GliflOzin in eLderly Diabetic patiENts: A praGmatic Intraclass Evaluation Trial (GOLDEN-AGE)
Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes
- Age 70+ years
- Male or female
- Prevalent cardiovascular disease (symptomatic or asymptomatic) or eGFR <90 ml/min/1.73 m2 and above the lower limit for initiation of SGLT2i according to label (currently eGFR <60 ml/min/1.73 m2)
- HbA1c above individualized target
- Indication to add SGLT2i
Exclusion Criteria:
- Age >90 years
- Estimated life expectancy <1 year
- Very high risk of genitourinary tract infections (>2 events in the last 6 months)
- Recent weight loss (>5% in <6 months)
- Inability to provide informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
canagliflozin
dapagliflozin
empagliflozin
100 mg (or 50/850 mg and 50/1000 mg of the fixed association with metformin) or 300 mg (or the 150/850 mg and the 150/1000 mg fixed association with metformin).
10 mg (or 5/850 mg and 5/1000 mg of the fixed association with metformin; or 10/5 mg of the fixed dapagliflozin / saxagliptin combination)
10 mg (or 5/850 mg and 5/1000 mg of the fixed association with metformin; or 5/5 mg of the empagliflozin / linagliptin combination) or 25 mg (or the 12.5/850 mg and the 12.5/1000 mg fixed association with metformin; or the 12.5/5 mg empagliflozin / linagliptin combination).