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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-FW-ITRG | Other Identifier | Eli Lilly and Company | |
| 2015-004737-27 | EudraCT Number |
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The study will be conducted in participants with type1 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will be conducted in two parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in both parts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY900014 - Test (Part A) | Experimental | Individualized doses of LY900014 administered by injection under the skin once in each of 3 periods |
|
| Insulin Lispro - Reference (Part A) | Active Comparator | Individualized doses of insulin lispro reference formulation administered by injection under the skin once in each of 3 periods |
|
| LY900014 - Test (Part B) | Experimental | Individualized doses of LY900014 administered by injection under the skin immediately before each meal for 14 days |
|
| Insulin Lispro - Reference (Part B) | Active Comparator | Individualized doses of insulin lispro reference formulation administered by injection under the skin immediately before each meal for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900014 | Drug | Administered subcutaneously (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part A) | PK: Insulin Lispro AUC(0-5h) (Part A) | Day 1: 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 |
| Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part B) | PK: Insulin Lispro AUC(0-5h) (Part B) | Days 1 and 14: 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) (Part A) | PD: AUC(0-5h) of Glucose Relative to a MMTT (Part A) | Day 1: -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 |
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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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| Label | URL |
|---|---|
| Click here for more information about this study: A Study of LY900014 in Participants With Type 1 Diabetes on Insulin Injection Therapy | View source |
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Two-part study compared individualized doses of LY900014 (Test) to insulin lispro (Reference). Part A: LY900014 or insulin lispro once subcutaneously (SC) before, at, or after start of meal in each of 6 periods. Minimum 1 day washout. Part B: LY900014 or insulin lispro SC before meals for 14 days. Participants were expected to complete both parts.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A Sequence 1, ABFCED | A = LY900014 Test (15 minutes [mins] before meal). B = LY900014 Test (at mealtime). C = LY900014 Test (15 mins after start of meal). D = Insulin Lispro Reference (15 mins before meal). E = Insulin Lispro Reference (at mealtime). F = Insulin Lispro Reference (15 mins after start of meal). |
| FG001 | Part A Sequence 2, BCADFE | A = LY900014 Test (15 mins before meal). B = LY900014 Test (at mealtime). C = LY900014 Test (15 mins after start of meal). D = Insulin Lispro Reference (15 mins before meal). E = Insulin Lispro Reference (at mealtime). F = Insulin Lispro Reference (15 mins after start of meal). |
| FG002 | Part A Sequence 3, CDBEAF | A = LY900014 Test (15 mins before meal). B = LY900014 Test (at mealtime). C = LY900014 Test (15 mins after start of meal). D = Insulin Lispro Reference (15 mins before meal). E = Insulin Lispro Reference (at mealtime). F = Insulin Lispro Reference (15 mins after start of meal). |
| FG003 | Part A Sequence 4, DECFBA | A = LY900014 Test (15 mins before meal). B = LY900014 Test (at mealtime). C = LY900014 Test (15 mins after start of meal). D = Insulin Lispro Reference (15 mins before meal). E = Insulin Lispro Reference (at mealtime). F = Insulin Lispro Reference (15 mins after start of meal). |
| FG004 | Part A Sequence 5, EFDACB | A = LY900014 Test (15 mins before meal). B = LY900014 Test (at mealtime). C = LY900014 Test (15 mins after start of meal). D = Insulin Lispro Reference (15 mins before meal). E = Insulin Lispro Reference (at mealtime). F = Insulin Lispro Reference (15 mins after start of meal). |
| FG005 | Part A Sequence 6, FAEBDC | A = LY900014 Test (15 mins before meal). B = LY900014 Test (at mealtime). C = LY900014 Test (15 mins after start of meal). D = Insulin Lispro Reference (15 mins before meal). E = Insulin Lispro Reference (at mealtime). F = Insulin Lispro Reference (15 mins after start of meal). |
| FG006 | Part B LY900014 (Test) | Individualized doses of LY900014 Test administered SC immediately before meals for 14 days. |
| FG007 | Part B Insulin Lispro (Reference) | Individualized doses of Insulin Lispro Reference administered SC immediately before meals for 14 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period One (Part A) |
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| Period Two (Part A) |
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| Period Three (Part A) |
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| Period Four (Part A) |
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| Period Five (Part A) |
