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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-FW-ITRJ | Other Identifier | Eli Lilly and Company |
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This study will evaluate how quickly the body absorbs, breaks down, and gets rid of the different formulations of LY900014. This study will determine how the different formulations, when injected under the skin, will affect the blood sugar levels in the body, and how safe it is.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY900014 Test B | Experimental | Test formulation B: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods |
|
| LY900014 Test A | Experimental | Test formulation B: Single dose of LY900014 formulation administered SC in one of five periods |
|
| LY900014 Test C | Experimental | Test formulation C: Single dose of LY900014 formulation administered SC in one of five periods |
|
| LY900014 Test D | Experimental | Formulation D: Single dose of LY900014 formulation administered SC in one of five periods |
|
| Insulin Lispro | Active Comparator | Reference formulation: Single dose of lispro administered SC in one of five periods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900014 | Drug | Administered subcutaneously (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro | Predose,5,10,15,20,25,30,35,40,45,50,55,60,70,90,120,150,180,240,300, 360 and 420 minutes postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp | Predose, every 2.5 minutes for 30 minutes, then every 5 min 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 | 117597 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 BDCAR | B = LY900014 Test B, D, LY900014 Test D, C = LY900014 Test C, A = LY900014 Test A, R = Reference, insulin lispro (Humalog) |
| FG001 | Sequence 2 ADCRB | A = LY900014 Test A, D=LY900014 Test D, C = LY900014 Test C, R = Reference, insulin lispro (Humalog), B = LY900014 Test B |
| FG002 | Sequence 3 ADRCB | A = LY900014 Test A, D=LY900014 Test D,R = Reference, insulin lispro (Humalog), C = LY900014 Test C, B = LY900014 Test B |
| FG003 | Sequence 4 BRDAC | B = LY900014 Test B,R = Reference, insulin lispro (Humalog),D=LY900014 Test D, A = LY900014 Test A,C = LY900014 Test C |
| FG004 | Sequence 5 RADCB | R = Reference, insulin lispro (Humalog)A = LY900014 Test A, D=LY900014 Test D, C = LY900014 Test C, B = 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 | All 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): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro | Participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomol per hours per liter (pmol*h/L) | Predose,5,10,15,20,25,30,35,40,45,50,55,60,70,90,120,150,180,240,300, 360 and 420 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 | Reference (Insulin Lispro, Humalog) | Reference formulation: Single dose of lispro administered 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 18.1 | Systematic Assessment |
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| 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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| Insulin lispro (Humalog) | Drug | Administered SC |
|
|
| 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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| 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 | LY900014 Test C | LY900014 Test Formulation C. Single dose of LY900014 administered subcutaneously (SC) in one of five periods. |
| OG003 | LY900014 Test D | LY900014 Test Formulation D. Single dose of LY900014 administered subcutaneously (SC) in one of five periods. |
| OG004 | Reference (Insulin Lispro, Humalog) | A single dose of Reference (insulin lispro, Humalog) administered SC in one of five periods |
|
|
| Secondary | Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp | All participants who received at least 1 dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams (mg) | Predose, every 2.5 minutes for 30 minutes, then every 5 min until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes. |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 1 |
| 24 |
| EG001 | LY900014 Test A | Test formulation A: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | LY900014 Test B | Test formulation B: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods | 0 | 24 | 0 | 24 | 2 | 24 |
| EG003 | LY900014 Test C | Test formulation C: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods | 0 | 23 | 0 | 23 | 1 | 23 |
| EG004 | LY900014 Test D | Test formulation D: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods | 0 | 24 | 0 | 24 | 3 | 24 |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |