NCT05418946

The Effects of Dapagliflozin in Normal Clinical Practice in T2D

Observational Retrospective Cohort Study to Evaluate the Benefits, Documented in Experimental Settings, of Treatment With DAPAGLIFLOZIN in Normal Clinical Practice, in Subjects With Type 2 Diabetes

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,400 (estimated)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the benefits, documented in experimental settings, of treatment with Dapagliflozin in subjects with type 2 diabetes in normal clinical practice. The type of study does not involve immediate risks or direct benefits for the subjects taking part in it. The potential benefits for clinicians and healthcare systems are: greater knowledge of diabetic disease and the study of new treatment options. However, the analysis of the data will allow us to better identify which patients benefit most from treatment with Dapagliflozin.

Detailed description

An observational, multicentric, non-interventional, non-profit, single-arm, retrospective prospective study is proposed, aimed at investigating the therapeutic efficacy at 4 months of a treatment with Dapagliflozin® in subjects with type 2 diabetes mellitus belonging to the Lombard centers who joined the study. Patient recruitment will be carried out at the Unit of Endocrine Diseases and Diabetology in the L. Sacco, Fatebenefratelli and Oftalmico e Macedonio Melloni hospitals, directed by Prof. Paolo Fiorina. Upon enrollment, the informed consent signed and dated by the doctor who informed the patient and by the patient himself will be collected as well as the patient's medical and anamnestic data. This study does not foresee that additional diagnostic or monitoring procedures will be implemented on patients outside of normal clinical practice. The duration of the study per patient after enrollment is 6 months. This study involves the collection of retrospective data (review of patient medical records). The collection of retrospective data will be done to study the clinical characteristics of the patients at the time they started Dapagliflozin®. The study aims to compare the results reported in the literature with the efficacy outcomes in real-life; to this end, the main clinical and biometric parameters of adult patients with type 2 diabetes belonging to the centers that have joined the study and have been on therapy with Dapagliflozin® for at least 4 months will be collected. By compiling an online database, the parameters and the respective 4-month variations will be entered anonymously and processed in an aggregate manner in compliance with current regulations and regulatory activities for the conduct of observational retrospective studies. The insertion of the observations will end after 6 months from the authorization.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10mg	Treatment of T2D and cardio-renal prevention

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2022-06-14
• Last updated: 2022-06-14

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study