A Study Comparing Insulin Peglispro With Insulin Glargine as Basal Insulin Treatment
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Peglispro; Insulin Glargine; Oral Antihyperglycemic Medications (OAMs)
Intervention description: Administered SC using a prefilled pen.; Administered SC using a prefilled pen; Administered orally
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Pioglitazone; Biguanides; Hypoglycemic Agents; Meglitinide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 388.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare insulin peglispro (LY2605541) to insulin glargine in
      Asian insulin naïve participants who have been treated with oral anti hyperglycemia
      medications. Participants will receive 26 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have Type 2 Diabetes Mellitus (T2DM) for at least 1 year not treated with insulin

          -  Have been receiving at least two oral antihyperglycemic medications (OAMs) for at
             least 3 months prior to screening

          -  Have Hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, according to central
             laboratory at screening

          -  Body mass index (BMI) ≤35.0 kilogram per square meter (kg/m^2)

          -  Inject insulin with a pre-filled insulin pen and perform Self-Monitored Blood Glucose
             (SMBG)

          -  Record keeping as required by this protocol

          -  Women of childbearing potential are not breastfeeding, have a negative pregnancy test
             at screening, do not plan to become pregnant during the study, have practiced reliable
             birth control during the study and 2 weeks following the last dose of investigational
             product

        Exclusion Criteria:

          -  Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except
             for short term treatment of acute conditions

          -  Have been treated with rosiglitazone, pramlintide, glucagon-like peptide-1 (GLP-1)
             receptor agonist within 3 months prior to screening

          -  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

          -  Local OAM restrictions: have any restrictions for cardiac, renal, and hepatic diseases
             in the local product regulations

          -  Are taking, or have taken within 3 months 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 had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the past 6
             months

          -  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 ≥2.0 milligram per deciliter (mg/dL) (177 micromole per liter
             [μmol/L]). Participants taking metformin should not exceed the creatinine level
             specified in the local label

          -  Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic
             fatty liver disease [NAFLD]), acute or any 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

          -  Have known hypersensitivity or allergy to any of LY2605541 and insulin glargine or
             their excipients

          -  Have pre proliferative and proliferative retinopathy, maculopathy requiring treatment
             or not clinically stable in the last 6 months, or participants with active changes in
             subjective eye symptoms as determined by the investigator if an eye exam has not been
             performed in the last 6 months

          -  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 as
             determined by the central laboratory

          -  Have an irregular sleep/wake cycle (for example, participants who sleep during the day
             and work during the night) in the investigator's opinion