drugset / Trial / NCT01999322
A Trial Evaluating Compatibility and Safety of FIAsp and Insulin Aspart With an External Continuous Subcutaneous Insulin Infusion System in Adult Subjects With Type 1 Diabetes
RandomizedParallel-groupDouble-blindTreatment
Summary
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate compatibility and safety of FIAsp (faster-acting insulin aspart) and insulin aspart (NovoRapid®) with an external continuous subcutaneous insulin infusion (CSII) system in adult subjects with type 1 diabetes.
Timeline
- Start
- 2013-11-19
- Primary completion
- 2014-05-14
- Completion
- 2014-05-14
Publications
- Background Zijlstra E, Demissie M, Graungaard T, Heise T, Nosek L, Bode B. Investigation of Pump Compatibility of Fast-Acting Insulin Aspart in Subjects With Type 1 Diabetes. J Diabetes Sci Technol. 2018 Jan;12(1):145-151. doi: 10.1177/1932296817730375. Epub 2017 Sep 18.
- Results Eric Zijlstra, Marek Demissie et al. Compatibility and Safety of Faster-Acting Insulin Aspart used in Continuous Subcutaneous Insulin Infusion Therapy in Patients with Type 1 Diabetes. ENDO-2016-98th Annual Meeting of the Endocrine Society 3 June 2016 http://press.endocrine.org/doi/abs/10.1210.endo-meetings.2016.DGM.22.FRI-697
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | insulin aspart | Protein / enzyme biologic | — | Subcutaneous |