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NCT Number: NCT06611904

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Urine Albumin (UAlb) Albuminuria Arterial Stiffness Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Glycocalyx Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Attikon University General Hospital

Chaïdári, Attica, 12462, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dulaglutide

Drug

Combined treatment with dulaglutide and dapagliflozin

DPP-4 inhibitors

Drug

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

Primary outcomes

  1. UACR

    Time frame: 4 and 12 months

    UACR change after 4 and 12 months of treatment

  2. PWV

    Time frame: 4 and 12 months

    PWV change after 4 and 12 months of treatment

  3. PBR

    Time frame: 4 and 12 months

    PBR change after 4 and 12 months of treatment

  4. GLS

    Time frame: 4 and 12 months

    GLS change after 4 and 12 months of ttreatment

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2024
First posted
Sep 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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