drugset / Trial / NCT01074268
Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is conducted in Asia, Europe, Japan and South America. The aim of the trial is to compare the efficacy, safety and tolerability of NN1250 (insulin degludec (\[Deg\]) with insulin detemir (IDet), both combined with insulin aspart. The main period is registered internally at Novo Nordisk as NN1250-3585 while the extension period is registered as NN1250-3725.
Timeline
- Start
- 2010-02
- Primary completion
- 2010-12
- Completion
- 2010-12
Publications
- Results Davies MJ, Gross JL, Ono Y, Sasaki T, Bantwal G, Gall MA, Niemeyer M, Seino H; BEGIN BB T1 Study Group. Efficacy and safety of insulin degludec given as part of basal-bolus treatment with mealtime insulin aspart in type 1 diabetes: a 26-week randomized, open-label, treat-to-target non-inferiority trial. Diabetes Obes Metab. 2014 Oct;16(10):922-30. doi: 10.1111/dom.12298. Epub 2014 May 8.
- Results Davies M, Sasaki T, Gross JL, Bantwal G, Ono Y, Nishida T, Tojjar D, Seino H. Comparison of insulin degludec with insulin detemir in type 1 diabetes: a 1-year treat-to-target trial. Diabetes Obes Metab. 2016 Jan;18(1):96-9. doi: 10.1111/dom.12573. Epub 2015 Oct 19.
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 |