NCT06611904

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

4 years

First QC Date

September 20, 2024

Last Update Submit

September 22, 2024

Conditions

Urine Albumin (UAlb)GlycocalyxArterial Stiffness

Keywords

type 2 diabetesalbuminuriaarterial stiffnessglycocalyx

Outcome Measures

Primary Outcomes (4)

  • UACR

    UACR change after 4 and 12 months of treatment

    4 and 12 months

  • PWV

    PWV change after 4 and 12 months of treatment

    4 and 12 months

  • PBR

    PBR change after 4 and 12 months of treatment

    4 and 12 months

  • GLS

    GLS change after 4 and 12 months of ttreatment

    4 and 12 months

Study Arms (2)

Patients receiving dulaglutide and dapagliflozin

ACTIVE COMPARATOR

Patients with T2DM and albuminuria receiving dulaglutide and dapagliflozin

Drug: Dulaglutide

Patients receiving DPP-4i

ACTIVE COMPARATOR

Patients with T2DM and albuminuria receiving DPP-4i

Drug: DPP-4 Inhibitors

Interventions

DulaglutideDRUG

Combined treatment with dulaglutide and dapagliflozin

Patients receiving dulaglutide and dapagliflozin
DPP-4 InhibitorsDRUG

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

Patients receiving DPP-4i

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus Albuminuria HbA1c: 7-10% eGFR\> 60 ml/min

You may not qualify if:

  • Type 1 diabetes mellitus Inflammation, chronic or acute Established cardiovascular disease Malignancy within the last 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Attikon University General Hospital

Chaïdári, Attica, 12462, Greece

Location

Related Publications (3)

  • Lambadiari V, Pavlidis G, Kousathana F, Maratou E, Georgiou D, Andreadou I, Kountouri A, Varoudi M, Balampanis K, Parissis J, Triantafyllidi H, Katogiannis K, Birba D, Lekakis J, Dimitriadis G, Ikonomidis I. Effects of Different Antidiabetic Medications on Endothelial Glycocalyx, Myocardial Function, and Vascular Function in Type 2 Diabetic Patients: One Year Follow-Up Study. J Clin Med. 2019 Jul 5;8(7):983. doi: 10.3390/jcm8070983.

    PMID: 31284526RESULT

  • Lambadiari V, Pavlidis G, Kousathana F, Varoudi M, Vlastos D, Maratou E, Georgiou D, Andreadou I, Parissis J, Triantafyllidi H, Lekakis J, Iliodromitis E, Dimitriadis G, Ikonomidis I. Effects of 6-month treatment with the glucagon like peptide-1 analogue liraglutide on arterial stiffness, left ventricular myocardial deformation and oxidative stress in subjects with newly diagnosed type 2 diabetes. Cardiovasc Diabetol. 2018 Jan 8;17(1):8. doi: 10.1186/s12933-017-0646-z.

    PMID: 29310645RESULT

  • Korakas E, Thymis J, Oikonomou E, Mourouzis K, Kountouri A, Pliouta L, Pililis S, Pavlidis G, Lampsas S, Katogiannis K, Palaiodimou L, Tsivgoulis G, Siasos G, Ikonomidis I, Raptis A, Lambadiari V. Dulaglutide and Dapagliflozin Combination Concurrently Improves the Endothelial Glycocalyx and Vascular and Myocardial Function in Patients with T2DM and Albuminuria vs. DPP-4i. J Clin Med. 2024 Dec 10;13(24):7497. doi: 10.3390/jcm13247497.

    PMID: 39768420DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Albuminuria

Interventions

dulaglutideDipeptidyl-Peptidase IV Inhibitors

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesProteinuriaUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Protease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of Drugs

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine and Endocrinology

Study Record Dates

First Submitted

September 20, 2024

First Posted

September 25, 2024

Study Start

February 1, 2018

Primary Completion

February 5, 2022

Study Completion

December 15, 2024

Last Updated

September 25, 2024

Record last verified: 2024-09

Locations

GR(1)