The main purpose of this study is to determine the efficacy and safety of insulin efsitora alfa (LY3209590) administered weekly using a fixed dose escalation compared to insulin glargine in adults with type 2 diabetes (T2D) who are starting basal insulin therapy for the first time.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Are insulin naive
Exceptions:
Have a diagnosis of T2D according to the World Health Organization criteria.
Have an HbA1c of 7.0% to 10.0%, inclusive, at screening.
Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study.
short-term insulin treatment for a maximum of 14 days, prior to screening, and
prior insulin treatment for gestational diabetes.

Criterios de exclusión

Have a diagnosis of type 1 diabetes (T1D), latent autoimmune diabetes, or specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug induced or chemical-induced diabetes.
Have a history of \>1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening.
Have had severe hypoglycemia episodes within 6 months prior to screening.
Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening
acute myocardial infarction
cerebrovascular accident (stroke), or
coronary bypass surgery.
Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening
Have had significant weight gain or loss within 3 months prior to screening, for example, ≥5%.

Ubicaciones

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

DIM Clínica Privada

Ramos Mejía, Buenos Aires, Argentina

Go Centro Medico San Nicolás

San Nicolás de los Arroyos, Buenos Aires, Argentina

Asociación de Beneficencia Hospital Sirio Libanés

Buenos Aires, Buenos Air, Argentina

Stat Research S.A.

Buenos Aires, Ciudad Aut, Argentina

Centro Médico Viamonte

Buenos Aires, Ciudad Aut, Argentina

Glenny Corp

Buenos Aires, Ciudad Aut, Argentina

CEMEDIAB

C.a.b.a., Ciudad Aut, Argentina

Investigaciones Medicas Imoba Srl

Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina

CIPREC

Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Ciudad Autonoma de Buenos Aire, Ciudad Autónoma de Buenos Aire, Argentina

Centro Medico Privado San Vicente Diabetes

Córdoba, Córdoba Province, Argentina

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina

CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

Godoy Cruz, Mendoza Province, Argentina

Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

Rosario, Santa Fe Province, Argentina

Clínica Mayo

San Miguel de Tucumán, Tucumán Province, Argentina

Fundación Respirar

Buenos Aires, Argentina

CENUDIAB

Ciudad Autónoma de Buenos Aire, Argentina

Centro de Diagnóstico y Rehabilitación (CEDIR)

Santa Fe, Argentina

Sanatorio Norte

Santiago del Estero, Argentina

A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 Administered Weekly Using a Fixed Dose Escalation Compared to Insulin Glargine in Insulin-Naïve Adults With Type 2 Diabetes

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Insulin Efsitora Alfa

Insulin Glargine

Ubicaciones

Centro de Investigaciones Metabólicas (CINME)

Instituto de Investigaciones Clínicas Mar del Plata

DIM Clínica Privada

Go Centro Medico San Nicolás

Asociación de Beneficencia Hospital Sirio Libanés

Stat Research S.A.

Centro Médico Viamonte

Glenny Corp

CEMEDIAB

Investigaciones Medicas Imoba Srl

CIPREC

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Centro Medico Privado San Vicente Diabetes

Instituto Médico Río Cuarto

CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

Clínica Mayo

Fundación Respirar

CENUDIAB

Centro de Diagnóstico y Rehabilitación (CEDIR)

Sanatorio Norte

Patrocinadores