A Multi-centre, Multinational, Open-labelled, Randomised, Parallel-Group Comparison of Insulin Detemir Plus Insulin Aspart With NPH Insulin Plus Human Soluble Insulin in Subjects With Type 1 Diabetes on a Basal-Bolus Regimen

CompletadoFase 3ClinicalTrials.gov

ID: NCT01486940Tipo: INTERVENTIONALInicio: 1 de mar de 2002Fin estimado: 1 de oct de 2002

Traducción no disponible, mostrando original

Resumen

This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Type 1 diabetes for at least 12 months
Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months
BMI below or equal to 35 kg/m\^2
HbA1c below or equal to 12%

Criterios de exclusión

Proliferative retinopathy or maculopathy requiring acute treatment
Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the Investigator)
Subjects with known hypoglycaemic unawareness as judged by the Investigator

Intervenciones

drug

insulin detemir

Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily

drug

insulin aspart

Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals

drug

insulin NPH

Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily

drug

human soluble insulin

Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals

Ubicaciones

Novo Nordisk Investigational Site

Junín, Argentina

Novo Nordisk Investigational Site

Morón, Argentina

Patrocinadores

PrincipalNovo Nordisk A/S

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