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Trial · Interventional

Status unknownNot applicableRegistry data

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

NCTNCT06611904 (opens ClinicalTrials.gov in a new tab)Other id456/11-06-2017
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Not applicable
Enrollment
60 participants (actual)
Sponsor
Attikon Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Greece

Start
1 Feb 2018
Primary completion
5 Feb 2022
Completion
15 Dec 2024 (estimated)
First posted
25 Sept 2024
Last update posted
25 Sept 2024
Conditions
Urine Albumin (UAlb) · Glycocalyx · Arterial Stiffness

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018202020222024
  1. N/A

    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

    NCT06611904

    1 Feb 2018 to est. 15 Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DulaglutideDrug
  • DPP-4 InhibitorsDrug

Arms2

  • Active comparator

    Patients receiving dulaglutide and dapagliflozin

    Patients with T2DM and albuminuria receiving dulaglutide and dapagliflozin

  • Active comparator

    Patients receiving DPP-4i

    Patients with T2DM and albuminuria receiving DPP-4i

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. UACR

    Time frame · 4 and 12 months

    Registry description

    UACR change after 4 and 12 months of treatment

  2. PWV

    Time frame · 4 and 12 months

    Registry description

    PWV change after 4 and 12 months of treatment

  3. PBR

    Time frame · 4 and 12 months

    Registry description

    PBR change after 4 and 12 months of treatment

  4. GLS

    Time frame · 4 and 12 months

    Registry description

    GLS change after 4 and 12 months of ttreatment

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

PubMed tag: none · 2024

5 results

Dulaglutide and Dapagliflozin Combination Concurrently Improves the Endothelial Glycocalyx and Vascular and Myocardial Function in Patients with T2DM and Albuminuria vs. DPP-4i.

Korakas et al. 2024Journal of clinical medicinecited by 3

PMID 39768420PMC11678541DOI 10.3390/jcm13247497PUB-39768420

CC BY5 results
Download PDFSee results (5)

Indexing hint: Randomized controlled trial · 2018

9 results

Effects of 6-month treatment with the glucagon like peptide-1 analogue liraglutide on arterial stiffness, left ventricular myocardial deformation and oxidative stress in subjects with newly diagnosed type 2 diabetes.

Lambadiari et al. 2018Cardiovascular diabetologycited by 127

PMID 29310645PMC5759220DOI 10.1186/s12933-017-0646-zPUB-29310645

CC BY9 results
Download PDFSee results (9)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultLambadiari V, Pavlidis G, Kousathana F, Maratou E, Georgiou D, Andreadou I, Kountouri A, Varoudi M, Balampanis K, Parissis J, Triantafyllidi H, Katogiannis K, Birba D, Lekakis J, Dimitriadis G, Ikonomidis I. Effects of Different Antidiabetic Medications on Endothelial Glycocalyx, Myocardial Function, and Vascular Function in Type 2 Diabetic Patients: One Year Follow-Up Study. J Clin Med. 2019 Jul 5;8(7):983. doi: 10.3390/jcm8070983. PMID 31284526

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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