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| ID | Type | Description | Link |
|---|---|---|---|
| I4L-MC-ABEE | Other Identifier | Eli Lilly and Company |
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The study involves a single injection of LY2963016 and a single injection of Lantus, on 2 separate occasions in participants with type I diabetes. Following each dose, participants will undergo a glucose clamp which lasts for 42 hours each time. There will be at least 7 days between the two periods, during which time there will be no study treatment, but participants will resume their regular therapy. The duration of this study can be up to 9.5 weeks. The purposes of this study are to understand how the blood sugar lowering effect of LY2963016 compares to that of Lantus, and to determine how LY2963016 and Lantus are metabolized by participants with type I diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2963016 | Experimental | A single 0.3 units per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously followed by a minimum washout period of 7 days. |
|
| Lantus | Active Comparator | A single 0.3 U/kg dose of Lantus will be administered subcutaneously followed by a minimum washout period of 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2963016 | Drug | Single 0.3 U/kg dose administered subcutaneously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics: Duration of Action of LY2963016 and Lantus | Duration of action is defined as the period of time elapsed between dose administration and the time at which the participant's blood glucose is consistently >150 milligrams/deciliter (mg/dL) without any glucose infusion. Participants whose blood glucose did not rise to 150 mg/dL were censored 42 hours postdose. | Periods 1 and 2: Baseline up to 42 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Glucose Infusion Rate (Rmax) | Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain a target blood glucose level of 100 milligrams/deciliter (mg/dL) [5.6 millimoles/Liter (mmol/L)] 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 study drug by adjusting the exogenous glucose infusion rate. Data presented are the maximum infusion rates, adjusted by 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. | Neuss | 41460 |
This was a randomized, 2-period, 2-sequence, crossover study.
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2963016/Lantus | A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 during Period 1 followed by a minimum washout period of 7 days. A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 during Period 2. |
| FG001 | Lantus/LY2963016 | A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 during Period 1 followed by a minimum washout period of 7 days. A single 0.3 U/kg dose of LY2963016 was administered subcutaneously on Day 1 during Period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | A single 0.3 units/kilogram (U/kg) dose of either LY2963016 or LANTUS was administered subcutaneously on Day 1 of Periods 1 or 2. |
| 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 | Pharmacodynamics: Duration of Action of LY2963016 and Lantus | Duration of action is defined as the period of time elapsed between dose administration and the time at which the participant's blood glucose is consistently >150 milligrams/deciliter (mg/dL) without any glucose infusion. Participants whose blood glucose did not rise to 150 mg/dL were censored 42 hours postdose. | All randomized participants who received study drug during Periods 1 or 2. Participants were analyzed based on treatment they received. The numbers of participants censored were 7 for both LY2963016 and Lantus groups. Maximum duration of actions is based on participants who reached the end of action before 42 hours: 13 participants for both groups. | Median | Full Range | hours (hr) | Periods 1 and 2: Baseline up to 42 hours postdose |
|
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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 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | 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 |
|---|---|
| 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 |
|---|---|
| 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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| Lantus |
| Drug |
Single 0.3 U/kg dose administered subcutaneously |
|
| Periods 1 and 2: Baseline up to 42 hours postdose |
| Total Glucose Infused (Gtot) | 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 study drug by adjusting the exogenous glucose infusion rate. Data presented are the total glucose infused, adjusted by body weight. | Periods 1 and 2: Baseline up to 42 hours postdose |
| Time of Maximum Glucose Infusion Rate (tRmax) | tRmax is the time to reach maximum glucose infusion rate 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 study drug by adjusting the exogenous glucose infusion rate. | Periods 1 and 2: Baseline up to 42 hours postdose |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2963016 and Lantus | Cmax was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay. | Periods 1 and 2: Baseline up to 42 hours postdose |
| Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2963016 and Lantus | AUC was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay. | Periods 1 and 2: Baseline up to 42 hours postdose |
| Germany |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Lantus | A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2. |
|
|
| Secondary | Maximum Glucose Infusion Rate (Rmax) | Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain a target blood glucose level of 100 milligrams/deciliter (mg/dL) [5.6 millimoles/Liter (mmol/L)] 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 study drug by adjusting the exogenous glucose infusion rate. Data presented are the maximum infusion rates, adjusted by body weight. | All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received. | Geometric Mean | Geometric Coefficient of Variation | milligrams/kilogram/minute (mg/kg/min) | Periods 1 and 2: Baseline up to 42 hours postdose |
|
|
|
| Secondary | Total Glucose Infused (Gtot) | 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 study drug by adjusting the exogenous glucose infusion rate. Data presented are the total glucose infused, adjusted by body weight. | All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received. | Geometric Mean | Geometric Coefficient of Variation | milligrams/kilogram (mg/kg) | Periods 1 and 2: Baseline up to 42 hours postdose |
|
|
|
| Secondary | Time of Maximum Glucose Infusion Rate (tRmax) | tRmax is the time to reach maximum glucose infusion rate 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 study drug by adjusting the exogenous glucose infusion rate. | All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received. | Median | Full Range | hours (hr) | Periods 1 and 2: Baseline up to 42 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) of LY2963016 and Lantus | Cmax was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay. | No participants were analyzed because of insufficient data. | Periods 1 and 2: Baseline up to 42 hours postdose |
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2963016 and Lantus | AUC was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay. | No participants were analyzed because of insufficient data. | Periods 1 and 2: Baseline up to 42 hours postdose |
|
|
| 0 |
| 20 |
| 4 |
| 20 |
| EG001 | Lantus | A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2. | 0 | 20 | 3 | 20 |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | 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 |