drugset / Trial / NCT01215435

Comparison of Two Biphasic Insulin Aspart 30 Treatment Regimens in Subjects With Type 2 Diabetes Not Achieving HbA1c Treatment Targets on OADs Alone

NCT01215435 ↗

Phase 4 Completed 245 enrolled Novo Nordisk A/S
RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in Asia. The aim of this trial is to compare the glycaemic control when subjects initiate a biphasic insulin aspart 30 treatment followed by an intensified treatment if treatment target of HbA1c below 7% is not reached by OAD (oral anti-diabetic drugs) alone.

Timeline

Start
2011-03
Primary completion
2012-09
Completion
2012-09

Outcome

Met primary endpoint

registry analysis (non-inferiority or equivalence test); Pre-breakfast BIAsp 30 vs Pre-dinner BIAsp 30; p <0.001 NCT01215435 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject biphasic insulin aspart 30 Protein / enzyme biologic — Subcutaneous