To assess safety of fixed dose combination of dapagliflozin and saxagliptin in Type 2 Diabetes Mellitus patients

Exclusion Criteria

• 1. Known allergies or contraindication to the contents of the IP, dapagliflozin or saxagliptin tablets.
• 2. Active participation in another clinical study with IP and/or investigational device
• 3. For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
• 4. Type 1 diabetes mellitus.
• 5. Treatment with a SGLT2 inhibitor, GLP-1 agonist or DPP4 inhibitors at Visit 1 or 2
• 6. Patients with moderate to severe renal impairment (eGFR persistently <45 mL/min/1.73 m2 by CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula or end-stage renal disease (ESRD) or ‘Unstable or rapidly progressing renal disease
• 7. Patients with severe hepatic impairment (Child-Pugh class C)
• 8. History of pancreatitis or pancreatic surgery
• 9. Patients with a history of any malignancy
• 10. Patients with any of the following CV/Vascular Diseases within 3 months prior to signing the consent at enrolment, as assessed by the investigator:
• • Myocardial infarction.
• • Cardiac surgery or revascularization (CABG/PTCA).
• • Unstable angina.
• • Transient ischemic attack (TIA) or significant cerebrovascular disease.
• • Unstable or previously undiagnosed arrhythmia.
• 11. History of heart failure
• 12. Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg at any visit up to randomisation
• 13. History of diabetic ketoacidosis
• 14. Any acute/chronic systemic infections
• 15. Recurrent urogenital infections
• 16. Patients at risk for volume depletion as judged by the investigator
• 17. Any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient or patient suspected or with confirmed poor protocol or medication compliance