Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes

Phase 2 Completed 245 enrolled Novo Nordisk A/S

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in Africa, Asia and North America. The aim of this trial is to compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.

Timeline

Start: 2008-01
Primary completion: 2008-08
Completion: 2008-08

Publications

Results Zinman B, Fulcher G, Rao PV, Thomas N, Endahl LA, Johansen T, Lindh R, Lewin A, Rosenstock J, Pinget M, Mathieu C. Insulin degludec, an ultra-long-acting basal insulin, once a day or three times a week versus insulin glargine once a day in patients with type 2 diabetes: a 16-week, randomised, open-label, phase 2 trial. Lancet. 2011 Mar 12;377(9769):924-31. doi: 10.1016/S0140-6736(10)62305-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	insulin degludec	Protein / enzyme biologic	10 iu	Subcutaneous
Subject	insulin degludec	Protein / enzyme biologic	20 iu	Subcutaneous
Comparator	insulin glargine	Protein / enzyme biologic	10 iu	Subcutaneous
Background	Metformin	Small molecule	1500 mg	Oral
Background	Metformin	Small molecule	2000 mg	Oral

Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes

Summary

Timeline

Publications

Drugs

Indications