A Trial Investigating the Effect of Oral Semaglutide Compared With Placebo on Postprandial Glucose and Triglyceride Metabolism, Energy Intake, Appetite Sensations and Gastric Emptying in Subjects With Type 2 Diabetes

What Was Tested

In this phase 1 trial, researchers set out to test Semaglutide.

This trial is conducted in Europe.

The aim of this trial is to investigate the effect of oral semaglutide compared with placebo on postprandial glucose and triglyceride metabolism, energy intake, appetite sensations and gastric emptying in subjects with Type 2 diabetes.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 15 actual participants took part.

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: Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. Subjects diagnosed with type 2 diabetes mellitus for at least 90 days prior to the day of screening. Body mass index (BMI) between 20.0-38 kg/m\^2 (both inclusive).

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: family or personal history of multiple endocrine neoplasia type 2 or medullary thyroids carcinoma; history of pancreatitis (acute or chronic); history of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).

How the Study Was Run

It was run as a randomized, crossover and double-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.

Each person switched between Semaglutide and the comparison at some point, usually with a gap in between.

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 2016-06-02 with completion listed for 2018-10-19.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the serum glucose concentration-time curve (time frame: At 12 weeks of treatment).

It also tracked 4 secondary outcomes, for example Ad libitum energy intake during a lunch meal (following a standardised breakfast meal) and Area under the paracetamol plasma concentration-time curve.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 15 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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