drugset / Trial / NCT01992588

A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp When Administered as a Bolus in a Continuous Subcutaneous Infusion Regimen in Subjects With Type 1 Diabetes

NCT01992588

Phase 1 Completed 48 enrolled Novo Nordisk A/S
RandomizedCrossoverDouble-blindTreatment

Summary

This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) properties of FIAsp (faster-acting insulin aspart) and insulin aspart (NovoRapid®) given as a bolus on top of a basal continuous subcutaneous insulin infusion (CSII).

Timeline

Start
2013-11
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin aspart Protein / enzyme biologic 0.02 iu/kg Subcutaneous
Subject insulin aspart Protein / enzyme biologic 0.15 iu/kg Subcutaneous