DRUG
Dulaglutide
Combined treatment with dulaglutide and dapagliflozin
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
Status
Active, not recruiting
Phase
Not applicable
Enrollment
60
Locations
1
Results
Not posted
Publications
3
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
DRUG
DPP-4 Inhibitors
DPP-4i treatment as an add-on to metformin
Timeline
From registration to results.
First posted
Sep 25, 2024
Study start
Feb 1, 2018
Primary completion
Feb 5, 2022
Study completion
Dec 15, 2024
Results posted
Not reported
Registry updated
Sep 25, 2024
Outcomes
What the study measures.
Primary outcomes
UACR
Time frame · 4 and 12 months
UACR change after 4 and 12 months of treatment
PWV
Time frame · 4 and 12 months
PWV change after 4 and 12 months of treatment
PBR
Time frame · 4 and 12 months
PBR change after 4 and 12 months of treatment
GLS
Time frame · 4 and 12 months
GLS change after 4 and 12 months of ttreatment
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Sex
- ALL
- Healthy volunteers
- No
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 locations
1 registered sites.
Greece. Showing up to 24 locations stored in the fast local snapshot.
Attikon University General Hospital
Chaïdári, Attica, Greece
Publications
Results and literature.
PMID 31284526 ↗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.PMID 29310645 ↗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.PMID 39768420 ↗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.
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