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

NCT ID: NCT06611904

Last Updated: 2024-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2024-12-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Urine Albumin (UAlb) Glycocalyx Arterial Stiffness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Patients receiving dulaglutide and dapagliflozin

Patients with T2DM and albuminuria receiving dulaglutide and dapagliflozin

Group Type ACTIVE_COMPARATOR

Dulaglutide

Intervention Type DRUG

Combined treatment with dulaglutide and dapagliflozin

Patients receiving DPP-4i

Patients with T2DM and albuminuria receiving DPP-4i

Group Type ACTIVE_COMPARATOR

DPP-4 Inhibitors

Intervention Type DRUG

DPP-4i treatment as an add-on to metformin

Interventions

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Dulaglutide

Combined treatment with dulaglutide and dapagliflozin

Intervention Type DRUG

DPP-4 Inhibitors

DPP-4i treatment as an add-on to metformin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Attikon Hospital

OTHER

Sponsor Role lead

Responsible Party

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VAIA LAMBADIARI

Professor of Internal Medicine and Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Attikon University General Hospital

Chaïdári, Attica, Greece

Site Status

Countries

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Greece

References

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Lambadiari 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.

Reference Type RESULT
PMID: 31284526 (View on PubMed)

Lambadiari V, Pavlidis G, Kousathana F, Varoudi M, Vlastos D, Maratou E, Georgiou D, Andreadou I, Parissis J, Triantafyllidi H, Lekakis J, Iliodromitis E, Dimitriadis G, Ikonomidis I. 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. Cardiovasc Diabetol. 2018 Jan 8;17(1):8. doi: 10.1186/s12933-017-0646-z.

Reference Type RESULT
PMID: 29310645 (View on PubMed)

Korakas E, Thymis J, Oikonomou E, Mourouzis K, Kountouri A, Pliouta L, Pililis S, Pavlidis G, Lampsas S, Katogiannis K, Palaiodimou L, Tsivgoulis G, Siasos G, Ikonomidis I, Raptis A, Lambadiari V. Dulaglutide and Dapagliflozin Combination Concurrently Improves the Endothelial Glycocalyx and Vascular and Myocardial Function in Patients with T2DM and Albuminuria vs. DPP-4i. J Clin Med. 2024 Dec 10;13(24):7497. doi: 10.3390/jcm13247497.

Reference Type DERIVED
PMID: 39768420 (View on PubMed)

Other Identifiers

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456/11-06-2017

Identifier Type: -

Identifier Source: org_study_id

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