drugset / Trial / NCT03180710
A Trial to Investigate the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes
RandomizedCrossoverTriple-blindTreatment
Summary
This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.
Timeline
- Start
- 2017-06-06
- Primary completion
- 2017-08-28
- Completion
- 2017-12-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BioChaperone® Combo 75/25 | Unknown | 0.6 iu/kg | Subcutaneous |
| Subject | BioChaperone® Combo 75/25 | Unknown | 0.8 iu/kg | Subcutaneous |
| Subject | BioChaperone® Combo 75/25 | Unknown | 1 iu/kg | Subcutaneous |
| Comparator | Humalog® Mix25 | Protein / enzyme biologic | 0.8 iu/kg | — |