A Study for Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2605541; insulin glargine
Intervention description: subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks; subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
Intervention MeSH terms: Insulin Glargine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 289.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Comparison of fasting blood glucose levels in patients with Type 2 diabetes after 12 weeks of
      treatment with a new basal insulin analog or with insulin glargine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus (T2DM) for at least 1 year

          -  At least 18 years of age

          -  Using metformin and/or sulfonylurea(s) with once daily glargine or NPH for at least 3
             months prior to the study. Prestudy dose requirements: insulin dose maximum 1.0
             unit/kilogram/day (U/kg/day). Oral antihyperglycemic medications (OAMs): Metformin
             dose at least 1500 milligram/day (mg/day) and/or sulfonylurea dose at least half the
             maximum daily dose specified in the local package insert. OAM doses stable for 6 weeks
             prior to the study.

          -  Hemoglobin A1c (HbA1c) less than or equal to 10.5% before randomization

          -  Body Mass Index (BMI) 19 to 45 kilogram/square meter (kg/m²)

          -  Capable and willing to prepare and inject insulin with a syringe while continuing to
             use the prestudy OAMs, monitor own blood glucose; complete the study diary; be
             receptive to diabetes education; comply with study visits and receive telephone calls
             between visits

          -  Women of childbearing potential must test negative for pregnancy before receiving
             treatment and agree to use reliable birth control until completing the follow-up visit

        Exclusion Criteria:

          -  Long-term use of short- or rapid-acting or premixed insulin within the 6 months before
             the study. Short-term insulin therapy or occasional use are permitted

          -  Use of any glucose-lowering medications not allowed by the inclusion criteria in the 3
             months before entry into the study

          -  Use of prescription or over-the-counter medications to promote weight loss within 3
             months before entry into the study

          -  Current participation in a weight loss program, or plans to do so during the study

          -  Treatment with any antibody-based therapy within 6 months prior to the study

          -  Use of chronic (>14 consecutive days) systemic glucocorticoid therapy currently or
             within 4 weeks prior to the study

          -  More than 1 episode of severe hypoglycemia within 6 months prior to the study, or
             currently diagnosed with hypoglycemia unawareness

          -  2 or more emergency room visits or hospitalizations due to poor glucose control in the
             6 months preceding the study

          -  Liver disease

          -  History of renal transplantation, current renal dialysis, or creatinine >2.0
             milligram/deciliter (mg/dL) (177 micromole/Liter [μmol]/L)

          -  Cardiac disease with a marked impact on physical functioning

          -  Clinically significant electrocardiogram (ECG) abnormalities at screening

          -  Malignancy other than basal cell or squamous cell skin cancer

          -  Fasting triglycerides >500 mg/dL

          -  Known diabetic autonomic neuropathy

          -  Known hypersensitivity or allergy to study insulin or its excipients

          -  Blood transfusion or severe blood loss within 3 months prior to entry into the study
             or known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other
             traits of hemoglobin abnormalities known to interfere with the HbA1c methodology

          -  Irregular sleep/wake cycle

          -  Women who are breastfeeding