Resumen

El propósito de este estudio es investigar la eficacia y la seguridad de retatrutida en comparación con semaglutida en participantes con diabetes tipo 2 y control glucémico inadecuado con metformina con o sin inhibidor del cotransportador sodio-glucosa tipo 2 (SGLT2i). El estudio tendrá una duración aproximada de 26 meses y puede incluir hasta 24 visitas.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have Type 2 Diabetes (T2D)
Have HbA1c ≥ 7.0% (53 millimoles per mole (mmol/mol)) to ≤ 10.5% (91 mmol/mol)
Have been on a stable diabetes treatment consisting of metformin ≥ 1500 milligrams per day (mg/day) with or without SGLT2i during 90 days prior to screening
Are of stable weight for at least 90 days prior to screening
Have a Body Mass Index (BMI) ≥ 25.0 kilograms per meter squared (kg/m\^2)

Criterios de exclusión

Have Type 1 Diabetes (T1D)
Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening
Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening
Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
Have an estimated glomerular filtration rate (eGFR) \<45 milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory
Have a prior or planned surgical treatment for obesity
Have New York Heart Association Functional Classification IV congestive heart failure
Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening
Have a known clinically significant gastric emptying abnormality
Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
Have any lifetime history of a suicide attempt
Had chronic or acute pancreatitis
Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2
Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening.

Ubicaciones

Instituto Centenario

CABA, Buenos Aires F.D., Argentina

Centro Medico Privado San Vicente Diabetes

Córdoba, Córdoba Province, Argentina

CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

Godoy Cruz, Mendoza Province, Argentina

Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, Santa Fe Province, Argentina

Instituto de Investigaciones Clinicas Rosario

Rosario, Santa Fe Province, Argentina

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina

Fundación Respirar

Buenos Aires, Argentina

Centro Diabetológico Dr. Waitman

Córdoba, Argentina