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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Single 0.3 U/kg dose administered subcutaneously
Single 0.3 U/kg dose administered subcutaneously
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, Germany
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.
Time frame: Periods 1 and 2: Baseline up to 42 hours postdose
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Periods 1 and 2: Baseline up to 42 hours postdose
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