Comparison of Oral Semaglutide w/ Placebo- Treatment for Latino Adults w/T2 Diabetes Receiving Enhanced Lifestyle Care

What Was Tested

The trial (phase 4) is built around Semaglutide.

It had two arms (groups): Oral Semaglutide (OS) with Enhanced Lifestyle Care (organic vegetables) (active comparator) and Oral Semaglutide (OS) Placebo with Enhanced Lifestyle Care (organic vegetables) (placebo comparator).

The registry classes the interventions as dietary supplement and drug.

More on the Plan

However in the United States (US), members of racial and ethnic minority groups are disproportionally affected by T2D and there is a paucity of information on what the potential impact of novel therapies such as oral Semaglutide might be for these populations.

For example, the prevalence of both diagnosed and undiagnosed T2D is nearly twice as high among Mexican- origin Hispanic/Latino (hereafter Latino) adults compared to non-Latino whites.

For Latinos and other US minorities, beyond genetics and biological factors, it is recognized that sociocultural influences are also important factors in determining an individual's response to a therapy.

In addition, self-identified race correlates with ancestry, which determines genomic variation, but this does not necessarily predict the response to a particular drug, nor can it be assumed that responses are similar between different races.

Who Took Part

12 actual participants took part.

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: Individuals ≥ 18 years of age at enrollment. Self-reported Hispanic/Latino heritage. Established diagnosis of T2D for at least 3 months prior to enrollment date. T2D treated with lifestyle alone or lifestyle + Metformin within the past 6 months prior to screening. Ability to provide informed consent before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject.

The full record lists 7 inclusion and 15 exclusion criteria; among the exclusions: T2D treated with oral medicines other than Metformin or any injectable GLP-1 receptor agonist or insulin within the past 6 months prior to screening; life expectancy \< 12 months; 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

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

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

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

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

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

It started in 2022-01-29 with completion listed for 2023-02-16.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

It also tracked 13 secondary outcomes, for example HbA1c, Weight, Waist circumference, Lying and standing blood pressure, Fasting glucose levels and Fasting insulin levels.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 12 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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