Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Type 2 Diabetes

Phase 3 Completed 75 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 of biphasic insulin aspart 50 three times a day to biphasic insulin aspart 70 three times a day in non-obese and obese with type 2 diabetes.

Timeline

Start: 2003-09
Primary completion: 2004-06
Completion: 2004-06

Outcome

Missed primary endpoint

paper AUC(Glu(0-24 h)) BIAsp 50/BIAsp 70 ratios were 0.97 (95% CI: 0.90-1.05, p = 0.49) for non-obese and 0.98 (95% CI: PMID 20415689 ↗

Publications

Results Parkner T, Dyrskog SE, Laursen T, Chen JW, Mouritzen U, Brondsted L, Hermansen K, Lauritzen T, Christiansen JS. Obesity does not influence the unique pharmacological properties of different biphasic insulin aspart preparations in patients with type 2 diabetes. Diabetes Obes Metab. 2010 May;12(5):414-20. doi: 10.1111/j.1463-1326.2009.01178.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	biphasic insulin aspart	Protein / enzyme biologic	—	Subcutaneous