The purpose of the trial is to assess the efficacy and safety of tirzepatide taken once a week to insulin glargine taken once daily in participants with type 2 diabetes and increased cardiovascular risk. The study will last about 108 weeks and may include up to 30 visits.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants must:
Have been diagnosed with type 2 diabetes mellitus (T2DM)
Have HbA1c between ≥7.5% and ≤10.5%
Be on stable treatment with unchanged dose of at least 1 and no more than 3 types of oral antihyperglycemic drugs, which may only include metformin, SGLT-2 inhibitors, and/or sulfonylureas for at least 3 months before screening
Have increased risk for cardiovascular (CV) events
Be of stable weight (± 5%)
Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

Criterios de exclusión

Participants must not:
Have type 1 diabetes mellitus
Have had chronic or acute pancreatitis any time prior to study entry
Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring immediate or urgent treatment
Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level \>3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range
Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months
Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
Have been taking any other diabetes medicines other than metformin, SGLT-2 inhibitors, and/or sulfonylureas during the last 3 months
Have been taking weight loss drugs, including over-the-counter medications during the last 3 months

Ubicaciones

Centro de Investigaciones Metabólicas (CINME)

CABA, Buenos Aires, Argentina

Mautalen Salud e Investigación - Servicio de Endocrinología

CABA, Buenos Aires, Argentina

Investigaciones Medicas IMOBA S.R.L.

Caba, Buenos Aires, Argentina

CEDIC-Centro de Investigaciones Clinicas

Caba, Buenos Aires, Argentina

CEMEDIC

CABA, Buenos Aires, Argentina

Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Centro de Investigacion y Prevencion Cardiovascular (CIPREC)

Ciudad Autonoma de, Buenos Aires, Argentina

CIPADI

Godoy Cruz, Mendoza Province, Argentina

AXISMED SRL - Bioclinica Research Network

Buenos Aires, Argentina

Centro Médico Viamonte

Ciudad Autonoma de Buenos Aire, Argentina

Instituto Centenario

Ciudad Autonoma de Buenos Aire, Argentina

Cemediab - Centro Médico Diabetológico Dr. Alejandro Chertkoff

Ciudad Autonoma de Buenos Aire, Argentina

Centro Diabetologico Dr Waitman

Córdoba, Argentina

Centro Medico Privado San Vicente Diabetes

Córdoba, Argentina

Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

Córdoba, Argentina

Efficacy and Safety of LY3298176 Once Weekly Versus Insulin Glargine in Patients With Type 2 Diabetes and Increased Cardiovascular Risk (SURPASS-4)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Tirzepatide

Insulin Glargine

Ubicaciones

Centro de Investigaciones Metabólicas (CINME)

Mautalen Salud e Investigación - Servicio de Endocrinología

Investigaciones Medicas IMOBA S.R.L.

CEDIC-Centro de Investigaciones Clinicas

CEMEDIC

Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada

Centro de Investigacion y Prevencion Cardiovascular (CIPREC)

CIPADI

AXISMED SRL - Bioclinica Research Network

Centro Médico Viamonte

Instituto Centenario

Cemediab - Centro Médico Diabetológico Dr. Alejandro Chertkoff

Centro Diabetologico Dr Waitman

Centro Medico Privado San Vicente Diabetes

Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

Patrocinadores