A Study of Insulin Glargine (LY2963016) in Healthy Chinese Participants
Condition: Healthy
Intervention: Insulin Glargine; Lantus
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare a study drug known as Insulin glargine with Lantus in
      healthy Chinese participants. Blood samples will be taken to compare how the body handles the
      drugs and how they affect blood sugar levels. Side effects and tolerability will be
      documented. The study will last at least 18 days, not including screening. Screening is
      required within 4 weeks prior to the start of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are native Chinese men or women. Native Chinese is defined as a participant who has
             both parents and all 4 grandparents of Chinese origin.

          -  For females of childbearing potential (defined as not surgically sterilised and
             between menarche and 1-year postmenopause) only:

               -  Negative serum pregnancy test at the time of screening.

               -  Are not lactating.

               -  Intend not to become pregnant during the study.

               -  Are sexually inactive or have practiced a reliable method of birth control for at
                  least 6 weeks prior to screening.

               -  Agree to continue to use a reliable method of birth control (as determined by the
                  investigator) during the study.

          -  For females not of childbearing potential, must be:

               -  Surgically sterile, defined as having had a hysterectomy or bilateral
                  oophorectomy or tubal ligation, and/or

               -  Menopausal, defined as having had no menses for at least 1 year, or a plasma
                  follicular stimulating hormone value of >40 milli-international units per
                  milliliter (mIU/mL) and no menses for at least 6 months, unless the participant
                  is taking hormone-replacement therapy.

          -  Having fasting plasma glucose <110 milligrams per deciliter (mg/dL) (<6.1 millimoles
             per liter [mmol/L]) and 2-hour glucose level <140 mg/dL (<7.8 mmol/L) on the 75 grams
             (g) oral glucose tolerance test.

          -  Have a body mass index (BMI) between 18 and 28 kilograms per meter squared (kg/m²),
             inclusive, at screening.

          -  Are nonsmokers, have not smoked for at least 6 months prior to entering the study, and
             agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the
             duration of the study.

          -  Have normal blood pressure and pulse rate 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
             or investigator site, or results with acceptable deviations that are judged to be not
             clinically significant by the investigator.

        Exclusion Criteria:

          -  Have a history of first-degree relatives known to have diabetes mellitus.

          -  Have known allergies to insulin glargine or its excipients, or related drugs, or
             heparin, or have a history of relevant allergic reactions of any origin.

          -  Have a significant history of or current cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, haematological, 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 human immunodeficiency virus infection (HIV) and/or positive human
             HIV antibodies.

          -  Have positive hepatitis B surface antigen.

          -  Have donated >400 mL of blood in the last 6 months or donated >100 mL within the last
             30 days.

          -  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 while resident
             in the clinical research unit (CRU) (1 unit = 12 ounces or 360 mL of beer; 5 ounces or
             150 mL of wine; 1.5 ounces or 45 mL of distilled spirits).

          -  Intend to use: prescription medication or over-the-counter medication or Chinese
             traditional medicine within 14 days before dosing (apart from vitamin/mineral
             supplements, occasional paracetamol, thyroid replacement, or birth control methods).
             If this situation arises, an otherwise suitable participant may be included at the
             discretion of the investigator.