drugset / Trial / NCT02514850
A Trial to Compare the Pharmacodynamic and Pharmacokinetic Properties of Biochaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes
RandomizedCrossoverTriple-blindTreatment
Summary
This is a single centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over, euglycaemic clamp study in subjects with type 2 diabetes on stable insulin treatment. Each subject will be randomly allocated to a treatment sequence and will be administered single subcutaneous doses of 0.8 U/kg Biochaperone® Combo, 0.8 U/kg Humalog® Mix25 or simultaneous subcutaneous injections of 0.2 U/kg Humalog® and 0.6 U/kg Lantus® during three separate dosing visits.
Timeline
- Start
- 2015-07
- Primary completion
- 2015-11
- Completion
- 2015-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Biochaperone Combo | Unknown | 0.8 iu/kg | Subcutaneous |
| Comparator | Humalog® Mix25 | Protein / enzyme biologic | 0.8 iu/kg | Subcutaneous |
| Comparator | Insulin Lispro | Protein / enzyme biologic | 0.2 iu/kg | Subcutaneous |
| Comparator | insulin glargine | Protein / enzyme biologic | 0.6 iu/kg | Subcutaneous |