A Study to Compare LY2963016 and US-approved Lantus® After Single Dose Administration to Healthy Participants

Phase 1

Completed

Brief Summary: The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of LY2963016 and US-approved Lantus®. The study involves four single injections; two doses of LY2963016 and two doses of US-approved Lantus®. The study will have 4 periods. In each period, a single injection will be administered before undergoing a euglycemic clamp that lasts for 24 hours. There will be at least a 7 day washout between each period. Side effects will be documented. Study participation is expected to last up to 14 weeks.

Recruitment & Eligibility

Inclusion Criteria

Are overtly healthy males or females
Have body mass index between 18.5 and 29.9 kilograms per meter square (kg/m^2)
Are nonsmokers and have not smoked for at least 2 months prior to entering the study
Have normal blood pressure and pulse rates at screening
Have electrocardiograms (ECGs) at screening considered as within normal limits
Have clinical laboratory test results within normal reference ranges

Exclusion Criteria

Are currently enrolled in or discontinued within the last 30 days from a clinical study involving an investigational drug or device or are concurrently enrolled in any other type of medical research
Have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin
Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
Show evidence of significant active neuropsychiatric disease, including taking prescription medication for such diseases
Show evidence of current use of known drugs of abuse or a history of use within the past year
Have a history of first-degree relatives known to have diabetes mellitus
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies at screening
Have positive hepatitis B surface antigen at screening
Intend to use over-the-counter or prescription medication within 7 or 14 days, respectively, prior to dosing (apart from vitamin/mineral supplements, occasional paracetamol, thyroid replacement medication, or birth control methods)
Have donated or had a blood loss of 450 milliliters (mL) within 3 months prior to study enrollment
Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) or are unwilling to stop alcohol consumption from 24 hours prior to each dosing until discharged from the clinical research unit (CRU)

Arm && Interventions

Group	Intervention	Description
US-approved Lantus	US Approved Lantus	Single 0.5 U/kg dose of US-approved Lantus administered subcutaneously, twice during the study
LY2963016	LY2963016	Single 0.5 units per kilogram (U/kg) dose of LY2963016 administered subcutaneously, twice during the study

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2963016 and US-Approved Lantus	30 minutes predose up to 24 hours postdose in all treatment periods	The AUC from time 0 to 24 hours (AUC0-24) of LY2963016 and US-Approved Lantus was measured.
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2963016 and US-Approved Lantus	30 minutes predose up to 24 hours postdose in all treatment periods

Secondary Outcome Measures

Name	Time	Method
Maximum Glucose Infusion Rate (Rmax)	30 minutes predose up to 24 hours postdose in all treatment periods	Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain target blood glucose level 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 LY2963016 or US-approved Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.
Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure	30 minutes predose up to 24 hours postdose in all treatment periods	Gtot was the total glucose infusion over the clamp duration and was used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations were held constant after the administration of LY2963016 or US-approved Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.

Locations (1): 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.
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Singapore, Singapore