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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This is a double-blind, randomised, three period crossover phase 1 trial using automated 8-hour euglycemic clamps in healthy Japanese subjects.
Each subject will be randomly allocated to one out of nine sequences to receive either three single doses of BioChaperone insulin lispro or one single dose of Humalog® and two single doses of BioChaperone insulin lispro on three separate dosing visits.
The total trial maximum duration for a subject will be up to 10 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioChaperone insulin lispro 0.1 U/kg | Experimental |
| |
| BioChaperone insulin lispro 0.2 U/kg | Experimental |
| |
| BioChaperone insulin lispro 0.4 U/kg | Experimental |
| |
| Humalog® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biochaperone insulin lispro 0.1 U/kg | Drug | Injection of a single dose of BioChaperone insulin lispro at the dose of 0.1 U/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCLispro(0-30min) | Area under the insulin lispro serum concentration - time curve from t=0 to 30 minutes | Up to 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| AUCGIR(0-last) | Area under the glucose infusion rate time curve from 0 hours until the end of clamp | Up to 8 hours |
| Adverse Events | Number of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grit Andersen, MD | Profil GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH | Neuss | 41460 | Germany |
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| Biochaperone insulin lispro 0.2 U/kg | Drug | Injection of a single dose of BioChaperone insulin lispro at the dose of 0.2 U/kg |
|
| Biochaperone insulin lispro 0.4 U/kg | Drug | Injection of a single dose of BioChaperone insulin lispro at the dose of 0.4 U/kg |
|
| Humalog® | Drug | Injection of a single dose of Humalog® at the dose of 0.2 U/kg |
|
| Up to 10 weeks |
| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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