A Study in Participants With Type 2 Diabetes Mellitus (AWARD-2)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Glargine; LY2189265; Metformin; Glimepiride
Intervention MeSH terms: Metformin; Insulin Glargine; Glimepiride; Dulaglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 810.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin
      A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes.
      Participants must also be taking metformin and glimepiride.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 Diabetes not well controlled on 1, 2, or 3 oral antidiabetic medications (at
             least one of them must be metformin and/or a sulfonylurea)

               1. Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal
                  to 11 if taking 1 oral antidiabetic medication

               2. HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral
                  antidiabetic medications

          -  Accept treatment with metformin and glimepiride throughout the study, as per protocol

          -  Willing to inject subcutaneous medication once weekly for LY2189265 or once daily for
             Insulin Glargine.

          -  Stable weight for 3 months prior to screening

          -  Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2)

          -  Females of child bearing potential must test negative for pregnancy at screening by
             serum pregnancy test 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

          -  HbA1c equal to or less than 6.5 at randomization

          -  Chronic insulin use

          -  Taking drugs to promote weight loss by prescription or over the counter

          -  Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or
             inhaled

          -  History of Heart Failure New York Heart Classification III or IV, or acute myocardial
             infarction, or stroke within 2 months of screening

          -  Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery
             (stomach stapling) or chronically taking drugs that directly affect GI motility

          -  Hepatitis or liver disease or ALT (alanine transaminase) greater than 3.0 of upper
             normal limit

          -  Acute or chronic pancreatitis of any form

          -  Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5
             milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for
             females, or a creatinine clearance of less than 60 milliliters per minute (ml/min)

          -  History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B)
             or medullary c-cell hyperplasia or thyroid cancer

          -  A serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/ml) at
             screening

          -  Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis

          -  History of or active malignancy except skin or in situ cervical or prostate cancer for
             within last 5 years

          -  Sickle cell, hemolytic anemia, or other hematological condition that may interfere
             with HbA1c testing

          -  Organ transplant except cornea

          -  Have enrolled in another clinical trial within the last 30 days

          -  Have previously signed an informed consent or participated in a LY2189265 study

          -  Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months
             prior to screening