Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes

Inclusion criteria:

1. Diagnosis of type 2 diabetes mellitus prior to informed consent

2. Male and female patients on diet and exercise regimen who are drug-naive, defined as
absence of any oral antidiabetic therapy for 12 weeks prior to randomization

3. HbA1c >=7.5% and <= 12% (>=58.5 mmol/mol and <=107.7 mmol/mol)

4. Body Mass Index (BMI) <= 45 kg/m2 at screening

Exclusion criteria:

1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an
overnight fast during placebo run-in and confirmed by a second laboratory measurement
(not on the same day)

2. Any antidiabetic drug within 12 weeks prior to randomization

3. Impaired renal function, defined as estimated creatinine clearance rate (eCCr) <60
ml/min (Cockcroft-Gault formula) as determined during screening and/or run-in period

4. Contraindications to metformin according to the local label