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The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.
The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and compare them to Humalog.
The secondary objectives are to assess other pharmacokinetic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, to assess pharmacodynamic characteristics of BIOD-123 and BIOD-125 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-123 and BIOD-125 compared to Humalog®
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIOD-123 | Experimental | SC administration of 0.20 U/kg |
|
| BIOD-125 | Experimental | SC administration of 0.20 U/kg |
|
| Humalog | Active Comparator | SC administration of 0.20 U/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIOD-123 | Drug |
| ||
| BIOD-125 |
| Measure | Description | Time Frame |
|---|---|---|
| Speed of absorption (TINS-50%-early) of BIOD-123 and BIOD-125 versus Humalog. | Subjects were to receive study drug at 3 separate dosing visits separated by 3-28 days. The estimated duration of study participation for 1 subject was approximately 12 weeks. The estimated duration of the study was approximately 6 months. | 0-30, 0-60, 0-90, 0-480, and 120-480 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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|
| Humalog | Drug |
|
| 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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