Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, 50, 70 and Insulin Aspart in Subjects With Type 1 Diabetes

Phase 1 Completed 32 enrolled Novo Nordisk A/S

RandomizedCrossoverDouble-blindTreatment

Summary

This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics after a single dose of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in subjects with type 1 diabetes.

Timeline

Start: 2006-04
Primary completion: 2006-07
Completion: 2006-07

Publications

Results Heise T, Eckers U, Kanc K, Nielsen JN, Nosek L. The pharmacokinetic and pharmacodynamic properties of different formulations of biphasic insulin aspart: a randomized, glucose clamp, crossover study. Diabetes Technol Ther. 2008 Dec;10(6):479-85. doi: 10.1089/dia.2008.0019.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	biphasic insulin aspart 30	Protein / enzyme biologic	0.4 iu/kg	Subcutaneous
Subject	biphasic insulin aspart 50	Unknown	0.4 iu/kg	Subcutaneous
Subject	biphasic insulin aspart 70	Unknown	0.4 iu/kg	Subcutaneous
Subject	insulin aspart	Protein / enzyme biologic	0.4 iu/kg	Subcutaneous

Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, 50, 70 and Insulin Aspart in Subjects With Type 1 Diabetes

Summary

Timeline

Publications

Drugs

Indications