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

Attikon University Hospital

Status: Active, not recruiting

Conditions: Urine Albumin (UAlb); Arterial Stiffness; Glycocalyx

Treatments: Drug: Dulaglutide; Drug: DPP-4 Inhibitors

Study type: Interventional

Funder types: Other

Identifiers

NCT06611904

456/11-06-2017

Details and patient eligibility

About

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 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Patients receiving dulaglutide and dapagliflozin

Active Comparator group

Description:

Patients with T2DM and albuminuria receiving dulaglutide and dapagliflozin

Treatment:

Drug: Dulaglutide

Patients receiving DPP-4i

Active Comparator group

Description:

Patients with T2DM and albuminuria receiving DPP-4i

Treatment:

Drug: DPP-4 Inhibitors