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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-MC-ITRQ | Other Identifier | Eli Lilly and Company |
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The study involves a comparison of a LY900014 U-200 formulation with a LY900014 U-100 formulation. LY900014 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-U200 | Experimental | Single subcutaneous (SC) dose of 15 units (U) LY900014 U-200 in two of four study periods |
|
| LY900014-U100 | Experimental | Single SC dose of 15 U LY900014 U-100 in two of four study periods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900014-U200 | Drug | Administered SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Insulin Lispro Area Under Plasma Concentration Curve Zero to 10 Hours (AUC[0-10]) | Insulin Lispro AUC From Time Zero to 10 hours post dose (AUC[0-10h]) | Predose, 5 minutes (mn), 10mn, 15mn, 20mn, 25mn, 30mn, 35mn, 40mn, 45 mn, 50mn, 55 mn, 60mn, 70mn,90mn,120mn,150mn,180mn, 240mn,300mn,360mn,320mn, 480mn, 540mn, and 600mn (10 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm | 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 (EC) procedure. | Predose, every minute from run-in and for the duration of the EC until up to 10 hours postdose |
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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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Single subcutaneous (SC) dose sequences with 3 day washout between doses: A. LY900014 U-200 B. LY900014 U-100 C. LY900014 U-200 D. LY900014 U-100 |
| FG001 | Sequence 2 | Single subcutaneous (SC) dose sequences with 3 day washout between doses: A. LY900014 U-100 B. LY900014 U-200 C. LY900014 U-100 D. LY900014 U-200 |
| FG002 | Sequence 3 | Single subcutaneous (SC) dose sequences with 3 day washout between doses: A. LY900014 U-200 B. LY900014 U-100 C. LY900014 U-100 D. LY900014 U-200 |
| FG003 | Sequence 4 | Single subcutaneous (SC) dose sequences with 3 day washout between doses: A. LY900014 U-100 B. LY900014 U-200 C. LY900014 U-200 D. LY900014 U-100 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout |
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| Period 2 |
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| Washout |
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| Period 3 |
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| Washout |
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| Period 4 |
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All randomized participant who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All randomized participants who received at least 1 dose of study drug |
| 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 Plasma Concentration Curve Zero to 10 Hours (AUC[0-10]) | Insulin Lispro AUC From Time Zero to 10 hours post dose (AUC[0-10h]) | All randomized participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours times picomols per milliliter | Predose, 5 minutes (mn), 10mn, 15mn, 20mn, 25mn, 30mn, 35mn, 40mn, 45 mn, 50mn, 55 mn, 60mn, 70mn,90mn,120mn,150mn,180mn, 240mn,300mn,360mn,320mn, 480mn, 540mn, and 600mn (10 hours) |
|
Up to 15 months
All participants who received at least 1 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-U100 | Single SC dose of LY900014 U-100 containing 15 units of insulin lispro in two of four study periods |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site bruise | 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 17, 2018 | Jun 6, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 19, 2017 | Apr 30, 2020 | Prot_001.pdf |
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| LY900014-U100 | Drug | Administered SC |
|
|
| COMPLETED |
|
| NOT COMPLETED |
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| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Weight | Mean | Standard Deviation | kilograms (kg) |
|
Single subcutaneous (SC) dose of LY900014 U-200 containing 15 units of insulin lispro (Humalog) in two of four study periods |
|
|
|
| Secondary | Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm | 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 (EC) procedure. | All randomized participants who received at least 1 dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams per kilogram (mg/kg) | Predose, every minute from run-in and for the duration of the EC until up to 10 hours postdose |
|
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 32 |
| 49 |
| EG001 | LY900014-U200 | Single subcutaneous (SC) dose of LY900014 U-200 containing 15 units of insulin lispro (Humalog) in two of four study periods | 0 | 49 | 0 | 49 | 35 | 49 |
| 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 bruising | 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 reaction | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
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