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)
Type2 Diabetes, Diabetes Mellitus, Diabetes Mellitus, Type 2
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
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
Experimental
Experimental
Placebo Comparator
Tirzepatide Dose 1
Tirzepatide Dose 2
Placebo
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.