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Real-World study tests Once-Daily pill for diabetes control

NCT ID NCT04878393

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study followed 650 adults with type 2 diabetes in Japan who were already prescribed oral semaglutide (Rybelsus) by their doctors. Researchers tracked changes in blood sugar levels and body weight over 8-10 months, along with any side effects. The goal was to see how the medication performs outside of controlled clinical trials, in routine care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oral semaglutide (Rybelsus)
What this could lead to
If successful, this could confirm that oral semaglutide effectively lowers blood sugar and helps with weight loss in everyday clinical practice for people with type 2 diabetes.
What could go wrong
This is an observational study without a comparison group, so results may be influenced by other factors. Side effects like nausea or diarrhea are possible with semaglutide.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

650 people

The number who actually took part.

Started

Apr 2021

Finished

Feb 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) * Diagnosed with type 2 diabetes mellitus * The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study * Male or female, age above or equal to 20 years at the time of signing informed consent * Available glycated haemoglobin (HbA1c) value greater than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (Visit 1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (Visit 1) if in line with local clinical practice * Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than 14 days Exclusion Criteria: * Previous participation in this study. Participation is defined as having given informed consent in this study * Treatment with any investigational drug within 30 days prior to enrolment into the study * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus, type 2

Contacts and locations

Locations

  • Master Centre for Japan

    Tokyo, 1000005, Japan

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