Study of LX4211 in Subjects With Type 2 Diabetes Mellitus

A Phase 2, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Safety and Efficacy of Orally Administered LX4211 in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety, tolerability, and efficacy of LX4211 versus a placebo control in subjects with type 2 diabetes mellitus.

Inclusion Criteria:

• Males and females (non-childbearing potential), aged 18-65 years
• Diagnosis of Type 2 diabetes mellitus for at least 6 months prior to screening
• Fasting plasma glucose ≤ 240 mg/dL prior to metformin washout
• Body mass index < 42 kg/m^2
• HbA1c value of 7 to 11%
• C-peptide ≥ 1.0 ng/mL
• Ability to provide written informed consent

Exclusion Criteria:

• History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, incontinence, or nocturia
• Use of any blood glucose lowering agent other than metformin
• Prior exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening
• Laboratory or electrocardiogram abnormalities deemed significant by the Sponsor or the Investigator
• Positive test result for glutamic acid decarboxylase (GAD) antibody
• Surgery within 6 months of screening
• Exposure to any investigational agent or participation in any investigational trial within 30 days prior to Day 1
• Hypersensitivity to an SGLT2 inhibitor
• History of drug or alcohol abuse within the last 12 months