Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM

Inclusion Criteria:

Age and Informed Consent

1. Patient must be 18 to 80 (years of age inclusive), at the time of signing theICF(s). Type of Patient and Disease Characteristics

2. Newly diagnosed T2DM (WHO diagnostic criteria 1999) ≤ 1 year with medicine treatmentnaïve.

3. HbA1c 7.5%-10% at screening by local lab and HbA1c 7.5-10% at pre-randomizationvisit (by central laboratory).

4. BMI ≥19 and ≤40 kg/m2 at screening. Other Inclusion Criteria

5. Capable of giving signed informed consent as described in Appendix A which includescompliance with the requirements and restrictions listed in the ICF and in thisprotocol.

Exclusion Criteria:

Medical Conditions

1. Congestive heart failure NYHA classes III or IV or major cardiovascular eventswithin 6 months before screening. (Significant cardiovascular history within thepast 6 months prior to screening defined as: myocardial infarction, coronaryangioplasty or bypass graft(s), valvular disease or repair, unstable anginapectoris, transient ischemic attack, or cerebrovascular accident.)

2. Patients with clinically apparent hepatobiliary disease, including but not limitedto chronic active hepatitis and/or severe hepatic insufficiency. ALT or AST > 3xULN, or serum TB >34.2 μmol/L (>2 mg/dL).

3. Patients with eGFR< 45 mL/min per 1.73 m².

4. Diagnosis or history of acute metabolic diabetic complications such as ketoacidosisor hyperglycemic hyperosmolar state, or diabetes insipidus within the past 6 months.

5. For women only - currently pregnant (confirmed with positive pregnancy test) orbreastfeeding.

6. Participation in any other study that included drug treatment during the past 3months before enrolment. Diagnostic Assessments

7. Patients with a known hypersensitivity to Dapa/Met or any of the excipients of theproduct.

8. Diagnosis or history of:

9. Chronic pancreatitis within past 6 months or idiopathic acute pancreatitiswithin past 4 weeks.

10. Gastrointestinal disease including gastroenterostomy, enterectomy, roemheldsyndrome, severe hernia, intestinal obstruction, intestinal ulcer within past 6months.

11. Genetic galactose intolerance, lapp lactase deficiency and glucose-galactosemalabsorption.

12. Medullary thyroid carcinoma within past 5 years.

13. Organ transplant or AIDS within the past 6 months.

14. Alcohol abuse or illegal drug abuse within the past 12 months.

15. Laser treatment for proliferative retinopathy within 6 months.

16. Stress condition, such as surgery, serious trauma, etc., within past 6 months,or plan to undergo a surgery during study period.

17. Chronic oxygen deficiency diseases, such as pulmonary emphysema, pulmonaryheart disease within past 6 months.

18. T1DM, diabetes resulting from pancreatic injury or secondary forms of diabetes,eg, acromegaly or Cushing's syndrome. Other Exclusions

19. Subject is, in the judgment of the Investigator, unlikely to comply with theprotocol or has any severe concurrent medical or psychological condition that mayaffect the interpretation of study results.

20. Involvement in the planning and/or conduct of the study (applies to both AstraZenecastaff and/or staff at the study site).