Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes

Inclusion criteria:

1) Diagnosis typ 2 diabetes mellitus, 2) male and female on diet and exercise regimen, pre-treated with metformin 12 weeks prior to randomisation, 3)HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1, 4) 18 years or more, 5) BMI equal or less than 45Kg/m2.

Exclusion criteria:

1) uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in, 2) any other antidiabetic drug within 12 weeks prior to randomisation except metformin,3) acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or transient ischemic attack within 12 weeks of informed consent,4) indication liver disease, 5) moderate to severe renal impairment, 6) bariatric surgery within past 2 years, 7) medical history of cancer or treatment for cancer within last 5 years, 8) blood dyscrasias or any disorders causing haemolysis or unstable red blood cell, 9) contraindications hypersensitivity to concomitant drugs,10) treatment with anti-obesity drugs