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| ID | Type | Description | Link |
|---|---|---|---|
| I2R-JE-BIDK | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate how the body processes the study drug known as insulin peglispro and how the study drug affects blood sugar in healthy male Japanese participants. This study will also evaluate safety of the study drug. The study will last up to 46 days for each participant, not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Peglispro | Experimental | Single subcutaneous dose of 1.3 Units per kilogram (U/kg) insulin peglispro on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Peglispro | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro | Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose | |
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of Insulin Peglispro | AUC from time zero to infinity (AUC[0-∞]) of insulin peglispro was evaluated. | Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose |
| Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Insulin Peglispro | Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose | |
| Glucodynamics: Maximum Glucose Infusion Rate (Rmax) | Predose up to 36 hours post clamp procedure | |
| Glucodynamics: Total Amount of Glucose Infused (Gtot) | Predose up to 36 hours post clamp procedure. |
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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. | Fukuoka | 812-0025 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Peglispro | Single subcutaneous dose of 1.3 Units per kilogram (U/kg) insulin peglispro on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Peglispro | Single subcutaneous dose of 1.3 U/kg insulin peglispro on Day 1. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro | All participants who received insulin peglispro and had evaluable Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomoles/liter (pmol/L) | Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Insulin Peglispro | Single subcutaneous dose of 1.3 U/kg insulin peglispro on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Body temperature increased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| C000621851 | basal insulin peglispro |
| C587357 | LY2605541 |
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| Japan |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Primary | Pharmacokinetics: Area Under the Concentration Curve (AUC) of Insulin Peglispro | AUC from time zero to infinity (AUC[0-∞]) of insulin peglispro was evaluated. | All participants who received insulin peglispro and had evaluable AUC(0-∞) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomoles*hours/liter (pmol*h/L) | Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose |
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| Primary | Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Insulin Peglispro | All participants who received insulin peglispro and had evaluable Tmax data. | Posted | Median | Full Range | hours | Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose |
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| Primary | Glucodynamics: Maximum Glucose Infusion Rate (Rmax) | All participants who received insulin peglispro and had evaluable Rmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams/minute/kilogram (mg/min/kg) | Predose up to 36 hours post clamp procedure |
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| Primary | Glucodynamics: Total Amount of Glucose Infused (Gtot) | All participants who received insulin peglispro and had evaluable Gtot data. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams/kilograms (mg/kg) | Predose up to 36 hours post clamp procedure. |
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