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The purpose of this study is to compare the effects of insulin VIAject with Regular Human Insulin and Insulin Lispro on measures of mealtime blood vessel stress and blood flow.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular Human Insulin | Active Comparator | Single Injection |
|
| Inuslin Lispro (90%) | Active Comparator | Single Injection |
|
| Insulin VIAject™ (75%) | Experimental | Single Injection |
|
| Insulin VIAject™ (90%) | Experimental | Single injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular Human Insulin | Drug | 0.10 U/Kg- 15 minutes before ingestion of a standardized liquid meal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial time course of Asymmetric dimethyl arginine (ADMA) after injection of insulin VIAjectTM compared with regular human insulin and insulin lispro. | 0 - 240 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objectives are to evaluate the postprandial time course of arterial elasticity (pulse wave analysis; PWA), blood glucose, insulin, intact proinsulin, nitrotyrosine, glucagon, ICAM-1, VCAM, E-selectin. | 0 - 240 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Forst, MD | IKFE Institute for Clinical Research and Development | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IKFE | Parcusstrasse 8 | Mainz | 55116 | Germany |
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| Insulin Lispro | Drug | 90% of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal. |
|
| Insulin VIAject™ (75%) | Drug | 75 % of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal |
|
| Insulin VIAject™ (90%) | Drug | 90 % of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| 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 |
| D061266 | Insulin, Short-Acting |
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