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

What Was Tested

The trial (phase 4) is built around Insulin Glargine and Dulaglutide.

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.

It had two arms (groups): patients treated with dulaglutide (experimental) and patients not treated with dulaglutide (active comparator).

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

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

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 92 actual participants took part.

It was open to people of any sex aged from 18 years up to 90 years.

Healthy volunteers could join, not only people with the condition.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: cancer, severe ckd, end stage liver disease.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Insulin Glargine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and care provider.

It started in 2017-04-01 with completion listed for 2017-10-01.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from Baseline Reactive Hyperemia Index at 3 and 9 months (time frame: 0 months, 3 months and 9 months).

It also tracked 7 secondary outcomes, for example Change from Baseline systolic blood pressure at 3 and 9 months, Change from Baseline Body Mass Index at 3 and 9 months, Change from Baseline cholesterol at 3 and 9 months, Change from Baseline triglycerides at 3 and 9 months, Change from Baseline glucose at 3 and 9 months and Change from Baseline diastolic blood pressure at 3 and 9 months.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Dulaglutide in 92 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page and the Dulaglutide compound page, all human trials.