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

Inclusion Criteria:

- Adults ≥18 to ≤55 years of age

- Confirmed diagnosis of T1DM, diagnosed prior to age 40 years, and for at least 6
months prior to Screening

- Willing to refrain from using carbohydrate counting to adjust insulin during the study

- Willing and able to wear and operate a continuous glucose monitor

- Willing and able to self-assess blood-glucose

- Willing and able to provide written informed consent

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

- Subjects 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

- Subjects with congestive heart failure

- Subjects 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

- Subjects who have undergone major surgery within 6 months prior to Screening

- Inability or difficulty swallowing whole tablets or capsules

- Women who are pregnant or breastfeeding