A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients

Prior treatment

• Previous enrolment or randomization in the present study
• Participation in an interventional clinical trial ≤ 3 months before enrolment.
• Physician decision to use, as second line treatment, insulin, a GLP1 agonist compound or a SGLT2 inhibitor different from dapagliflozin.

Lab values

• Known moderate to severe renal impairment (eGFR\<60ml/min).

Age

• Age \> 75 years

Other

• Patients should not enter the study if any of the following exclusion criteria are fulfilled:
• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
• Pregnancy/active breast feeding at the time of inclusion
• Unsuitable to participate on mental health grounds, as judged by the investigator.
• Presence of any of the characteristics in which the products in study are contraindicated, as per current labels.

• For inclusion in the study patients should fulfil the following criteria at the time of screening:
• Provision of informed consent prior to any study specific procedures
• Females and males aged ≥18 years up to ≤ 75 years
• Diagnosed with Type 2 Diabetes Mellitus.
• Uncontrolled on first-line metformin treatment, defined as ≥8 weeks on maximum tolerated dose of metformin and HbA1c \> 6.5%.
• Ability to read and write as judged by the investigator.