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| Name | Class |
|---|---|
| Italian Society of Diabetology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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) |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin | Drug | Canagliflozin If the patient is already on metformin, the fixed combination Canagliflozin / Metformin can be used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Objectives - HbA1c | Change in HbA1c level (as a continuous variable) - % | Up to 24 months |
| Secondary Objectives - body weight | Change in body weight (as a continuous variable) - Kg |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Objectives | Hospitalization for any cause | Up to 24 months |
| Safety Objectives | Hospitalization for heart failure and/or cardiovascular causes |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| C529054 | dapagliflozin |
| C570240 | empagliflozin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Dapagliflozin | 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 | 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. |
|
| Up to 24 months |
| Secondary Objectives - systolic blood pressure | Change in systolic blood pressure (as a continuous variable) - mmHG | 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 | Up to 24 months |
| Secondary Objectives - urinary albumin excretion rate | Change in urinary albumin excretion rate (as a continuous variable) - mg/L | Up to 24 months |
| Secondary Objectives - medications | Change concomitant medications and their daily dosages | Up to 24 months |
| Secondary Objectives - treatment satisfaction | Change in treatment satisfaction quantified as Diabetes Treatment Satisfaction Questionnaire (DTSQ). | Up to 24 months |
| Secondary Objectives - biomarkers | Plasma/serum biomarkers of bone metabolism and cardiac function (in a subset of patients) with physiological parameter | Up to 24 months |
| Up to 24 months |
| Safety Objectives | All-cause death and Cardiovascular death | Up to 24 months |
| Safety Objectives | Severe hypoglycemia | Up to 24 months |
| Safety Objectives | Genitourinary tract infections | Up to 24 months |
| Safety Objectives | Dehydration / hypovolemia events | Up to 24 months |
| Safety Objectives | Bone fractures | Up to 24 months |
| Safety Objectives | Leg/foot amputations | Up to 24 months |
| Safety Objectives | Diabetic ketoacidosis | Up to 24 months |
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |