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Evaluation of post-prandial blood glucose excursions after a standardized meal and pre meal injections of individual doses of the study insulins.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular Human Insulin | Experimental | Single injection |
|
| Lispro | Experimental | Single injection |
|
| VIAject | Experimental | Single injection |
|
| VIAject 50% | Experimental | Single injection |
|
| VIAject/Insulin glargine | Experimental | Single injection |
|
| Insulin Glargine/VIAject | Experimental | Single injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular Human Insulin | Drug | Individual dose of RHI administered subcutaneously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the maximal post prandial blood glucose concentration and the time to maximal post prandial glucose concentration between the different treatments | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the ppGlucmax for all treatments, the ppTGluc-max, the AUCGluc 0-180 and the AUCGluc 0-360, CGluc-baseline for all treatments. | 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcus Hompesch, MD | Profil Institute for Clinical Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institute for Clinical Research, Inc. (PICR) | Chula Vista | California | 91911 | United States |
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| Lispro |
| Drug |
Individual dose of lispro administered subcutaneously |
|
| VIAject | Drug | Individual dose of VIAject administered subcutaneously |
|
| VIAject 50% | Drug | Individual dose of VIAject 50% administered subcutaneously |
|
| VIAject/Insulin Glargine | Drug | VIAject mixed wiht insulin glargine and administered subcutaneously |
|
| Insulin Glargine/VIAject | Drug | Individual dose of VIAject and Insulin Glargine administered seperately and subcutaneously |
|
| 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 |
|---|---|
| D007328 | Insulin |
| D061268 | Insulin Lispro |
| D000069036 | Insulin Glargine |
| 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 |
| D049528 | Insulin, Long-Acting |
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