A Study in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Glargine; LY2605541
Intervention MeSH terms: Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1538.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes mellitus; type 2 diabetes mellitus; insulin naive; insulin treatment

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 night time 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 after
           52 weeks of treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes mellitus, not treated with insulin, for at least 1 year prior to
             the study

          -  Have been receiving at least 2 OAMs for at least 3 months before entering the study

          -  Have a hemoglobin A1c (HbA1c) value between 7.0% and 11.0%, inclusive, at screening

          -  Are capable of and willing to inject insulin with a vial and syringe and perform self
             blood glucose monitoring

          -  Women of childbearing potential only: are not breastfeeding, have a negative pregnancy
             test at the time of screening and randomization, intend to not become pregnant during
             the trial, have practiced a reliable method of birth control for at least 6 weeks
             prior to screening, and agree to use a reliable method of birth control during the
             study and until 2 weeks following the last dose of study drug

        Exclusion Criteria:

          -  Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except
             for short-term treatment of acute conditions, and up to a maximum of 4 continuous
             weeks

          -  Use of rosiglitazone, pramlintide, or glucagon-like peptide 1 (GLP-1) receptor agonist
             (for example, exenatide, exenatide once weekly, or liraglutide) concurrently or within
             3 months prior to screening

          -  Are currently taking, or have taken within the 3 months preceding screening,
             medications to promote weight loss

          -  Have had any episodes of severe hypoglycemia within 6 months prior to screening

          -  Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the 6 months
             prior to the study

          -  Have cardiac disease with functional status that is New York Heart Association Class
             III or IV (per New York Heart Association [NYHA] Cardiac Disease Classification)

          -  Have a history of renal transplantation, or are currently receiving renal dialysis or
             have serum creatinine greater or equal than 2 milligrams per deciliter (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 at screening

          -  Have had a blood transfusion or severe blood loss within 3 months prior to screening
             or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other
             traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c

          -  Have active or untreated malignancy or have been in remission from clinically
             significant malignancy for less than 5 years

          -  Have fasting or non-fasting triglycerides greater than 400 mg/dL (greater than 4.5
             millimoles per liter [mmol/L]) at screening

          -  Are using lipid-lowering medication at a dose that has not been stable for 90 days
             prior to screening

          -  Are using niacin preparations as a lipid lowering medication and bile acid
             sequestrants within 90 days prior to screening