NCT03824002

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for phase_4 diabetes-mellitus

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

December 6, 2018

Last Update Submit

January 29, 2019

Conditions

Diabetes Mellitus

Keywords

diabetes mellitusdulaglutideendothelial function

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Reactive Hyperemia Index at 3 and 9 months

    Endothelial function index RHI

    0 months, 3 months and 9 months

Secondary Outcomes (7)

  • Change from Baseline systolic blood pressure at 3 and 9 months

    0 months, 3 months and 9 months

  • Change from Baseline Body Mass Index at 3 and 9 months

    0 months, 3 months and 9 months

  • Change from Baseline cholesterol at 3 and 9 months

    0 months, 3 months and 9 months

  • Change from Baseline triglycerides at 3 and 9 months

    0 months, 3 months and 9 months

  • Change from Baseline glucose at 3 and 9 months

    0 months, 3 months and 9 months

  • +2 more secondary outcomes

Study Arms (2)

patients treated with dulaglutide

EXPERIMENTAL

Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide

Drug: DulaglutideDrug: Aspart insulinDrug: GlargineDrug: MetforminDrug: Repaglinide

patients not treated with dulaglutide

ACTIVE COMPARATOR

Diabetes therapy with various combinations of aspart insulin, glargine, metformin, repaglinide but without dulaglutide

Drug: Aspart insulinDrug: GlargineDrug: MetforminDrug: Repaglinide

Interventions

DulaglutideDRUG

Diabetes therapy with dulaglutide and various combinations of insulin, metformin, glinides

Also known as: aspart insulin, glargine insulin, metformin, repaglinide
patients treated with dulaglutide
Aspart insulinDRUG

Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide

patients not treated with dulaglutidepatients treated with dulaglutide
GlargineDRUG

Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide

patients not treated with dulaglutidepatients treated with dulaglutide
MetforminDRUG

Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide

patients not treated with dulaglutidepatients treated with dulaglutide
RepaglinideDRUG

Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide

patients not treated with dulaglutidepatients treated with dulaglutide

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diabetes mellitus

You may not qualify if:

  • cancer, severe ckd, end stage liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internal Medicine Ward, University of Palermo

Palermo, 90127, Italy

Location

Related Publications (1)

  • 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.

    PMID: 39963952DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

dulaglutideInsulin AspartInsulin GlargineMetforminrepaglinide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Long-ActingBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University professor

Study Record Dates

First Submitted

December 6, 2018

First Posted

January 31, 2019

Study Start

April 1, 2017

Primary Completion

October 1, 2017

Study Completion

April 20, 2018

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations

IT(1)