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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-MC-ITRU | Other Identifier | Eli Lilly and Company | |
| 2017-001305-33 | EudraCT Number |
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The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 2 diabetes mellitus. The study will be conducted in participants with type 2 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog).
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 and 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY900014 | Experimental | Single, subcutaneous (SC) dose of 15 Units (U) LY900014 in one of two study periods |
|
| Insulin Lispro (Humalog) | Active Comparator | Single SC dose of 15 U insulin lispro (Humalog) in one of two study periods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900014 | Drug | Administered SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Insulin Lispro Area Under the Plasma Concentration Curve Zero to 10 Hours (AUC[0-10) Following Each Treatment Arm | Pharmacokinetics(PK): Insulin Lispro AUC from zero to 10 hours postdose [AUC(0-10)] following each treatment arm | Predose, 5 minutes (mn), 10mn, 15mn, 20mn, 25mn, 30mn, 35mn, 40mn,45 mn,50mn, 55mn, 60mn, 70mn, 90mn, 120mn, 150mn, 180mn, 240mn, 300mn, 360mn, 420mn, 480mn, 540mn, and 600 minutes(10 hours) postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD): 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. | Predose, every minute starting from run-in and throughout the duration of the 10 hours |
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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. | Neuss | North Rhine-Westphalia |
| 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. | |
| 32468448 |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY900014/Humalog | Participants receive a single, subcutaneous (SC) dose of LY900014 with a 3 day washout and a single subcutaneous (SC) 15 U dose of Humalog (insulin lispro) |
| FG001 | Humalog/LY900014 | Participants receive a single, subcutaneous (SC) dose of 15 U of Humalog (insulin lispro) with a 3 day washout and a single subcutaneous (SC) LY900014. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| ||||||||||||||||
| Washout |
| ||||||||||||||||
| Period 2 |
|
All participants who received SC LY900014 or SC Humalog.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All participants received LY900014 or 15 U Humalog in a crossover design with an approximately 3 day washout 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 Plasma Concentration Curve Zero to 10 Hours (AUC[0-10) Following Each Treatment Arm | Pharmacokinetics(PK): Insulin Lispro AUC from zero to 10 hours postdose [AUC(0-10)] following each treatment arm | All participants who received at least 1 dose of study drug and have measurable insulin lispro concentrations. No statistical analysis was done, per protocol. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour times picomol per liter (pmol*h/L) | Predose, 5 minutes (mn), 10mn, 15mn, 20mn, 25mn, 30mn, 35mn, 40mn,45 mn,50mn, 55mn, 60mn, 70mn, 90mn, 120mn, 150mn, 180mn, 240mn, 300mn, 360mn, 420mn, 480mn, 540mn, and 600 minutes(10 hours) postdose |
|
Baseline until the end of study (60 days)
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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 | 15 U LY900014 | Participants received a single, subcutaneous (SC) dose 15U LY900014. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery stenosis | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vessel puncture site thrombosis | General 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 | Jul 14, 2017 | Nov 19, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 2, 2017 | Nov 19, 2018 | 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 |
|
|
| Germany |
| Leohr J, Dellva MA, Coutant DE, LaBell E, Heise T, Andersen G, Zijlstra E, Hermanski L, Nosek L, Linnebjerg H. Pharmacokinetics and Glucodynamics of Ultra Rapid Lispro (URLi) versus Humalog(R) (Lispro) in Patients with Type 2 Diabetes Mellitus: A Phase I Randomised, Crossover Study. Clin Pharmacokinet. 2020 Dec;59(12):1601-1610. doi: 10.1007/s40262-020-00901-2. |
| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| 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) |
|
| OG001 |
| Humalog |
Participants receive a single, subcutaneous (SC) dose of 15 U of Humalog (insulin lispro). |
|
|
| Secondary | Pharmacodynamics (PD): 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 1 dose of study drug and had evaluable data. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligram/kilogram (mg/kg) | Predose, every minute starting from run-in and throughout the duration of the 10 hours |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 4 |
| 38 |
| EG001 | Humalog | Participants received a single, subcutaneous (SC) dose 15 U of Humalog (insulin lispro). | 0 | 38 | 1 | 38 | 2 | 38 |
| 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 |