| Trial ID: | L4013 |
| Source ID: | NCT01600950
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| Associated Drug: |
Ly2963016
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| Title: |
A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT01600950/results
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| Conditions: |
Diabetes Mellitus, Type 1
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| Interventions: |
DRUG: LY2963016|DRUG: Lantus
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| Outcome Measures: |
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., Periods 1 and 2: Baseline up to 42 hours postdose | 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., 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
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| Sponsor/Collaborators: |
Sponsor: Eli Lilly and Company
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| Gender: |
ALL
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| Age: |
ADULT
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| Phases: |
PHASE1
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| Enrollment: |
20
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
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| Start Date: |
2012-05
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| Completion Date: |
2012-07
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| Results First Posted: |
2014-10-07
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| Last Update Posted: |
2014-10-07
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| Locations: |
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, Germany
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| URL: |
https://clinicaltrials.gov/show/NCT01600950
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