The Impact of Semaglutide Compared to Energy Restriction on Type 2 Diabetes

What Was Tested

The trial (phase 4) is built around Semaglutide.

To evaluate the effects of subcutaneous injection of semaglutide for 12 weeks on patients with type 2 diabetes mellitus (T2DM), compared with concurrent energy-restricted management, on glycemic control, weight loss, inflammatory markers, liver fat content, and other parameters.

The study also observed the subcutaneous and visceral fat of the participants and explored the molecular mechanisms of action, providing high-quality evidence-based support for the timing and targets of intervention in this population.

It had two arms (groups): semaglutide group (experimental) and caloric restriction group (active comparator).

The caloric restriction group followed a gender-specific daily caloric restriction (1,500-1,800 kcal for males; 1,200-1,500 kcal for females).

The registry classes the interventions as behavioral and drug.

Who Took Part

Enrollment: 100 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Age 18-75 years;. Duration of diabetes ≤3 months, and no use of antihyperglycemic drugs;.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: BMI \< 25 kg/m²;; age \< 18 years, or \> 75 years;; use of glp-1 receptor agonists, sodium-glucose cotransporter 2 inhibitors, dipeptidyl peptidase-4 inhibitors, thiazolidinediones, or other related drugs within the past 3 months;.

How the Study Was Run

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

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

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

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-02-10 with completion listed for 2026-06-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HbA1c (time frame: From enrollment to the end of treatment at 12 weeks). FPG (time frame: From enrollment to the end of treatment at 12 weeks). 2hPG (time frame: From enrollment to the end of treatment at 12 weeks).

It also tracked 5 secondary outcomes, for example HOMA-IR, TC, TG, LDL-C and HDL-C.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 100 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.