A Study in Participants With Type 2 Diabetes Mellitus (AWARD-3)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Metformin; LY2189265; Placebo (oral); Placebo (subcutaneous)
Intervention MeSH terms: Metformin; Dulaglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 807.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if LY2189265 is safe and effective in reducing
      glycosylated hemoglobin (HbA1c) as compared to metformin in participants with Type 2
      Diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes for greater than or equal to 3 months and less than or equal to 5
             years based on the disease diagnostic criteria (refer to the World Health
             Organization's [WHO] Classification of Diabetes).

          -  Are treatment-naïve, not optimally controlled with diet and exercise alone, or are
             taking 1 oral antihyperglycemic medication (OAM) as monotherapy (excluding
             thiazolidinediones). For those on 1 OAM, the dose must be less than or equal to 50%
             the maximum authorized per local label.

          -  Are able and willing to tolerate a minimum dose of 1500 milligrams per day (mg/day) or
             up to 2000 mg/day of metformin.

          -  Have glycosylated hemoglobin (HbA1c) greater than or equal to 6.5% to less than or
             equal to 9.5%.

          -  Females of childbearing potential (not surgically sterilized and between menarche and
             1-year postmenopausal) must: a) test negative for pregnancy at screening based on a
             serum pregnancy test, and b) agree to use a reliable method of birth control during
             the study and for 1 month following the last dose of study drug; or c) not be
             breastfeeding.

          -  Have a stable weight (plus or minus 5%) greater than or equal to 3 months prior to
             screening.

          -  Have a body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2),
             inclusive.

          -  Are well-motivated, capable, and willing to: a) perform self-monitored blood glucose
             (SMBG) testing; b) learn how to self-inject treatment (LY2189265 or placebo) and c)
             maintain a study diary.

        Exclusion Criteria:

          -  Have type 1 diabetes mellitus.

          -  Are being or have been treated with any of the following medications: a) chronically
             treated with insulin for the treatment of diabetes in the past; however, a short-term
             use of insulin more than 3 months prior to screening is allowable, b) glucagon-like
             peptide 1 (GLP-1) analogs within 3 months prior to this screening, c) drugs to cause
             weight loss within 3 months prior to screening, d) thiazolidinediones (TZDs) within 3
             months prior to screening, e) chronically treated (greater than or equal to 14 days)
             with an oral glucocorticoid or have received this type of therapy within 4 weeks prior
             to screening, or f) illegal drugs.

          -  Have had 1 or more cases of uncontrolled diabetes that required hospitalization in the
             6 months prior to screening.

          -  Have stomach problems, have chronically taken medication to increase movement in the
             digestive tract or slow down the emptying of the digestive tract, or have had gastric
             bypass (bariatric) surgery.

          -  Have had problems with the heart or brain in the past 2 months prior to screening,
             such as a heart attack, chest pain, heart failure, heart bypass operation, angioplasty
             or stent insertion, a heart rhythm problem, or a stroke.

          -  Have a serum creatinine result which shows a greater than or equal to 1.5 milligrams
             per deciliter (mg/dL) for men or greater than or equal to 1.4 mg/dL for women.

          -  Have a problem with the liver or pancreas.

          -  Have a creatinine clearance result which shows less than 60 milliliters per minute
             (mL/min), evidence of a significant active, uncontrolled endocrine (hormone), or
             active autoimmune abnormality.

          -  Have a serum calcitonin test which shows greater than or equal to 20 picograms per
             milliliter (pcg/mL) at the time of screening.

          -  Have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A
             or type 2B.

          -  Have cancer (except for skin cancer) or have been in remission from cancer for less
             than 5 years.

          -  Have had an organ transplant except for corneal transplant.

          -  Have received treatment within the last 30 days with a drug which has not been
             regulatory approved.

          -  Have participated in a medical, surgical, or pharmaceutical study where these types of
             procedures were performed within 30 days prior to screening.

          -  Have any condition that is a contraindication to or would interfere with medications
             provided for this study to treat diabetes.

          -  Have a blood disorder that would interfere with the drawing of blood glucose
             measurements or lab samples.

          -  Have previously participated or signed an informed consent document for this same type
             of study and study drug.