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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-MC-ITRW | Other Identifier | Eli Lilly and Company | |
| 2017-001501-33 | EudraCT Number |
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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 following a standard meal. For each participant, the study will consist of 4 periods and will last approximately 12 weeks from screening to final study follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY900014 Before Meal | Experimental | Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods. |
|
| LY900014 After Meal | Experimental | Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods. |
|
| Insulin Lispro (Humalog) Before Meal | Active Comparator | Individualized dose of insulin lispro administered SC immediately before meal in one of four study periods. |
|
| Insulin Lispro (Humalog) After Meal | Active Comparator | Individualized dose of insulin lispro administered SC 20 minutes after start of meal in one of four study periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900014 | Biological | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve Zero to Seven Hours (AUC0-7hr) | PK: Insulin Lispro AUC for Each Treatment Arm. PK: Insulin Lispro AUC for Each Treatment Arm. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol . | Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes (7 hours) postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm | GD: Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm | -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes post-meal |
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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. | Mainz | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Individualized dose of LY900014 or insulin lispro (Humalog) administered subcutaneously (SC) with 21 hours between doses Period 1: LY900014 administered subcutaneously (SC) immediately before meal Period 2: insulin lispro (Humalog) administered SC 20 minutes after start of meal Period 3:LY900014 administered SC 20 minutes after start of meal Period 4: insulin lispro administered SC immediately before meal |
| FG001 | Cohort 2 | Individualized dose of LY900014 or insulin lispro (Humalog) administered subcutaneously (SC) with 21 hours between doses Period 1:LY900014 administered SC 20 minutes after start of meal Period 2: LY900014 administered subcutaneously (SC) immediately before meal Period 3: insulin lispro (Humalog) administered SC immediately before meal Period 4: insulin lispro (Humalog) administered SC 20 minutes after start of meal |
| FG002 | Cohort 3 | Individualized dose of LY900014 or insulin lispro (Humalog) administered subcutaneously (SC) with 21 hours between doses Period 1: insulin lispro (Humalog) administered SC immediately before meal Period 2:LY900014 administered SC 20 minutes after start of meal Period 3: insulin lispro (Humalog) administered SC 20 minutes after start of meal Period 4: LY900014 administered subcutaneously (SC) immediately before meal |
| FG003 | Cohort 4 | Individualized dose of LY900014 or insulin lispro (Humalog) administered subcutaneously (SC) with 21 hours between doses Period 1: insulin lispro (Humalog) administered SC 20 minutes after start of meal Period 2: insulin lispro (Humalog) administered SC immediately before meal Period 3: LY900014 administered subcutaneously (SC) immediately before meal Period 4:LY900014 administered SC 20 minutes after start of meal |
| 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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All randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All randomized 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 Seven Hours (AUC0-7hr) | PK: Insulin Lispro AUC for Each Treatment Arm. PK: Insulin Lispro AUC for Each Treatment Arm. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol . | All randomized participants who received at least 1 dose of study drug and evaluable PK data. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol . | Posted | Geometric Mean | Geometric Coefficient of Variation | picomol times hour per Liter | Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes (7 hours) postdose |
|
4 weeks
All participants who received at least one 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 Before Meal | Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | 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 |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 12, 2017 | Jun 25, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 25, 2018 | Jun 25, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 | Biological | Administered SC |
|
|
| 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. | Neuss | Germany |
| 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 |
|
| years |
|
| 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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| Duration of T2DM | Mean | Standard Deviation | years |
|
All participants who received individualized dose of LY900014 SC before meal or 20 minutes after start of meal
| OG001 | Insulin Lispro (Humalog) | All participants who received individualized dose of insulin lispro (Humalog) SC before meal or 20 minutes after start of meal |
|
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| Secondary | Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm | GD: Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm | All randomized participants who received at least 1 dose of study drug and had evaluable glucodynamic parameters. | Posted | Mean | Standard Deviation | milligrams times hour per deciliter | -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes post-meal |
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|
| 0 |
| 35 |
| 0 |
| 35 |
| 1 |
| 35 |
| EG001 | LY900014 After Meal | Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods. | 0 | 36 | 0 | 36 | 2 | 36 |
| EG002 | Insulin Lispro (Humalog) Before Meal | Individualized dose of insulin lispro (Humalog) administered SC immediately before meal in one of four study periods. | 0 | 35 | 0 | 35 | 1 | 35 |
| EG003 | Insulin Lispro (Humalog) After Meal | Individualized dose of insulin lispro (Humalog) administered SC 20 minutes after start of meal in one of four study periods. | 0 | 35 | 0 | 35 | 0 | 35 |
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| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| ratio of LS Means |
| 0.74 |
| 2-Sided |
| 95 |
| 0.49 |
| 1.01 |
| Superiority |