A Study Comparing the Effect of Dulaglutide With Liraglutide in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2189265; Liraglutide; Metformin
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Metformin; Liraglutide; Dulaglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 599.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the benefits and risks of once-weekly dulaglutide
      compared to once-daily liraglutide in participants with type 2 diabetes who have inadequate
      glycemic control on metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Not optimally controlled on diet and exercise and a dose of metformin that is at least
             1500 milligrams/day (mg/day) and has been at a stable dose for at least 3 months prior
             to the first study visit

          -  Glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than or equal
             to 10.0%

          -  Accept continued treatment with metformin throughout the trial, as required per
             protocol

          -  Men and nonpregnant women aged greater than or equal to 18 years

          -  Stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening

          -  Body Mass Index (BMI) less than or equal to 45 kilograms/square meter (kg/m^2)

        Exclusion Criteria:

          -  Have type 1 diabetes mellitus

          -  Have been treated with ANY other antihyperglycemic medications (other than metformin)
             at the time of the first study visit or within the 3 months prior to the first study
             visit

          -  Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except
             for short-term treatment of acute conditions, and up to a maximum of 4 weeks; any
             insulin use within 3 months prior to the first study visit

          -  Have been treated with drugs that promote weight loss within 3 months of the first
             study visit

          -  Are receiving chronic (greater than 14 days) systemic glucocorticoid therapy or have
             received such therapy within the 4 weeks immediately prior to the first study visit

          -  Have had any of the following cardiovascular conditions within 2 months prior to the
             first study visit: acute myocardial infarction, New York Heart Association Class III
             or Class IV heart failure, or cerebrovascular accident

          -  Have a known clinically significant gastric emptying abnormality (such as, severe
             diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass
             (bariatric) surgery or restrictive bariatric surgery

          -  Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or
             alanine transaminase level greater than or equal to 3 times the upper limit of normal

          -  Have a history of chronic pancreatitis or acute idiopathic pancreatitis or were
             diagnosed with any type of acute pancreatitis within the 3 month period prior to the
             first study visit

          -  Have a serum creatinine greater than or equal to 1.5 milligrams/deciliter (mg/dL)
             (male) or greater than or equal to 1.4 mg/dL (female), or a creatinine clearance less
             than 60 milliliters/minute (mL/minute)

          -  Have any self or family history of type 2A or type 2B multiple endocrine neoplasia
             (MEN 2A or 2B, respectively) in the absence of known C-cell hyperplasia (this
             exclusion includes those participants with a family history of MEN 2A or 2B whose
             family history for the syndrome is Rearranged during Transfection (RET) negative; the
             only exception for this exclusion will be for participants whose family members with
             MEN 2A or 2B have a known RET mutation and the potential participant for the study is
             negative for that RET mutation)

          -  Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or
             carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)

          -  Have a serum calcitonin greater than or equal to 20 picograms/milliliter (pg/mL)