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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-MC-ITSL | Other Identifier | Eli Lilly and Company | |
| 2017-003459-47 | EudraCT Number |
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Two forms of insulin lispro (LY900014 and Humalog®) and two forms of insulin aspart (NovoRapid® and Fiasp®) will be given to trial participants with diabetes mellitus type 1 by injection under the skin. The study will assess how fast the active ingredient (insulin lispro or insulin aspart) gets into the blood stream and how long it takes the body to remove it. A test meal will be given to trial participants to assess the course of the blood sugar lowering effect of the investigational products. The safety and tolerability of LY900014 will also be assessed. Screening is required within 14 days prior to the lead in. For each participant, the study will last up to 91 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY900014 | Experimental | T1DM participants received a single, individualized, subcutaneous (SC) dose of LY900014. |
|
| Insulin Lispro (Humalog®) | Active Comparator | T1DM participants received a single, individualized, SC dose of insulin lispro. |
|
| Insulin Aspart (NovoRapid®) | Active Comparator | T1DM participants received a single, individualized, SC dose of insulin aspart. |
|
| Insulin Aspart (Fiasp®) | Active Comparator | T1DM participants received a single, individualized, SC dose of insulin aspart. |
|
| Healthy Participants | No Intervention | Healthy participants who received no study drug. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900014 | Drug | Administered SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm | PK: Insulin Lispro or Insulin Aspart AUC(0-7h) | 0 (predose), 1, 2, 3,5,10, 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 |
|---|---|---|
| Pharmacodynamics (PD): Change From Baseline Area Under the Concentration Curve of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) | PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) | Time Frame:-30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes postdose |
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Inclusion Criteria:
Exclusion Criteria:
- Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
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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 |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung | Neuss | North Rhine-Westphalia | 41460 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Type 1 Diabetes Mellitus (T1DM) Cohort 1 | Period 1: LY900014 administered subcutaneously (SC) immediately before meal Period 2: insulin n Aspart (Fiasp®) administered SC Period 3:Insulin Lispro (Humalog®) administered SC Period 4: Insulin Aspart (NovoRapid®) administered SC with 21 hours between doses |
| FG001 | T1DM Cohort 2 | Period 1: Insulin Aspart (Fiasp®) administered SC Period 2: LY900014 administered subcutaneously (SC) Period 3: Insulin Aspart (NovoRapid®) administered SC Period 4:Insulin Lispro (Humalog®) administered SC with 21 hours between doses |
| FG002 | T1DM Cohort 3 | Period 1: Insulin Aspart (NovoRapid®) administered SC Period 2:Insulin Lispro (Humalog®) administered SC Period 3: insulin Aspart (Fiasp®) administered SC Period 4: LY900014 administered subcutaneously (SC) with 21 hours between doses |
| FG003 | T1DM Cohort 4 | Period 1:Insulin Lispro (Humalog®) administered SC Period 2: Insulin Aspart (NovoRapid®) administered SC Period 3: LY900014 administered SC Period 4: insulin Aspart (Fiasp®) administered SC with 21 hours between doses |
| FG004 | Healthy Participants | Healthy participant cohort did not receive any dose of study drug. |
| 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 that received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | T1DM Cohort | All randomized participants with T1DM participants who received at least 1 dose of study drug. |
| BG001 | Healthy Participants | All healthy participants. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm | PK: Insulin Lispro or Insulin Aspart AUC(0-7h) | All randomized, T1DM participants who received at least 1 dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomols times hour per Liter | 0 (predose), 1, 2, 3,5,10, 15, 20, 25, 30,35, 40, 45, 50, 55,60, 70, 90, 120, 150,180, 240, 300, 360 and 420 minutes postdose |
|
up to 6 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 | T1DM participants received a single, subcutaneous (SC) dose of LY900014. |
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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 | Apr 10, 2018 | Jun 25, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 8, 2018 | Jun 25, 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 |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin Lispro | Drug | Administered SC |
|
|
| Insulin Aspart | Drug | Administered SC |
|
|
| Insulin Aspart | Drug | Administered SC |
|
|
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
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| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilograms per meter squared |
|
T1DM participants received a single,individualized, SC dose of insulin lispro (Humalog)
| OG002 | Insulin Aspart (NovoRapid®) | T1DM participants received a single,individualized, SC dose of insulin |
| OG003 | Insulin Aspart (Fiasp®) | T1DM participants received a single,individualized, SC dose of insulin aspart |
|
|
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| Secondary | Pharmacodynamics (PD): Change From Baseline Area Under the Concentration Curve 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 randomized participants who evaluable PD parameters. | Posted | Mean | Standard Deviation | milligrams times hour per deciliter | Time Frame:-30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes postdose |
|
|
|
| 0 |
| 68 |
| 0 |
| 68 |
| 0 |
| 68 |
| EG001 | Insulin Lispro (Humalog®) | T1DM participants received a single, SC dose of insulin lispro (Humalog®). | 0 | 67 | 0 | 67 | 0 | 67 |
| EG002 | Insulin Aspart (Fiasp®) | T1DM participants received a single, SC dose of insulin aspart (Fiasp®). | 0 | 68 | 0 | 68 | 0 | 68 |
| EG003 | Insulin Aspart (NovoRapid®) | T1DM participants received a single, SC dose of insulin aspart (NovoRapid®). | 0 | 67 | 0 | 67 | 0 | 67 |
| EG004 | Healthy Participants | Healthy subject cohort, cohort did not receive any dose of study drug. | 0 | 12 | 0 | 12 | 0 | 12 |
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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 |