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

Not Applicable

Active, not recruiting

• Conditions: Urine Albumin (UAlb); Glycocalyx; Arterial Stiffness
• Interventions: Drug: Dulaglutide; Drug: DPP-4 Inhibitors

• Registration Number: NCT06611904
• Lead Sponsor: Attikon Hospital

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.

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2022-02-05
• Status Verified: 2024-09
• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-22
• Last Update Submitted: 2024-09-22
• Study First Posted: 2024-09-25
• Last Update Posted: 2024-09-25
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients receiving dulaglutide and dapagliflozin	Dulaglutide	Patients with T2DM and albuminuria receiving dulaglutide and dapagliflozin
Patients receiving DPP-4i	DPP-4 Inhibitors	Patients with T2DM and albuminuria receiving DPP-4i

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Attikon University General Hospital; 🇬🇷 Chaidari, Attica, Greece