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The study is to compare meal time glucose control associated with BIOD-531, a rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIOD-531 pre-meal | Experimental | Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast |
|
| Humalog Mix 75/25 pre-meal | Active Comparator | Subcutaneous injection of 0.6 U/kg immediately before the start of the standardized breakfast |
|
| Humulin R U-500 | Active Comparator | Subcutaneous injection of 0.6 U/kg immediately before the start of a standardized breakfast |
|
| BIOD-531 post-meal | Experimental | Subcutaneous injection of 0.6 U/kg 20 minutes after the start of the standardized breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIOD-531 | Drug |
| ||
| Humalog Mix 75/25 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-standardized meal glucose exposure (AUC) | 0-120 minutes after meal |
| Measure | Description | Time Frame |
|---|---|---|
| Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations) | 0-720 minutes | |
| Insulin exposure (AUC) | Various time frames over 720 minutes | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institute for Clinical Research | Chula Vista | California | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Drug |
|
| Humulin R U-500 | Drug |
|
| Maximal insulin concentration |
| 0-720 minutes |
| Post breakfast and post-lunch glucose exposure (AUC) | Various times frames over 720 minutes |
| Post-breakfast and post-lunch maximal glucose concentrations | 0-720 minutes |
| Injection site toleration (VAS and severity scales) | 30 minutes post injection |
| Draize injection site erythema and edema scoring | 0-720 minutes |
| D004700 | Endocrine System Diseases |