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

Sponsor
University of Palermo
Study ID
NCT03824002
Phase
PHASE4
Status
Completed

Conditions

  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Dulaglutide — DRUG
    Diabetes therapy with dulaglutide and various combinations of insulin, metformin, glinides
  • Aspart insulin — DRUG
    Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
  • Glargine — DRUG
    Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
  • Metformin — DRUG
    Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
  • Repaglinide — DRUG
    Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide

Study Details

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

Key Dates

Start date
Apr 1, 2017
Status verified
Jan 2019
Primary completion
Oct 1, 2017
Completion
Apr 20, 2018

Study Design

Enrollment
92 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 Outcome Measure

Change from Baseline Reactive Hyperemia Index at 3 and 9 months [ Time Frame: 0 months, 3 months and 9 months ]

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