drugset / Trial / NCT00824668

Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30 and Insulin Glargine and Insulin Glulisine Therapy in Subjects With Type 2 Diabetes

NCT00824668

Phase 1 Completed 24 enrolled Novo Nordisk A/S
RandomizedCrossoverOpen-labelTreatment

Summary

This trial is conducted in Europe. The aim of this clinical trial is to compare the 24-hour pharmacodynamics/ pharmacokinetics of biphasic insulin aspart 30 (BiAsp 30) thrice daily treatment with that of a basal-bolus treatment with insulin glargine and insulin glulisine in type 2 diabetic subjects. Pharmacodynamics is the glucose-lowering effect of the study medication over the entire observation phase from the time of administration and the efficacy period while the pharmacokinetics is the amount of the study insulin that can be determined in the blood.

Timeline

Start
2007-08
Primary completion
2007-10
Completion
2007-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin glulisine Protein / enzyme biologic
Subject biphasic insulin aspart 30 Protein / enzyme biologic
Subject insulin glargine Protein / enzyme biologic