Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes

What Was Tested

The trial (phase 3) is built around Semaglutide.

The researchers will include 2000 participants.

It had two arms (groups): Multifactorial intervention group (active comparator) and Standard intervention group (no intervention).

During the whole study period the standard intervention shall be done according to current Danish and international (ADA/EASD) guidelines. This will address similar risk factors as in the intensive group, but to a less ambitious treatment target for blood pressure and lipid lowering and will not include the use of SGTL2i, finerenone or GLP-1RA, unless these drug classes become recommended in future versions of guidelines.

The registry classes the interventions as drug.

More on the Plan

Even with optimal glycemic control, the risk is doubled compared to healthy individuals.

MFI acknowledges the need for control and interventions directed towards several risk factors for CVD, and not focus merely on glucose levels.

Design: This study uses a PROBE design (prospective, cluster-randomized, open, blinded endpoint evaluation), as it will not be possible to mask the MFI.

Randomization: There will be formed three clusters (large patient pool, intermediate- and small).

Who Took Part

2000 planned participants were the target.

It was open to people of any sex aged from 40 years up to 90 years.

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

Examples of who could join: Given written informed consent. Ability to communicate with the investigator and understand informed consent.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: history of pancreatitis; body mass index \< 18.5 kg/m2; females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

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

Being open-label, the Semaglutide study did not mask who received what.

It started in 2024-07-01 with completion listed for 2029-07-01.

It ran at 2 sites in Denmark (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: MACE + HHF (time frame: 5 years).

It also tracked 3 secondary outcomes, for example All-cause mortality, Renal function and Diabetic ketoacidosis, safety.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 2000 people.

With 2000 participants it is a large trial for this field.

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.