drugset / Trial / NCT01868555

Safety, Pharmacokinetics and Pharmacodynamics of Two IDegAsp (One Explorative) Preparations and Two Insulin Degludec (One Explorative) Preparations in Japanese Subjects

NCT01868555

Phase 1 Completed 32 enrolled Novo Nordisk A/S
RandomizedParallel-groupDouble-blindTreatment

Summary

This trial is conducted in Asia. The aim of this trial is to assess the safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of two insulin degludec/insulin aspart (IDegAsp) preparations and two insulin degludec (insulin 454) preparations in healthy Japanese male subjects. IDegAsp 45 (B) and insulin degludec (B) are explorative formulations, not similar to the proposed commercial formulations.

Timeline

Start
2007-12
Primary completion
2008-02
Completion
2008-02

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin degludec Protein / enzyme biologic 0.6 unknown Subcutaneous

Indications