The Effects of Dapagliflozin in Normal Clinical Practice in T2D (PRECARE)

June 13, 2022 updated by: Paolo Fiorina, MD, University of Milan

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20157
        • ASST FBF Sacco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

T2D patients who undergone treatment with Dapagliflozin

Description

Inclusion Criteria:

  • Diagnosis of type II diabetes mellitus, according to ADA indications for at least 3 months
  • Males or females> 18 years old
  • Stable therapy for at least 3 months with oral hypoglycemic agents / insulin
  • Prescription of Dapagliflozin®, according to normal clinical practice and local indications for the prescription / reimbursement of the drug.

Exclusion Criteria:

  • Mental incapacity, unavailability or language barriers that preclude adequate understanding or cooperation;
  • Diagnosis of type 1 diabetes mellitus, maturity-onset diabetes of the young (MODY), latent autoimmune diabetes in adults (LADA), gestational diabetes mellitus, secondary diabetes mellitus or any other hyperglycemic state other than type 2 diabetes (T2D);
  • Women who are pregnant or breastfeeding, or women planning to become pregnant;
  • Previous participation in the study. Participation is defined by having given informed consent to the study;
  • Participation in another clinical study on T2D that includes any clinical intervention or administration of an investigational drug within 3 months prior to enrollment in the study;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment group
Patient in treatment with Dapagliflozin 10 mg/day
Drug: Dapagliflozin 10mg
Treatment of T2D and cardio-renal prevention
Other Names:
  • Forxiga

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variation in glycated hemoglobin (HbA1c) values (% -point) from baseline to 4 months from enrollment
Time Frame: From baseline to 4 months
From baseline to 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the change in fasting glycemic control (mg/dl)
Time Frame: From baseline to 4 months
From baseline to 4 months
Evaluation of Body Mass Index (BMI) (kg/m2)
Time Frame: From baseline to 4 months
From baseline to 4 months
Evaluation of hip and waist circumferences (cm)
Time Frame: From baseline to 4 months
From baseline to 4 months
Evaluation of systolic and diastolic blood pressure (mmHg)
Time Frame: From baseline to 4 months
From baseline to 4 months
Evaluation of glomerular filtration rate (GFR) (ml/min/1.73m2)
Time Frame: From baseline to 4 months
From baseline to 4 months
Evaluation of albuminuria (mg/g creatinine)
Time Frame: From baseline to 4 months
Albuminuria will be assessed as albumin to creatinine ratio (ACR) which is obtained from the ratio of urinary protein concentration to creatinine in spot urine
From baseline to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Investigators

  • Principal Investigator: Paolo Fiorina, MD, PhD, University of Milan, ASST-FBF-Sacco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

April 13, 2022

First Submitted That Met QC Criteria

June 13, 2022

First Posted (Actual)

June 14, 2022

Study Record Updates

Last Update Posted (Actual)

June 14, 2022

Last Update Submitted That Met QC Criteria

June 13, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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