Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Patient in treatment with Dapagliflozin 10 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10mg | Drug | Treatment of T2D and cardio-renal prevention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variation in glycated hemoglobin (HbA1c) values (% -point) from baseline to 4 months from enrollment | From baseline to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the change in fasting glycemic control (mg/dl) | From baseline to 4 months | |
| Evaluation of Body Mass Index (BMI) (kg/m2) | From baseline to 4 months | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
T2D patients who undergone treatment with Dapagliflozin
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elio Ippolito, MS | Contact | +390239042648 | elio.ippolito@unimi.it |
| Name | Affiliation | Role |
|---|---|---|
| Paolo Fiorina, MD, PhD | University of Milan, ASST-FBF-Sacco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST FBF Sacco | Milan | 20157 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28583425 | Background | Wilding J, Bailey C, Rigney U, Blak B, Kok M, Emmas C. Dapagliflozin therapy for type 2 diabetes in primary care: Changes in HbA1c, weight and blood pressure over 2 years follow-up. Prim Care Diabetes. 2017 Oct;11(5):437-444. doi: 10.1016/j.pcd.2017.04.004. Epub 2017 Jun 2. | |
| 34619106 | Background | Jongs N, Greene T, Chertow GM, McMurray JJV, Langkilde AM, Correa-Rotter R, Rossing P, Sjostrom CD, Stefansson BV, Toto RD, Wheeler DC, Heerspink HJL; DAPA-CKD Trial Committees and Investigators. Effect of dapagliflozin on urinary albumin excretion in patients with chronic kidney disease with and without type 2 diabetes: a prespecified analysis from the DAPA-CKD trial. Lancet Diabetes Endocrinol. 2021 Nov;9(11):755-766. doi: 10.1016/S2213-8587(21)00243-6. Epub 2021 Oct 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C529054 | dapagliflozin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Evaluation of hip and waist circumferences (cm) |
| From baseline to 4 months |
| Evaluation of systolic and diastolic blood pressure (mmHg) | From baseline to 4 months |
| Evaluation of glomerular filtration rate (GFR) (ml/min/1.73m2) | From baseline to 4 months |
| Evaluation of albuminuria (mg/g creatinine) | 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 |
| 30415602 | Background | Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; DECLARE-TIMI 58 Investigators. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019 Jan 24;380(4):347-357. doi: 10.1056/NEJMoa1812389. Epub 2018 Nov 10. |
| 30882238 | Background | Kato ET, Silverman MG, Mosenzon O, Zelniker TA, Cahn A, Furtado RHM, Kuder J, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Bonaca MP, Ruff CT, Desai AS, Goto S, Johansson PA, Gause-Nilsson I, Johanson P, Langkilde AM, Raz I, Sabatine MS, Wiviott SD. Effect of Dapagliflozin on Heart Failure and Mortality in Type 2 Diabetes Mellitus. Circulation. 2019 May 28;139(22):2528-2536. doi: 10.1161/CIRCULATIONAHA.119.040130. Epub 2019 Mar 18. |
| D004700 | Endocrine System Diseases |