Urine Albumin (UAlb)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
A study testing Dulaglutide and DPP-4 Inhibitors in people with Urine Albumin (UAlb) and Glycocalyx, run by Attikon Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urine Albumin (UAlb), Glycocalyx, Arterial Stiffness
- What is being tested?
- Dulaglutide and DPP-4 Inhibitors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 1 Feb 2018to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus Albuminuria HbA1c: 7-10% eGFR\> 60 ml/min
Who cannot join
- Type 1 diabetes mellitus Inflammation, chronic or acute Established cardiovascular disease Malignancy within the last 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Urine Albumin (UAlb), Glycocalyx, Arterial Stiffness
- Being tested
- Dulaglutide, DPP-4 Inhibitors
- Keywords
- type 2 diabetes, albuminuria, arterial stiffness, glycocalyx
- Medical subject headings
- Diabetes Mellitus, Type 2, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DulaglutideDrug
Combined treatment with dulaglutide and dapagliflozin
DPP-4 InhibitorsDrug
DPP-4i treatment as an add-on to metformin
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving dulaglutide and dapagliflozin | Active comparator | Patients with T2DM and albuminuria receiving dulaglutide and dapagliflozin Receives: Drug: Dulaglutide |
| Patients receiving DPP-4i | Active comparator | Patients with T2DM and albuminuria receiving DPP-4i Receives: Drug: DPP-4 Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
UACR
UACR change after 4 and 12 months of treatment
Measured: 4 and 12 months
PWV
PWV change after 4 and 12 months of treatment
Measured: 4 and 12 months
PBR
PBR change after 4 and 12 months of treatment
Measured: 4 and 12 months
GLS
GLS change after 4 and 12 months of ttreatment
Measured: 4 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Feb 2018
- Primary completion5 Feb 2022
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urine Albumin (UAlb)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VAIA LAMBADIARI, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611904
- Sponsor's protocol ID
- 456/11-06-2017
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31284526Lambadiari 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.
PubMed 29310645Korakas 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.
PubMed 39768420
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06611904
- Acronym / sponsor ID
- 456/11-06-2017
- Conditions
- Urine Albumin (UAlb), Glycocalyx, Arterial Stiffness
- Keywords
- type 2 diabetes, albuminuria, arterial stiffness, glycocalyx
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 5 Feb 2022 (actual)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receiving dulaglutide and dapagliflozin | Active comparator | Drug: DulaglutidePatients with T2DM and albuminuria receiving dulaglutide and dapagliflozin |
| Patients receiving DPP-4i | Active comparator | Drug: DPP-4 InhibitorsPatients with T2DM and albuminuria receiving DPP-4i |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes mellitus Albuminuria HbA1c: 7-10% eGFR\> 60 ml/min
Key exclusion criteria (1 listed)
- Type 1 diabetes mellitus Inflammation, chronic or acute Established cardiovascular disease Malignancy within the last 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DulaglutideCombined treatment with dulaglutide and dapagliflozin | Drug | Patients receiving dulaglutide and dapagliflozin |
| DPP-4 InhibitorsDPP-4i treatment as an add-on to metformin | Drug | Patients receiving DPP-4i |
Primary outcome
UACR
Time frame: 4 and 12 months
UACR change after 4 and 12 months of treatment
PWV
Time frame: 4 and 12 months
PWV change after 4 and 12 months of treatment
PBR
Time frame: 4 and 12 months
PBR change after 4 and 12 months of treatment
GLS
Time frame: 4 and 12 months
GLS change after 4 and 12 months of ttreatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Results publication: PubMed 31284526Lambadiari 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.
- Results publication: PubMed 29310645Lambadiari 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.
- Derived from this study: PubMed 39768420Korakas 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dulaglutide and DPP-4 Inhibitors in people with Urine Albumin (UAlb) and Glycocalyx, run by Attikon Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UACR (time frame: 4 and 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06611904, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.