drugset / Trial / NCT01865292

Comparing the Pharmacodynamics and Pharmacokinetics of Explorative Formulation of Insulin Degludec With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes

NCT01865292

Phase 1 Completed 40 enrolled Novo Nordisk A/S
RandomizedCrossoverDouble-blindTreatment

Summary

This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the trial drug in the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, with insulin glargine in subjects with type 1 and type 2 diabetes.

Timeline

Start
2006-08
Primary completion
2006-11
Completion
2006-11

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin degludec Protein / enzyme biologic Subcutaneous
Comparator insulin glargine Protein / enzyme biologic Subcutaneous