A Study of LY2189265 in Japanese Patients With Type 2 Diabetes

• Percentage of patients achieving glycosylated hemoglobin (HbA1c) < 7% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Percentage of patients achieving glycosylated hemoglobin (HbA1c) < 6.5% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Change in fasting blood glucose values (FBG) from baseline to 12 weeks endpoint [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
• Change in mean daily blood glucose (based on Self monitoring blood glucose) from baseline to 12 weeks endpoint [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
• Change in total body weight from baseline to 12 weeks endpoint [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
• Change from baseline in insulin sensitivity (HOMA2-S) using the updated Homeostasis Model Assessment (HOMA2) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
• Change from baseline in Beta-cell function (HOMA2-B) using the updated Homeostasis Model Assessment (HOMA2) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
• Pharmacokinetics Cmax [ Time Frame: 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
• Incidence of Self-reported hypoglycemic episodes [ Time Frame: 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: Yes ]

The main purpose of this study is to assess dose-response characteristics in Japanese patients with Type 2 Diabetes taking LY2189265 monotherapy.

• Drug: LY2189265
  Administered by subcutaneous injection, once weekly for 12 weeks
• Drug: Placebo
  Administered by subcutaneous injection, once weekly for 12 weeks

• Experimental: 0.75mg LY2189265
  Intervention: Drug: LY2189265
• Experimental: 0.5mg LY2189265
  Intervention: Drug: LY2189265
• Experimental: 0.25mg LY2189265
  Intervention: Drug: LY2189265
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

Inclusion Criteria:

• Japanese patients with type 2 diabetes with a body mass index of 18.5kg/m2 to 40.0kg/m2.
• Patients who are oral antidiabetic drug(OAD) naïve or are taking OAD monotherapy except for a dipeptidyl peptidase-4 inhibitor(DPP-IV) and are willing to discontinue their OAD.
• Patients who are OAD naïve with screening HbA1c value of 7.0% to 9.5% and randomization HbA1c value of 7.0% to 9.5%, or who are taking OAD monotherapy with screening HbA1c value of 6.0% to 8.5% and randomization HbA1c value of 7.0% to 9.5%.
• Patients who have, in the opinion of the investigator, a stable weight during the 12 weeks prior to screening.

Exclusion Criteria:

• Patients who are currently taking ethical medications to promote weight loss
• Patients who are receiving chronic systemic glucocorticoid therapy, or have received such therapy within 4 weeks immediately prior to screening.
• Patients who have a known clinically significant gastrointestinal disorder, have undergone excision of gastrointestinal tract, have undergone gastric bypass surgery for treatment of obesity, or chronically take drugs that directly influence gastrointestinal motility.
• Patients who have poorly controlled hypertension, renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension.
• Patients who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis or acute pancreatitis. Patients who have amylase and/or lipase of 1.5 times or more the upper limit of the reference range.
• Have a family history, obvious clinical signs, or symptoms of medullary carcinoma of thyroid.