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| Period Six (Part A) |
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| Part B |
|
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) administered once SC at various mealtime intervals in each of six periods (Part A) and immediately before meals for 14 days (Part B). |
| 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): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part A) | PK: Insulin Lispro AUC(0-5h) (Part A) | All participants in Part A who received study drug and had evaluable PK data. For one participant in the LY900014 - Test (Part A) group, the insulin lispro PK profile (period three) was excluded from the mean PK analysis, as there was no absorption phase observed. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomole*hour per liter (pmol*h/L) | Day 1: 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 -15 Min (Part A) | Individualized doses of insulin lispro (Reference) administered once SC 15 minutes prior to meal in one of six periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | 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 |
|---|---|
| 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 |
|
|
| 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) (Part B) |
PD: AUC(0-5h) of Glucose Relative to a MMTT (Part B) |
| Days 1 and 14: Day 1: -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 in each study period |
| 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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| 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 |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
|
| OG001 |
| LY900014 - Test (Part A) |
Individualized doses of LY900014 (Test) administered once SC in three of six periods. |
|
|
| Primary | Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part B) | PK: Insulin Lispro AUC(0-5h) (Part B) | All participants in Part B who received study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol*h/L | Days 1 and 14: 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 |
|
|
|
| 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) (Part A) | PD: AUC(0-5h) of Glucose Relative to a MMTT (Part A) | All participants in Part A who received study drug immediately before a meal (0 min) and had evaluable PD data. Data were excluded if the participant did not keep identical insulin lispro dose during the MMTT assessments, did not complete the entire test meal, or had significant changes in nutrient consumption of the test meal. | Posted | Mean | Standard Deviation | milligram*hour/deciliter (mg*h/dL) | Day 1: -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 |
|
|
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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) (Part B) | PD: AUC(0-5h) of Glucose Relative to a MMTT (Part B) | All participants in Part B who received study drug and had evaluable PD data. Data were excluded if the participant did not keep identical insulin lispro dose during the MMTT assessments, did not complete the entire test meal, or had significant changes in nutrient consumption of the test meal. | Posted | Mean | Standard Deviation | mg*h/dL | Days 1 and 14: Day 1: -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 in each study period |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Insulin Lispro - Reference 0 Min (Part A) | Individualized doses of insulin lispro (Reference) administered once SC immediately before meal in one of six periods. | 0 | 30 | 1 | 30 |
| EG002 | Insulin Lispro - Reference +15 Min (Part A) | Individualized doses of insulin lispro (Reference) administered once SC 15 minutes after start of meal in one of six periods. | 0 | 30 | 0 | 30 |
| EG003 | LY900014 - Test -15 Min (Part A) | Individualized doses of LY900014 (Test) administered once SC 15 minutes prior to meal in one of six periods. | 0 | 30 | 0 | 30 |
| EG004 | LY900014 - Test 0 Min (Part A) | Individualized doses of LY900014 (Test) administered once SC immediately before meal in one of six periods. | 0 | 30 | 0 | 30 |
| EG005 | LY900014 - Test +15 Min (Part A) | Individualized doses of LY900014 (Test) administered once SC 15 minutes after start of meal in one of six periods. | 0 | 30 | 1 | 30 |
| EG006 | Insulin Lispro Open Label - (Part A) | Individualized doses of insulin lispro administered SC between periods. | 0 | 30 | 0 | 30 |
| EG007 | Insulin Lispro - Reference (Part B) | Individualized doses of insulin lispro (Reference) administered SC immediately before meals for 14 days. | 0 | 15 | 2 | 15 |
| EG008 | LY900014 - Test (Part B) | Individualized doses of LY900014 (Test) administered SC immediately before meals for 14 days. | 0 | 15 | 1 | 15 |
| EG009 | Insulin Lispro Open Label - (Part B) | Individualized doses of insulin lispro administered SC immediately before meals. | 0 | 30 | 0 | 30 |
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
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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 14 |
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|