Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes

Inclusion criteria

• Diagnosis of type 2 diabetes mellitus prior to informed consent;
• Male and female patients on diet and exercise regimen who are drug-naïve;
• HbA1c >= 7.0% and <= 10.0% at Visit 1 (screening) for randomised treatment; HbA1c > 10.0% at visit 1 (screening) for the open-label BI 10773 arm;
• Age >= 20 (Japan); Age >= 18 (countries other than Japan);
• BMI <= 45 kg/m2 at Visit 1 (screening);
• Signed and dated written informed consent by date of Visit 1

Exclusion criteria

• Uncontrolled hyperglycaemia;
• Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent;
• Indication of liver disease, either ALT, AST, or alkaline phosphatase above 3 x ULN;
• Impaired renal function (eGFR<50 ml/min);
• Bariatric surgery within the past two years or other GI surgeries;
• Medical history of cancer;
• Contraindications to sitagliptin;
• Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell;
• Treatment with any anti-diabetes drug within 12 weeks prior to randomisation;
• Treatment with anti-obesity drugs or any other treatment leading to unstable body weight;
• Current treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM;
• Pre-menopausal women who are nursing or pregnant or are of child-bearing potential and not practicing an acceptable method of birth control;
• Alcohol or drug abuse;
• Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial;
• Any other clinical condition that would jeopardize patients safety while participating in this clinical trial