NN1250-3585: A Trial Investigating the Efficacy and Safety of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen / NN1250-3725: An Extension Trial to NN1250-3585 Investigating Safety and Efficacy of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen (BEGIN™: BB T1)

CompletadoFase 3ClinicalTrials.gov

ID: NCT01074268Tipo: INTERVENTIONALInicio: 1 de feb de 2010Fin estimado: 1 de dic de 2010

Traducción no disponible, mostrando original

Resumen

This trial is conducted in Asia, Europe, Japan and South America. The aim of the trial is to compare the efficacy, safety and tolerability of NN1250 (insulin degludec (\[Deg\]) with insulin detemir (IDet), both combined with insulin aspart. The main period is registered internally at Novo Nordisk as NN1250-3585 while the extension period is registered as NN1250-3725.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Type 1 diabetes mellitus for at least 12 months
Current treatment with any basal bolus insulin for at least 12 months
HbA1c below or equal to 10.0%
Body Mass Index (BMI) below or equal to 35.0 kg/m\^2
For Japan only: Minimum age is 20 years
For the extension trial only: Completed the six-month treatment period in trial NN1250-3585 (NCT01074268)

Criterios de exclusión

Use of any other antidiabetic drug than insulin within the last 3 months
Cardiovascular disease within the last 6 months
Uncontrolled treated/untreated severe hypertension
Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
Cancer and medical history of cancer

Intervenciones

drug

insulin degludec

Injected s.c. (under the skin) once daily. Dose was individually adjusted.

drug

insulin detemir

Injected s.c. (under the skin) once daily or twice daily (BID). Dose was individually adjusted.

drug

insulin aspart

Injected s.c. (under the skin) as mealtime insulin. Dose was individually adjusted.

Ubicaciones

Novo Nordisk Investigational Site

Caba, Argentina

Novo Nordisk Investigational Site

Ciudad Autónoma de Bs As, Argentina

Novo Nordisk Investigational Site

Mar del Plata, Argentina

Novo Nordisk Investigational Site

Rosario, 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.

NN1250-3585: A Trial Investigating the Efficacy and Safet... | EligiMed