Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo

Inclusion criteria

- Has a diagnosis of T2DM.

- Has HbA1c of 8.0% to 12.0%, inclusive, at Visit 1 and Visit 2.

- Treated with a stable dose of metformin ≥1500 mg/day for at least 2 months prior to
Screening.

Exclusion criteria

- FPG ≥280 mg/dL (15.6 mmol/L).

- Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)

- Clinically significant abnormal free T4 values or patients needing initiation or
adjustment of thyroid treatment according to the investigator.

- Abnormal thyroid stimulating hormone (TSH) value at Screening will be further
evaluated by free T4.Patients with clinically significant abnormal free T4 values will
be excluded.

- Known active proliferative retinopathy.

- History of, or currently have, acute or chronic pancreatitis, or have triglyceride
concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1

- History or presence of inflammatory bowel disease or other severe GI diseases,
particularly those which may impact gastric emptying, such as gastroparesis or pyloric
stenosis.

- History of gastric bypass surgery or gastric banding surgery, or either procedure is
planned during the time period of the study. Current use of gastric balloons is also
excluded.