A Study of Two Doses of Dulaglutide (LY2189265) in Japanese Patients With Type 2 Diabetes
Condition: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Disease; Endocrine System Diseases; Hypoglycemic Agents; Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases
Intervention: Dulaglutide; Oral antihyperglycemics
Intervention description: Administered SC; Administered orally
Intervention MeSH terms: Dulaglutide; Hypoglycemic Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 591.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of 2 doses of dulaglutide in
      Japanese participants with type 2 diabetes. The study duration is approximately 58 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with type 2 diabetes (T2D) ≥ 6 months according to the World Health
             Organization (WHO) classification.

          -  Treated with stable doses of a single OAM for at least 8 weeks prior to screening; the
             dose must be more than or equal to minimum maintenance dose.

          -  Have the following HbA1c result at screening.

               -  Participants taking DPP-4i: ≥7.5% and ≤9.5%,

               -  Participants taking another OAM: ≥8.0% and ≤10.0%

          -  Stable body weight for at least 8 weeks prior to screening or not changed by more than
             5 % in the past 8 weeks

          -  Have a body mass index (BMI) ≥18.5 kilogram/square meter (kg/m²) and <35 kg/m² at Day
             1.

        Exclusion Criteria:

          -  Have type 1 diabetes (T1D)

          -  Have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma

          -  Have had any myocardial infarction (MI), heart failure or cerebrovascular accident
             (stroke)

          -  Have a known clinically significant gastric empty abnormality

          -  Have acute or chronic hepatitis

          -  Have had chronic or acute pancreatitis

          -  Have any self or family history of type 2A or type 2B multiple endocrine neoplasia in
             the absence of known C-cell hyperplasia

          -  Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or
             carcinoma (including sporadic, familial, or part of Multiple endocrine neoplasia (MEN)
             2A or 2B syndrome)

          -  Have evidence of significant, active autoimmune abnormality

          -  Have evidence of significant, uncontrolled endocrine abnormality

          -  Have active or untreated malignancy, or have been in remission from clinically
             significant malignancy (other than basal cell or squamous cell skin cancer) for less
             than 5 years

          -  Have any hematologic condition that may interfere with HbA1c measurement