Clinical trial NCT05418946: The Effects of Dapagliflozin in Normal Clinical Practice in T2D
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes
Keywords: Dapagliflozin
Renal function
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: T2D patients who undergone treatment with Dapagliflozin

Brief 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Variation in glycated hemoglobin (HbA1c) values (% -point) from baseline to 4 months from enrollment
timeFrame: From baseline to 4 months
Secondary outcomes:
measure: Assessment of the change in fasting glycemic control (mg/dl)
timeFrame: From baseline to 4 months
measure: Evaluation of Body Mass Index (BMI) (kg/m2)
timeFrame: From baseline to 4 months
measure: Evaluation of hip and waist circumferences (cm)
timeFrame: From baseline to 4 months
measure: Evaluation of systolic and diastolic blood pressure (mmHg)
timeFrame: From baseline to 4 months
measure: Evaluation of glomerular filtration rate (GFR) (ml/min/1.73m2)
timeFrame: From baseline to 4 months
measure: Evaluation of albuminuria (mg/g creatinine)
timeFrame: From baseline to 4 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: ASST FBF Sacco
Study officials:
affiliation: University of Milan, ASST-FBF-Sacco
name: Paolo Fiorina, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.