🇧Leicester, Leicestershire, United Kingdom