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

What Was Tested

This registered not phased trial tested Dulaglutide.

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.

It had two arms (groups): Patients receiving dulaglutide and dapagliflozin (active comparator) and Patients receiving DPP-4i (active comparator).

Patients with T2DM and albuminuria receiving dulaglutide and dapagliflozin.

Patients with T2DM and albuminuria receiving DPP-4i.

The registry classes the interventions as drug.

More on the Plan

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 Took Part

The registry lists 60 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: type 1 diabetes mellitus inflammation, chronic or acute established cardiovascular disease malignancy within the last 5 years.

How the Study Was Run

Design: randomized, single-group and open-label.

The participants were allocated by chance, so the Dulaglutide group and the comparison group should start out alike.

Being open-label, the Dulaglutide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2018-02-01 with completion listed for 2022-02-05.

It ran at 1 site in Greece.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: UACR (time frame: 4 and 12 months). PWV (time frame: 4 and 12 months). PBR (time frame: 4 and 12 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Dulaglutide in 60 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Dulaglutide compound page, all human trials.