GliflOzin in eLderly Diabetic patiENts: A praGmatic Intraclass Evaluation Trial
Status:
Not yet recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Center for Outcomes Research and Clinical Epidemiology, Italy