A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro, Both in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 2 Diabetes

CompletadoFase 3ClinicalTrials.gov

ID: NCT03952143Tipo: INTERVENTIONALInicio: 27 de may de 2019Fin estimado: 20 de ene de 2021

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in combination with insulin glargine or insulin degludec, is safe and effective in participants with type 2 diabetes (T2D).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants must have T2D based on the disease diagnostic criteria World Health Organization (WHO) classification.
Participants must have been treated for at least 90 days prior to screening with either basal insulin + at least 1 prandial injection of bolus insulin or premixed analog/human insulin regimens at least twice daily.
Participants must be treated no more than 3 oral anti-hyperglycemic medications (OAMs).
Participants must have a HbA1c ≥7.0% and ≤11.0%.
Participants must have body mass index (BMI) of ≤35.0 kilograms per meter squared (kg/m2).

Criterios de exclusión

Participants must not have been diagnosed, at any time, with type 1 diabetes (T1D) or latent autoimmune diabetes in adults.
Participants must not have had any episode of severe hypoglycemia within the 6 months prior to screening.
Participants must not have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.
Participants must not have used thiazolidinediones, glucagon-like peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.

Intervenciones

drug

LY900014

Administered SC

drug

Insulin Lispro

Administered SC

drug

Insulin Glargine

Administered SC

drug

Insulin Degludec

Administered SC

Ubicaciones

Centro Médico Viamonte

Buenos Aires, AR-C, Argentina

Centro de Investigaciones Metabólicas (CINME)

CABA, Buenos Aires, Argentina

Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

Córdoba, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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