← Back to Search

GLP-1 Receptor Agonist

Oral Semaglutide for Type 2 Diabetes in Youth (PIONEER TEENS Trial)

Phase 3
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, aged 10 to below 18 years at the day of randomisation
Diagnosed with type 2 diabetes mellitus according to the American Diabetes Association criteria and treated with:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 57 weeks
Awards & highlights

PIONEER TEENS Trial Summary

This trial is testing a new diabetes medication, semaglutide, to see how well it works compared to a placebo. It will also test if semaglutide is safe for children and teenagers. Participants will take the medicine every morning on an empty stomach and have 12 clinic visits over the course of the 66-week study.

Who is the study for?
This trial is for children and teenagers aged 10 to under 18 with type 2 diabetes, who are on a stable dose of insulin or metformin. They must have an HbA1c level between 6.5%-11.0%. Participants cannot join if they have type 1 diabetes, certain diabetes-related antibodies, or other forms of diabetes like MODY.Check my eligibility
What is being tested?
The study tests oral semaglutide (a new medicine) against a placebo (dummy medicine). It aims to see how effective and safe semaglutide is in young people with type 2 diabetes over approximately one year, involving clinic visits and phone calls.See study design
What are the potential side effects?
While the specific side effects for this trial aren't listed, common ones for similar medications include digestive issues like nausea or diarrhea, potential low blood sugar events especially when combined with insulin therapy, and possible allergic reactions.

PIONEER TEENS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 10 and 17 years old.
Select...
I have type 2 diabetes as diagnosed by the American Diabetes Association.
Select...
I am on a consistent dose of basal insulin.

PIONEER TEENS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 57 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 57 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Anti-semaglutide antibodies cross reacting with endogenous GLP-1
Anti-semaglutide antibodies with in vitro neutralising effect to semaglutide
Anti-semaglutide antibody status
+45 more

Side effects data

From 2021 Phase 3 trial • 1441 Patients • NCT04017832
8%
Upper respiratory tract infection
4%
Diarrhoea
4%
Nausea
3%
Lipase increased
1%
Coronary artery disease
1%
COVID-19 pneumonia
1%
Decreased appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sitagliptin 100 mg
Oral Semaglutide 3 mg
Oral Semaglutide 14 mg
Oral Semaglutide 7 mg

PIONEER TEENS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Semaglutide - max. tolerated doseExperimental Treatment1 Intervention
Participants will receive semaglutide tablets once daily in addition to background treatment with metformin or basal insulin or both, in addition to diet and exercise.
Group II: Placebo (semaglutide)Placebo Group1 Intervention
Participants will receive semaglutide placebo tablets once daily in addition to background treatment with metformin or basal insulin or both, in addition to diet and exercise.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral semaglutide
2021
Completed Phase 3
~6570

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,518 Previous Clinical Trials
2,415,798 Total Patients Enrolled
Clinical Reporting Anchor and Disclosure (1452)Study DirectorNovo Nordisk A/S
104 Previous Clinical Trials
103,122 Total Patients Enrolled

Media Library

Oral Semaglutide (GLP-1 Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04596631 — Phase 3
Type 2 Diabetes Research Study Groups: Placebo (semaglutide), Semaglutide - max. tolerated dose
Type 2 Diabetes Clinical Trial 2023: Oral Semaglutide Highlights & Side Effects. Trial Name: NCT04596631 — Phase 3
Oral Semaglutide (GLP-1 Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04596631 — Phase 3
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT04596631 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project include adults aged 45 or older?

"This trial is designed for children between the ages of 10 and 18."

Answered by AI

If I meet the requirements, can I take part in this research?

"This study is looking for 132 children aged 10-18 who have type 2 diabetes mellitus. Candidates must meet the following criteria: Informed consent from parent(s) or legally acceptable representative (LAR) and child assent from the subject obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial., Male or female, aged 10 to below 18 years at the day of randomisation, HbA1c 6.5%-11.0% (47-97 mmol/mol) (both inclusive), stable"

Answered by AI

What do we know about semaglutide from other research?

"As of now, 59 clinical trials are underway testing Oral semaglutide. Of these, 27 are in Phase 3. The overwhelming majority of these studies are based in Loma Linda, California; however, there are 3696 total locations running these tests."

Answered by AI

What does Oral semaglutide typically treat?

"Oral semaglutide is often used as a chronic weight management medication. Additionally, it can help patients who are following a reduced-calorie diet or exercise plan, and those who suffer from at least one weight-related comorbid condition."

Answered by AI

Are researchers still looking for volunteers for this clinical trial?

"Unfortunately, this trial is no longer looking for new patients. The listing was first posted on November 2nd, 2020 and was last updated on November 3rd, 2020. If you are interested in other studies, there are 1,446 trials currently recruiting patients with diabetes mellitus type 2 and 59 studies for Oral semaglutide."

Answered by AI

Have other researchers conducted similar investigations in the past?

"As of right now, 59 clinical trials involving Oral semaglutide are ongoing in 711 cities located in 55 countries. The first trial started in 2018 and was sponsored by Novo Nordisk A/S. That specific study reached Phase 4 drug approval and involved 1387 participants. In the years since 2018, 123 more trials have been conducted."

Answered by AI

When was the FDA's most recent decision on semaglutide's classification?

"While Phase 3 trials are typically associated with a higher level of safety, our team at Power still rates Oral semaglutide as a 3."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
New York
Tennessee
Other
How old are they?
18 - 65
What site did they apply to?
Novo Nordisk Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0
3+

Why did patients apply to this trial?

I’m desperate for some help. I’m curious about better management of diabetes.
PatientReceived no prior treatments
to find help with my diabetes and to learn more about it. I have been on Metformin for several years, but my A1C is still outside the target range.
PatientReceived 1 prior treatment
I have tried 4 drugs for my diabetes. I need more help because my numbers still are not good.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long do screenings take? Do you have any pilot studies for weight loss without pre diabetes?
PatientReceived 1 prior treatment
How long do screening visits take? Where will the study visits take place?
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. Novo Nordisk Investigational Site: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes
2020. "A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04596631.
All > Diabetes Type 2 > Type 2 Diabetes
~21 spots leftby Feb 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top