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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-MC-ITRR | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in elderly and younger adults with type 1 diabetes mellitus.
Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be between 3 to 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elderly Adults LY900014 | Experimental | Single, subcutaneous (SC) 15-U dose of LY900014 in the elderly adult group. |
|
| Elderly Adults Insulin Lispro | Active Comparator | Single, SC 15-U dose of insulin lispro (Humalog) in in the elderly adult group. |
|
| Younger Adults LY900014 | Experimental | Single, SC 15-U dose of LY900014 in the younger adult group. |
|
| Younger Adults Insulin Lispro | Active Comparator | Single, SC 15-U dose of insulin lispro (Humalog) in the younger adult group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900014 | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) for Each Treatment Arm | Pharmacokinetics: Insulin lispro AUC from time zero to 10 hours postdose [AUC(0-10h)] for each treatment arm. | Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm | Glucodynamics: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp procedure. | 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 | 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. | |
| 32468447 |
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This is a 2-period, crossover study, up to 10-hour euglycemic clamp in which participants were randomized to 1 of 2 treatment sequences: LY900014 in Period 1 switching to Humalog period 2 or Humalog in Period 1 switching to LY900014 in Period 2. A washout period of 3 to 15 days occurred between study drug administration.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 AB Elderly Adults | Sequence 1: A: Single, subcutaneous (SC) 15-U dose of LY900014 in Period 1. B: Single, SC 15-U dose of Humalog in Period 2. Washout period of 3-15 days between study drug administration. |
| FG001 | Sequence 1 AB Younger Adults | Sequence 1 A: Single, SC 15-U dose of LY900014 in Period 1. B: single, SC 15-U dose of Humalog in Period 2. Washout 3-15 days between study drug administration. |
| FG002 | Sequence 2 BA Elderly Adults | Sequence 2: B: Single, SC 15-U dose of Humalog in Period 1. A: Single, SC 15-U dose of LY900014 in Period 2. A Washout period of 3-15 days between study drug administration. |
| FG003 | Sequence 2 BA Younger Adults | Sequence 2: B: Single, SC 15-U dose of Humalog in Period 1. A: Single SC 15-U dose of LY900014 in Period 2. A Washout period of 3-15 days between study drug administration. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Wash-out Period |
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| Treatment Period 2 |
|
All participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Elderly Adults | Male and female participants age 65 or older inclusive. |
| BG001 | Younger Adults | Male and female participants age 18 to 45 inclusive. |
| 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: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) for Each Treatment Arm | Pharmacokinetics: Insulin lispro AUC from time zero to 10 hours postdose [AUC(0-10h)] for each treatment arm. | All participants who received at least one dose of study drug and have measurable insulin lispro concentrations. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomole * hour per Liter (pmol*h/L) | Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose |
|
Baseline to end of study (up to 39 days)
All participants who received at least one dose of study drug.
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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 | Elderly Adults LY900014 | Single, subcutaneous (SC) 15-U dose of LY900014. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | 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 | Aug 4, 2017 | Aug 27, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 11, 2017 | Aug 27, 2018 | 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 | Drug | Administered SC |
|
|
| 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 |
| Linnebjerg H, Zhang Q, LaBell E, Dellva MA, Coutant DE, Hovelmann U, Plum-Morschel L, Herbrand T, Leohr J. Pharmacokinetics and Glucodynamics of Ultra Rapid Lispro (URLi) versus Humalog(R) (Lispro) in Younger Adults and Elderly Patients with Type 1 Diabetes Mellitus: A Randomised Controlled Trial. Clin Pharmacokinet. 2020 Dec;59(12):1589-1599. doi: 10.1007/s40262-020-00903-0. |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| 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 | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilograms (kg) |
|
All elderly adults who received a single 15-U SC dose Humalog. |
| OG002 | Younger Adults LY900014 | All younger adults who received a single 15-U SC dose LY900014. |
| OG003 | Younger Adults Humalog | All younger adults who received single 15-U SC dose Humalog. |
|
|
|
| Secondary | Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm | Glucodynamics: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp procedure. | 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 | milligram per kilogram (mg/kg) | Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose |
|
|
|
|
| 37 |
| 0 |
| 37 |
| 5 |
| 37 |
| EG001 | Elderly Adults Humalog | Single, SC 15-U dose of Humalog. | 0 | 38 | 0 | 38 | 7 | 38 |
| EG002 | Younger Adults LY900014 | Single, SC 15-U dose of LY900014. | 0 | 40 | 1 | 40 | 3 | 40 |
| EG003 | Younger Adults Humalog | Single, SC 15-U dose of Humalog. | 0 | 39 | 0 | 39 | 6 | 39 |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Headache | Nervous system 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 |
| Mixed Models Analysis |
| Ratio of Geometric LSMeans |
| 1.02 |
| 2-Sided |
| 95 |
| 0.94 |
| 1.10 |
| Superiority |