GliflOzin in eLderly Diabetic patiENts: A praGmatic Intraclass Evaluation Trial

NCT ID: NCT04796428

Last Updated: 2021-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 1167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2023-12-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Canagliflozin

Intervention Type: DRUG

Canagliflozin If the patient is already on metformin, the fixed combination Canagliflozin / Metformin can be used.

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)

Group Type: ACTIVE_COMPARATOR

Dapagliflozin

Intervention Type: 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

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).

Group Type: ACTIVE_COMPARATOR

Empagliflozin

Intervention Type: 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.

Interventions

Canagliflozin

Canagliflozin If the patient is already on metformin, the fixed combination Canagliflozin / Metformin can be used.

Intervention Type: DRUG

Dapagliflozin

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.

Intervention Type: DRUG

Empagliflozin

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Italian Society of Diabetology

OTHER

Sponsor Role: collaborator

Center for Outcomes Research and Clinical Epidemiology, Italy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

TRS-2019-00002051

Identifier Type: -

Identifier Source: org_study_id