Comparing the Efficacy and Safety of NN1250 Once Daily When Titrated Using 2 Different Algorithms in Insulin naïve Subjects With Type 2 Diabetes Mellitus

Phase 3 Completed 222 enrolled Novo Nordisk A/S

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) once daily in insulin naïve subjects with type 2 diabetes mellitus when titrated using two different self-titration algorithms (dose individually adjusted) in combination with metformin.

Timeline

Start: 2011-03
Primary completion: 2011-12
Completion: 2011-12

Publications

Results Philis-Tsimikas A, Brod M, Niemeyer M, Ocampo Francisco AM, Rothman J. Insulin degludec once-daily in type 2 diabetes: simple or step-wise titration (BEGIN: once simple use). Adv Ther. 2013 Jun;30(6):607-22. doi: 10.1007/s12325-013-0036-1. Epub 2013 Jun 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	insulin degludec	Protein / enzyme biologic	0.5 iu/kg	Subcutaneous
Subject	insulin degludec	Protein / enzyme biologic	0.61 iu/kg	Subcutaneous

Comparing the Efficacy and Safety of NN1250 Once Daily When Titrated Using 2 Different Algorithms in Insulin naïve Subjects With Type 2 Diabetes Mellitus

Summary

Timeline

Publications

Drugs

Indications