GliflOzin in eLderly Diabetic patiENts: A praGmatic Intraclass Evaluation Trial
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.
Timeline
- Start
- 2021-06-30
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CANAGLIFLOZIN ANHYDROUS | Small molecule | 50 mg | — |
| Comparator | CANAGLIFLOZIN ANHYDROUS | Small molecule | 100 mg | — |
| Comparator | CANAGLIFLOZIN ANHYDROUS | Small molecule | 150 mg | — |
| Comparator | CANAGLIFLOZIN ANHYDROUS | Small molecule | 300 mg | — |
| Comparator | Dapagliflozin | Small molecule | 5 mg | — |
| Comparator | Dapagliflozin | Small molecule | 10 mg | — |
| Comparator | Empagliflozin | Small molecule | 5 mg | — |
| Comparator | Empagliflozin | Small molecule | 10 mg | — |
| Comparator | Empagliflozin | Small molecule | 12.5 mg | — |
| Comparator | Empagliflozin | Small molecule | 25 mg | — |