GliflOzin in eLderly Diabetic patiENts: A praGmatic Intraclass Evaluation Trial

Sponsor
Center for Outcomes Research and Clinical Epidemiology, Italy
Study ID
NCT04796428
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
70 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin — DRUG
    Canagliflozin If the patient is already on metformin, the fixed combination Canagliflozin / Metformin can be used.
  • Dapagliflozin — DRUG
    Dapagliflozin If the patient is already on metformin, the fixed combination dapagliflozin / metformin can be used. If the patient is already on a DPP-4 inhibitor, the fixed dose combination dapagliflozin / saxagliptin can be used.
  • Empagliflozin — DRUG
    If the patient is already on metformin, the fixed combination empagliflozin / metformin can be used. If the patient is already on a DPP-4 inhibitor, the fixed dose combination empagliflozin / linagliptin can be used.

Study Details

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.

Key Dates

Start date
Jun 30, 2021
Status verified
Mar 2021
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
1,167 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: canagliflozin
    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).
  • Active Comparator: dapagliflozin
    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)
  • Active Comparator: empagliflozin
    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).

Primary Outcome Measure

Primary Objective [ Time Frame: Up to 24 months ]

Related Studies