A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dulaglutide; Placebo; Insulin Glargine
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Insulin Glargine; Dulaglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 291.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: T2DM; LY2189265

Summary:

      The main purpose of this study is to evaluate the safety and efficacy of once weekly
      dulaglutide when added to insulin glargine, with metformin and/or acarbose in Chinese
      participants with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  have type 2 diabetes

          -  are men or nonpregnant women aged ≥18 years at screening

          -  have been treated with basal insulin glargine once daily and metformin and/or acarbose
             for at least 3 months prior to screening

          -  doses of once daily insulin glargine and OAMs must be stable during the 3-month period
             prior to screening. Insulin glargine dose is considered stable when all doses during
             this period are within the range defined by ±20% of the most commonly used insulin
             glargine dose during this same period. Doses of metformin and/or acarbose are
             considered stable when doses are unchanged during the same period, and the doses
             should be in the inclusive range of the half maximum to maximum approved daily dose
             per the locally-approved label

          -  have an HbA1c value ≥7.0% and ≤11.0% as assessed by the central laboratory at
             screening

          -  require further insulin glargine dose increase at baseline per the TTT algorithm based
             on the SMBG data (FBG ≥5.6mmol/L) collected during the prior week

          -  have stable weight (±5%) ≥3 months prior to screening

          -  have body mass index (BMI) between ≥19.0 and ≤35.0 kg/m2 at screening

        Exclusion Criteria:

          -  have type 1 diabetes (T1D)

          -  have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma

          -  have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6
             months prior to screening

          -  have had any of the following CV conditions within the 2 months prior to screening:
             acute myocardial infarction (MI), New York Heart Association (NYHA) Class III or Class
             IV heart failure, or cerebrovascular accident (stroke)

          -  have a known clinically significant gastric emptying abnormality (eg, severe diabetic
             gastroparesis or gastric outlet obstruction) or have undergone or plan to have a
             gastric bypass (bariatric) surgery or restrictive bariatric surgery (eg, Lap-Band®)
             during the course of the study, or chronically take drugs that directly affect
             gastrointestinal (GI) motility

          -  have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were
             diagnosed with any type of acute pancreatitis within the 3 months prior to screening

          -  for participants on metformin or metformin and acarbose, have renal disease or renal
             dysfunction (eGFR [CKD-EPI] <45 mL/min/1.73 m2), as determined by the central
             laboratory; for participants on acarbose, have renal disease or renal dysfunction
             (eGFR [CKD-EPI] <25 mL/min/1.73 m2), as determined by the central laboratory

          -  have any self or family history of type 2A or type 2B multiple endocrine neoplasia
             (MEN 2A or 2B) syndrome in the absence of known C-cell hyperplasia (the only exception
             for this exclusion will be for participants whose family members with MEN 2A or 2B
             syndrome have a known RET mutation and the potential participant for the study is
             negative for the 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 serum calcitonin ≥20 pg/mL at screening, as determined by the central laboratory

          -  have any hematologic condition that may interfere with HbA1c measurement (eg,
             hemolytic anemias, sickle-cell disease)

          -  have been treated with any other antihyperglycemia regimen, other than basal insulin
             glargine once daily and metformin and/or acarbose, within the 3 months prior to
             screening or between screening and baseline