Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus

Exclusion Criteria

• •History of type 2 diabetes mellitus or diabetes resulting from acromegaly, Cushing's disease, chronic pancreatitis, or pancreatectomy
• •Two or more severe episodes of hypoglycemia that required emergency treatment within 3 months prior to Screening
• •Use of premixed insulin
• •History of diabetic ketoacidosis within 1 year of screening
• •Presence of active hepatic disease or clinically significant abnormal liver function tests
• •History of chronic pancreatitis
• •Participants with a history of heart attack, severe/unstable angina, or coronary revascularization procedure
• •History of clinically significant cardiac arrhythmias within 1 year prior to screening
• •Participants with congestive heart failure
• •Participants with uncontrolled Stage III hypertension
• •History of human immunodeficiency virus (HIV) or hepatitis C
• •History of illicit drug or alcohol abuse within 12 months prior to Screening
• •Use of any investigational agent or device within 30 days prior to Screening or any therapeutic protein or antibody within 90 days prior to Screening
• •Use of medication or herbal supplements taken for weight loss within 2 weeks of screening
• •Chronic use of any antidiabetic therapy other than insulin within 2 months prior to Screening
• •Use of systemic or inhaled corticosteroids within 2 weeks prior to Screening
• •Participants who underwent major surgery within 6 months prior to Screening
• •Inability or difficulty swallowing whole tablets or capsules
• •Women who were pregnant or breastfeeding.