Diabetes Mellitus, Type 2Phase 4GOLDEN-AGENCT04796428
GliflOzin in eLderly Diabetic patiENts: A praGmatic Intraclass Evaluation Trial
A Phase 4 study testing Canagliflozin, Dapagliflozin and Empagliflozin in people with Diabetes Mellitus, Type 2, run by Center for Outcomes Research and Clinical Epidemiology, Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Canagliflozin, Dapagliflozin and Empagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,167 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2021to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
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
- Being tested
- Canagliflozin, Dapagliflozin, Empagliflozin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanagliflozinDrug
Canagliflozin If the patient is already on metformin, the fixed combination Canagliflozin / Metformin can be used.
DapagliflozinDrug
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.
EmpagliflozinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| canagliflozin | Active comparator | 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). Receives: Drug: Canagliflozin |
| dapagliflozin | Active comparator | 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) Receives: Drug: Dapagliflozin |
| empagliflozin | Active comparator | 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). Receives: Drug: Empagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 months
Secondary outcomes (8)
Secondary Objectives - HbA1c
Change in HbA1c level (as a continuous variable) - %
Measured: Up to 24 months
Secondary Objectives - body weight
Change in body weight (as a continuous variable) - Kg
Measured: Up to 24 months
Secondary Objectives - systolic blood pressure
Change in systolic blood pressure (as a continuous variable) - mmHG
Measured: Up to 24 months
Secondary Objectives - e-GFR
Change in e-GFR (as a continuous variable). The slope of eGFR decline will be calculated over time in the three treated groups - mL/min
Measured: Up to 24 months
Secondary Objectives - urinary albumin excretion rate
Change in urinary albumin excretion rate (as a continuous variable) - mg/L
Measured: Up to 24 months
Secondary Objectives - medications
Change concomitant medications and their daily dosages
Measured: Up to 24 months
Secondary Objectives - treatment satisfaction
Change in treatment satisfaction quantified as Diabetes Treatment Satisfaction Questionnaire (DTSQ).
Measured: Up to 24 months
Secondary Objectives - biomarkers
Plasma/serum biomarkers of bone metabolism and cardiac function (in a subset of patients) with physiological parameter
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start30 Jun 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Outcomes Research and Clinical Epidemiology, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Italian Society of Diabetology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796428
- Sponsor's protocol ID
- TRS-2019-00002051
- Acronym
- GOLDEN-AGE
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04796428
- Acronym / sponsor ID
- GOLDEN-AGE / TRS-2019-00002051
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,167 participants (estimated)
- Lead sponsor
- Center for Outcomes Research and Clinical Epidemiology, ItalyUniversity, hospital or other
- Collaborators
- Italian Society of Diabetology
- Study start
- 30 Jun 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| canagliflozin | Active comparator | Drug: Canagliflozin100 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 comparator | Drug: Dapagliflozin10 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 comparator | Drug: Empagliflozin10 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). |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CanagliflozinCanagliflozin If the patient is already on metformin, the fixed combination Canagliflozin / Metformin can be used. | Drug | canagliflozin |
| DapagliflozinDapagliflozin 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. | Drug | dapagliflozin |
| EmpagliflozinIf 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. | Drug | empagliflozin |
Primary outcome
Primary Objective
Time frame: Up to 24 months
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.
8 secondary outcomes
Secondary Objectives - HbA1c
Time frame: Up to 24 months
Secondary Objectives - body weight
Time frame: Up to 24 months
Secondary Objectives - systolic blood pressure
Time frame: Up to 24 months
Secondary Objectives - e-GFR
Time frame: Up to 24 months
Secondary Objectives - urinary albumin excretion rate
Time frame: Up to 24 months
Secondary Objectives - medications
Time frame: Up to 24 months
Secondary Objectives - treatment satisfaction
Time frame: Up to 24 months
Secondary Objectives - biomarkers
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Canagliflozin, Dapagliflozin and Empagliflozin in people with Diabetes Mellitus, Type 2, run by Center for Outcomes Research and Clinical Epidemiology, Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.