drugset / Trial / NCT01364428

Comparison of Two Insulin Degludec Formulations in Subjects With Type 2 Diabetes Mellitus

NCT01364428 ↗

Phase 3 Completed 373 enrolled Novo Nordisk A/S
RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy and safety of two different formulations of insulin degludec (IDeg) in subjects with type 2 diabetes.

Timeline

Start
2011-06
Primary completion
2012-01
Completion
2012-01

Outcome

Met primary endpoint

paper A1C reduction with IDeg 200 U/mL was noninferior to that of IDeg 100 U/mL PMID 24518180 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin degludec Protein / enzyme biologic — Subcutaneous