Eficacia y seguridad de FIAsp en un régimen basal-bolo ve... | EligiMed

Eficacia y seguridad de FIAsp en un régimen basal-bolo versus terapia con insulina basal, ambos en combinación con metformina, en sujetos adultos con diabetes tipo 2.

CompletadoFase 3ClinicalTrials.gov

ID: NCT01850615Tipo: INTERVENTIONALInicio: 23 de sept de 2013Fin estimado: 17 de nov de 2014

Resumen

Este ensayo clínico se lleva a cabo en Asia, Europa, América del Sur y los Estados Unidos de América (EE. UU.). El objetivo del ensayo es investigar la eficacia y seguridad de FIAsp en un régimen basal-bolo versus terapia con insulina basal, ambos en combinación con metformina, en sujetos adultos con diabetes tipo 2.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Type 2 diabetes (diagnosed clinically) for at least 6 months prior to the screening visit (Visit 1)
Current treatment with once daily insulin detemir, insulin glargine or human isophane insulin, NPH for at least 3 months prior to the screening visit (Visit 1)
Current treatment with a) metformin with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg or b) metformin in combination with sulfonylurea (SU) or glinide or Dipeptidyl peptidase-IV inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg
HbA1c by central laboratory a) 7.5-9.5% (58 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (Visit 1) or b) 7.5-9.0% (58 - 75 mmol/mol) (both inclusive) in the metformin + other oral antidiabetic drug (OAD) (sulphonylurea (SU), glinide, dipeptidyl peptidase-IV (DDP-IV) inhibitors, alpha-glucosidase inhibitors (AGI) combination group at the screening visit (Visit 1)
Body mass index (BMI) equal or less than 40.0 kg/m\^2

Criterios de exclusión

Any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days of consecutive treatment) and not within 3 months prior to the screening visit (Visit 1)
Use of Glucagon-like peptide-1 (GLP-1) agonists and/or Thiazolidinediones (TZD) within the last 3 months prior to screening (visit 1)
Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (Visit 1)

Intervenciones

drug

Faster-acting insulin aspart

Administrated subcutaneously (s.c., under the skin) at each main meal.

drug

basal insulin

Administrated subcutaneously (s.c., under the skin) once daily.

Ubicaciones

Novo Nordisk Investigational Site

Buenos Aires, Argentina

Novo Nordisk Investigational Site

Capital Federal, Argentina

Novo Nordisk Investigational Site

Córdoba, Argentina

Novo Nordisk Investigational Site

Godoy Cruz, Argentina

Novo Nordisk Investigational Site

San Isidro, Argentina

Patrocinadores

PrincipalNovo Nordisk A/S

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.