A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dulaglutide
Intervention description: Administered SC
Intervention MeSH terms: Dulaglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1842.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of investigational doses of
      once weekly dulaglutide when added to metformin in participants with type 2 diabetes with
      inadequate blood sugar control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes mellitus (T2DM) for at least 6 months

          -  Have been treated with stable metformin dose for at least 3 months

          -  Have HbA1c ≥7.5% and ≤11.0% at study entry

          -  Have body mass index (BMI) ≥25 kilograms per meter squared (kg/m^2)

        Exclusion Criteria:

          -  Have type 1 diabetes mellitus

          -  Have used any glucagon-like peptide-1 receptor agonist (GLP-1 RA) or insulin, not
             including prior short term insulin use (≤14 days)

          -  Have been taking any other medicine for diabetes (other than metformin) during the
             last 3 months

          -  Have used in the last 3 months (or plan to use) prescription weight loss medications

          -  Have disorders associated with slowed emptying of the stomach contents, or have had
             any stomach surgeries for the purpose of weight loss

          -  Current participation in or intent to begin during the study an organized diet and/or
             exercise weight reduction program (other than the lifestyle and dietary measures for
             diabetes)

          -  Have acute or chronic hepatitis, signs and symptoms of any other liver disease other
             than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (ALT) level
             >2.5 times the upper limit of the reference range, as determined by the central
             laboratory at study entry; participants with NAFLD are eligible for participation in
             this trial

          -  Had chronic or acute pancreatitis any time prior to study entry

          -  Have had a heart attack or stroke in the past 2 months, or have heart failure that
             significantly limits their physical activity

          -  Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73m^2 (or lower
             than the country-specific threshold for discontinuing metformin therapy per local
             label), calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as
             determined by the central laboratory at study entry and confirmed at lead-in

          -  Have a personal or family history of medullary thyroid carcinoma or personal history
             of multiple endocrine neoplasia syndrome type 2

          -  Have proliferative retinopathy or maculopathy requiring acute treatment according to
             the opinion of the investigator