drugset / Trial / NCT01868568
Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes
RandomizedCrossoverDouble-blindTreatment
Summary
This trial is conducted in Europe. The aim of this trial is to compare insulin degludec and insulin aspart (IDegAsp) co-formulations with separately injected, simultaneous doses of insulin degludec (insulin 454) and insulin aspart, compared with biphasic insulin aspart 30 (NovoMix® 30) in subjects with type 1 diabetes mellitus. Each subject will be randomised to four out of nine possible treatment arms. IDegAsp 40, IDegAsp 45, IDegAsp 55 and IDeg high concentration were explorative formulations, not similar to the proposed commercial formulation.
Timeline
- Start
- 2008-04
- Primary completion
- 2008-08
- Completion
- 2008-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | biphasic insulin aspart 30 | Protein / enzyme biologic | — | Subcutaneous |
| Subject | insulin aspart | Protein / enzyme biologic | — | Subcutaneous |
| Subject | insulin degludec | Protein / enzyme biologic | — | Subcutaneous |
| Subject | insulin degludec/insulin aspart | Unknown | — | Subcutaneous |