GliflOzin in eLderly Diabetic patiENts: A praGmatic Intraclass Evaluation Trial

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Three SGLT2i were commercially available in Italy at the time the trial was designed:

canagliflozin, dapagliflozin, and empagliflozin. Preliminary evidence suggests that the higher dose canagliflozin (300 mg/day) might exert a stronger glucose-lowering effect than dapagliflozin or empagliflozin. The clinical relevance of this putative difference is however unknown. On the other side, the use of canagliflozin, but not empagliflozin and dapagliflozin, has been associated with an increased risk of some adverse events, namely bone fractures and lower limb amputations. Currently, the available information on the efficacy and safety of SGLT2i in elderly (70+ years) patients with type 2 diabetes are is very scant. Thus, a compelling need now exists of comparing efficacy and safety of the commercially available SGLT2i in a population of frail patients at high risk of cardiovascular and renal diseases.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Center for Outcomes Research and Clinical Epidemiology, Italy
• Collaborator: Italian Society of Diabetology
• Treatments: 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol; Canagliflozin; Dapagliflozin; Empagliflozin

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