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The study is designed 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 in patients with diabetes and severe insulin resistance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIOD-531 pre-meal | Experimental | Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner. |
|
| Humalog Mix 75/25 pre-meal | Active Comparator | Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner. |
|
| Humulin R U-500 pre-meal | Active Comparator | Subcutaneous injections of 1.2 U/kg before the start of a standardized breakfast and 0.8 U/kg before the start of a standardized dinner. |
|
| BIOD-531 post-meal | Experimental | Subcutaneous injections of 1.2 U/kg 20 minutes after the start of a standardized breakfast and 0.8 U/kg 20 minutes after the start of a standardized dinner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIOD-531 | Drug |
| ||
| Humalog Mix 75/25 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-breakfast glucose exposure (AUC) | 0-330 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations) | 0-330 and 660-1020 minutes | |
| Insulin exposure (AUC) | 0-1440 minutes | |
| Maximal insulin concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurie Han-Conrad, 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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| 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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|
| Humulin R U-500 | Drug |
|
| BIOD-531 | Drug |
|
| 0-330 and 660-1020 minutes |
| Post-lunch and post-dinner glucose exposures (AUC) | 330-660 and 660-1020 minutes |
| Injection site toleration (VAS and severity scales) | 30 and 690 minutes |