A Phase 3, Open-Label, Multicenter, Single-Arm Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Dulaglutide 3.0 mg and 4.5 mg in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes Mellitus

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06739122Tipo: INTERVENTIONALInicio: 10 de ene de 2025Fin estimado: 1 de dic de 2027

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to evaluate additional dosing options for dulaglutide in pediatric participants with Type 2 Diabetes. Participation in this study will last about 8 months.

Elegibilidad

Edad mínima: 10 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

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 8 weeks prior to screening.
Have a body weight ≥50 kilograms (kg) and Body Mass Index (BMI) of \>85th percentile

Criterios de exclusión

Have Type 1 diabetes
Have received treatment with any glucose-lowering agent(s) other than metformin or basal insulin within 8 weeks prior to screening
After the Type 2 diabetes 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)
Have prior chronic, recurrent, or idiopathic pancreatitis, or known gallbladder disease
Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 8 weeks prior to screening

Intervenciones

drug

Dulaglutide

Administered SC

Ubicaciones

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, Argentina

NOT_YET_RECRUITING

Centro de Investigaciones Médicas Mar del Plata

Mar del Plata, Argentina

NOT_YET_RECRUITING

INECO Neurociencias Oroño

Rosario, Argentina

NOT_YET_RECRUITING

Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L

San Miguel de Tucumán, Argentina

NOT_YET_RECRUITING

Go Centro Medico San Nicolás

San Nicolás, Argentina

NOT_YET_RECRUITING

Patrocinadores

PrincipalEli Lilly and Company

Contactos

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

LillyTrials@Lilly.com 1-317-615-4559

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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