GliflOzin in eLderly Diabetic patiENts: A praGmatic Intraclass Evaluation Trial (GOLDEN-AGE)

Center for Outcomes Research and Clinical Epidemiology, Italy

Status and phase: Unknown; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Empagliflozin; Drug: Canagliflozin; Drug: Dapagliflozin

Study type: Interventional

Funder types: Other

Identifiers

NCT04796428

TRS-2019-00002051

Details and patient eligibility

About

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.

Enrollment: 1,167 estimated patients

Sex: All

Ages: 70 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,167 participants in 3 patient groups

canagliflozin

Active Comparator group

Description:

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).

Treatment:

Drug: Canagliflozin

dapagliflozin

Active Comparator group

Description:

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)

Treatment:

Drug: Dapagliflozin

empagliflozin

Active Comparator group

Description:

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).

Treatment:

Drug: Empagliflozin