A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Relative Bioavailability of LY2963016 to LANTUS® After Single Dose Subcutaneous Administration to Healthy Subjects

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: LY2963016
* Drug: Lantus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are overtly healthy males or females Have a body mass index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m^2) Are nonsmokers Have normal blood pressure and pulse rate Have an electrocardiogram (ECG) considered as within normal limits Have clinical laboratory test results within normal reference range Exclusion Criteria: Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device Have known allergies to insulin or its excipients Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders Show evidence of significant active neuropsychiatric disease Have a history of first-degree relatives known to have diabetes mellitus Have a fasting venous blood glucose >6.0 millimoles per liter (mmol/L) Intend to use over-the-counter or prescription medication Have donated or had a blood loss of 450 milliliters (mL) or more in the past 3 months Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY2963016<br>A single 0.5-unit per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously. | Drug: LY2963016<br>* Administered subcutaneously<br>|
| Active Comparator: Lantus<br>A single 0.5-U/kg dose of Lantus will be administered subcutaneously. | Drug: Lantus<br>* Administered subcutaneously<br>* Other names: Insulin Glargine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |