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

Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Lantus	Lantus	A single 0.5-U/kg dose of Lantus will be administered subcutaneously.
LY2963016	LY2963016	A single 0.5-unit per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)	Periods 1 and 2: Baseline up to 24 hours	AUC from time zero to 24 hours (AUC0-24) is reported for this outcome measure.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Maximum Concentration (Cmax)	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
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
Number of Participants With Clinically Significant Effects	Baseline up to 30 days	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.

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