Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes

Phase 2 Completed 65 enrolled Novo Nordisk A/S

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue or intermediate-acting insulin to insulin degludec (NN1250, SIBA) on a basal-bolus regimen in subjects with type 1 diabetes mellitus.

Timeline

Start: 2009-01
Primary completion: 2009-05
Completion: 2009-05

Publications

Results Iwamoto Y, Clauson P, Nishida T, Kaku K. Insulin degludec in Japanese patients with type 1 diabetes mellitus: A randomized controlled trial. J Diabetes Investig. 2013 Jan 29;4(1):62-8. doi: 10.1111/j.2040-1124.2012.00240.x. Epub 2012 Sep 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	insulin degludec	Protein / enzyme biologic	—	Subcutaneous
Comparator	insulin detemir	Protein / enzyme biologic	—	Subcutaneous
Background	insulin aspart	Protein / enzyme biologic	—	Subcutaneous

Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes

Summary

Timeline

Publications

Drugs

Indications