The Effect of Combined Dulaglutide and Dapagliflozin Treatment vs DPP-4 Inhibitors in Endothelial and Vascular Function in Patients With Type 2 Diabetes Mellitus and Albuminuria

September 22, 2024 updated by: VAIA LAMBADIARI, Attikon Hospital

Study of Endothelial Glycocalyx and Vascular Function in Patients With Type 2 Diabetes and Albuminuria After Administration of Dulaglutide and Dapagliflozin vs DPP-4 Inhibitors

Patients with Type 2 Diabetes Mellitus and albuminuria will be randomised eitheer to dulaglutide and dapagliflozin combination or DPP-4 inhibitor, as an add-on treatment to metformin. Arterial stiffness, UACR, endothelial glycocalyx and global longitudinal strain will be assesed at baseline, 4 and 12 months.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with Type 2 Diabetes Mellitus and albuminuria will be randomised eitheer to dulaglutide and dapagliflozin combination or DPP-4 inhibitor, as an add-on treatment to metformin. Arterial stiffness via pulse wave velocity (PWV), UACR, endothelial glycocalyx via Microscan camera, and global longitudinal strain via echocardiography will be assesed at baseline, 4 and 12 months after treatment.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attica
      • Chaidari, Attica, Greece, 12462
        • Attikon University General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Type 2 diabetes mellitus Albuminuria HbA1c: 7-10% eGFR> 60 ml/min

Exclusion Criteria:

  • Type 1 diabetes mellitus Inflammation, chronic or acute Established cardiovascular disease Malignancy within the last 5 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients receiving dulaglutide and dapagliflozin
Patients with T2DM and albuminuria receiving dulaglutide and dapagliflozin
Drug: Dulaglutide
Combined treatment with dulaglutide and dapagliflozin
Active Comparator: Patients receiving DPP-4i
Patients with T2DM and albuminuria receiving DPP-4i
Drug: DPP-4 Inhibitors
DPP-4i treatment as an add-on to metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UACR
Time Frame: 4 and 12 months
UACR change after 4 and 12 months of treatment
4 and 12 months
PWV
Time Frame: 4 and 12 months
PWV change after 4 and 12 months of treatment
4 and 12 months
PBR
Time Frame: 4 and 12 months
PBR change after 4 and 12 months of treatment
4 and 12 months
GLS
Time Frame: 4 and 12 months
GLS change after 4 and 12 months of ttreatment
4 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Attikon Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

February 5, 2022

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 22, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

September 25, 2024

Last Update Submitted That Met QC Criteria

September 22, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 456/11-06-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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