A Study in Participants With Type I Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Glargine; LY2605541; Insulin Lispro
Intervention MeSH terms: Insulin Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is:

        -  To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of
           treatment.

        -  To compare the rate of nocturnal low blood sugar episodes on LY2605541 with insulin
           glargine during 52 weeks of treatment.

        -  To compare the number of participants on LY2605541 reaching blood sugar targets without
           low blood sugar episodes at night to those taking insulin glargine after 52 weeks of
           treatment.

        -  To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine
           during 52 weeks of treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetes for at least 1 year

          -  HbA1c value less than 12 percent according to the central laboratory at screening

          -  Body mass index of less than or equal to 35.0 kilograms per square meter (kg/m^2)

          -  Have been treated for at least 90 days prior to screening with

               -  insulin detemir, insulin glargine, or Neutral Protamine Hagedorn (NPH) in
                  combination with pre-meal insulin, or

               -  self-mixed or pre-mixed insulin regimens with any basal and bolus insulin
                  combination administered at least twice daily, or

               -  continuous SC insulin infusion therapy

          -  Women who are not breast feeding and test negative for pregnancy before receiving
             treatment and agree to use reliable birth control until 2 weeks after last treatment
             with study drug

          -  Are capable and willing to adhere to multiple daily injections, inject with a vial and
             syringe and prefilled pen and perform self-monitored blood glucose (SMBG) readings and
             record keeping

        Exclusion Criteria:

          -  Are using twice daily insulin glargine having been inadequately controlled on single
             daily dose of glargine prior to screening

          -  Excessive insulin resistance defined as having received a total daily dose of insulin
             greater than 1.5 units per kilogram (U/kg) at the time of randomization

          -  Receiving any oral or injectable medication (other than insulins or metformin for
             treatment of polycystic ovarian disease) intended for the treatment of diabetes
             mellitus in the 90 days prior to screening

          -  Lipid lowering medications:

               -  are using niacin preparations as lipid lowering medication and/or bile acid
                  sequestrants within 90 days prior to screening; or,

               -  are using lipid lowering medication at a dose that has not been stable for 90
                  days or more prior to screening

          -  Have fasting hypertriglyceridemia (defined as greater than 4.5 millimoles per liter
             [mmol/L], greater than 400 milligrams per deciliter [mg/dL]) at screening, as
             determined by the central laboratory.

          -  Have had more than 1 episode of severe hypoglycemia (defined as requiring assistance
             due to neurologically disabling hypoglycemia) within 6 months prior to screening

          -  Have had 2 or more emergency room visits or hospitalizations due to poor glucose
             control within 6 months prior to screening

          -  Have cardiac disease with functional status that is New York Heart Association Class
             III or IV

          -  Have a history of renal transplantation or are currently receiving renal dialysis or
             have serum creatinine greater than 2.5 mg/dL

          -  Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic
             fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic
             steatohepatitis (NASH), or elevated liver enzyme measurements as indicated below:

               -  total bilirubin 2 times or more than the upper limit of normal (ULN) as defined
                  by the central laboratory, or

               -  alanine aminotransferase (ALT)/(serum glutamic pyruvic transaminase (SGPT) more
                  than 2.5 times ULN as defined by the central laboratory, or

               -  aspartate aminotransferase (AST)/(serum glutamic oxaloacetic transaminase (SGOT)
                  more than 2.5 times ULN as defined by the central laboratory

          -  Have active or untreated malignancy, have been in remission from clinically
             significant malignancy (other than basal cell or squamous cell skin cancer) for less
             than 5 years, or are at increased risk for developing cancer or a recurrence of cancer

          -  Diagnosed clinically significant diabetic autonomic neuropathy