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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001859-32 | EudraCT Number | ||
| I8B-MC-ITSH | Other Identifier | Eli Lilly and Company |
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This study compares LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog). Both drugs are given by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels in comparison with insulin lispro. The study will last about 7 to 12 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY900014 | Experimental | Single dose of 7 units (U), 15 U, and 30 U of LY900014 administered subcutaneously (SC) in three of six periods. |
|
| Insulin Lispro (Humalog) | Active Comparator | Single dose of 7 U, 15 U, and 30 U of insulin lispro administered SC in three of six periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900014 | Drug | Administered SC |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) | Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours Post Dose [AUC(0-10h)] | Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Glucodynamics: Total Amount of Glucose Infused (Gtot) | Glucodynamics: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp | Day 1: Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours 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 1-877-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 | 55116 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34041713 | Derived | Leohr J, Dellva MA, Carter K, LaBell E, Linnebjerg H. Ultra Rapid Lispro (URLi) Accelerates Insulin Lispro Absorption and Insulin Action vs Humalog(R) Consistently Across Study Populations: A Pooled Analysis of Pharmacokinetic and Glucodynamic Data. Clin Pharmacokinet. 2021 Nov;60(11):1423-1434. doi: 10.1007/s40262-021-01030-0. Epub 2021 May 27. | |
| 32900535 |
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This was a 6-period crossover study in which participants received a single 7 Unit (U), 15 U, or 30 U subcutaneous (SC) dose of LY900014 or Humalog in one of six sequences. There was a washout period of ≥ 3 days between each euglycemic clamp procedure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: ABFCED | Participants received a single SC dose in each treatment period. A = 7 U LY900014 B = 15 U LY900014 F = 30 U Humalog C = 30 U LY900014 E = 15 U Humalog D = 7 U Humalog |
| FG001 | Sequence 2: BCADFE | Participants received a single SC dose in each treatment period. B = 15 U LY900014 C = 30 U LY900014 A = 7 U LY900014 D = 7 U Humalog F = 30 U Humalog E = 15 U Humalog |
| FG002 | Sequence 3: CDBEAF | Participants received a single SC dose in each treatment period. C = 30 U LY900014 D = 7 U Humalog B = 15 U LY900014 E = 15 U Humalog A = 7 U LY900014 F = 30 U Humalog |
| FG003 | Sequence 4: DECFBA | Participants received a single SC dose in each treatment period. D = 7 U Humalog E = 15 U Humalog C = 30 U LY900014 F = 30 U Humalog B = 15 U LY900014 A = 7 U LY900014 |
| FG004 | Sequence 5: EFDACB | Participants received a single SC dose in each treatment period. E = 15 U Humalog F = 30 U Humalog D = 7 U Humalog A = 7 U LY900014 C = 30 U LY900014 B = 15 U LY900014 |
| FG005 | Sequence 6: FAEBDC | Participants received a single SC dose in each treatment period. F = 30 U Humalog A = 7 U LY900014 E = 15 U Humalog B = 15 U LY900014 D = 7 U Humalog C = 30 U LY900014 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
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| Period 1 |
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| Washout Period 1 |
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| Period 5 |
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| Period 6 |
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All Participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All participants who received at least on 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 Versus Time Curve (AUC) | Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours Post Dose [AUC(0-10h)] | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomole * hour per liter(pmol*/L) | Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose |
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Baseline to study completion (up to 12 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 | 7 U LY900014 | Single SC dose 7 U LY900014. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal 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 | Jun 26, 2017 | Jan 16, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 18, 2018 | Jan 16, 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 | Drug | Administered SC |
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| 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 | 41460 | Germany |
| Leohr J, Dellva MA, LaBell E, Coutant DE, Klein O, Plum-Moerschel L, Zijlstra E, Linnebjerg H. Pharmacokinetic and Glucodynamic Responses of Ultra Rapid Lispro vs Lispro Across a Clinically Relevant Range of Subcutaneous Doses in Healthy Subjects. Clin Ther. 2020 Sep;42(9):1762-1777.e4. doi: 10.1016/j.clinthera.2020.07.005. Epub 2020 Sep 6. |
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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 | Number | participants |
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| OG002 | 15 U Humalog | Single SC dose 15 U Humalog. |
| OG003 | 15 U LY900014 | Single SC dose 15 U LY900014. |
| OG004 | 30 U Humalog | Single SC dose 30 U Humalog. |
| OG005 | 30 U LY900014 | Single SC dose 30 U LY900014. |
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| Secondary | Glucodynamics: Total Amount of Glucose Infused (Gtot) | Glucodynamics: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp | All participants who received at least one dose of study drug and completed at least one clamp procedure. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams per kilogram (mg/kg) | Day 1: Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose |
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| 40 |
| 0 |
| 40 |
| 7 |
| 40 |
| EG001 | 15 U LY900014 | Single SC dose 15 U LY900014. | 0 | 40 | 0 | 40 | 5 | 40 |
| EG002 | 30 U LY900014 | Single SC dose 30 U LY900014. | 0 | 41 | 0 | 41 | 14 | 41 |
| EG003 | 7 U Humalog | Single SC dose 7 U Humalog. | 0 | 40 | 0 | 40 | 8 | 40 |
| EG004 | 15 U Humalog | Single SC dose 15 U Humalog. | 0 | 41 | 0 | 41 | 6 | 41 |
| EG005 | 30 U Humalog | Single SC dose 15 U Humalog. | 0 | 40 | 0 | 40 | 5 | 40 |
| Injection site reaction | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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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 Geometric LSMeans |
| 0.92 |
| 2-Sided |
| 95 |
| 0.83 |
| 1.03 |
| Superiority |
| Mixed Models Analysis | 0.1351 | Ratio of Geometric LSMeans | 0.92 | 2-Sided | 95 | 0.83 | 1.03 | Superiority |