Diabetes MellitusPhase 4NCT03824002
Dulaglutide in Diabetic Patients, Relationship Between Arterial Stiffness, Endothelial Function, Clinical and Laboratory Variables
A Phase 4 study testing Dulaglutide, Aspart insulin and Glargine in people with Diabetes Mellitus, run by University of Palermo at 1 site in Italy.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Dulaglutide, Aspart insulin and Glargine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2017to 20 Apr 2018
- Phase
- Phase 4
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diabetes mellitus
Who cannot join
- cancer, severe ckd, end stage liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arterial Stiffness and Endothelial Function Indexes, Relationships With Clinical and Laboratory Variables in a Group of Diabetic Patients in Treatment With Dulaglutide: a Case-control Study
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
Read the detailed description
46 patients with type 2 diabetes mellitus were recruited at the Internal Medicine with Stroke care ward of the University hospital of Palermo "P. Giaccone" from April 2017 to April 2018. For all patients treatment with dulaglutide was undertaken. As control group were recruited 46 patients from the same ward not affected by diabetes mellitus or affected by diabetes mellitus but not in treatment with dulaglutide.
The study was carried out in accordance with the principles of the Helsinki Declaration revised in 2001 and all patients gave their written consent to take part in this research.
Each patient treated with dulaglutide was compared for age, sex and cardiovascular risk with control patients. The diagnosis of type 2 diabetes mellitus was based on the revised criteria of the American Diabetes Association (ADA), and using a clinical algorithm that considered the age of onset of the disease, the symptoms and weight present, the family history and the therapy practiced. Arterial hypertension was defined according to the 2017 ESC-ESH criteria. Dyslipidemia was defined based on total cholesterol levels> 200 mg/dl, triglycerides> 150 mg/dl and HDL levels <40 mg/dl regardless of the patient's gender.
Among the cases enrolled, 46 (100%) had type 2 diabetes mellitus, 37 (80.43%) had arterial hypertension and 26 (56.52%) hypercholesterolemia.
Clinical and anthropometric data were collected at the time of recruitment. Blood samples were taken from each patient (cases and controls) to determine serum glucose, HbA1c, total cholesterol, HDL and LDL cholesterol, triglycerides, creatinine, and a urine sample to assess the presence of microalbuminuria. These withdrawals were then repeated three months and nine months from the time of recruitment.
The digital endothelial function was evaluated through the RHI-pat analysis using Endo-PAT2000. Pulse Wave Velocity (PWV) Carotid-Femoral Pulse was measured in the supine position using an automatic device (SphygmoCor version 7.1) that evaluated the propagation time of the sphygmic wave between the carotid and femoral pulse.
- Conditions
- Diabetes Mellitus
- Being tested
- Dulaglutide, Aspart insulin, Glargine, Metformin, Repaglinide
- Keywords
- diabetes mellitus, dulaglutide, endothelial function
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DulaglutideDrug
Also called aspart insulin, glargine insulin, metformin, repaglinide
Diabetes therapy with dulaglutide and various combinations of insulin, metformin, glinides
Aspart insulinDrug
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
GlargineDrug
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
MetforminDrug
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
RepaglinideDrug
Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
| Study group | Role | What they receive |
|---|---|---|
| patients treated with dulaglutide | Experimental | Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide Receives: Drug: Dulaglutide; Drug: Aspart insulin; Drug: Glargine; Drug: Metformin; Drug: Repaglinide |
| patients not treated with dulaglutide | Active comparator | Diabetes therapy with various combinations of aspart insulin, glargine, metformin, repaglinide but without dulaglutide Receives: Drug: Aspart insulin; Drug: Glargine; Drug: Metformin; Drug: Repaglinide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Reactive Hyperemia Index at 3 and 9 months
Endothelial function index RHI
Measured: 0 months, 3 months and 9 months
Secondary outcomes (7)
Change from Baseline systolic blood pressure at 3 and 9 months
systolic blood pressure in mmHg
Measured: 0 months, 3 months and 9 months
Change from Baseline Body Mass Index at 3 and 9 months
weight and height will be combined to report BMI in kg/m^2
Measured: 0 months, 3 months and 9 months
Change from Baseline cholesterol at 3 and 9 months
blood cholesterol in mg/dl
Measured: 0 months, 3 months and 9 months
Change from Baseline triglycerides at 3 and 9 months
blood triglycerides in mg/dl
Measured: 0 months, 3 months and 9 months
Change from Baseline glucose at 3 and 9 months
fasting blood glucose in mg/dl
Measured: 0 months, 3 months and 9 months
Change from Baseline diastolic blood pressure at 3 and 9 months
diastolic blood pressure in mmHg
Measured: 0 months, 3 months and 9 months
Change from Baseline Pulse Wave Velocity at 3 and 9 months
Pulse Wave Velocity in m/s
Measured: 0 months, 3 months and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start1 Apr 2017
- Primary completion1 Oct 2017
- Study completion20 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonino Tuttolomondo, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824002
- Sponsor's protocol ID
- 21772
- Status last verified
- Jan 2019
- First submitted
- 6 Dec 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
PubMed 39963952
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Stiffness and Endothelial Function Indexes, Relationships With Clinical and Laboratory Variables in a Group of Diabetic Patients in Treatment With Dulaglutide: a Case-control Study
- ClinicalTrials.gov ID
- NCT03824002
- Acronym / sponsor ID
- 21772
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes mellitus, dulaglutide, endothelial function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 31 Jan 2019 (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.
