drugset / Trial / NCT00613951
Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination \[SIAC\], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, 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 Niskanen L, Leiter LA, Franek E, Weng J, Damci T, Munoz-Torres M, Donnet JP, Endahl L, Skjoth TV, Vaag A. Comparison of a soluble co-formulation of insulin degludec/insulin aspart vs biphasic insulin aspart 30 in type 2 diabetes: a randomised trial. Eur J Endocrinol. 2012 Aug;167(2):287-94. doi: 10.1530/EJE-12-0293. Epub 2012 Jun 1.
- Results Ma Z, Parkner T, Christiansen JS, Laursen T. IDegAsp: a novel soluble insulin analogs combination. Expert Opin Biol Ther. 2012 Nov;12(11):1533-40. doi: 10.1517/14712598.2012.722203. Epub 2012 Sep 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | biphasic insulin aspart | Protein / enzyme biologic | — | Subcutaneous |
| Subject | insulin degludec/insulin aspart | Protein / enzyme biologic | — | Subcutaneous |
| Background | Metformin | Small molecule | 1500 mg | — |
| Background | Metformin | Small molecule | 2000 mg | — |