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| ID | Type | Description | Link |
|---|---|---|---|
| I4L-MC-ABEF | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to compare a study drug known as Insulin glargine with Lantus in healthy Chinese participants. Blood samples will be taken to compare how the body handles the drugs and how they affect blood sugar levels. Side effects and tolerability will be documented. The study will last at least 18 days, not including screening. Screening is required within 4 weeks prior to the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Glargine | Experimental | Participants received 0.5 units per kilogram (U/kg) of Insulin Glargine subcutaneously (SC). |
|
| Lantus | Active Comparator | Participants received 0.5 U/Kg of Lantus subcutaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine | Drug | Administered SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Insulin Glargine and Lantus | Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Insulin glargine and Lantus. | -0.5 and 0 hours predose; 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours postdose |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Insulin Glargine and Lantus | PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Insulin glargine and Lantus. | -0.5 and 0 hours predose; 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) | 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 Insulin glargine or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight. |
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Inclusion Criteria:
Are native Chinese men or women. Native Chinese is defined as a participant who has both parents and all 4 grandparents of Chinese origin.
For females of childbearing potential (defined as not surgically sterilised and between menarche and 1-year postmenopause) only:
For females not of childbearing potential, must be:
Having fasting plasma glucose <110 milligrams per deciliter (mg/dL) (<6.1 millimoles per liter [mmol/L]) and 2-hour glucose level <140 mg/dL (<7.8 mmol/L) on the 75 grams (g) oral glucose tolerance test.
Have a body mass index (BMI) between 18 and 28 kilograms per meter squared (kg/m²), inclusive, at screening.
Are nonsmokers, have not smoked for at least 6 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study.
Have normal blood pressure and pulse rate at screening, as determined by the investigator.
Have an electrocardiogram (ECG), at screening, considered as within normal limits by the investigator.
Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
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 |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34410042 | Derived | Liu H, Wang F, Ji Y, Ma T, Li H, Linnebjerg H, Chua L, Tham LS, Yu Y. A Euglycemic Glucose Clamp Study to Evaluate the Bioavailability of LY2963016 Relative to Insulin Glargine in Healthy Chinese Subjects. Clin Pharmacol Drug Dev. 2021 Dec;10(12):1452-1459. doi: 10.1002/cpdd.1014. Epub 2021 Aug 19. |
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Two period crossover study, with a minimum of 7 days washout period between each period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Period 1: Participants received 0.5 units per kilogram (U/kg) of Insulin glargine subcutaneously. Period 2: Participants received 0.5 U/Kg of Lantus subcutaneously. |
| FG001 | Sequence 2 | Period 1: Participants received 0.5 U/Kg of Lantus subcutaneously. Period 2: Participants received 0.5 U/Kg of Insulin glargine subcutaneously. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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All randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Participants received 0.5 U/Kg of Insulin glargine and Lantus subcutaneously as per dosing schedule. |
| 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): Maximum Serum Concentration (Cmax) of Insulin Glargine and Lantus | Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Insulin glargine and Lantus. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomole per liter (pmol/L) | -0.5 and 0 hours predose; 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours postdose |
|
Up to 14 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 | 0.5 U/kg Insulin Glargine | Participants received single 0.5 U/kg dose of Insulin glargine administered subcutaneously. |
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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 | Dec 18, 2018 | Jun 15, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 6, 2019 | Jun 15, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| C000606659 | LY2963016 insulin glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Lantus | Drug | Administered SC |
|
|
| 30 minutes predose through 24 hours postdose |
| PD: 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 Insulin glargine or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight. | 30 minutes predose through 24 hours postdose |
| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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|
|
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| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Insulin Glargine and Lantus | PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Insulin glargine and Lantus. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomole*hour per liter (pmol*hr/L) | -0.5 and 0 hours predose; 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours postdose |
|
|
|
|
| Secondary | Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) | 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 Insulin glargine or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight. | All randomized participants who received at least one dose of study drug and had evaluable Gtot data. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams/kilogram (mg/kg) | 30 minutes predose through 24 hours postdose |
|
|
|
| Secondary | PD: 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 Insulin glargine or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight. | All randomized participants who received at least one dose of study drug and had evaluable Rmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams/kilograms/minute (mg/kg/min) | 30 minutes predose through 24 hours postdose |
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| 0 |
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | 0.5 U/kg Lantus | Participants received single 0.5 U/kg dose of Lantus administered subcutaneously. | 0 | 58 | 0 | 58 | 0 | 58 |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |