Comparison of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

Phase 3 Completed 324 enrolled Novo Nordisk A/S

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type 2 diabetes.

Timeline

Start: 2004-09
Primary completion: 2005-12
Completion: 2005-12

Outcome

Met primary endpoint

paper detemir was noninferior to glargine in its effects on overall glycemic control. PMID 19108786 ↗

Publications

Results Hollander P, Cooper J, Bregnhoj J, Pedersen CB. A 52-week, multinational, open-label, parallel-group, noninferiority, treat-to-target trial comparing insulin detemir with insulin glargine in a basal-bolus regimen with mealtime insulin aspart in patients with type 2 diabetes. Clin Ther. 2008 Nov;30(11):1976-87. doi: 10.1016/j.clinthera.2008.11.001.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	insulin detemir	Protein / enzyme biologic	—	—
Subject	insulin glargine	Protein / enzyme biologic	—	—
Background	insulin aspart	Protein / enzyme biologic	—	—