A Study to Compare LY2963016 and US-approved Lantus® After Single Dose Administration to Healthy Participants
Condition: Healthy
Intervention: LY2963016; US Approved 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: 91.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Volunteers

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.
    

Eligibility criteria:

        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)