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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-MC-ITRY | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014 and the effect of LY900014 on blood sugar levels. For each participant, the study will consist of 3 periods and will last about 51 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Lispro (Humalog) | Active Comparator | 15 units (U) Insulin Lispro (Humalog) administered once, subcutaneously (SC), in one of three study periods. |
|
| LY900014 | Experimental | 7 U, and 15 U LY900014 administered once, SC, in two of three study periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900014 | Drug | Administered SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h]) | PK: Insulin Lispro AUC(0-10h) | Day 1: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) | Gtot is the total amount of glucose infused over the duration of the clamp procedure (10 hours) for each study period. | Day 1: Predose: -10, -20, -30 minutes; During clamp: every 2.5 to 3 minutes for the first 30 minutes; every 5 minutes for 30 to 120 minutes; every 10 minutes for 120 to 480 minutes and every 20 minutes for 480 to 600 minutes postdose |
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Inclusion Criteria:
Are overtly healthy native Chinese males or females
Female participants:
Have a body mass index (BMI) of 18 to 28 kilograms per square meter (kg/m²)
Are nonsmokers
Have a fasting plasma glucose value >71 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]) and <108 mg/dL (6.0 mmol/L)
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 |
|---|---|---|---|---|---|---|
| West China Hospital Sichuan University | Chengdu | Cn-51 | 610041 | China |
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This was a 3-period crossover study in which participants received a single 7 Unit (U), and a single 15 U subcutaneous (SC) dose of LY900014 in two of three dosing sequences, and 15 U SC dose of Humalog in one of three dosing sequences. There was a washout period of ≥ 3 days between euglycemic clamp visits.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: CAB | Participants received a single SC dose in each treatment period. C = 15 U Humalog A = 7 U LY900014 B = 15 U LY900014 |
| FG001 | Sequence 2: ACB | Participants received a single SC dose in each treatment period. A = 7 U LY900014 C = 15 U Humalog B = 15 U LY900014 |
| FG002 | Sequence 3: ABC | Participants received a single SC dose in each treatment period. A = 7 U LY900014 B = 15 U LY900014 C = 15 U Humalog |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| ||||||||||||||||
| Period 2 |
| ||||||||||||||||
| Period 3 |
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All enrolled participants whether or not they completed all protocol requirements.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Baseline | Participants received a single 7 U, and a single 15 U SC dose of LY900014 in 2 of 3 periods and 15 U SC dose of Humalog in 1 of 3 periods. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h]) | PK: Insulin Lispro AUC(0-10h) | All participants who received at least one dose of study drug and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomole * hour per Liter (pmol*h/L) | Day 1: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes postdose |
|
Baseline to end of study (up to 183 days).
All enrolled participants, whether or not they completed all protocol requirements.
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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 | 7 Unit (U) LY900014 | Single subcutaneous (SC) dose 7 U LY900014. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nodal rhythm | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-595-5979 | ClinicalTrials.gov@llilly.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 | Feb 20, 2019 | Sep 29, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 1, 2017 | Sep 29, 2021 | SAP_001.pdf |
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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 |
|
|
| 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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| OG002 | 15 U Humalog | Single SC dose 15 U Humalog. |
|
|
| Secondary | Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) | Gtot is the total amount of glucose infused over the duration of the clamp procedure (10 hours) for each study period. | All participants who received at least one dose of study drug and had evaluable glucodynamic (GD) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligram per kilogram (mg/kg) | Day 1: Predose: -10, -20, -30 minutes; During clamp: every 2.5 to 3 minutes for the first 30 minutes; every 5 minutes for 30 to 120 minutes; every 10 minutes for 120 to 480 minutes and every 20 minutes for 480 to 600 minutes postdose |
|
|
|
| 15 |
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | 15 U LY900014 | Single SC dose 15 U LY900014. | 0 | 15 | 0 | 15 | 4 | 15 |
| EG002 | 15 U Humalog | Single SC dose 15 U Humalog. | 0 | 15 | 0 | 15 | 0 | 15 |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |