A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Glargine; LY2189265; Insulin Lispro
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro; Dulaglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 884.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to
      Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in
      participants with Type 2 Diabetes treated with 1 or 2 injections of insulin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Currently using insulin for at least 3 months with a conventional insulin regimen with
             or without oral medications

          -  Glycosylated hemoglobin (HbA1c) greater than or equal to 7% and less than or equal to
             11%

          -  Willing to inject subcutaneous medication

          -  Willing to monitor blood glucose levels and adjust insulin dose

          -  Willing to maintain a study diary

          -  Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2)

          -  Stable weight for 3 months prior to screening

          -  Females of child bearing potential must test negative for pregnancy at screening and
             be willing to use a reliable method of birth control during the study and for 1 month
             following the last dose of study drug

        Exclusion Criteria:

          -  Type 1 Diabetes

          -  Previous therapy with glucagon-like peptide 1 (GLP-1) agonists within 3 months prior
             to screening

          -  1 or more episodes of ketoacidosis within 6 months prior to screening

          -  Have been treated with prescription or over the counter medication to promote weight
             loss within 3 months prior to screening

          -  Estimated glomerular filtration rate (eGFR) less than or equal to 30 milliliters per
             minute per 1.73 square meters (mL/min/1.73 m^2) at screening

          -  Taking steroids for greater than 14 days except for topical, eye, nasal, or inhaled

          -  History of heart failure, New York Heart Classification III or IV within 2 months
             prior to screening

          -  Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery
             (stomach stapling) or chronically taking medications that directly affect GI motility

          -  Acute or chronic hepatitis or pancreatitis

          -  Self or family history of 2A or type 2B multiple endocrine neoplasia or medullary
             C-Cell hyperplasia

          -  Serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/mL) at
             screening

          -  Organ transplant except cornea

          -  Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis

          -  History of or active malignancy except skin or in situ cervical or prostate cancer
             within the last 5 years

          -  Known drug or alcohol abuse

          -  Have enrolled in another clinical trial within the last 30 days

          -  Have previously signed an informed consent or participated in a LY2189265 study