drugset / Trial / NCT01272193
Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is conducted in Japan. The aim of this trial is to investigate the efficacy and safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects continued at the same dose and dosing frequency.
Timeline
- Start
- 2011-01
- Primary completion
- 2011-09
- Completion
- 2011-09
Publications
- Results Onishi Y, Ono Y, Rabol R, Endahl L, Nakamura S. Superior glycaemic control with once-daily insulin degludec/insulin aspart versus insulin glargine in Japanese adults with type 2 diabetes inadequately controlled with oral drugs: a randomized, controlled phase 3 trial. Diabetes Obes Metab. 2013 Sep;15(9):826-32. doi: 10.1111/dom.12097. Epub 2013 Apr 5.
- Yang W, Akhtar S, Franek E, Haluzik M, Hirose T, Kalyanam B, Kar S, Wu T, Gogas Yavuz D, Unnikrishnan AG. Postprandial Glucose Excursions in Asian Versus Non-Asian Patients with Type 2 Diabetes: A Post Hoc Analysis of Baseline Data from Phase 3 Randomised Controlled Trials of IDegAsp. Diabetes Ther. 2022 Feb;13(2):311-323. doi: 10.1007/s13300-021-01196-7. Epub 2022 Jan 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | insulin degludec/insulin aspart | Unknown | — | Subcutaneous |
| Subject | insulin glargine | Protein / enzyme biologic | — | — |