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Clinical Trial Details

Trial ID: L6848
Source ID: NCT04796428
Associated Drug: Canagliflozin
Title: GliflOzin in eLderly Diabetic patiENts: A praGmatic Intraclass Evaluation Trial
Acronym: GOLDEN-AGE
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Canagliflozin|DRUG: Dapagliflozin|DRUG: Empagliflozin
Outcome Measures: Primary: 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: 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, 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 | Other: Safety Objectives, Hospitalization for any cause, Up to 24 months|Safety Objectives, Hospitalization for heart failure and/or cardiovascular causes, 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
Sponsor/Collaborators: Sponsor: Center for Outcomes Research and Clinical Epidemiology, Italy | Collaborators: Italian Society of Diabetology
Gender: ALL
Age: OLDER_ADULT
Phases: PHASE4
Enrollment: 1167
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-06-30
Completion Date: 2023-12-31
Results First Posted:
Last Update Posted: 2021-03-12
Locations:
URL: https://clinicaltrials.gov/show/NCT04796428