A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes Mellitus

• Percentage of Participants Who Achieve HbA1c <=6.5% or <7% at 26 Weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Fasting Blood Glucose (FBG) at 26 Weeks [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Body Weight at 26 Weeks [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: Yes ]
• Percentage of Participants with Hypoglycemic Episodes [ Time Frame: Baseline through 26 Weeks ] [ Designated as safety issue: Yes ]

The purpose of this trial is to examine the efficacy and safety of once-weekly dulaglutide in participants with type 2 diabetes mellitus taking an oral antihyperglycemic medication (OAM).

• Drug: Dulaglutide
  Administered by SC injection.
  Other Name: LY2189265
• Drug: Insulin glargine
  Administered by SC injection.
• Drug: Sulfonylureas (SU)
  Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
• Drug: Biguanide
  Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.

• Experimental: Dulaglutide + OAM
  0.75 mg dulaglutide administered once weekly as a subcutaneous (SC) injection added to participant's pre-study physician prescribed dose of SU and/or Biguanide.
  Interventions:

  • Drug: Dulaglutide
  • Drug: Sulfonylureas (SU)
  • Drug: Biguanide
• Active Comparator: Insulin glargine + OAM
  Add Insulin glargine administered per sliding scale for 26 weeks as a once daily SC injection added to participant's pre-study physician prescribed dose of SU and/or Biguanide.
  Interventions:

  • Drug: Insulin glargine
  • Drug: Sulfonylureas (SU)
  • Drug: Biguanide

Inclusion Criteria:

• Participants who have had a diagnosis of type 2 diabetes mellitus for at least 6 months before screening
• Participants who have been taking SU (Glibenclamide, Gliclazide, or Glimepiride) and/or biguanide (Metformin or Buformin). The dose of the drug(s) during the 8 weeks before screening must be stable
• Participants who have a qualifying glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% at screening
• Participants who have a body mass index (BMI) of 18.5 kg/m^2 to 35.0 kg/m^2

Exclusion Criteria:

• Participants who have a diagnosis of type 1 diabetes
• Participants who have previously been treated with any other GLP-1 analog
• Participants who have received therapy with an alpha-glucosidase inhibitor (a-GI), thiazolidinedione (TZD), glinide, or dipeptidyl peptidase-IV (DPP-IV) inhibitor within 3 months before screening
• Participants who have been currently taking insulin or have had previous insulin treatment within 3 months before screening
• Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥ 3 times the upper limit of the reference range and/or a serum lipase concentration ≥ 2 times the upper limit of the reference range, as determined by the central laboratory at screening
• Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC)