Date

2015-10-29

Protocol

Protocol changed

Item Changed

Exclusion criteria

Previous Version

1. Known type 1 diabetes mellitus or documented evidence of positive diabetes auto-antibodies (if performed when patient was diagnosed with diabetes). 2. Known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known to affect glucose tolerance other than diabetes. 3. Symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of another antihyperglycemic agent. 4. Participant has previously taken a DPP-4 inhibitor (such as sitagliptin, vildagliptin,alogliptin, or saxagliptin) or GLP-1 receptor agonist (such as exenatide or liraglutide). 5. Exhibits abnormal growth patterns or is being treated with growth hormone. 6. History of idiopathic acute pancreatitis or chronic pancreatitis

Next Version

1.Patient has previously taken a DPP-4 inhibitor (such as sitagliptin, vildagliptin, alogliptin, or saxagliptin) or GLP-1 receptor agonist (such as exenatide or liraglutide). Note: Patients who have participated in single-dose studies with these agents at least 12 weeks prior to screening are eligible to participate. 2. Patient has initiated chronic treatment with a medication known to cause: a. weight gain within 30 days of Visit 1 or b. weight loss (such as orlistat) or c. increase blood glucose within 8 weeks of Visit 1. Note: Patients on a weight loss program and not in the maintenance phase, or who have undergone bariatric surgery within 12 months prior to signing the informed consent will be excluded. Note: Patients who have been treated with an anti-psychotic agent within the past 12 weeks will be excluded. 3. Patient is currently participating in or has participated in another study with an investigational compound or device within the prior 12 weeks of signing the informed consent (including patients who have participated in single-dose studies with these agents) and does not agree to refrain from participating in any other study while participating in this study. Note: A patient who has participated in a non-interventional or placebo study may be enrolled. 4. Patient is on or likely to require treatment with ?14 consecutive days or repeated courses of pharmacologic doses of corticosteroids. Note: Inhaled, nasal, and topical corticosteroids are permitted. 5. Patient has undergone a surgical procedure within the prior 4 weeks or has major surgery planned during the study. Note: Patients who have undergone minor surgery within the prior 4 weeks and are fully recovered or patients who have planned minor surgery may participate. Minor surgery is defined as a surgical procedure involving local anesthesia.