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Clinical Trial Details

Trial ID: L3337
Source ID: NCT05477017
Associated Drug: Sglt2 Inhibitor
Title: Evaluation of SGLT2-i Effectivness and Safety in Elderly Type 2 Diabetes Patients
Acronym: SOLDMiDiab02
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type2Diabetes
Interventions: DRUG: SGLT2 inhibitor
Outcome Measures: Primary: Variation in HbA1c values (% -point), Variation in HbA1c values (% -point) from baseline to 12 months from enrollment, From Baseline to 12 months | Secondary: Evaluation of the maintenance of glycemic compensation, Evaluation of the maintenance of glycemic compensation after the initiation of glycosuric therapy in clinical practice, From Baseline to 12 months|Evaluation of fasting glycemic control, Evaluation of fasting glycemic control (mg/dl), From Baseline to 12 months|Evaluation of the weight, Evaluation of the weight (Kg), From Baseline to 12 months|Evaluation of the BMI, Evaluation of the BMI (Kg/m2), From Baseline to 12 months|Evaluation of the waist circumference, Evaluation of the waist circumference (cm), From Baseline to 12 months|Evaluation of the systolic and diastolic pressure, Evaluation of the systolic and diastolic pressure (mmHg), From Baseline to 12 months|Evaluation of the heart rate, Evaluation of the heart rate (bpm), From Baseline to 12 months|Evaluation of the serum creatinine, Evaluation of the serum creatinine (mg/dl), From Baseline to 12 months|Evaluation of the e-GFR, Evaluation of the e-GFR (mL/min/1.73m2), From Baseline to 12 months|Evaluation of the main side effects and the withdrawal rate, Evaluation of the main side effects and the withdrawal ratein the first year of treatment. It will be evalueted through scheduled clinical visit, From Baseline to 12 months
Sponsor/Collaborators: Sponsor: University of Milan
Gender: ALL
Age: OLDER_ADULT
Phases:
Enrollment: 800
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2022-09
Completion Date: 2023-03
Results First Posted:
Last Update Posted: 2022-07-28
Locations: ASST FBF Sacco, Milan, 20157, Italy
URL: https://clinicaltrials.gov/show/NCT05477017