Trial · Interventional

CompletedPhase 4Registry data

Dulaglutide in Diabetic Patients, Relationship Between Arterial Stiffness, Endothelial Function, Clinical and Laboratory Variables

NCTNCT03824002Other id21772

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 92 participants (actual)
Sponsor: University of Palermo · Other
Design: Randomized · Double masking
Countries: 1 country
Italy
Start: 1 Apr 2017
Primary completion: 1 Oct 2017
Completion: 20 Apr 2018
First posted: 31 Jan 2019
Last update posted: 31 Jan 2019
Conditions: Diabetes Mellitus

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201720182019

Ph 4
Dulaglutide in Diabetic Patients, Relationship Between Arterial Stiffness, Endothelial Function, Clinical and Laboratory Variables
NCT03824002
1 Apr 2017 to 20 Apr 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The study aims to evaluate arterial stiffness and endothelial function indexes and their relationship with clinic and laboratory varible in a group of diabetic patients in treatment with dulaglutide

Interventions

DulaglutideDrug
Aspart insulinDrug
GlargineDrug
MetforminDrug
RepaglinideDrug

Arms2

Experimental
patients treated with dulaglutide
Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide
Active comparator
patients not treated with dulaglutide
Diabetes therapy with various combinations of aspart insulin, glargine, metformin, repaglinide but without dulaglutide

Primary outcomes1

Outcomes the sponsor listed as primary.

Change from Baseline Reactive Hyperemia Index at 3 and 9 months
Time frame · 0 months, 3 months and 9 months
Registry description
Endothelial function index RHI

Secondary outcomes(7)

Change from Baseline systolic blood pressure at 3 and 9 months
Time frame · 0 months, 3 months and 9 months
Registry description
systolic blood pressure in mmHg
Change from Baseline Body Mass Index at 3 and 9 months
Time frame · 0 months, 3 months and 9 months
Registry description
weight and height will be combined to report BMI in kg/m\^2
Change from Baseline cholesterol at 3 and 9 months
Time frame · 0 months, 3 months and 9 months
Registry description
blood cholesterol in mg/dl
Change from Baseline triglycerides at 3 and 9 months
Time frame · 0 months, 3 months and 9 months
Registry description
blood triglycerides in mg/dl
Change from Baseline glucose at 3 and 9 months
Time frame · 0 months, 3 months and 9 months
Registry description
fasting blood glucose in mg/dl
Change from Baseline diastolic blood pressure at 3 and 9 months
Time frame · 0 months, 3 months and 9 months
Registry description
diastolic blood pressure in mmHg
Change from Baseline Pulse Wave Velocity at 3 and 9 months
Time frame · 0 months, 3 months and 9 months
Registry description
Pulse Wave Velocity in m/s

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Meta-analysis (pooled) · 2025

15 results

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.

Natale et al. 2025The Cochrane database of systematic reviewscited by 8

PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952

Rights unknown15 results

Source link See results (15)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 90 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * diabetes mellitus Exclusion Criteria: * cancer, severe ckd, end stage liver disease

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