ClinicalTrials.gov posted results on 21 August 2026 from a completed Phase 3 trial of oral semaglutide in children and teenagers with type 2 diabetes. Among 132 participants, mean HbA1c fell more with oral semaglutide than with placebo at week 26: -1.0 percentage point versus -0.3 percentage point.

Background

The study evaluated oral semaglutide against a dummy medicine in children and teenagers with type 2 diabetes. Participants took one study tablet each morning on an empty stomach and waited 30 minutes before eating, drinking, or taking other oral medication. The registry describes the trial as a test of how well semaglutide worked compared with placebo and whether it was safe in this population.

Trial design

This was a Phase 3, completed study in participants with type 2 diabetes. Participants were assigned by chance to oral semaglutide or placebo. The registered interventions were oral semaglutide and placebo (semaglutide). The data block does not list a primary outcome measurement, but reports changes in HbA1c, fasting plasma glucose, and body mass index standard deviation score.

Key results

At week 26, mean HbA1c changed by -1.0 percentage point with oral semaglutide, with a standard deviation of 1.5 percentage points, compared with -0.3 percentage point with placebo, with a standard deviation of 1.3 percentage points. The corresponding HbA1c change was -11.2 mmol/mol versus -2.8 mmol/mol.

An ANCOVA analysis estimated a treatment difference of -0.83 percentage point, with a 95% confidence interval of -1.25 to -0.4 and p=0.0002. A second analysis reported a treatment difference of -9.06 mmol/mol, with a 95% confidence interval of -13.69 to -4.42 and p=0.0002.

At week 26, fasting plasma glucose changed by -28.2 mg/dL with oral semaglutide and -8.1 mg/dL with placebo. BMI standard deviation score changed by -0.1 in both groups, with a standard deviation of 0.3.

At week 52, mean HbA1c changed by -0.8 percentage point with oral semaglutide and 0.2 percentage point with placebo. In mmol/mol, the changes were -9.0 and 2.5 mmol/mol, respectively. The registry provides no adverse-event summary in the supplied data.

What this means

The posted results show greater average HbA1c reductions with oral semaglutide than placebo at both reported time points. The findings also include lower mean fasting plasma glucose at week 26, while BMI standard deviation score changes were the same in the two groups. The available data do not establish an approval or provide a safety conclusion.

Source

Source: ClinicalTrials.gov, trial-results record for NCT04596631, posted 21 August 2026. The registry record is available at clinicaltrials.gov/study/NCT04596631.