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The primary objective of this study is to assess the speed of absorption and onset of action of BIOD-105 and BIOD-107 and compare them to Humalog®.
The secondary objectives of this study are to assess other pharmacokinetic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, to assess other pharmacodynamic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-105 and BIOD-107 compared to Humalog®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Humalog® | Active Comparator | Humalog®, administered subcutaneously on 1 occasion |
|
| BIOD- 105 | Experimental | BIOD- 105 administered subcutaneously on 1 occasion |
|
| BIOD-107 | Experimental | BIOD-107 administered subcutaneously on 1 occasion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin LISPRO | Drug | Single doses of: 0.15 U/kg |
| |
| recombinant human insulin |
| Measure | Description | Time Frame |
|---|---|---|
| Speed of absorption | The speed of absorption will be assessed by the time to reach 50% of maximum insulin concentration (TINS-50%-early, time before CINS max) and the onset of action will be assessed by the time to reach 50% of the maximum glucose infusion rate (TGIR-50%- early). | 480 minutes |
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Inclusion Criteria:
Subjects must present with the following:
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Morrow, MD | Profil Institute for Clinical Research, Inc. (PICR) | 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 |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Drug |
Single doses of: 0.15 U/kg |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |