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

Inclusion criteria:

- Diagnosis typ 2 diabetes mellitus

- Male and female on diet and exercise regimen, pre-treated with metformin 12 weeks
prior to randomisation

- HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1

- 18 years or more

- BMI equal or less than 45Kg/m2

Exclusion criteria:

- Uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight
fast during placebo run-in

- Any other antidiabetic drug within 12 weeks prior to randomisation except metformin

- Acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or
transient ischemic attack within 12 weeks of informed consent

- Indication of liver disease

- Moderate to severe renal impairment

- Bariatric surgery within past 2 years

- Medical history of cancer or treatment for cancer within last 5 years

- Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell

- Contraindications hypersensitivity to concomitant drugs

- Treatment with anti-obesity drugs