Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes

What Was Tested

This registered phase 2 trial tested Dulaglutide.

It had two arms (groups): Placebo (placebo comparator) and Dulaglutide (active comparator).

The registry classes the interventions as drug.

More on the Plan

Participants will undergo two study admissions at baseline and 14 weeks.

Prior to each admission, participants will wear a continuous glucose monitor (Dexcom G6 Professional) for 10 days to assess glycemic variability (GV).

Prior to admissions, they will undergo cardiorespiratory fitness testing.

On study admission days, participants will undergo an antecubital vein endothelial cell biopsy prior to commencing vascular testing.

Who Took Part

The registry lists 47 planned participants were the target.

It was open to people of any sex aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18-40 years. BMI 19-34.9 kg/m2. On stable regimen of non-diabetic medications for the last 6 months.

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: pregnancy or currently breastfeeding; smoking history within 6 months; taking vasoactive medications (i.e. calcium channel blockers, angiotensin-converting enzyme or renin inhibitors, angiotensin-receptor blockers, nitrates, alpha-blockers).

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

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

The Dulaglutide group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant, care provider and outcomes assessor.

It started in 2023-10-05 with completion listed for 2028-06-30.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Microvascular blood volume (MBV) (time frame: At baseline and after 14 weeks of treatment).

It also tracked 4 secondary outcomes, for example Brachial artery flow mediated dilation (FMD), Glucose infusion rate (GIR), Cardiorespiratory fitness, maximum consumption of oxygen (VO2max) and Skeletal muscle oxygenation, deoxyhemoglobin (HHb).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Dulaglutide in 47 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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