A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy

CompletadoFase 3ClinicalTrials.gov

ID: NCT05463744Tipo: INTERVENTIONALInicio: 12 de ago de 2022Fin estimado: 7 de may de 2024

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to measure the safety and efficacy of insulin efsitora alfa (LY3209590) compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have a clinical diagnosis of type 1 diabetes for at least 1 year prior to screening
Have received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening
Have an HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central laboratory at screening.
Have a body mass index of ≤35 kilogram/square meter (kg/m²)

Criterios de exclusión

Have a diagnosis of type 2 diabetes, latent autoimmune diabetes, or specific types of diabetes other than type 1 diabetes
Have a history of more than 1 episode of severe hypoglycemia, within the 6 months prior to screening.
Have a history of more than 1 episode of diabetic ketoacidosis or hyperosmolar state or coma requiring hospitalization within the 6 months prior to screening.

Intervenciones

drug

Insulin Efsitora Alfa

Administered SC

drug

Insulin Degludec

Administered SC

Ubicaciones

CEDIC

CABA, Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina

Consultorio de Investigación Clínica EMO SRL

Ciudad Autonoma de Buenos Aire, Buenos Air, Argentina

CIAD Moron

Morón, Buenos Air, Argentina

Investigaciones Medicas Imoba Srl

Balvanera, Ciudad Autónoma de Buenos Aire, Argentina

Mautalen Salud e Investigación

Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina

Centro Medico Privado CEMAIC

Capital, Córdoba Province, Argentina

Centro Medico Privado San Vicente Diabetes

Córdoba, Córdoba Province, Argentina

Centro de Salud e Investigaciones Médicas

Santa Rosa, La Pampa Province, Argentina

CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

Godoy Cruz, Mendoza Province, Argentina

Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L

San Miguel de Tucumán, Tucumán Province, Argentina

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Tucumán Province, Argentina

Instituto Médico Especializado (IME)

Buenos Aires, Argentina

Centro Diabetológico Dr. Waitman

Córdoba, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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