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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-FW-ITRF | Other Identifier | Eli Lilly and Company | |
| 2015-004705-16 | EudraCT Number |
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This study evaluated a blood sugar lowering insulin, LY900014, delivered by an insulin pump continuously under the skin. The study was conducted in participants with type 1 diabetes mellitus to investigate how the human body processed LY900014 and its effect on blood sugar levels when it was delivered via an insulin pump. Side effects and tolerability were be documented.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY900014 | Experimental | LY900014 delivered via an insulin pump as a continuous infusion under the skin with intermittent bolus doses during meals for two 3-day periods |
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| Insulin Lispro | Active Comparator | Insulin lispro delivered via an insulin pump as a continuous infusion under the skin with intermittent bolus doses during meals for two 3-day periods |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900014 | Drug | Administered subcutaneously (SC) |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) | PK: Insulin Lispro AUC(0-5h) | Days 1 and 3: -15, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300 minutes post dose for each treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) | PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) | Days 1 and 3: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes post dose for each treatment |
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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. | Neuss | Germany |
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| Label | URL |
|---|---|
| Click here for more information about this study: A Study of LY900014 in Participants With Type 1 Diabetes Mellitus Using Insulin Pumps | View source |
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This study compared individualized doses of LY900014 (Test) to insulin lispro (Reference) when delivered via an insulin pump. The study consisted of four, three-day treatment periods, with a maximum of one week between doses in consecutive periods.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1, TRTR | T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous subcutaneous (SC) infusion with intermittent bolus doses immediately before meals for three days. |
| FG001 | Sequence 2, RTRT | T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals for three days. |
| FG002 | Sequence 3, TTRR | T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals for three days. |
| FG003 | Sequence 4, RRTT | T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals for three days. |
| FG004 | Sequence 5, TRRT | T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals for three days. |
| FG005 | Sequence 6, RTTR | T = LY900014 Test. R = Insulin Lispro Reference. In each of four periods, individualized doses of study drug were delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals for three days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period One |
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| Period Two |
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| Period Three |
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| Period Four |
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All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Individualized doses of LY900014 (Test) or insulin lispro (Reference) delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals in four, three-day periods. |
| 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 From Time Zero to 5 Hours (AUC[0-5h]) | PK: Insulin Lispro AUC(0-5h) | All participants who received both study drugs and had evaluable PK data. For one participant in the Insulin Lispro - Reference group, the insulin lispro PK profile (Period Two, Day 3) was excluded from the mean PK analysis, as there was no absorption phase observed. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | picomole*hour per liter (pmol•h/L) | Days 1 and 3: -15, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300 minutes post dose for each treatment |
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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 | Insulin Lispro - Reference | Individualized doses of insulin lispro delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses during meals for two three-day periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system 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 |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| 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 | Drug | Administered SC |
|
| Received Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| Received Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| Received 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 |
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| OG001 | LY900014 - Test | Individualized doses of LY900014 delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses during meals for two 3-day periods. |
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| Secondary | Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) | PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) | All participants who received study drug and had evaluable PD data. | Posted | Mean | Standard Deviation | milligram*hour/deciliter (mg*h/dL) | Days 1 and 3: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes post dose for each treatment |
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|
|
| 0 |
| 29 |
| 4 |
| 29 |
| EG001 | LY900014 - Test | Individualized doses of LY900014 delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses during meals for two three-day periods. | 0 | 30 | 3 | 30 |
| EG002 | Insulin Lispro - Open Label | Individualized doses of open label insulin lispro delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses between periods. | 0 | 30 | 0 | 30 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Day 3 |
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