Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes

Phase 3 Completed 394 enrolled Novo Nordisk A/S

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.

Timeline

Start: 2004-01
Primary completion: 2004-07
Completion: 2004-07

Outcome

Met primary endpoint

paper Glycaemic control provided by BIAsp was non-inferior to that obtained by the IAsp+NPH (intention to treat ITT) population: diff, HbAlc -0.05%; 95% CI (-0.24; 0.14) PMID 17115349 ↗

Publications

Results Ligthelm RJ, Mouritzen U, Lynggaard H, Landin-Olsson M, Fox C, le Devehat C, Romero E, Liebl A. Biphasic insulin aspart given thrice daily is as efficacious as a basal-bolus insulin regimen with four daily injections: a randomised open-label parallel group four months comparison in patients with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2006 Oct;114(9):511-9. doi: 10.1055/s-2006-924424.

Drugs

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