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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-FW-ITRA | Other Identifier | Eli Lilly and Company |
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This study evaluated four test formulations of a glucose lowering drug (LY900014) administered by injection under the skin of the abdomen. The study was conducted in healthy people to investigate how the human body handles LY900014 and the effect of LY900014 on blood sugar levels. Side effects and tolerability were documented. The study was to be conducted in two parts (Part A and Part B) to achieve its objectives. Each part of the study was to last for about 11 to 12 weeks, including screening and follow up. Screening was required within 28 days prior to entering into either study Part A or Part B. Part B was not executed because no suitable formulation was identified.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: LY900014 Test A | Experimental | Test Formulation A. Single dose of LY900014 administered subcutaneously (SC) in one of five periods. |
|
| Part A:Insulin Lispro | Experimental | Reference formulation. 15 U insulin lispro administered SC in one of five periods. |
|
| Part A: LY900014 Test B | Experimental | Test Formulation B. Single dose LY900014 administered subcutaneously (SC) in one of five periods. |
|
| Part A: LY900014 Test C | Experimental | Test Formulation C. Single dose LY900014administered subcutaneously (SC) in one of five periods. |
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| Part A: LY900014 Test D | Experimental | Test Formulation D. Single dose LY900014administered subcutaneously (SC) in one of five periods. |
|
| Part B: LY900014 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900014 | Biological | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacokinetics (PK ): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast) | 30 minutes predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Visual Analog Scale (VAS) Score for Injection Site Pain | The Visual Analog Scale (VAS) assessed injection site pain on a scale of 0-100 millimeter (mm) range (0 = no pain and 100 worst imaginable pain). | Predose, 1, 20, 60 minutes postdose and at the end of the clamp procedure |
| Part A: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp |
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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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Singapore | 117597 |
Part A was a 5-period crossover study of four LY900014 formulations (Tests A, B, C, and D) and insulin lispro (Reference (R)). A minimum of 3 days washout between each period.
Part B was not executed and no data were collected.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A Sequence 1, CDABR | Period 1: LY900014 Test C, Period 2: LY900014 Test D, Period 3: LY900014 Test A, Period 4: LY900014 Test B, Period 5: Reference (R) = insulin lispro |
| FG001 | Part A Sequence 2, ABDRC | Period 1: LY900014 Test A, Period 2: LY900014 Test B, Period 3: LY900014 Test D, Period 4: Reference (R) = insulin lispro, Period 5: LY900014 Test C |
| FG002 | Part A Sequence 3, BCRAD | Period 1: LY900014 Test B, Period 2: LY900014 Test C, Period 3: Reference (R) = insulin lispro, Period 4: LY900014 Test A, Period 5: LY900014 Test D |
| FG003 | Part A Sequence 4, DRBCA | Period 1: LY900014 Test D, Period 2: Reference (R) = insulin lispro, Period 3: LY900014 Test B, Period 4: LY900014 Test C, Period 5: LY900014 Test A |
| FG004 | Part A Sequence 5, RACDB | Period 1: Reference (R) = insulin lispro, Period 2: LY900014 Test A, Period 3: LY900014 Test C, Period 4: LY900014 Test D, Period 5: LY900014 Test B |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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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 | Participants were administered LY900014 SC Tests A, B, C, and D, with that of 15 U of insulin lispro alone (Reference) in healthy subjects. |
| 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 | Part A: Pharmacokinetics (PK ): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast) | All participants who received at least 1 dose of study drug and completed the dose sequence. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | picomol times hour per liter (pmol*h/L) | 30 minutes predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose |
|
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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 | Part A: Formulation A, LY900014 | Single dose LY900014 administered subcutaneously (SC) in one of five periods |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site related reaction | General disorders | MedDRA 17.1 | Systematic Assessment |
Part B was not executed per protocol because no formulation was identified in Part A.
| 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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Test formulation selected from Part A. Single dose of LY900014 administered SC in one of four periods. |
|
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| Insulin Lispro | Biological | Administered SC |
|
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Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. |
| 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 300 minutes postdose |
| Part B: Total Amount of Glucose Infused (Gtot) Over the Duration of the Clamp - Interparticipant Variability | Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. | 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 300 minutes, then every 20 minutes from 300 to 480 minutes postdose |
| Part B: Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast) - Interparticipant Variability | Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose |
| Singapore |
| Withdrawal by Subject |
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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 | No |
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| Weight | Mean | Standard Deviation | kilograms (kg) |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per meter squared (kg/m²) |
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| OG002 | Part A: Formulation C, LY900014 | Single dose LY900014 administered subcutaneously (SC) in one of five periods |
| OG003 | Part A: Formulation D, LY900014 | Single dose LY900014 administered subcutaneously (SC) in one of five periods |
| OG004 | Part A: Reference | 15 U of insulin lispro administered subcutaneously (SC) in one of five periods |
|
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| Secondary | Part A: Visual Analog Scale (VAS) Score for Injection Site Pain | The Visual Analog Scale (VAS) assessed injection site pain on a scale of 0-100 millimeter (mm) range (0 = no pain and 100 worst imaginable pain). | All participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | millimeter (mm) | Predose, 1, 20, 60 minutes postdose and at the end of the clamp procedure |
|
|
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| Secondary | Part A: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp | Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. | All participants who received at least 1 dose of study drug and completed the dose sequence. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | milligram (mg) | 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 300 minutes postdose |
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| Secondary | Part B: Total Amount of Glucose Infused (Gtot) Over the Duration of the Clamp - Interparticipant Variability | Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. | Zero participants were analyzed as Part B was not executed. | Posted | 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 300 minutes, then every 20 minutes from 300 to 480 minutes postdose |
|
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| Secondary | Part B: Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast) - Interparticipant Variability | Zero participants were analyzed as Part B was not executed. | Posted | Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose |
|
|
| 0 |
| 27 |
| 5 |
| 27 |
| EG001 | Part A: Formulation B, LY900014 | Single dose LY900014 administered subcutaneously (SC) in one of five periods | 0 | 27 | 5 | 27 |
| EG002 | Part A: Forumulation C, LY900014 | Single dose LY900014 administered subcutaneously (SC) in one of five periods | 0 | 28 | 2 | 28 |
| EG003 | Part A: Forumulation D, LY900014 | Single dose LY900014 administered subcutaneously (SC) in one of five periods | 0 | 27 | 6 | 27 |
| EG004 | Part A: Reference | 15 U insulin lispro administered subcutaneously (SC) | 0 | 27 | 2 | 27 |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| 20 minutes |
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| 60 minutes |
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| End of clamp |
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