Comparison of Insulin Mix25 Versus Mix50
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Lispro Mix25; Insulin Lispro Mix50
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 403.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy and safety of insulin Lispro Mix25
      (LM25) compared to insulin Lispro Mix50 (LM50) as an insulin starter in participants with
      Type 2 diabetes mellitus (T2DM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of Type 2 Diabetes Mellitus (T2DM) for at least 6 months

          -  Have been taking sulfonylureas, biguanide, thiazolidinedione, alpha-glucosidase
             inhibitor, glinide, or dipeptidyl peptidase IV inhibitor, or any combination of these

          -  Have a qualifying hemoglobin A1c (HbA1C) value ≥7.0% and ≤11.0% at screening

          -  Have a body mass index (BMI) ≥18.5 and <35.0 kilogram per square meter (kg/m²)

          -  Have given written informed consent to participate in the study in accordance with
             local regulations and the ethical review board (ERB) governing the study site

        Exclusion Criteria:

          -  Have a diagnosis of type 1 diabetes

          -  Have had more than 1 episode of severe hypoglycemia within the 6 months before
             screening

          -  Have any of the following cardiovascular conditions within 3 months prior to
             screening: acute myocardial infarction, New York Heart Association (NYHA) class III or
             class IV heart failure, or cerebrovascular accident (stroke)

          -  Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis,
             or alanine aminotransferase levels ≥3.0 times the upper limit of the reference range
             at screening, as determined by the central laboratory

          -  Have an estimated creatinine clearance (CrCl), Cockcroft-Gault formula <30 milliliter
             per minute (mL/min), as determined by the central laboratory at screening

          -  Have evidence of a significant, active, uncontrolled endocrine or autoimmune
             abnormality, as judged by the investigator

          -  Have an active or untreated malignancy or have been in remission from a clinically
             significant malignancy for <5 years

          -  Have any other condition (such as, known drug or alcohol abuse or a psychiatric
             disorder) that may prevent the participants from following and completing the protocol

          -  Are currently enrolled in, or discontinued within the last 30 days from, a clinical
             trial involving an investigational product or non-approved use of a drug or device, or
             concurrently enrolled in any other type of medical research judged not to be
             scientifically or medically compatible with this study