A Study of LY2963016 in Healthy Participants
Condition: Healthy Volunteers
Intervention: LY2963016; Lantus
Intervention description: Administered subcutaneously; Administered subcutaneously
Intervention MeSH terms: Insulin Glargine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study involves 2 single injections of LY2963016 and 2 single injections of Lantus. There
      will be at least 6 days between each injection.

      The study will compare LY2963016 to Lantus at two different doses.

      This study is approximately 10 weeks long, not including screening. Screening is required
      within 4 weeks of the start of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males or females

          -  Women must be either surgically sterile, post-menopausal, or agree to use a reliable
             method of birth control during the study

          -  Have a body mass index between 18.5 and 29.9 kilograms per meter squared (kg/m²)

          -  Are nonsmokers and have not smoked for at least 6 months prior to entering the study

          -  Have normal blood pressures and pulse rates at screening, as determined by the
             investigator

          -  Have an electrocardiogram (ECG) at screening considered as within normal limits by the
             investigator

          -  Have clinical laboratory test results within normal reference range for the population

          -  Have fasting plasma glucose <110 milligrams per deciliter (mg/dL) (<6.0 micromoles per
             liter [mmol/L]) at screening

          -  Have venous access sufficient to allow for blood sampling, intravenous drug
             administration, and clamp procedures as per the protocol

          -  Have given written informed consent approved by Lilly and the ethical review board
             (ERB) governing the site

        Exclusion Criteria:

          -  Are persons who have previously completed or withdrawn from this study

          -  Are currently enrolled in or have discontinued within the last 30 days from a clinical
             trial involving an investigational drug or device or are concurrently enrolled in any
             other type of medical research judged not to be scientifically or medically compatible
             with this study

          -  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 capable of
             significantly altering the absorption, metabolism, or elimination of drugs; of
             constituting a risk when taking the study medication; or of interfering with the
             interpretation of data

          -  Show evidence of significant active neuropsychiatric disease

          -  Show evidence of current use of known drugs of abuse or have a history of use within
             the past year

          -  Have a history of first-degree relatives known to have diabetes mellitus

          -  Show evidence of an acute infection with fever or infectious disease at the time of
             study entry

          -  Show evidence of human immunodeficiency virus (HIV) infection and/or positive human
             HIV antibodies at screening

          -  Have positive hepatitis B surface antigens at screening

          -  Intend to use over-the-counter medication within 7 days or prescription medication
             within 14 days prior to dosing (apart from vitamin/mineral supplements, occasional
             paracetamol, thyroid replacement, or birth control methods)

          -  Have donated blood or had a blood loss of 450 milliliters (mL) 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 48 hours
             prior to each dosing until discharged from the clinical research unit (CRU)