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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-MC-ITRL | Other Identifier | Eli Lilly and Company |
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This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is administered by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will last about 6 to 7 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY900014 | Experimental | Test formulation. 15-U dose of LY900014 administered subcutaneously (SC) in one of two periods. |
|
| Insulin Lispro | Active Comparator | Reference formulation. 15-U dose of Insulin Lispro administered SC in one of two periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900014 | Drug | Administered subcutaneously (SC) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours]) | Area Under the Concentration Versus Time Curve (AUC) was measured from time zero to 8 hours (AUC[0-8 Hours]). | Predose (0), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 210, 240, 300, 330, 360, 420, and 480 minutes, post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) | Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY900014 or Insulin Lispro by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight. |
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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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34041713 | Derived | Leohr J, Dellva MA, Carter K, LaBell E, Linnebjerg H. Ultra Rapid Lispro (URLi) Accelerates Insulin Lispro Absorption and Insulin Action vs Humalog(R) Consistently Across Study Populations: A Pooled Analysis of Pharmacokinetic and Glucodynamic Data. Clin Pharmacokinet. 2021 Nov;60(11):1423-1434. doi: 10.1007/s40262-021-01030-0. Epub 2021 May 27. |
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The study consisted of two treatment periods, with a minimum of 3 days washout period between each period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | A single 15U dose of LY900014 or Insulin Lispro was administered subcutaneously (SC) as per the dosing schedule (Period 1: LY900014 ; Period 2: Insulin Lispro). |
| FG001 | Sequence 2 | A single 15U dose of Insulin Lispro or LY900014 was administered subcutaneously (SC) as per the dosing schedule (Period 1: Insulin Lispro; Period 2: LY900014). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| ||||||||||||||||
| Washout |
| ||||||||||||||||
| Period 2 |
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All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Each participant was administered with 15 U dose of LY900014 and Insulin Lispro. |
| 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]) | Area Under the Concentration Versus Time Curve (AUC) was measured from time zero to 8 hours (AUC[0-8 Hours]). | All randomized participants who receive at least 1 dose of study drug and have measurable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Picomoles*hour/Liter (pmol*h/L) | Predose (0), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 210, 240, 300, 330, 360, 420, and 480 minutes, post dose |
|
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All randomized participants who received at least one dose of the 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 | 15-U dose of LY900014 administered subcutaneously (SC) in one of two periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site bruise | General disorders | MedDRA 19.1 | 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 |
|---|---|
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin Lispro | Drug | Administered SC |
|
| 2.5 minutes for the first 30 minutes, then every 5 minutes until 120 minutes postdose, and then every 10 minutes until 480 minutes postdose |
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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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15-U dose of Insulin Lispro administered SC in one of two periods. |
|
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| Secondary | Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) | Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY900014 or Insulin Lispro by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight. | All randomized participants who received at least one dose of study drug and have evaluable glucodynamic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Milligrams (mg) | 2.5 minutes for the first 30 minutes, then every 5 minutes until 120 minutes postdose, and then every 10 minutes until 480 minutes postdose |
|
|
|
| 0 |
| 32 |
| 3 |
| 32 |
| EG001 | Insulin Lispro | 15-U dose of Insulin Lispro administered SC in one of two periods. | 0 | 32 | 7 | 32 |
| Infusion site bruising | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Vessel puncture site swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |