drugset / Trial / NCT01865279
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Explorative Formulation of Insulin Degludec
RandomizedCrossoverDouble-blindTreatment
Summary
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commerical formulation.
Timeline
- Start
- 2005-12
- Primary completion
- 2006-04
- Completion
- 2006-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | insulin degludec | Protein / enzyme biologic | — | — |
| Comparator | isophane human insulin | Protein / enzyme biologic | 0.4 iu/kg | — |
| Comparator | isophane human insulin | Protein / enzyme biologic | 0.6 iu/kg | — |