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

A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of LX4211 in Patients With Inadequately Controlled Type 1 Diabetes Mellitus

This Phase 2 study was intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and efficacy of sotagliflozin following daily oral administration for 29 days in participants with type 1 diabetes mellitus (T1DM).

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
• 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.