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| ID | Type | Description | Link |
|---|---|---|---|
| I4L-MC-ABEO | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of LY2963016 and US-approved Lantus®. The study involves four single injections; two doses of LY2963016 and two doses of US-approved Lantus®. The study will have 4 periods. In each period, a single injection will be administered before undergoing a euglycemic clamp that lasts for 24 hours. There will be at least a 7 day washout between each period. Side effects will be documented. Study participation is expected to last up to 14 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2963016 | Experimental | Single 0.5 units per kilogram (U/kg) dose of LY2963016 administered subcutaneously, twice during the study |
|
| US-approved Lantus | Experimental | Single 0.5 U/kg dose of US-approved Lantus administered subcutaneously, twice during the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2963016 | Drug | Administered subcutaneously |
| |
| US Approved Lantus |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2963016 and US-Approved Lantus | The AUC from time 0 to 24 hours (AUC0-24) of LY2963016 and US-Approved Lantus was measured. | 30 minutes predose up to 24 hours postdose in all treatment periods |
| Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2963016 and US-Approved Lantus | 30 minutes predose up to 24 hours postdose in all treatment periods |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Glucose Infusion Rate (Rmax) | Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain target blood glucose level and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or US-approved Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight. |
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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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Singapore | 117597 |
The study comprised 2 sequences with 4 treatment periods. Participants were randomly assigned to 1 of the 2 sequences.
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| ID | Title | Description |
|---|---|---|
| FG000 | LY/Lantus/LY/Lantus | A single 0.5-units/kilogram (U/kg) dose of LY2963016 (LY) administered subcutaneously during Periods 1 and 3. A single 0.5-U/kg dose of US-approved Lantus (Lantus) administered subcutaneously during Periods 2 and 4. There was at least a 7-day washout between treatment periods. |
| FG001 | Lantus/LY/Lantus/LY | A single 0.5-U/kg dose of US-approved Lantus administered subcutaneously during Periods 1 and 3. A single 0.5-U/kg dose of LY2963016 administered subcutaneously during Periods 2 and 4. There was at least a 7-day washout between treatment periods. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout 1 |
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| Period 2 |
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| Washout 2 |
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| Period 3 |
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| Washout 3 |
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| Period 4 |
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All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | LY2963016 and US-approved Lantus | Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study; Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study. There was at least a 7-day washout between treatment periods. |
| 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): Area Under the Concentration Time Curve (AUC) of LY2963016 and US-Approved Lantus | The AUC from time 0 to 24 hours (AUC0-24) of LY2963016 and US-Approved Lantus was measured. | Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate AUC(0-24). Participants were analyzed based on the treatment they received. | Geometric Mean | Geometric Coefficient of Variation | picomoles*hour/liter (pmol*h/L) | 30 minutes predose up to 24 hours postdose in all treatment periods |
|
Randomization to study completion
Study-specific clinical outcomes due to progressive disease were not considered to be serious adverse events (SAEs) unless it was deemed related to study drug by the investigator.
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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 | LY2963016 | Single 0.5 units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study. There was at least a 7-day washout between the treatment periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site haematoma | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| C000606659 | LY2963016 insulin glargine |
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| Drug |
Administered subcutaneously |
|
| 30 minutes predose up to 24 hours postdose in all treatment periods |
| Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure | Gtot was the total glucose infusion over the clamp duration and was used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations were held constant after the administration of LY2963016 or US-approved Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight. | 30 minutes predose up to 24 hours postdose in all treatment periods |
| Singapore |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
|
| US-approved Lantus |
Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study. There was at least a 7-day washout between treatment periods. |
|
|
| Primary | Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2963016 and US-Approved Lantus | Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate Cmax. Participants were analyzed based on the treatment they received | Geometric Mean | Geometric Coefficient of Variation | picomoles/liter (pmol/L) | 30 minutes predose up to 24 hours postdose in all treatment periods |
|
|
|
| Secondary | Maximum Glucose Infusion Rate (Rmax) | Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain target blood glucose level and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or US-approved Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight. | Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable pharmacodynamic data to calculate Rmax. Participants were analyzed based on the treatment they received. | Geometric Mean | Geometric Coefficient of Variation | milligrams/kilograms/minute (mg/kg/min) | 30 minutes predose up to 24 hours postdose in all treatment periods |
|
|
|
| Secondary | Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure | Gtot was the total glucose infusion over the clamp duration and was used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations were held constant after the administration of LY2963016 or US-approved Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight. | Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable pharmacodynamic data to calculate Gtot. Participants were analyzed based on the treatment they received. | Geometric Mean | Geometric Coefficient of Variation | milligrams/kilogram (mg/kg) | 30 minutes predose up to 24 hours postdose in all treatment periods |
|
|
|
| 0 |
| 89 |
| 42 |
| 89 |
| EG001 | US-approved Lantus | Single 0.5 U/kg dose of US-approved Lantus administered subcutaneously twice during the study. There was at least a 7-day washout between the treatment periods. | 0 | 90 | 42 | 90 |
| Catheter site pain | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Infusion site pain | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Infusion site swelling | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
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