A Study to Compare a New Long-Acting Insulin (LY2605541) and Human Insulin NPH in Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2605541; Human Insulin NPH; Oral Antihyperglycemic Medications (OAM)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef; Hypoglycemic Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 641.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare LY2605541 and human insulin isophane suspension (NPH)
      using the following measures for participants treated for up to 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 night time blood
           sugar episodes

        -  The total number of low blood sugar episodes reported
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had type 2 diabetes mellitus for at least 1 year, not treated with insulin

          -  Have been receiving 2 or more OAMs for at least 3 months prior to the study

          -  Have a hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, 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 are not breastfeeding, have a negative pregnancy test
             at screening and randomization, do not plan to become pregnant during the study, 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 used insulin therapy in the past 2 years (except for use during pregnancy or for
             short term use for acute conditions)

          -  Have been treated with glucagon-like peptide-1 (GLP-1) receptor agonist,
             rosiglitazone, pramlintide, or weight-loss medication within 3 months before 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 before screening, prescription or
             over-the-counter medications to promote weight loss

          -  Have had any episodes of severe hypoglycemia, diabetic ketoacidosis, or hyperosmolar
             state/coma 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 or equal to 2 milligrams per deciliter (mg/dL) [177
             millimoles per liter (mmol/L)]

          -  Have obvious clinical signs or symptoms of liver disease [excluding nonalcoholic fatty
             liver disease (NAFLD)], acute or chronic hepatitis, nonalcoholic 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 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

          -  Are using or have used any of the following lipid-lowering medications: niacin
             preparations as a lipid-lowering medication and/or bile acid sequestrants within 90
             days prior to screening