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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-MC-ITSC | Other Identifier | Eli Lilly and Company | |
| 2016-004093-18 | EudraCT Number |
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This study will be conducted in participants with type 1 diabetes mellitus to investigate how the human body processes LY900014, a new blood sugar lowering insulin, and its effect on blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability will be documented. The study will last about 4 to 11 weeks for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY900014 | Experimental | LY900014 (Treatment B) delivered via an insulin pump as a continuous infusion under the skin, with various intermittent bolus doses immediately before meals over 3-days per period. |
|
| Insulin Lispro (Humalog) | Active Comparator | Insulin lispro (Treatment A) delivered via an insulin pump as a continuous infusion under the skin, with various intermittent bolus doses immediately before meals over 3-days per period. |
|
| 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(h) (AUC [0-5 h]) Following Administration of Each Study Arm With a Standard Single-wave Bolus | 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, and 300 minutes post dose |
| Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC [0-5 h]) of Following Administration of Each Study Arm With a Standard Dual-wave Bolus | 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, and 300 minutes post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Glucodynamics (GD): Change From Baseline Area Under the Concentration Curve From Time Zero to 5 Hours (AUC [0-5h]) of Glucose Relative to Mixed Meal Tolerance Test Following Administration of Each Study Arm With a Standard Single-wave Bolus | GD: Change from baseline in AUC (0-5h) of glucose relative to mixed meal tolerance test (MMTT). | Days 1 and 3: -30, -15, 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180,195, 210, 225, 240, and 300 minutes post dose |
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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 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Neuss | 41460 |
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Participants were randomized to receive LY900014 and Insulin lispro (Humalog) via CSII with intermittent bolus doses, standard single-wave (SS) and standard dual-wave (SD) immediately before meals, over 3 days per period.
For the time between consecutive periods, participants continued their CSII with their personal pump using Insulin lispro (Humalog) until the evening of Day -1 (after administration of the standardized dinner) of the next period when they will receive either LY900014 or Insulin lispro (Humalog), according to assigned treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Administration modes for LY900014 or Insulin lispro (Humalog) for Days 1 through 3 for breakfast (B): Period 1: Insulin lispro (Humalog) Day 1: B: SD Day 3: B: SD Period 2: Insulin lispro (Humalog) Day 1: B: SS Day 3: B: SS Period 3: LY900014 Day 1: B: SD Day 3: B: SD Period 4: LY900014 Day 1: B: SS Day 3: B: SS |
| FG001 | Sequence 2 | Administration modes for LY900014 or Insulin lispro (Humalog) for Days 1 through 3 for breakfast: Period 1:Insulin lispro (Humalog) Day 1: B: SS Day 3: B: SS Period 2: LY900014 Day 1: B: SS Day 3: B: SS Period 3: Insulin lispro (Humalog) Day 1: B: SD Day 3: B: SD Period 4: LY900014 Day 1: B: SD Day 3: B: SD |
| FG002 | Sequence 3 | Administration modes for LY900014 or Insulin lispro (Humalog) for Days 1 through 3 for breakfast: Period 1: LY900014 Day 1: B: SD Day 3: B: SD Period 2: Insulin lispro (Humalog) Day 1: B: SD Day 3: B: SD Period 3: LY900014 Day 1: B: SS Day 3: B: SS Period 4: Insulin lispro (Humalog) Day 1: B: SS Day 3: B: SS |
| FG003 | Sequence 4 | Administration modes for LY900014 or Insulin lispro (Humalog) for Days 1 through 3 for breakfast: Period 1:LY900014 Day 1: B: SS Day 3: B: SS Period 2: LY900014 Day 1: B: SD Day 3: B: SD Period 3: Insulin lispro (Humalog) Day 1: B: SS Day 3: B: SS Period 4: Insulin lispro (Humalog) Day 1: B: SD Day 3: B: SD |
| 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 participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Baseline | Participants received individualized doses of LY900014 and Insulin lispro (Humalog) via CSII with various intermittent bolus doses immediately before meals, over 3 days per period. |
| 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(h) (AUC [0-5 h]) Following Administration of Each Study Arm With a Standard Single-wave Bolus | PK: Insulin Lispro AUC(0-5h) | All participants who received at least one dose of both study drugs and had evaluable PK data during the breakfast test meal. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomole x 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, and 300 minutes post dose |
|
Baseline through end of study (Up to 11 weeks)
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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 | LY900014 administered via CSII | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
Rapid-Single wave bolus data is not reported as the target fasting blood glucose was not achieved, which prevented many participants from taking part in the MMTT for Day 2 resulting in unreliable data.
