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

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06611904

Enrollment

Registered

2024-09-25

Start date

2018-02-01

Completion date

2024-12-15

Last updated

2024-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urine Albumin (UAlb), Glycocalyx, Arterial Stiffness

Keywords

type 2 diabetes, albuminuria, arterial stiffness, glycocalyx

Brief summary

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

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

DRUGDulaglutide

Combined treatment with dulaglutide and dapagliflozin

DRUGDPP-4 Inhibitors

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026