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| ID | Type | Description | Link |
|---|---|---|---|
| I4L-MC-ABEA | Other Identifier | Eli Lilly and Company |
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The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin. The study will also gather information on the safety and tolerability of LY2963016 in healthy participants.
Each study period will be approximately 8.5 days (1.5 days for treatment and 7 day washout period). There are 4 study periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2963016 | Experimental | A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days. |
|
| Lantus | Experimental | A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2963016 | Drug | Administered subcutaneously |
| |
| Lantus |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 and Lantus | 1 hour predose up to 24 hours postdose in all treatment periods | |
| Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2963016 and Lantus | 1 hour 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 Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight. |
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Inclusion Criteria:
are overtly healthy males or females, as determined by medical history and physical examination
have a body weight of at least 55 kilograms (kg), and body mass index (BMI) of 18.5 to 32.0 kilograms/square meter (kg/m²)
have clinical laboratory test results within normal reference range for the population
have venous access sufficient to allow for blood sampling
are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
have given written informed consent
participants should have a normal oral glucose tolerance test
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. | Bloemfontein | 9301 |
This was a randomized, 2-sequence, 4-period, crossover study.
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| ID | Title | Description |
|---|---|---|
| FG000 | LY/Lantus/LY/Lantus | Sequence 1: 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 Lantus administered subcutaneously during Periods 2 and 4. Minimum washout interval of 7 days between each period. |
| FG001 | Lantus/LY/Lantus/LY | Sequence 2: A single 0.5 U/kg dose of Lantus administered subcutaneously during Periods 1 and 3. A single 0.5 U/kg dose of LY2963016 administered subcutaneously during Periods 2 and 4. Minimum washout interval of 7 days between each period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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| Period 4 |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | A single 0.5 units/kilogram (U/kg) dose of LY2963016 or a single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence. |
| 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: Area Under the Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 and Lantus | All randomized participants who received at least 1 dose of study drug and had evaluable pharmacokinetic 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) | 1 hour predose up to 24 hours postdose in all treatment periods |
|
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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 | A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | 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 |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000606659 | LY2963016 insulin glargine |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Drug |
Administered subcutaneously |
|
| 1 hour predose up to 24 hours postdose in all treatment periods |
| Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure | Gtot is the total glucose infusion over the clamp duration 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 Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight. | 1 hour predose up to 24 hours postdose in all treatment periods |
| South Africa |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2963016 and Lantus | All randomized participants who received at least 1 dose of study drug and had evaluable pharmacokinetic data to calculate Cmax. Participants were analyzed based on the treatment they received. | Geometric Mean | Geometric Coefficient of Variation | picomoles/Liter (pmol/L) | 1 hour 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 Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight. | All randomized participants who received at least 1 dose of study drug and had evaluable data to calculate Rmax. Participants were analyzed based on the treatment they received. | Geometric Mean | Geometric Coefficient of Variation | milligrams/kilogram/minute (mg/kg/min) | 1 hour predose up to 24 hours postdose in all treatment periods |
|
|
|
| Secondary | Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure | Gtot is the total glucose infusion over the clamp duration 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 Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight. | All randomized participants who received at least 1 dose of study drug and had evaluable data to calculate Gtot. Participants were analyzed based on the treatment they received. | Geometric Mean | Geometric Coefficient of Variation | milligrams/kilogram (mg/kg) | 1 hour predose up to 24 hours postdose in all treatment periods |
|
|
|
| 0 |
| 80 |
| 50 |
| 80 |
| EG001 | Lantus | A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence. | 0 | 80 | 54 | 80 |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |