drugset / Trial / NCT00993096
Investigation of the Response Relationship of NN5401 in Type 1 Diabetics
RandomizedCrossoverDouble-blindTreatment
Summary
This trial was conducted in Europe. The aim of this clinical trial was to evaluate the pharmacodynamic dose-response relationship of NN5401 (insulin degludec/insulin aspart) at three therapeutically relevant doses in subjects with type 1 diabetes. The trial is designed as a four period, incomplete block cross-over trial where the trial participant will be randomised to a treatment sequence by which the subject will receive two matched dose levels of NN5401 and biphasic insulin aspart, respectively.
Timeline
- Start
- 2009-09
- Primary completion
- 2009-12
- Completion
- 2009-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | biphasic insulin aspart 30 | Protein / enzyme biologic | 0.4 iu/kg | Subcutaneous |
| Subject | biphasic insulin aspart 30 | Protein / enzyme biologic | 0.6 iu/kg | Subcutaneous |
| Subject | biphasic insulin aspart 30 | Protein / enzyme biologic | 0.8 iu/kg | Subcutaneous |
| Subject | insulin degludec/insulin aspart | Protein / enzyme biologic | 0.4 iu/kg | Subcutaneous |
| Subject | insulin degludec/insulin aspart | Protein / enzyme biologic | 0.6 iu/kg | Subcutaneous |
| Subject | insulin degludec/insulin aspart | Protein / enzyme biologic | 0.8 iu/kg | Subcutaneous |