drugset / Trial / NCT01865331
Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Characteristics of Explorative Formulations of Insulin Degludec and IDegAsp 50 in Healthy Japanese Subjects
RandomizedParallel-groupDouble-blindTreatment
Summary
This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability and pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) characteristics of insulin degludec (insulin 454) and insulin degludec/insulin aspart (IDegAsp) 50 - formerly SIAM), both explorative formulations, not similar to the proposed commercial formulation, in healthy male Japanese subjects.
Timeline
- Start
- 2006-12
- Primary completion
- 2007-03
- Completion
- 2007-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | insulin degludec | Protein / enzyme biologic | — | Subcutaneous |
| Subject | insulin degludec/insulin aspart | Unknown | — | Subcutaneous |