Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus (DURATION-NEO-2)

• Proportion of subjects achieving HbA1c <7% at Week 28 [ Time Frame: Baseline to Week 28 ] [ Designated as safety issue: No ]
• Change in fasting plasma glucose concentrations from baseline to Week 28 [ Time Frame: Baseline to Week 28 ] [ Designated as safety issue: No ]
• Change in body weight (kg) from baseline to Week 28 [ Time Frame: Baseline to Week 28 ] [ Designated as safety issue: No ]
• Change in systolic blood pressure from baseline to Week 28 [ Time Frame: Baseline to Week 28 ] [ Designated as safety issue: No ]
• Change in 2-hour postprandial glucose concentrations from baseline to Week 16 [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
• Proportion of subjects achieving HbA1c <=6.5% at Week 28 [ Time Frame: Baseline to Week 28 ] [ Designated as safety issue: No ]

To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by sitagliptin or placebo administered once daily for 28 weeks in subjects with type 2 diabetes mellitus.

• Drug: Exenatide once weekly suspension
• Drug: Sitagliptin

• Experimental: Exenatide once weekly suspension
  Exenatide once weekly suspension 2mg subcutaneous injection
  Intervention: Drug: Exenatide once weekly suspension
• Active Comparator: Sitagliptin 100mg
  Sitagliptin 100mg oral tablet once daily
  Intervention: Drug: Sitagliptin
• Placebo Comparator: Placebo
  Placebo oral tablet once daily

Inclusion Criteria:

• At least 18 years old
• Diagnosed with type 2 diabetes mellitus
• HbA1c of 7.1% to 11.0%, inclusive, at screening
• Has stable body weight, i.e., not varying by >3% for at least 3 months prior to screening
• Fasting plasma glucose concentration <280 mg/dL (15.5 mmol/L) at screening
• Body mass index of <45 kg/m2 at screening
• Has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2 months prior to Visit 1 (Screening)

Exclusion Criteria:

• History of pancreatitis or triglycerides >=500 mg/dL
• Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either
• History of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance <50 mL/min
• Active cardiovascular disease
• Presence or history of severe congestive heart failure
• Central nervous system disease, including epilepsy
• Liver disease
• History of severe gastrointestinal diseases
• Clinically significant malignant disease
• Repeated severe hypoglycemia within the last 6 months
• Any exposure to exenatide (BYETTA® or BYDUREON™) or any GLP-1 analog
• Any DPP-4 inhibitor within 3 months prior screening