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Cardiovascular Outcomes SGLT-2 Inhibitors Versus GLP-1 Receptor Agonists

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ClinicalTrials.gov Identifier: NCT04184947
Recruitment Status : Completed
First Posted : December 4, 2019
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
University of Padova

Brief Summary:
Patients with type 2 diabetes (T2D) suffer from an excess risk of adverse cardiovascular events. Recently, two classes of glucose lowering agents, namely SGLT-2 inhibitors (SGLT2i) and GLP-1 receptor agonists (GLP-1RA), have proved superior to placebo in protecting T2D patients from cardiovascular events in dedicated trials. Patient populations in such trials were mainly composed of T2D individuals with established cardiovascular disease (CVD) or at very high risk for CVD. In addition, no clinical trial has so far compared cardiovascular outcomes of T2D associated with SGLT2i versus GLP-1RA. In addition, whether different results would incur in patients at lower CVD risk is unclear. On this basis, we designed this retrospective real-world study to compare cardiovascular outcomes of patients newly treated with SGLT2i versus GLP-1RA in routine clinical practice

Condition or disease Intervention/treatment
Type 2 Diabetes Drug: SGLT2 inhibitor Drug: GLP-1 receptor agonist

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Study Type : Observational
Actual Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cardiovascular Outcomes of Type 2 Diabetic Patients Treated With SGLT-2 Inhibitors Versus GLP-1 Receptor Agonists in Real-life. An Observational Study Using Clinical-administrative Data
Actual Study Start Date : March 1, 2014
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
SGLT2i
Patients who received new prescription of a SGLT-2 inhibitor
Drug: SGLT2 inhibitor
New prescription of a SGLT-2 inhibitor (dapagliflozin, empagliflozin or canagliflozin) at any dosage during routine clinical practice

GLP-1RA
Patients who received new prescription of a GLP-1 receptor agonist
Drug: GLP-1 receptor agonist
New prescription of a GLP-1 receptor agonisty (exenatide, liraglutide, lixisenatide, dulaglutide) at any dosage during routine clinical practice




Primary Outcome Measures :
  1. 3 point major adverse cardiovascular events (4P-MACE) [ Time Frame: 3-26 months after index date ]
    First occurrence of myocardial infarction, stroke, or death


Secondary Outcome Measures :
  1. Hospitalization for cardiovascular causes [ Time Frame: 3-26 months after index date ]
    First hospitalization for any cardiovascular cause

  2. Death [ Time Frame: 3-26 months after index date ]
    All-cause death

  3. Myocardial infarction [ Time Frame: 3-26 months after index date ]
    Myocardial infarction

  4. Heart failure [ Time Frame: 3-26 months after index date ]
    Hospitalization for heart failure

  5. Stroke [ Time Frame: 3-26 months after index date ]
    Stroke or transient ischemic attack

  6. Revascularization [ Time Frame: 3-26 months after index date ]
    Any arterial site revascularization (surgical or endovascular)


Other Outcome Measures:
  1. Occurrence of adverse events [ Time Frame: 3-26 months after index date ]
    Occurrence of: amputation, Fournier's gangrene, bone fracture, diabetic ketoacidosis, infections, pancreatitis, pancreatic cancer, acute kidney injury



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Type 2 diabetes
Criteria

Inclusion Criteria:

  • Italian citizens, residing in the Region
  • Registered as beneficiaries for at least one year between January 1st, 2012 and September 30th, 2018
  • Diagnosis of type 2 diabetes
  • Newly initiating SGLT-2 inhibitors or GLP-1 receptor agonists
  • Being treated with glucose lowering medications before (at least one prescription of an antidiabetic agent in ATC class A10B prior to the index date)
  • Time between the index date and the last SGLT2 inhibitors or GLP-1 receptor agonists prescription shorter than 8 months,
  • Follow-up time or time-to-endpoint of at least three months

Exclusion Criteria:

  • Patients who started SGLT2i or GLP-1RA before 2014
  • Patients with an insufficient exposure time
  • Patients with an incident event within three months after the index date.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04184947


Locations
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Italy
Division of Metabolic Diseases, University Hospital of Padova
Padova, Italy, 35128
Sponsors and Collaborators
University of Padova
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Padova
ClinicalTrials.gov Identifier: NCT04184947    
Other Study ID Numbers: DIMEDDEI3
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data cannot be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs