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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-MC-ITSS | Other Identifier | Eli Lilly and Company |
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The study involves a comparison of 2 formulations of LY900014, which is a type of fast acting insulin. Study participants will be administered LY900014 U-100 two times and LY900014 U-200 two times, over 4 study periods, by injection under the skin. Blood samples will be taken to compare how the body handles the study drugs and how they affect the blood sugar levels. Side effects and tolerability will be documented. The study will last about 4 weeks, not including screening and follow up. Screening is required within 28 days prior to the start of the study and follow up is required at least 2 weeks after the last dose of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY900014 U-200 | Experimental | Single subcutaneous (SC) dose of LY900014 U-200 in two of four study periods. |
|
| LY900014 U-100 | Experimental | Single SC dose of LY900014 U-100 in two of four study periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900014 U-200 | Drug | Administered SC |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours(h) (AUC [0-10h]) Following Administration of Each Study Arm | Pharmacokinetics (PK): Insulin Lispro AUC time zero to 10 hours. | Period 1 through 4 Day 1: Predose, 5 minutes(m),10m,15m, 20m, 25m, 30m, 35m, 40m, 45m, 50m, 55m, 60m, 70m, 90m, 120m,150m,180m, 240m, 300m, 360m, 420m, 480m, 540m, and 600m postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp Following Administration of Each Study Arm | GD: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp procedure. During the euglycemic clamp procedure, blood glucose concentrations are held constant after the administration of study treatment by adjusting the exogenous glucose infusion rate. |
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Inclusion Criteria:
- Healthy male or a female (not pregnant and agreeable to take birth control measures until study completion)
Exclusion Criteria:
- Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
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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 |
|---|---|---|---|---|---|---|
| Lilly Centre for Clinical Pharmacology | Singapore | 138623 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32535742 | Derived | Linnebjerg H, LaBell ES, Dellva MA, Coutant DE, Leohr J. Bioequivalence of Ultra Rapid Lispro (URLi) U100 and U200 Formulations in Healthy Subjects. Diabetes Ther. 2020 Aug;11(8):1709-1720. doi: 10.1007/s13300-020-00848-4. Epub 2020 Jun 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Single SC dose of LY900014 U-200 in Periods 1 and 3. Single SC dose of LY900014 U-100 in Periods 2 and 4. |
| FG001 | Sequence 2 | Single SC dose of LY900014 U-100 in Periods 1 and 3. Single SC dose of LY900014 U-200 in Periods 2 and 4. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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| Period 4 |
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All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Single subcutaneous (SC) dose of LY900014 U-200 in two of four study periods. Single SC dose of LY900014 U-100 in two of four 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, Categorical | Count of Participants |
| 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: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours(h) (AUC [0-10h]) Following Administration of Each Study Arm | Pharmacokinetics (PK): Insulin Lispro AUC time zero to 10 hours. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomole times hour per liter (pmol*h/L) | Period 1 through 4 Day 1: Predose, 5 minutes(m),10m,15m, 20m, 25m, 30m, 35m, 40m, 45m, 50m, 55m, 60m, 70m, 90m, 120m,150m,180m, 240m, 300m, 360m, 420m, 480m, 540m, and 600m postdose |
|
Baseline to end of study (Up to 62 days)
All participants who received at least one dose of study drug.
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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 U-100 | Single SC dose of LY900014 U-100. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site swelling | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | Clinicaltrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 20, 2018 | Aug 6, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 12, 2018 | Aug 6, 2019 | SAP_001.pdf |
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| LY900014 U-100 | Drug | Administered SC |
|
|
| Period 1 through 4 Day 1: Predose, every 10 minutes(m) for 30m prior to dosing; During clamp: every 2.5m for 30m; every 5m for 30 to 120m; every 10m for 120 to 480m, and every 20m for 480m to 600m postdose |
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| COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Participants |
| No |
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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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Single subcutaneous (SC) dose of LY900014 U-200 in two of four study periods. LY900014 U-200: Administered SC |
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| Secondary | Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp Following Administration of Each Study Arm | GD: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp procedure. During the euglycemic clamp procedure, blood glucose concentrations are held constant after the administration of study treatment by adjusting the exogenous glucose infusion rate. | All participants who received at least one dose of study drug and have evaluable glucodynamic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligram per kilogram (mg/kg) | Period 1 through 4 Day 1: Predose, every 10 minutes(m) for 30m prior to dosing; During clamp: every 2.5m for 30m; every 5m for 30 to 120m; every 10m for 120 to 480m, and every 20m for 480m to 600m postdose |
|
|
|
| 68 |
| 0 |
| 68 |
| 20 |
| 68 |
| EG001 | LY900014 U-200 | Single SC dose of LY900014 U-200. | 0 | 68 | 0 | 68 | 19 | 68 |
| Infusion site pain | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Infusion site swelling | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
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