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This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects.
Each subject will be randomly allocated to a sequence of four treatments, i.e. two single doses of BioChaperone insulin lispro U-200 of 0.2 U·kg BW-1 and two single doses of BioChaperone insulin lispro U-100 of 0.2 U·kg BW-1 on four separate dosing visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioChaperone Lispro U-100 | Active Comparator | injection of 2 doses of 0.2 U/kg on separate visits |
|
| BioChaperone Lispro U-200 | Experimental | injection of 2 doses of 0.2 U/kg on separate visits |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioChaperone Lispro U-100 | Drug | Injection of BioChaperone Lispro U-100 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUCLisp (0-inf) | Area under the insulin lispro serum concentration - time curve from t=0 to infinity | 8 hours |
| Cmax Lisp | Maximum observed insulin lispro serum concentration | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| tmax Lisp | Time to maximum observed serum insulin lispro concentration | 8 hours |
| AUCGIR(0-8h) | Area under the glucose infusion rate-time curve from t=0 to 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grit Andersen, MD | Profil Institut Für Stoffwechselfforschung GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH | Neuss | 41460 | Germany |
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| BioChaperone Lispro U-200 |
| Drug |
Injection of BioChaperone Lispro U-200 |
|
| 8 hours |
| GIRmax | Maximum glucose infusion rate | 8 hours |
| tGIRmax | Time to maximum glucose infusion rate | 8 hours |
| Number of Adverse events | Number of adverse events | Up to 9 weeks |
| Local tolerability | Record of injection site reaction | Up to 9 weeks |