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| ID | Type | Description | Link |
|---|---|---|---|
| I4L-MC-ABEI | 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 subjects. The study is approximately 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2963016 | Experimental | A single 0.5-unit per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously. |
|
| Lantus | Active Comparator | A single 0.5-U/kg dose of Lantus will be administered subcutaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2963016 | Drug | Administered subcutaneously |
| |
| Lantus |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) | AUC from time zero to 24 hours (AUC0-24) is reported for this outcome measure. | Periods 1 and 2: Baseline up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) | Periods 1 and 2: Baseline up to 24 hours | |
| Maximum Glucose Infusion Rate (Rmax) | Periods 1 and 2: Baseline up to 24 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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Singapore |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2963016 First, Then Lantus | A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg Lantus dose was administered subcutaneously during Period 2 (1 period=24 hours). |
| FG001 | Lantus First, Then LY2963016 | A single 0.5-U/kg dose of Lantus was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg dose of LY2963016 was administered subcutaneously during Period 2 (1 period=24 hours). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (up to 24 Hours After Dosing) |
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| Washout Period of at Least 7 Days |
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| Period 2 (up to 24 Hours After Dosing) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | For the LY2963016 first, then Lantus group: A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg Lantus dose was administered subcutaneously during Period 2 (1 period=24 hours). For the Lantus first, then LY2963016 group: A single 0.5-U/kg dose of Lantus was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg dose of LY2963016 was administered subcutaneously during Period 2 (1 period=24 hours). |
| 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 (AUC) | AUC from time zero to 24 hours (AUC0-24) is reported for this outcome measure. | All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable pharmacokinetic data were included in the analysis. | Geometric Mean | Geometric Coefficient of Variation | picomole*hour per liter (pmol*hr/L) | Periods 1 and 2: Baseline up to 24 hours |
|
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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-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac 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 |
|
|
| Total Glucose Infused (Gtot) |
| Periods 1 and 2: Baseline up to 24 hours |
| Time of Maximum Glucose Infusion Rate (tRmax) | Periods 1 and 2: Baseline up to 24 hours |
| Number of Participants With Clinically Significant Effects | Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module. | Baseline up to 30 days |
| Singapore |
| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
|
| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) | All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable pharmacokinetic data were included in the analysis. | Geometric Mean | Geometric Coefficient of Variation | picomole per liter (pmol/L) | Periods 1 and 2: Baseline up to 24 hours |
|
|
|
| Secondary | Maximum Glucose Infusion Rate (Rmax) | All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable glucodynamic data were included in the analysis. | Geometric Mean | Geometric Coefficient of Variation | grams per hour (g/h) | Periods 1 and 2: Baseline up to 24 hours |
|
|
|
| Secondary | Total Glucose Infused (Gtot) | All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable glucodynamic data were included in the analysis. | Geometric Mean | Geometric Coefficient of Variation | gram (g) | Periods 1 and 2: Baseline up to 24 hours |
|
|
|
| Secondary | Time of Maximum Glucose Infusion Rate (tRmax) | All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable glucodynamic data. | Median | Full Range | hour (h) | Periods 1 and 2: Baseline up to 24 hours |
|
|
|
| Secondary | Number of Participants With Clinically Significant Effects | Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module. | All randomized participants were included in the analysis. | Number | participants | Baseline up to 30 days |
|
|
|
| 0 |
| 16 |
| 8 |
| 16 |
| EG001 | Lantus | A single 0.5-U/kg dose of Lantus was administered subcutaneously. | 0 | 13 | 6 | 13 |
| Dry mouth | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Catheter site erythema | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |