Status:
UNKNOWN
GliflOzin in eLderly Diabetic patiENts: A praGmatic Intraclass Evaluation Trial
Lead Sponsor:
Center for Outcomes Research and Clinical Epidemiology, Italy
Collaborating Sponsors:
Italian Society of Diabetology
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
70-90 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
1167 Patients enrolled
Trial Details
Trial ID
NCT04796428
Start Date
June 30 2021
End Date
December 31 2023
Last Update
March 12 2021
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