A Phase III, multicentre, international, randomised, parallel group, double blind cardiovascular safety study of BI 10773 (10 mg and 25 mg administered orally once daily) compared to usual care in type 2 diabetes mellitus patients with increased cardiovascular risk.

(see paragraph 3.3.2 of the protocol for the complete list)
1.Diagnosis of type 2 diabetes mellitus prior to informed consent
2.Male and female patients on diet and exercise regimen who are drug-naïve or pre-treated with any background therapy. Antidiabetic therapy has to be unchanged for 12 weeks prior to randomization. If insulin is part of the background therapy, the insulin prescribed dose should not be changed within the 12 weeks prior to randomisation by more than 10% daily from the baseline value at randomisation
3.HbA1c of >=7.0% and <=10% at Visit 1 (screening) for patients on background therapy or HbA1c of >=7.0% and <=9.0% At Visit 1 (screening) for drug-naïve patients.
4.Age >= 18 years
5.BMI <= 45 kg/m2 (Body Mass Index) at Visit 1
7.Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation
8.High cardiovascular risk (see protocol paragraph 3.3.2 for definition)

1. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)
2. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run in phase.
3. Planned cardiac surgery or angioplasty within 3 months.
4. Impaired renal function, defined as GFR<30 ml/min (severe renal impairment, MDRD formula) as determined during screening and/or run in phase.
5. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption.
6. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia)
7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
8. Contraindications to background therapy according to the local label.
9. Treatment with anti-obesity drugs (e.g., sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e., surgery, aggressive diet regimen, etc.) leading to unstable body weight
10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM
11. Pre-menopausal women (last menstruation * 1 year prior to informed consent) who:
- are nursing or pregnant or
- are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if allowed by local Authorities), double barrier method and vasectomised partner.
12. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
13. Participation in another trial with Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial, or participating in another trial (involving an investigational drug and/or follow-up) after discontinuing medication in this trial.
14. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
15. Acute coronary syndrome, stroke or TIA within 2 months prior to informed consent