Efficacy and Safety of EGT0001442 in Patients With Type 2 Diabetes Mellitus

Inclusion Criteria: * Male or female subjects ≥18 years old * Diagnosed with type 2 diabetes * Body mass index (BMI) ≤ 45 kg/m2 * HbA1c between 7 and 10% (inclusive) at screening * FPG \<250 mg/dL at screening for subjects not treated with oral anti-diabetic therapies or FPG \<240 mg/dL at screening for subjects treated with anti-diabetic therapies * Diabetes currently treated with diet and exercise only or diet and exercise along with one approved oral anti-diabetic agent * If taking anti-diabetic medication, dose and regimen must be stable for past 3 months * If taking anti-hypertensive medication, dose and regimen must be stable for past 3 months * If taking lipid modifying therapy, dose and regimen must be stable for past 3 months * Blood glucose \<250 mg/dL based on finger stick blood glucose for all subjects at randomization Exclusion Criteria: * Hemoglobinopathy that affects HbA1c measurement * Current use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor based therapy) * Genitourinary tract infection within 6 weeks of screening * Greater than 2 episodes of genitourinary tract infection in the past year * History of kidney stones, bladder malfunction or other significant risk factor for urinary tract infections * eGFR, as calculated by the modification of diet in renal disease study equation (MDRD), \< 50 mL/min/1.73 m2 * Abnormal tests of liver function ALT, AST or bilirubin ≥ 3x ULN * Diagnosis of retinopathy or significant nephropathy (eGFR \< 50 mL/min/1.73 m2 * Uncontrolled hypertension (systolic blood pressure \>160 or diastolic blood pressure \>95) * Not willing to use effective birth control, if female with child-bearing potential * Life expectancy \< 2 years * New York Heart Association (NYHA) Class 4 heart failure * Sera positive of HCV, HIV, or positive on drug screen * Currently participating in another interventional trial * Previous treatment with EGT0001442 or EGT0001474 * Not able to comply with the study scheduled visits