Semaglutide vs Sitagliptin

What Was Tested

The trial (phase 4) is built around Semaglutide.

It had two arms (groups): Semaglutide (experimental) and Sitagliptin (active comparator).

The registry classes the interventions as drug.

More on the Plan

This will be a Phase IV, randomized, parallel, active-controlled, double-blind clinical trial, with one group receiving oral Semaglutide and the other group receiving oral sitagliptin, while continuing any background glucose-lowering medications such as metformin or insulin.

Treatment duration will be 26 weeks.

Sitagliptin has been chosen as comparator since it is an established oral antidiabetic drug (OAD) within the DPP-4i drug class.

There will be a screening period, treatment period, and follow-up period.

Who Took Part

The registry lists 58 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: Male or female, age ≥18 years at the time of signing informed consent. Willing and able to provide informed consent. Recipient of liver graft (Liver/Kidney recipients and retransplants allowed). Patient diagnosed with type 2 diabetes or post-transplant diabetes. Patients transplanted for hepatocellular carcinoma may be included provide their latest surveillance imaging is negative for recurrence.

The full record lists 11 inclusion and 18 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial products or related products; previous participation in this trial; active graft dysfunction that requires investigation (at screening).

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

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

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

It started in 2022-10-26 with completion listed for 2026-12.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c level (time frame: Baseline to 26 weeks). Change in body weight (kg) (time frame: Baseline to week 26).

It also tracked 5 secondary outcomes, for example Change in fasting plasma glucose, Change in body weight %, Change in Body mass index (BMI), Change in waist circumference and Number of treatment-emergent adverse events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 58 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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