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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-FW-ITRE | 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 for about 8 to 9 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 7.5 Units (U) | Experimental | Single dose of 7.5 U LY900014 administered subcutaneously (SC) in one to two of five periods. |
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| Insulin Lispro | Active Comparator | Reference formulation. Single dose of Insulin Lispro administered SC in one to two of five periods. |
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| LY900014 15 U | Experimental | Single dose of 15 U LY900014 administered subcutaneously (SC) in one to two of five periods. |
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| LY900014 30 U | Experimental | Single dose of 30 U LY900014 administered subcutaneously (SC) in one to two of five periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900014 | Drug | Administered SC |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) ) | 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes per period. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp | Every 10 minutes for 30 minutes Predose, Postdose: every 2.5 minutes for 30 minutes, then every 5 minutes until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes |
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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 CBARC | Participants receive single subcutaneous dose: C: 30 U LY900014 B: 15 U LY900014 A: 7.5 Units (U) LY900014 R: 15 U insulin lispro(Reference) C: 30 U LY900014 with 3 day washout between doses |
| FG001 | Sequence 2 ACRBA | Participants receive single subcutaneous dose: A: 7.5 Units (U) LY900014 C: 30 U LY900014 R: 15 U insulin lispro(Reference) B: 15 U LY900014 A: 7.5 Units (U) LY900014 with 3 day washout between doses |
| FG002 | Sequence 3 BRCAB | Participants receive single subcutaneous dose: B: 15 U LY900014 R: 15 U insulin lispro(Reference) C: 30 U LY900014 A: 7.5 Units (U) LY900014 B: 15 U LY900014 with 3 day washout between doses |
| FG003 | Sequence 4 RABCR | Participants receive single subcutaneous dose: R: 15 U insulin lispro(Reference) A: 7.5 Units (U) LY900014 B: 15 U LY900014 C: 30 U LY900014 R: 15 U insulin lispro(Reference) with 3 day washout between doses |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 4 |
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| Period 5 |
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All participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All participants who received at least 1 dose of study drug. |
| 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 Zero to Infinity (AUC[0-∞]) ) | Participants who received at least 1 dose of study drug and had evaluable PK profile data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomol per hour per L (pmol.h/L) | 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes per period. | PK Profiles | PK Profiles |
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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 Insulin Lispro (Reference,Humalog) | Participants received single subcutaneous dose of 15 U insulin lispro (Reference, Humalog) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site related reaction | General disorders | MedDRA 18.0 | 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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| 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 (Humalog) | Drug | Administered SC |
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| Received at Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| Received at Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| Received at Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| Received at Least 1 Dose of Study Drug |
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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 | No |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kilograms per meter squared (kg/m2) |
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| OG002 |
| LY900014 30 U |
Participants receive single subcutaneous dose of 30 U LY900014 |
| OG003 | Insulin Lispro 15 U | Participants receive single subcutaneous dose of 15 U insulin lispro (Reference, Humalog) |
|
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| Secondary | Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp | Participants who received at least 1 dose of study drug and had evaluable GD profiles. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams (mg) | Every 10 minutes for 30 minutes Predose, Postdose: every 2.5 minutes for 30 minutes, then every 5 minutes until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes | Glucodynamic (GD) Profiles | Glucodynamic (GD) Profiles |
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| 0 |
| 23 |
| 0 |
| 23 |
| 3 |
| 23 |
| EG001 | LY900014 7.5 U | Participants received single subcutaneous dose of 7.5 U LY900014 | 0 | 22 | 0 | 22 | 3 | 22 |
| EG002 | LY900014 15 U | Participants received single subcutaneous dose of 15 U LY900014 | 0 | 22 | 0 | 22 | 6 | 22 |
| EG003 | LY900014 30 U | Participants received single subcutaneous dose of 30 U LY900014 | 0 | 23 | 0 | 23 | 2 | 23 |
| Infusion site haematoma | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Infusion site pain | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Infusion site reaction | General disorders | MedDRA 18.0 | Systematic Assessment |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Glucodynamic (GD) Profiles |
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