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Table 2 List of inclusion and exclusion criteria for randomization

From: Study rationale and design of a study of EMPAgliflozin’s effects in patients with type 2 diabetes mellitus and Coronary ARtery disease: the EMPA-CARD randomized controlled trial

Inclusion criteria

1. Age between 40 and 75 years

2. HbA1c between 6.5 and 9.5%

3. Documented known diabetes mellitus type 2 under continuous fixed-dose anti-diabetic treatment for at least 3 months prior to the randomization

4. Documented known coronary artery disease established by coronary angiography under continuous fixed-dose of anti-ischemic treatment for at least 3 months prior to the randomization

5. BMI less than 40 kg/m2

6. Fixed diet and physical activity

7. eGFR greater than 45 ml/min/1.73m2

8. Informed consent given in written form

9. Resting heart rate between 60 to 100 b/min

Exclusion criteria

1. Pregnancy

2. Heart Failure (NYHA class 3–4)

3. Left ventricular ejection fraction < 40%

4. Use of anti-coagulant or anti-platelet drugs (except aspirin 80 mg/daily) for at least 3 months prior to the blood sampling

5. Consumption of alcohol, continuous anti-inflammatory drugs (except aspirin 80 mg/daily) or anti-oxidant supplement

6. Use of pioglitazone

7. History of allergic reaction to SGLT2-i medications

8. History of SGLT2-i medication usage

9. Gastrointestinal malabsorption disease

10. History of CABG, ACS, TIA, CVA or PCI during past 3 month

11. History or presence of malignancy

12. Severe HTN

 Resting systolic blood pressure ≥ 180 mmHg

and/or

 Resting diastolic blood pressure ≥ 120 mmHg

13. Anemia (Hb < 10 g/dl)

14. Platelet count < 100,000/µl

15. History of infection during 1 one month prior to blood sampling

16. History of heart or lung transplant

17. Major psychiatric disorders

18. History of DKA

19. Elevated liver enzymes > 3 times upper normal limit

20. Use of drugs which prolong QT interval

21. Presence of arrhythmia

22. Electrolyte imbalance

23. Patients with pace maker

  1. HbA1c glycated hemoglobin A1c, BMI body mass index, eGFR estimated glomerular filtration rate, NYHA New York Heart Association, SGLT2-I sodium-glucose co-transporter-2 inhibitor, CABG coronary artery bypass graft, ACS acute coronary syndrome, TIA transient ischemic attack, CVA cerebrovascular accident, PCI percutaneous coronary intervention, HTN hypertension, Hb hemoglobin, DKA diabetic ketoacidosis