A Multi-national, Open-labelled, Randomised, Parallel Group, 4 Week run-in and 26 Weeks Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Insulin naïve Subjects With Type 2 Diabetes

CompletadoFase 4ClinicalTrials.gov

ID: NCT00469092Tipo: INTERVENTIONALInicio: 1 de may de 2007Fin estimado: 1 de abr de 2008

Traducción no disponible, mostrando original

Resumen

This trial is conducted in Africa, Asia, Europe, Oceania and South America. This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Type 2 diabetes
Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months
Ongoing stable treatment with metformin for at least 2 months
Ongoing stable treatment with minimum half maximal dose of any insulin secretagogue for at least 2 months
Insulin naive
HbA1c (glycosylated haemoglobin A1c) between 7.0% and 11.0% (inclusive of both values)

Criterios de exclusión

Metformin contraindication according to local practice
TZD (thiazolidinedione) treatment for the last 5 months before trial start
Systemic treatment with any corticosteroid 3 months before trial start
Any disease or condition which according to the Investigator would interfere with the trial

Intervenciones

drug

biphasic insulin aspart

Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.

drug

insulin glargine

Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.

drug

metformin

Tablets, 2550 mcg. Administered once daily.

drug

glimepiride

Tablets 2 mg. 4, 6 or 8 mg administered once daily.

Ubicaciones

Novo Nordisk Investigational Site

Buenos Aires, Argentina

Novo Nordisk Investigational Site

Ciudad Autonoma de Bs As, Argentina

Novo Nordisk Investigational Site

Ciudad Autónoma de BsAs, Argentina

Novo Nordisk Investigational Site

Mar del Plata, Argentina

Patrocinadores

PrincipalNovo Nordisk A/S

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