Clinical trial NCT04796428: GliflOzin in eLderly Diabetic patiENts: A praGmatic Intraclass Evaluation Trial
Official title: Intraclass Safety and Efficacy Comparison Among SGLT-2 Inhibitors in Elderly Patients With Type 2 Diabetes. A Pragmatic, Phase IV, Multicenter, Open-label, Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Center for Outcomes Research and Clinical Epidemiology, Italy
Sponsor class: OTHER
Collaborators: name: Italian Society of Diabetology
First posted: 2021-03-12
Enrollment: 1167
Sex: ALL
Minimum age (years): 70
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Primary Objective
timeFrame: Up to 24 months
Secondary outcomes:
measure: Secondary Objectives - HbA1c
timeFrame: Up to 24 months
measure: Secondary Objectives - body weight
timeFrame: Up to 24 months
measure: Secondary Objectives - systolic blood pressure
timeFrame: Up to 24 months
measure: Secondary Objectives - e-GFR
timeFrame: Up to 24 months
measure: Secondary Objectives - urinary albumin excretion rate
timeFrame: Up to 24 months
measure: Secondary Objectives - medications
timeFrame: Up to 24 months
measure: Secondary Objectives - treatment satisfaction
timeFrame: Up to 24 months
measure: Secondary Objectives - biomarkers
timeFrame: Up to 24 months
Other outcomes:
measure: Safety Objectives
timeFrame: Up to 24 months
measure: Safety Objectives
timeFrame: Up to 24 months
measure: Safety Objectives
timeFrame: Up to 24 months
measure: Safety Objectives
timeFrame: Up to 24 months
measure: Safety Objectives
timeFrame: Up to 24 months
measure: Safety Objectives
timeFrame: Up to 24 months
measure: Safety Objectives
timeFrame: Up to 24 months
measure: Safety Objectives
timeFrame: Up to 24 months
measure: Safety Objectives
timeFrame: Up to 24 months
Locations:
Study officials:
References: