A Phase 2, Parallel, Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Insulin-Naïve Patients With Type 2 Diabetes Mellitus

CompletadoFase 2ClinicalTrials.gov

ID: NCT04450394Tipo: INTERVENTIONALInicio: 1 de jul de 2020Fin estimado: 8 de oct de 2021

Traducción no disponible, mostrando original

Resumen

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Participants must have type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with a stable dose of metformin in combination with a stable dose of Dipeptidyl Peptidase IV (DPPIV) inhibitor and/or a Sodium-glucose co-transporter-2 (SGLT2) inhibitor for at least 3 months prior to screening
Participants must have a HbA1c value of 7.0% to 9.5%, inclusive
Participants must have a body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m²), inclusive

Criterios de exclusión

Have type 1 diabetes mellitus or latent autoimmune diabetes
Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
Have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
Have an estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 m²
Have active or untreated cancer
Are receiving chronic (\>14 days) systemic glucocorticoid therapy

Intervenciones

drug

LY3209590

Administered SC

drug

Insulin Degludec

Administered SC

Ubicaciones

Centro Médico Viamonte

CABA, Buenos Aires, Argentina

Investigaciones Medicas Imoba Srl

CABA, Buenos Aires, Argentina

Fundacion Sanatorio Guemes

CABA, Buenos Aires, Argentina

Consultorio de Investigación Clínica EMO SRL

Caba, Buenos Aires, Argentina

CEDIC

CABA, Buenos Aires, Argentina

Instituto Médico Catamarca

Rosario, Santa Fe Province, Argentina

CEMEDIC

Buenos Aires, Argentina

Asociación de Beneficencia Hospital Sirio Libanés

Buenos Aires, Argentina

Instituto Centenario

Ciudad Autonoma de Buenos Aire, Argentina

Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

Córdoba, Argentina

Clínica Mayo

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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