Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin

Exclusion Criteria

• •History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, or diabetes resulting from pancreatic disorder or secondary diabetes
• •History of renal disease or clinically significant abnormal kidney function tests
• •Presence of active hepatic disease or clinically significant abnormal liver function tests
• •Subjects with a history of heart attack, severe/unstable angina, or coronary revascularization procedure within 6 months prior to study Day 1
• •History of clinically significant cardiac arrhythmias within one year of study Day 1
• •Subjects with congestive heart failure
• •Subjects with uncontrolled Stage III hypertension
• •Triglycerides \>1000 mg/dL at Screening
• •Known history of HIV or hepatitis C
• •History of illicit drug or alcohol abuse with one year of study Day 1
• •Have had 2 or more emergency room visits, doctor visits, or hospitalizations due to hypoglycemia within 6 months of study Day 1
• •Use of any other investigational drug within 30 days of study Day 1
• •Prior exposure to LX4211
• •Use of any medication or herbal supplement for the purpose of weight loss
• •Chronic use of any antidiabetic therapy other than metformin in the 3 months prior to study Day 1
• •Use of corticosteroids within 2 weeks prior to study Day 1
• •Major surgery within 6 months of study Day 1
• •Subjects with any history of severe gastroparesis
• •Inability or difficulty swallowing whole capsules or tablets
• •Women who are pregnant or breast feeding