A Study to Compare the Pharmacokinetics and Pharmacodynamics of LY2963016 to Lantus in Healthy Participants
Condition: Diabetes Mellitus
Intervention: LY2963016; Lantus
Intervention description: Administered subcutaneously; Administered subcutaneously
Intervention MeSH terms: Insulin Glargine
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

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 participants.

      Each study period will be approximately 8.5 days (1.5 days for treatment and 7 day washout
      period). There are 4 study periods.
    

Eligibility criteria:

        Inclusion Criteria:

          -  are overtly healthy males or females, as determined by medical history and physical
             examination

               -  male participants: agree to use a reliable method of birth control during the
                  study.

               -  female participants of child-bearing potential must test negative for pregnancy
                  at the time of enrollment and agree to either abstain from sexual activity or to
                  use a medically accepted means of contraception when engaging in sexual
                  intercourse throughout the study, or female participants not of child-bearing
                  potential due to surgical sterilization or menopause

          -  have a body weight of at least 55 kilograms (kg), and body mass index (BMI) of 18.5 to
             32.0 kilograms/square meter (kg/m²)

          -  have clinical laboratory test results within normal reference range for the population

          -  have venous access sufficient to allow for blood sampling

          -  are reliable and willing to make themselves available for the duration of the study
             and are willing to follow study procedures

          -  have given written informed consent

          -  participants should have a normal oral glucose tolerance test

        Exclusion Criteria:

          -  are currently enrolled in, have completed or discontinued within the last 30 days
             from, a clinical trial involving an investigational product other than the
             investigational product used in this study; 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 heparin, insulin glargine, related compounds or any components
             of the formulation

          -  are persons who have previously received the investigational product in this study,
             have completed or withdrawn from this study or any other study investigating LY2963016

          -  have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the
             investigator, increases the risks associated with participating in the study

          -  have an abnormal blood pressure as determined by the investigator

          -  have a significant history or presence of 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

          -  show evidence of significant active neuropsychiatric disease

          -  regularly use known drugs of abuse and/or show positive findings on urinary drug
             screening

          -  show evidence of human immunodeficiency virus (HIV) infection and/or positive human
             HIV antibodies

          -  show evidence of hepatitis C and/or positive hepatitis C antibody

          -  show evidence of hepatitis B and/or positive hepatitis B surface antigen

          -  are women with a positive pregnancy test or women who are lactating

          -  intend to use over-the-counter or prescription medication

          -  have donated blood of more than 500 milliliters (mL) within the last 56 days before
             dosing of Period 1

          -  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 for 24 hours
             before dosing and throughout the duration of each study period

          -  smoke more than 10 cigarettes (or equivalent other tobacco products) per day

          -  have a fasting blood glucose > 5.5 millimoles/Liter (mmol/L) [>99 milligrams/deciliter
             (mg/dL)]at screening

          -  have a positive test for anti-LY2963016 or anti-glargine antibodies