drugset / Trial / NCT01520831

Comparison of Biphasic Insulin Aspart (30, 50 and 70) and Insulin Aspart in Healthy Subjects

NCT01520831

Phase 1 Completed 35 enrolled Novo Nordisk A/S
RandomizedCrossoverDouble-blindTreatment

Summary

This trial is conducted in Europe. The aim of this trial is to demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.

Timeline

Start
1999-04
Primary completion
2000-05
Completion
2000-05

Publications

  • Results Heise T, Kapitza C, Jacobsen LV, Brøndsted L, Heinemann L. Pharmacokinetic and pharmacodynamic differences between premixed suspensions of insulin aspart: biphasic insulin aspart 30, 50 and 70. Diabetologia 2005; 48 (Suppl. 1): A301

Drugs

EvaluationDrugModalityDoseRoute
Subject biphasic insulin aspart 30 Protein / enzyme biologic 0.3 iu/kg Subcutaneous
Subject biphasic insulin aspart 50 Unknown 0.3 iu/kg Subcutaneous
Subject biphasic insulin aspart 70 Unknown 0.3 iu/kg Subcutaneous
Comparator insulin aspart Protein / enzyme biologic 0.3 iu/kg Subcutaneous

Indications