The main purpose of this study is to determine safety and efficacy of orforglipron compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study will last approximately 2 years may include up to 27 visits.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have been diagnosed with type 2 diabetes mellitus (T2DM)
Are at least 18 years of age or legal age of consent in the jurisdiction in which the study is taking place, whichever is older.
Have HbA1c at screening
≥7.0% and ≤10.5% if background diabetes medication does not include a sulfonylurea, or
≥7.5% and ≤10.5% if background diabetes medication includes a sulfonylurea.
Are on stable treatment of at least 1 and no more than 3 oral antihyperglycemic drugs for at least 90 days before screening. Antihyperglycemic drugs may include metformin, SGLT-2 inhibitors, and/or sulfonylureas
Have increased risk for cardiovascular (CV) events due to:
Coronary heart disease
Peripheral arterial disease, presumed to be of atherosclerotic origin
Cerebrovascular disease, presumed to be of atherosclerotic origin
Chronic kidney disease (CKD)
Congestive heart failure (CHF) New York Heart Association (NYHA) functional classification II to III
Are of stable weight (± 5%) for at least 90 days prior to screening
Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

Criterios de exclusión

Have type 1 diabetes mellitus
Have had chronic or acute pancreatitis any time prior to screening
Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (e.g. laster photocoagulation or intravitreal injections of anty-VEGF inhibitors
Have a known clinically significant gastric emptying abnormality
Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) or aspartate aminotransferase (AST) enzyme level ≥5.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory
Have had any of the following within 60 days prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or hospitalization for congestive heart failure
Have an eGFR \<15 mL/min/1.73 m2 as determined at screening
Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or 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 90 days
Have used any weight loss drugs, including herbal or nutritional supplements, within 90 days of screening

Ubicaciones

Buenos Aires Macula S.A

Buenos Aires, Argentina

CEMEDIC

Buenos Aires, Argentina

Centro Privado de Medicina Familiar / Mindout Research

Buenos Aires, Argentina

Cardiología Palermo

Buenos Aires, Argentina

CIPREC

Buenos Aires, Argentina

Centro Médico Viamonte

Buenos Aires, Argentina

Mautalen Salud e Investigación

Buenos Aires, Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, Argentina

Glenny Corp. S.A.

Buenos Aires, Argentina

CENUDIAB

Buenos Aires, Argentina

Organizacion Medica de Investigacion

CABA, Argentina

Hospital San Roque

Córdoba, Argentina

Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, Argentina

Polo de Salud Vistalba

Luján de Cuyo, Argentina

Instituto Médico Catamarca IMEC

Rosario, Argentina

Investigaciones Clínicas Tucumán

San Miguel de Tucumán, Argentina

A Phase 3, Open-Label Study of Once Daily LY3502970 Compared With Insulin Glargine in Adult Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Orforglipron

Insulin Glargine

Ubicaciones

Buenos Aires Macula S.A

CEMEDIC

Centro Privado de Medicina Familiar / Mindout Research

Cardiología Palermo

CIPREC

Centro Médico Viamonte

Mautalen Salud e Investigación

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Glenny Corp. S.A.

CENUDIAB

Organizacion Medica de Investigacion

Hospital San Roque

Centro de Investigaciones Clínicas Baigorria

Polo de Salud Vistalba

Instituto Médico Catamarca IMEC

Investigaciones Clínicas Tucumán

Patrocinadores