A Clinical Trial to Evaluate The Effects of Semaglutide and Empagliflozin Combined to Automated Insulin Delivery on Diabetes Control in Adults Living With Type 1 Diabetes

What Was Tested

The trial (phase 3) is built around Semaglutide.

It will also evaluate the safety of Empagliflozin and Semaglutide in this context.

It had two arms (groups): one (experimental) and Placebo + Automated Insulin Delivery system (active comparator).

The registry classes the interventions as drug.

More on the Plan

Study Design and Randomization: Factorial Design: The 2x2 factorial design allows for the simultaneous assessment of two interventions (semaglutide and empagliflozin) and their interaction.

This design efficiently explores the individual and combined effects of the drugs.

Randomization: Participants will be randomized in a 1:1 ratio to determine the order of the semaglutide and placebo injections (Arm A: semaglutide first, Arm B: placebo first).

Within each arm, the order of empagliflozin and placebo tablets will also be randomized 1:1.

Who Took Part

Enrollment: 36 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Males and females aged 18 or older. Clinical diagnosis of T1D for at least one year. Use of AID system for at least three months. Body Mass Index (BMI) ≥ 23 kg/m2.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: use of glp1-ra within one month of admission; use of sglt2i within two weeks of admission; planned or ongoing pregnancy.

How the Study Was Run

The set-up was randomized, factorial and double-blind.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2025-04 with completion listed for 2027-01.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time-in-Range (time frame: At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention).

It also tracked 12 secondary outcomes, for example Overall Time In Range, Optimal Time In Range, Time In Hypoglycemia, Time In Mild Hyperglycemia, Time Above Range and Time In Severe Hyperglycemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 36 people.

Its size is small, so on its own it can only give an early look.

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.