A Study of LY2605541 in Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2605541; Insulin glargine
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 466.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare LY2605541 and insulin glargine using the following
      measures after participants have been treated for 26 weeks:

        -  Change in participants' overall blood sugar control

        -  The rate of night time low blood sugar episodes

        -  The number of participants that reach blood sugar targets without low blood sugar
           episodes at night

        -  The rate of low blood sugar episodes reported over a 24-hour period
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had type 2 diabetes mellitus for at least 1 year

          -  Have been receiving basal insulin (neutral protamine Hagedorn [NPH], detemir, or
             glargine) and a stable dose of 0 to 3 oral antihyperglycemic medications (OAMs) used
             as specified in the local prescribing information for at least 90 days prior to
             screening. At least 1 of the OAMs must be dosed at, or above, half the maximum daily
             dose allowed by local regulations or at the maximally tolerated dose

          -  Have a hemoglobin A1c (HbA1c) less than or equal to 9.0% at screening

          -  Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter
             (kg/m^2)

          -  Women of childbearing potential who are not breastfeeding, have a negative pregnancy
             test at screening and randomization, do not plan to become pregnant during the study,
             and have practiced reliable birth control for at least 6 weeks prior to screening and
             will continue to do so during the study and until 2 weeks after the last dose of study
             drug

        Exclusion Criteria:

          -  Have routinely used insulin glargine twice daily in the 90 days prior to the study or
             have used routine, mealtime insulin therapy (outside of pregnancy) anytime in the past
             6 months, except for short-term treatment up to a maximum of 4 continuous weeks

          -  Have used rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist
             concurrently or within 90 days prior to screening

          -  For participants on OAMs: have any restrictions for cardiac, renal, and hepatic
             diseases in the local product regulations

          -  Are taking, or have taken within the 90 days preceding screening, prescription or
             over-the-counter 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 diabetic ketoacidosis or hyperosmolar state/coma in the
             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 or equal to 2 milligrams per deciliter (mg/dL) (177
             micromoles per liter [µmol/L])

          -  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

          -  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 cancer, have been in remission from clinically significant
             cancer(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 in the opinion
             of the investigator

          -  Are receiving chronic (lasting longer than 14 consecutive days) systemic
             glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled
             preparations) or have received such therapy within the 8 weeks immediately preceding
             screening

          -  Have fasting triglycerides greater than 400 mg/dL (4.5 millimoles per liter [mmol/L])
             at screening

          -  Have an irregular sleep/wake cycle (for example, participants who sleep during the day
             and work during the night) in the investigator's opinion

          -  Lipid-lowering medication: Are using or have used any of the following:

               -  niacin preparations as a lipid-lowering medication and/or bile acid sequestrants
                  within 90 days prior to screening or

               -  lipid-lowering medication at a dose that has not been stable for at least 90 days
                  prior to screening