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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Canagliflozin
Dapagliflozin
Empagliflozin
Sponsored by
Center for Outcomes Research and Clinical Epidemiology, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

70 Years - 90 Years (Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    canagliflozin

    dapagliflozin

    empagliflozin

    Arm 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).

    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)

    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).

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Secondary Objectives - HbA1c
    Change in HbA1c level (as a continuous variable) - %
    Secondary Objectives - body weight
    Change in body weight (as a continuous variable) - Kg
    Secondary Objectives - systolic blood pressure
    Change in systolic blood pressure (as a continuous variable) - mmHG
    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
    Secondary Objectives - urinary albumin excretion rate
    Change in urinary albumin excretion rate (as a continuous variable) - mg/L
    Secondary Objectives - medications
    Change concomitant medications and their daily dosages
    Secondary Objectives - treatment satisfaction
    Change in treatment satisfaction quantified as Diabetes Treatment Satisfaction Questionnaire (DTSQ).
    Secondary Objectives - biomarkers
    Plasma/serum biomarkers of bone metabolism and cardiac function (in a subset of patients) with physiological parameter

    Full Information

    First Posted
    March 1, 2021
    Last Updated
    March 10, 2021
    Sponsor
    Center for Outcomes Research and Clinical Epidemiology, Italy
    Collaborators
    Italian Society of Diabetology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04796428
    Brief Title
    GliflOzin in eLderly Diabetic patiENts: A praGmatic Intraclass Evaluation Trial
    Acronym
    GOLDEN-AGE
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 30, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Center for Outcomes Research and Clinical Epidemiology, Italy
    Collaborators
    Italian Society of Diabetology

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    1167 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    canagliflozin
    Arm Type
    Active Comparator
    Arm 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).
    Arm Title
    dapagliflozin
    Arm Type
    Active Comparator
    Arm 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)
    Arm Title
    empagliflozin
    Arm Type
    Active Comparator
    Arm 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).
    Intervention Type
    Drug
    Intervention Name(s)
    Canagliflozin
    Intervention Description
    Canagliflozin If the patient is already on metformin, the fixed combination Canagliflozin / Metformin can be used.
    Intervention Type
    Drug
    Intervention Name(s)
    Dapagliflozin
    Intervention Description
    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
    Intervention Name(s)
    Empagliflozin
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Primary Objective
    Description
    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.
    Time Frame
    Up to 24 months
    Secondary Outcome Measure Information:
    Title
    Secondary Objectives - HbA1c
    Description
    Change in HbA1c level (as a continuous variable) - %
    Time Frame
    Up to 24 months
    Title
    Secondary Objectives - body weight
    Description
    Change in body weight (as a continuous variable) - Kg
    Time Frame
    Up to 24 months
    Title
    Secondary Objectives - systolic blood pressure
    Description
    Change in systolic blood pressure (as a continuous variable) - mmHG
    Time Frame
    Up to 24 months
    Title
    Secondary Objectives - e-GFR
    Description
    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
    Time Frame
    Up to 24 months
    Title
    Secondary Objectives - urinary albumin excretion rate
    Description
    Change in urinary albumin excretion rate (as a continuous variable) - mg/L
    Time Frame
    Up to 24 months
    Title
    Secondary Objectives - medications
    Description
    Change concomitant medications and their daily dosages
    Time Frame
    Up to 24 months
    Title
    Secondary Objectives - treatment satisfaction
    Description
    Change in treatment satisfaction quantified as Diabetes Treatment Satisfaction Questionnaire (DTSQ).
    Time Frame
    Up to 24 months
    Title
    Secondary Objectives - biomarkers
    Description
    Plasma/serum biomarkers of bone metabolism and cardiac function (in a subset of patients) with physiological parameter
    Time Frame
    Up to 24 months
    Other Pre-specified Outcome Measures:
    Title
    Safety Objectives
    Description
    Hospitalization for any cause
    Time Frame
    Up to 24 months
    Title
    Safety Objectives
    Description
    Hospitalization for heart failure and/or cardiovascular causes
    Time Frame
    Up to 24 months
    Title
    Safety Objectives
    Description
    All-cause death and Cardiovascular death
    Time Frame
    Up to 24 months
    Title
    Safety Objectives
    Description
    Severe hypoglycemia
    Time Frame
    Up to 24 months
    Title
    Safety Objectives
    Description
    Genitourinary tract infections
    Time Frame
    Up to 24 months
    Title
    Safety Objectives
    Description
    Dehydration / hypovolemia events
    Time Frame
    Up to 24 months
    Title
    Safety Objectives
    Description
    Bone fractures
    Time Frame
    Up to 24 months
    Title
    Safety Objectives
    Description
    Leg/foot amputations
    Time Frame
    Up to 24 months
    Title
    Safety Objectives
    Description
    Diabetic ketoacidosis
    Time Frame
    Up to 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    70 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    GliflOzin in eLderly Diabetic patiENts: A praGmatic Intraclass Evaluation Trial

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