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
Detailed description
46 patients with type 2 diabetes mellitus were recruited at the Internal Medicine with Stroke care ward of the University hospital of Palermo "P. Giaccone" from April 2017 to April 2018. For all patients treatment with dulaglutide was undertaken. As control group were recruited 46 patients from the same ward not affected by diabetes mellitus or affected by diabetes mellitus but not in treatment with dulaglutide.
The study was carried out in accordance with the principles of the Helsinki Declaration revised in 2001 and all patients gave their written consent to take part in this research.
Each patient treated with dulaglutide was compared for age, sex and cardiovascular risk with control patients. The diagnosis of type 2 diabetes mellitus was based on the revised criteria of the American Diabetes Association (ADA), and using a clinical algorithm that considered the age of onset of the disease, the symptoms and weight present, the family history and the therapy practiced. Arterial hypertension was defined according to the 2017 ESC-ESH criteria. Dyslipidemia was defined based on total cholesterol levels> 200 mg/dl, triglycerides> 150 mg/dl and HDL levels <40 mg/dl regardless of the patient's gender.
Among the cases enrolled, 46 (100%) had type 2 diabetes mellitus, 37 (80.43%) had arterial hypertension and 26 (56.52%) hypercholesterolemia.
Clinical and anthropometric data were collected at the time of recruitment. Blood samples were taken from each patient (cases and controls) to determine serum glucose, HbA1c, total cholesterol, HDL and LDL cholesterol, triglycerides, creatinine, and a urine sample to assess the presence of microalbuminuria. These withdrawals were then repeated three months and nine months from the time of recruitment.
The digital endothelial function was evaluated through the RHI-pat analysis using Endo-PAT2000. Pulse Wave Velocity (PWV) Carotid-Femoral Pulse was measured in the supine position using an automatic device (SphygmoCor version 7.1) that evaluated the propagation time of the sphygmic wave between the carotid and femoral pulse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients treated with dulaglutide | Experimental | Drug: Dulaglutide, Drug: Aspart insulin, Drug: Glargine, Drug: Metformin, Drug: RepaglinideDiabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide |
| patients not treated with dulaglutide | Active comparator | Drug: Aspart insulin, Drug: Glargine, Drug: Metformin, Drug: RepaglinideDiabetes therapy with various combinations of aspart insulin, glargine, metformin, repaglinide but without dulaglutide |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diabetes mellitus
Key exclusion criteria (1 listed)
- cancer, severe ckd, end stage liver disease
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 |
|---|---|---|
| DulaglutideAlso: aspart insulin, glargine insulin, metformin, repaglinideDiabetes therapy with dulaglutide and various combinations of insulin, metformin, glinides | Drug | patients treated with dulaglutide |
| Aspart insulinDiabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide | Drug | patients not treated with dulaglutide, patients treated with dulaglutide |
| GlargineDiabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide | Drug | patients not treated with dulaglutide, patients treated with dulaglutide |
| MetforminDiabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide | Drug | patients not treated with dulaglutide, patients treated with dulaglutide |
| RepaglinideDiabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide | Drug | patients not treated with dulaglutide, patients treated with dulaglutide |
Primary outcome
Change from Baseline Reactive Hyperemia Index at 3 and 9 months
Time frame: 0 months, 3 months and 9 months
Endothelial function index RHI
7 secondary outcomes
Change from Baseline systolic blood pressure at 3 and 9 months
Time frame: 0 months, 3 months and 9 months
Change from Baseline Body Mass Index at 3 and 9 months
Time frame: 0 months, 3 months and 9 months
Change from Baseline cholesterol at 3 and 9 months
Time frame: 0 months, 3 months and 9 months
Change from Baseline triglycerides at 3 and 9 months
Time frame: 0 months, 3 months and 9 months
Change from Baseline glucose at 3 and 9 months
Time frame: 0 months, 3 months and 9 months
Change from Baseline diastolic blood pressure at 3 and 9 months
Time frame: 0 months, 3 months and 9 months
Change from Baseline Pulse Wave Velocity at 3 and 9 months
Time frame: 0 months, 3 months and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Derived from this study: PubMed 39963952Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
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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 Phase 4 study testing Dulaglutide, Aspart insulin and Glargine in people with Diabetes Mellitus, run by University of Palermo at 1 site in Italy.
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: finished, as of the sponsor's last update on 31 Jan 2019. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline Reactive Hyperemia Index at 3 and 9 months (time frame: 0 months, 3 months and 9 months). 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 NCT03824002, which also lists 1 linked publication.
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 31 Jan 2019.