| 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 | Feb 6, 2017 | Aug 8, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2017 | Aug 8, 2019 | SAP_001.pdf |
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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 (Humalog) | Drug | Administered SC |
|
|
| Glucodynamics (GD): Change From Baseline Area Under the Concentration Curve From Time Zero to 5 Hours (AUC [0-5 h]) of Glucose Relative to MMTT Following Administration of Each Study Arm With a Standard Dual-wave Bolus | GD: Change from baseline in AUC (0-5h) of glucose relative to MMTT. | Day 1 and 3: -30, -15, 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180,195, 210, 225, 240, and 300 minutes post dose |
| Germany |
| 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 |
|
| Insulin Lispro (Humalog) SS |
Individualized doses of Insulin lispro (Humalog) delivered via CSII with intermittent bolus dose administered as a standard single-wave bolus on Day 1 and 3. |
|
|
|
| Primary | Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC [0-5 h]) of Following Administration of Each Study Arm With a Standard Dual-wave Bolus | PK: Insulin Lispro AUC(0-5h) | All participants who received both study drugs and had evaluable PK during the breakfast test meal. | Posted | Geometric Mean | Geometric Coefficient of Variation | 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, and 300 minutes post dose |
|
|
|
|
| Secondary | Glucodynamics (GD): Change From Baseline Area Under the Concentration Curve From Time Zero to 5 Hours (AUC [0-5h]) of Glucose Relative to Mixed Meal Tolerance Test Following Administration of Each Study Arm With a Standard Single-wave Bolus | GD: Change from baseline in AUC (0-5h) of glucose relative to mixed meal tolerance test (MMTT). | All participants who received at least one dose of both study drugs and had evaluable GD during the breakfast test meal. Last observation carried forward (LOCF) was used for last observed glucose values prior to treatment intervention for hypoglycemic or hyperglycemic events. | Posted | Mean | Standard Deviation | milligrams * hour/deciliter (mg*h/dL) | Days 1 and 3: -30, -15, 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180,195, 210, 225, 240, and 300 minutes post dose |
|
|
|
| Secondary | Glucodynamics (GD): Change From Baseline Area Under the Concentration Curve From Time Zero to 5 Hours (AUC [0-5 h]) of Glucose Relative to MMTT Following Administration of Each Study Arm With a Standard Dual-wave Bolus | GD: Change from baseline in AUC (0-5h) of glucose relative to MMTT. | All participants who received at least one dose of both study drugs and had evaluable GD data during the breakfast test meal. LOCF was used for last observed glucose values prior to treatment intervention for hypoglycemic or hyperglycemic events. | Posted | Mean | Standard Deviation | mg*h/dL | Day 1 and 3: -30, -15, 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180,195, 210, 225, 240, and 300 minutes post dose |
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|
|
| 24 |
| 0 |
| 24 |
| 19 |
| 24 |
| EG001 | Humalog | Humalog administered via CSII | 0 | 24 | 0 | 24 | 18 | 24 |
| EG002 | Open-label Humalog | Humalog administered via CSII as post-blinded study standard of care. | 0 | 24 | 0 | 24 | 10 | 24 |
| Asthenia | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Hunger | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Restlessness | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
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| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
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| Phlebitis | Vascular disorders | MedDRA 19.1 | 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 |
| Ratio of Geometric LS Means |
| 1.04 |
| 2-Sided |
| 90 |
| 0.820 |
| 1.32 |
| Superiority |
Day 3 |