drugset / Trial / NCT01981031
A Trial to Assess the Efficacy and Safety of BioChaperone Combo and Humalog Mix 25 in Subjects With Type 1 Diabetes
RandomizedCrossoverDouble-blindTreatment
Summary
BioChaperone Combo is a liquid formulation containing both Insulin Glargine and Insulin Lispro. The aim of this trial is to assess the efficacy and safety of BioChaperone® Combo in subjects with type 1 diabetes under a dose of 0.8 U/kg. This trial is a phase 1 single-center, randomized, double-blinded, two-treatment, two-period cross-over, 30-hour euglycaemic glucose clamp trial in subjects with type 1 diabetes mellitus. Each subject will be randomly allocated to one single dose of 0.8 U/kg of BioChaperone® Combo and to one single dose of 0.8 U/kg of Humalog® Mix 25 on two separate dosing visits.
Timeline
- Start
- 2013-11
- Primary completion
- 2013-12
- Completion
- 2014-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Humalog® Mix25 | Protein / enzyme biologic | 0.8 iu/kg | Subcutaneous |
| Subject | Insulin Lispro | Protein / enzyme biologic | 0.8 iu/kg | Subcutaneous |
| Subject | insulin glargine | Protein / enzyme biologic | 0.8 iu/kg | Subcutaneous |