GliflOzin in eLderly Diabetic patiENts: A praGmatic Intraclass Evaluation Trial
GOLDEN-AGE
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.
1 other identifier
interventional
1,167
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes-mellitus-type-2
Started Jun 2021
Typical duration for phase_4 diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2021
CompletedFirst Posted
Study publicly available on registry
March 12, 2021
CompletedStudy Start
First participant enrolled
June 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMarch 12, 2021
March 1, 2021
2.5 years
March 1, 2021
March 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Objective
The primary objective is to compare the proportion of patients treated with each SGLT2i drug, who achieve the individualized HbA1c target without level-2 hypoglycaemia.
Up to 24 months
Secondary Outcomes (8)
Secondary Objectives - HbA1c
Up to 24 months
Secondary Objectives - body weight
Up to 24 months
Secondary Objectives - systolic blood pressure
Up to 24 months
Secondary Objectives - e-GFR
Up to 24 months
Secondary Objectives - urinary albumin excretion rate
Up to 24 months
- +3 more secondary outcomes
Other Outcomes (9)
Safety Objectives
Up to 24 months
Safety Objectives
Up to 24 months
Safety Objectives
Up to 24 months
- +6 more other outcomes
Study Arms (3)
canagliflozin
ACTIVE COMPARATOR100 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).
dapagliflozin
ACTIVE COMPARATOR10 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)
empagliflozin
ACTIVE COMPARATOR10 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).
Interventions
Canagliflozin If the patient is already on metformin, the fixed combination Canagliflozin / Metformin can be used.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2021
First Posted
March 12, 2021
Study Start
June 30, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
March 12, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share