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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-MC-ITST | Other Identifier | Eli Lilly and Company | |
| 2019-003493-13 | EudraCT Number |
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The main purpose of this study is to compare LY900014 to insulin lispro (Humalog) in participants with type 1 diabetes who are using an insulin pump and have high blood sugar after eating. For each participant, the study will last about two to nine weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 U/mL LY900014 | Experimental | 100 units per milliliter (U/mL) LY900014 administered by continuous subcutaneous insulin infusion (CSII) in one of two study periods. |
|
| 100 U/mL Insulin Lispro (Humalog) | Active Comparator | 100 U/mL Insulin Lispro (Humalog) administered by CSII in one of two study periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900014 | Drug | Administered by CSII |
| |
| Insulin Lispro |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Missed Meal Bolus | Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 Milligrams per deciliter (mg/dL). | Day 1: Baseline up to 5 hours after missed meal bolus |
| Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Pump Suspension | Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 mg/dL. | Day 2: Baseline up to 5 hours after pump suspension |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD): Maximum Observed Plasma Glucose (PGmax) Following Administration of LY900014 and Insulin Lispro (Humalog) | PD: PGmax following administration of LY900014 and insulin lispro (Humalog) | Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspension |
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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 |
|---|---|---|---|---|---|---|
| Profil Mainz GmbH & Co. KG | Mainz | Rhineland-Palatinate | 55116 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37814517 | Derived | Leohr J, Dellva MA, LaBell E, Coutant DE, Arrubla J, Plum-Morschel L, Zijlstra E, Fukuda T, Hardy T. Ultra rapid lispro (Lyumjev(R)) shortens time to recovery from hyperglycaemia compared to Humalog(R) in individuals with type 1 diabetes on continuous subcutaneous insulin infusion. Diabetes Obes Metab. 2024 Jan;26(1):215-223. doi: 10.1111/dom.15307. Epub 2023 Oct 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence AB (LY900014, Insulin Lispro (Humalog)) | Period 1: Participants received 100 units per milliliter (U/mL) of LY900014 administered by continuous subcutaneous insulin infusion (CSII). Period 2: Participants received 100 U/mL of Insulin lispro Humalog) administered by CSII. |
| FG001 | Sequence BA (Insulin Lispro (Humalog), LY900014)) | Period 1: Participants received 100 U/mL of Insulin lispro (Humalog) administered by CSII. Period 2: Participants received 100 U/mL of LY900014 administered by CSII. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| |||||||||||||||||||||
| Washout (3- 14 Days) |
| ||||||||||||||||||||||
| Period 2 |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 100 U/mL LY900014 and 100 U/mL Insulin Lispro (Humalog) | Participants received 100 U/mL LY900014 administered by CSII in one of two study periods. Participants received 100 U/mL Insulin Lispro (Humalog) administered by CSII in one of two study periods. |
| 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 | Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Missed Meal Bolus | Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 Milligrams per deciliter (mg/dL). | All participants who received both study treatments with the same insulin dose and achieved recovery from hyperglycemia on day 1 | Posted | Median | Full Range | Hours | Day 1: Baseline up to 5 hours after missed meal bolus |
|
Baseline Up To 42 Days
All randomized 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 | 100 U/mL LY900014 | Participants received 100 U/mL of LY900014 administered by CSII in one of the two study periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycaemia | Endocrine disorders | MedDRA 21.0 | 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 | Jan 22, 2020 | Jul 15, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 15, 2020 | Jul 15, 2021 | 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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| Drug |
Administered by CSII |
|
|
| Pharmacokinetics (PK): Time to Maximum Observed Insulin Lispro Concentration (Tmax) Following Administration of LY900014 and Insulin Lispro (Humalog) |
PK: Tmax following administration of LY900014 and insulin lispro (Humalog) |
| Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspension |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
Participants received 100 U/mL of Insulin lispro (Humalog) administered by CSII in one of the two study periods.
|
|
|
| Primary | Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Pump Suspension | Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 mg/dL. | All participants who received both study treatments with the same insulin dose and achieved recovery from hyperglycemia on day 2 | Posted | Median | Full Range | Hours | Day 2: Baseline up to 5 hours after pump suspension |
|
|
|
|
| Secondary | Pharmacodynamics (PD): Maximum Observed Plasma Glucose (PGmax) Following Administration of LY900014 and Insulin Lispro (Humalog) | PD: PGmax following administration of LY900014 and insulin lispro (Humalog) | All participants who received both study treatments with the same insulin dose and achieved recovery from hyperglycemia on days 1 and 2 | Posted | Mean | Standard Deviation | Milligrams per deciliter (mg/dL) | Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspension |
|
|
|
|
| Secondary | Pharmacokinetics (PK): Time to Maximum Observed Insulin Lispro Concentration (Tmax) Following Administration of LY900014 and Insulin Lispro (Humalog) | PK: Tmax following administration of LY900014 and insulin lispro (Humalog) | All participants who received both study treatments with the same insulin dose and achieved recovery from hyperglycemia on days 1 and 2 | Posted | Median | Full Range | Hours | Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspension |
|
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 3 |
| 31 |
| EG001 | 100 U/mL Insulin Lispro (Humalog) | Participants received 100 U/mL of Insulin lispro (Humalog) administered by CSII in one of the two study periods. | 0 | 32 | 0 | 32 | 2 | 32 |
| Headache | Nervous system disorders | MedDRA 21.0 | 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 |
| Day 2 |
|
|
| 0.0243 |
| Mean Difference (Final Values) |
| -5.75 |
| 2-Sided |
| 95 |
| -10.69 |
| 0.81 |
| Superiority |
| Day 2 |
|
|
| 0.888 |
| Superiority |