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Type 2 DiabetesPRECARENCT05418946

The Effects of Dapagliflozin in Normal Clinical Practice in T2D

An observational study of Type 2 Diabetes, run by University of Milan at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Dapagliflozin 10mg
How many people
1,400 participants
Where
1 siteItaly
Study dates
Jun 2022to Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: T2D patients who undergone treatment with Dapagliflozin

Who may be able to join

  • 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.

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

Elio Ippolito, MS contact

+390239042648

elio.ippolito@unimi.it

Italy1 site

  • ASST FBF Sacco

    Milan, 20157

Other trials in Italy

About this study

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

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.

Read the 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
Being tested
Dapagliflozin 10mg
Keywords
Dapagliflozin, Renal function
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dapagliflozin 10mgDrug

    Also called Forxiga

    Treatment of T2D and cardio-renal prevention

Study groups in NCT05418946
Study groupRoleWhat they receive
Treatment groupPatient in treatment with Dapagliflozin 10 mg/day
Receives: Drug: Dapagliflozin 10mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: From baseline to 4 months

Secondary outcomes (6)

  1. Assessment of the change in fasting glycemic control (mg/dl)

    Measured: From baseline to 4 months

  2. Evaluation of Body Mass Index (BMI) (kg/m2)

    Measured: From baseline to 4 months

  3. Evaluation of hip and waist circumferences (cm)

    Measured: From baseline to 4 months

  4. Evaluation of systolic and diastolic blood pressure (mmHg)

    Measured: From baseline to 4 months

  5. Evaluation of glomerular filtration rate (GFR) (ml/min/1.73m2)

    Measured: From baseline to 4 months

  6. 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

    Measured: From baseline to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2022
  2. Study startJun 2022 (estimated)
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05418946
Sponsor's protocol ID
2022002
Acronym
PRECARE
Status last verified
Jun 2022
First submitted
13 Apr 2022
Last updated
14 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28583425

  • 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.

    PubMed 34619106

  • 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.

    PubMed 30415602

  • 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.

    PubMed 30882238

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes, run by University of Milan at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Elio Ippolito, MS (+390239042648, elio.ippolito@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variation in glycated hemoglobin (HbA1c) values (% -point) from baseline to 4 months from enrollment (time frame: From baseline to 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05418946, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.

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