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| ID | Type | Description | Link |
|---|---|---|---|
| H9D-MC-ITAG | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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BC106 is a molecule that when injected with insulin lispro may change the speed of absorption of insulin lispro. The purpose of this study will be to evaluate the safety of BC106 insulin lispro and any side effects that might be associated with it, blood levels of insulin lispro after injection under the skin and how BC106 insulin lispro affects blood sugar after injection under the skin. There is a minimum 7 day washout between single doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Lispro | Active Comparator | 15 international units (IU) insulin lispro administered once subcutaneously (SC) during 1 of 3 dosing periods. There is a minimum 7 day washout between dosing periods. |
|
| BC106 Insulin Lispro | Experimental | 15 up to 30 IU BC106 insulin lispro administered once SC during 2 of 3 dosing periods. There is a minimum 7 day washout between dosing periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Lispro | Drug | Administered SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under the concentration curve (AUC) | Baseline up to 8 hours post administration of study drug | |
| Pharmacokinetics: Maximum concentration (Cmax) | Baseline up to 8 hours post administration of study drug | |
| Pharmacokinetics: Time of maximum concentration (Tmax) | Baseline up to 8 hours post administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Glucodynamic response: Time to maximum infusion rate (tRmax) during euglycemic clamps of BC106 insulin lispro | Baseline up to 30 days | |
| Pharmacokinetics: Within-participant variability of time to maximum drug concentration (tmax) of BC106 insulin lispro |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri, 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Singapore | 117597 |
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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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| BC106 insulin lispro | Drug | Administered SC |
|
|
| Baseline up to 30 days |
| Glucodynamic within-participant variability of time to maximum glucose infusion rate (tRmax) for BC106 insulin lispro | Baseline up to 30 days |
| Singapore |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |