The Effects of Dapagliflozin in Normal Clinical Practice in T2D

NCT05418946 | Unknown FDA Drug

• 1 other identifier: 2022002
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Dapagliflozin; Renal function

Outcome Measures

Primary Outcomes (1)

• Variation in glycated hemoglobin (HbA1c) values (% -point) from baseline to 4 months from enrollment

  From baseline to 4 months

Secondary Outcomes (6)

• 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

• 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

Study Arms (1)

Treatment group

Patient in treatment with Dapagliflozin 10 mg/day

Drug: Dapagliflozin 10mg

Interventions

Dapagliflozin 10mg DRUG

Treatment of T2D and cardio-renal prevention

Also known as: Forxiga

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

T2D patients who undergone treatment with Dapagliflozin

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

ASST FBF Sacco

Milan, 20157, Italy

Location

Related Publications (4)

• 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.

  PMID: 28583425 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.

  PMID: 34619106 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.

  PMID: 30415602 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.

  PMID: 30882238 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Paolo Fiorina, MD, PhD

  University of Milan, ASST-FBF-Sacco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elio Ippolito, MS

CONTACT

+390239042648; elio.ippolito@unimi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: June 14, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)