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The primary objective of this study is to test for bioequivalence of VIAject®7 and VIAject®25 and to compare the pharmacokinetic/Pharmacodynamic/tolerability characteristics of VIAject®7 with those of VIAject®25 and insulin lispro.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation A | Experimental | VIAject®25 for subcutaneous application |
|
| Formulation B | Experimental | VIAject®7 for subcutaneous application |
|
| Formulation C | Experimental | Insulin Lispro for subcutaneous application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIAject®25 | Drug | Two vial presentation for reconstitution and single dose of 12 IU subcutaneous injection and 25 IU/mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum insulin concentration | Area under the serum insulin concentration curve for the time interval 0-480 min (AUC-INS 0-480) and maximum serum insulin concentration (C-INS max) (VIAject®7and VIAject®25 only) | 0-480 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Serum insulin concentration |
| 0-240 minutes |
| Glucose infusion rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Heise, M.D | Profil Institut fĂĽr Stoffwechselforschung GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut fĂĽr Stoffwechselforschung GmbH | Neuss | 41460 | Germany |
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| VIAject®7 | Drug | One vial presentation and single dose of 12 U for subcutaneous injection and 100 IU/mL |
|
| Insulin Lispro | Drug | One vial presentation and single dose of 12 IU for subcutaneous injection and 100 IU/mL |
|
•AUCGIR: area under the glucose infusion rate curve for the following time periods: 0-240, 0-480 minutes |
| Between 0-240 minutes and 0-480 minutes |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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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