Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

What Was Tested

This registered phase 3 trial tested Semaglutide.

This trial plans to learn more about the effects of a medication, semaglutide, on cardiovascular function, kidney function, and insulin sensitivity in adults with type 1 diabetes.

This study aims to look at how well the medication works in people with type 1 diabetes.

It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 49 years.

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

Examples of who could join: Age 18-49 years. 1\) T1D diagnosis defined as positive T1D-associated antibody(ies) or 2) a clinical diagnosis of T1D plus insulin requirement since diagnosis. Insulin pump or automated insulin delivery systems. BMI 20-45 kg/m2. Adequate contraceptive method for females.

The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: history/family history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (men2), pancreatitis; current/planned pregnancy or nursing; uncontrolled thyroid disease or hypertension (htn) (≥ 160/100 mm hg despite optimal therapy).

How the Study Was Run

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

Because people in this Semaglutide 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.

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

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

It started in 2023-06-21 with completion listed for 2027-10-01.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Ascending Aortic Pulse Wave Velocity (AA PWV) (time frame: Baseline, month 8). Change in Carotid and Femoral Artery Pulse Wave Velocity (CF-PWV) (time frame: Baseline, month 8). Change in Carotid and Radial Artery Pulse Wave Velocity (CR-PWV) (time frame: Baseline, month 8).

It also tracked 2 secondary outcomes, for example Change in Insulin Sensitivity and Change in Renal Vascular Resistance (RVR).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 60 people.

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

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