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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-MC-ITRP | Other Identifier | Eli Lilly and Company |
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This study of healthy participants evaluated the concentration of a test LY900014 and a reference LY900014 formulation in the bloodstream and how it affected the blood sugar levels. The whole study, including screening, took up to 8 weeks to complete.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| U-193 LY900014 Test | Experimental | LY900014 test dose administered via subcutaneous (SC) injection |
|
| U-95 LY900014 Reference | Active Comparator | LY900014 reference dose administered via SC injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900014 | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours]) | PK: Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours]) | 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, and 480 minutes post study dose for each treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) | Gtot is the total glucose infusion over the clamp duration. It is used to measure the study drug action over time as measured by the euglycemic clamp procedure. | Blood glucose was measured approximately every 2.5 minutes for the first 30 minutes, then every 5 minutes until 120 minutes post dose, and then every 10 minutes until 480 minutes post dose |
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Inclusion Criteria:
Female participants who can potentially get pregnant:
Have a body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m²), inclusive, at screening
Are nonsmokers, have not smoked for at least 2 months before entering the study
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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Singapore | 117597 |
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This was a four-period crossover study of U-193 LY900014 test formulation and U-95 LY900014 reference formulation with a minimum of 3 days between dosing.
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| ID | Title | Description |
|---|---|---|
| FG000 | LY900014 Test/Reference/Test/Reference | U-193 LY900014 test formulation administered once subcutaneously (SC) in Study Periods 1 and 3. U-95 LY900014 reference formulation administered once SC in Study Periods 2 and 4. |
| FG001 | LY900014 Reference/Test/Reference/Test | U-95 LY900014 reference formulation administered once SC in study periods 1 and 3. U-193 LY900014 test formulation administered once SC in study periods 2 and 4. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Period 1 |
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| Washout |
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| Study Period 2 |
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| Washout |
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| Study Period 3 |
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| Washout |
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| Study Period 4 |
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| Follow-up |
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All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | U-193 LY900014 test formulation administered once SC in 2 of 4 study periods. U-95 LY900014 reference formulation administered once SC in 2 of 4 study periods. |
| 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 (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours]) | PK: Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours]) | All participants who completed at least 1 study period and had measurable insulin lispro concentrations. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomole*hour/liter (pmol*h/L) | 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, and 480 minutes post study dose for each treatment | Number of observations | Number of observations |
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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 | LY900014 Test | U-193 LY900014 test formulation administered once SC in 2 of 4 study periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion site erythema | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| Singapore |
| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| 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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U-193 LY900014 test formulation administered once SC in 2 of 4 study periods. |
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| Secondary | Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) | Gtot is the total glucose infusion over the clamp duration. It is used to measure the study drug action over time as measured by the euglycemic clamp procedure. | All participants who completed at least 1 clamp procedure. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligram (mg) | Blood glucose was measured approximately every 2.5 minutes for the first 30 minutes, then every 5 minutes until 120 minutes post dose, and then every 10 minutes until 480 minutes post dose | Number of observations | Number of observations |
|
|
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| 0 |
| 24 |
| 9 |
| 24 |
| EG001 | LY900014 Reference | U-95 LY900014 reference formulation administered once SC in 2 of 4 study periods. | 0 | 23 | 8 | 23 |
| Infusion site swelling | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Vessel puncture site rash | General disorders | MedDRA 18.0 | Systematic Assessment |
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