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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-MC-ITRT | Other Identifier | Eli Lilly and Company |
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This study evaluates a new formulation of insulin lispro, LY900014, a drug that lowers blood sugar. It is administered by injection into the vein and under the skin of the abdomen, thigh and arm.
The study will be conducted in healthy people to investigate the effect of different injection sites on the amount of insulin lispro in the bloodstream.
Side effects and tolerability will be documented. The study will last for about 10 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 (SC Abdomen) | Experimental | Single dose of 15-U of LY900014 administered subcutaneously (SC) into the abdomen in one period |
|
| LY900014 (SC Thigh) | Experimental | Single dose of 15-U of LY900014 administered SC into the thigh in one period |
|
| LY900014 (SC Arm) | Experimental | Single dose of 15-U of LY900014 administered SC into the arm (deltoid) in one period |
|
| LY900014 (IV) | Active Comparator | Single dose of 15-U of LY900014 administered intravenously (IV) in one period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900014 (SC) | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) Following LY900014 Administration | Pharmacokinetics(PK): Insulin lispro AUC from time zero to 10 hours post dose [AUC(0-10h)]. | Day 1: Pre-dose, 2.5, 5, 10, 15, 20, 25, 30, 40, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Total Amount of Glucose Infused (Gtot) Over Duration of the Clamp Procedure | Glucodynamics: 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 LY900014 by adjusting the exogenous glucose infusion rate. |
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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 | 117597 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35577602 | Derived | Leohr JK, Dellva MA, LaBell E, Coutant DE, Linnebjerg H. Evaluation of the Pharmacokinetic Profile of Ultra Rapid Lispro Administered Subcutaneously at Different Injection Sites. Clin Ther. 2022 Jun;44(6):836-847. doi: 10.1016/j.clinthera.2022.04.001. Epub 2022 May 13. |
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This is an open-label, randomized, crossover, up to 10-hour euglycemic clamp study in which participants were randomized into one of four treatment sequences. Participants received single doses of 15 units of LY900014 on 4 occasions (treatment Periods 1 through 4) with a wash-out period of at least 3 days between study drug administration.
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| ID | Title | Description |
|---|---|---|
| FG000 | LY900014 Treatment Sequence 1: Abdomen,Thigh, Deltoid(Arm), IV | Single dose of 15-U of LY900014 administered subcutaneously (SC) into the abdomen in Period 1, Thigh in Period 2, Deltoid (Arm) in Period 3, and single 15-U intravenous (IV) bolus injection in Period 4. |
| FG001 | LY900014 Treatment Sequence 2: Deltoid, Abdomen, IV, Thigh | Single dose of 15-U of LY900014 administered SC into the: Deltoid in Period 1, Abdomen in Period 2, single 15-U IV bolus injection in Period 3, and single 15-U SC administration into the Thigh in Period 4. |
| FG002 | LY900014 Treatment Sequence 3: IV, Deltoid, Thigh, Abdomen | Single 15-U IV bolus injection of LY900014 administered in Period 1, single 15-U dose administered SC in the Deltoid in Period 2, Thigh in Period 3, and Abdomen in Period 4. |
| FG003 | LY900014 Treatment Sequence 4: Thigh, IV, Abdomen, Deltoid | Single dose of 15-U of LY900014 administered SC in Thigh in Period 1, single 15-U IV bolus injection in Period 2, single dose of 15-U administered SC in the Abdomen in Period 3, and Deltoid in Period 4. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout Period 1 |
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| Period 2 |
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| Washout Period 2 |
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| Period 3 |
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| Washout Period 3 |
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| Period 4 |
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All participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Single 15-U dose of LY900014 administered in treatment Period 1- 4, as SC injection into the abdomen, the thigh, the deltoid or an IV bolus injection, per randomized treatment sequence. |
| 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: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) Following LY900014 Administration | Pharmacokinetics(PK): Insulin lispro AUC from time zero to 10 hours post dose [AUC(0-10h)]. | All participants who have received at least one dose of study drug and have measurable insulin lispro concentrations and evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomole * hour/Liter (pmol * hr/L) | Day 1: Pre-dose, 2.5, 5, 10, 15, 20, 25, 30, 40, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose |
|
Baseline to end of study (up to 49 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 | 15-U LY900014 Abdomen | Single dose of 15-U of LY900014 administered subcutaneously (SC) into the abdomen. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site erythema | General disorders | MedDRA 20.0 | 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 14, 2017 | Aug 27, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 4, 2017 | Aug 27, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| LY900014 (IV) | Drug | Administered IV |
|
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| Every 10 minutes for 30 minutes predose, every 2.5 minutes for 30 minutes, then every 5 minutes for 120 minutes, then every 10 minutes for 120 to 480 minutes and every 10 minutes for 480 to 600 minutes post-dose |
| Singapore |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| 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 |
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| Weight | Geometric Mean | Standard Deviation | kilograms (kg) |
|
Single 15-U dose of LY900014 administered SC into the deltoid in one period. |
| OG002 | LY900014 (IV) | Single 15-U injection IV bolus of LY900014 administered in one period. |
| OG003 | LY900014 (SC Thigh) | Single 15-U dose of LY900014 administered SC into the thigh in one period. |
|
|
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| Secondary | Total Amount of Glucose Infused (Gtot) Over Duration of the Clamp Procedure | Glucodynamics: 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 LY900014 by adjusting the exogenous glucose infusion rate. | All participants who have received at least one dose of study drug administered and have completed at least one clamp procedure. The IV treatment arm was needed only for PK as it served as the reference to determine the absolute bioavailability. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | milligram per kilogram (mg/kg) | Every 10 minutes for 30 minutes predose, every 2.5 minutes for 30 minutes, then every 5 minutes for 120 minutes, then every 10 minutes for 120 to 480 minutes and every 10 minutes for 480 to 600 minutes post-dose |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 6 |
| 25 |
| EG001 | 15-U LY900014 Thigh | Single dose of 15-U of LY900014 administered SC into the Thigh. | 0 | 26 | 0 | 26 | 7 | 26 |
| EG002 | 15-U LY900014 Deltoid | Single dose of 15-U of LY900014 administered SC into the Deltoid. | 0 | 26 | 0 | 26 | 11 | 26 |
| EG003 | 15-U LY900014 IV | Single 15-U LY900014 administered IV bolus injection. | 0 | 28 | 0 | 28 | 4 | 28 |
| Catheter site bruise | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Catheter site erythema | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Catheter site swelling | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Infusion site erythema | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Infusion site pain | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Infusion site swelling | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA 20.0 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| Mixed Models Analysis |
| Ratio of Geometric LSMeans |
| 1.14 |
| 2-Sided |
| 90 |
| 1.04 |
| 1.25 |
| Superiority |