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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:
Must not have
Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.
Maturity onset diabetes of the young (MODY)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 57 weeks
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new diabetes medicine called semaglutide. It focuses on children and teenagers with type 2 diabetes to see if the new medicine is safe and effective. Semaglutide helps control blood sugar levels, which is crucial for managing diabetes. It has been shown to improve blood sugar control and promote weight loss in patients with type 2 diabetes.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have positive IA-2 or anti-GAD antibodies.
Select...
I have been diagnosed with MODY.
Select...
I have been diagnosed with type 1 diabetes.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
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
10%
Nausea
8%
Diarrhoea
7%
Upper respiratory tract infection
6%
Decreased appetite
4%
Lipase increased
4%
Vomiting
1%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Semaglutide 3 mg
Oral Semaglutide 14 mg
Sitagliptin 100 mg
Oral Semaglutide 7 mg

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~7150

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
GLP-1 receptor agonists, such as Semaglutide, work by mimicking the incretin hormone GLP-1, which enhances insulin secretion in response to meals, inhibits glucagon release, and slows gastric emptying. This results in better blood glucose control and potential weight loss, which is crucial for Type 2 Diabetes patients. Other common treatments include SGLT2 inhibitors, which reduce blood glucose by increasing urinary glucose excretion, and DPP-4 inhibitors, which prolong the action of incretin hormones. These mechanisms are important as they offer different pathways to manage blood glucose levels, reduce complications, and improve overall health outcomes for patients with Type 2 Diabetes.

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,551 Previous Clinical Trials
2,444,774 Total Patients Enrolled
Clinical Reporting Anchor and Disclosure (1452)Study DirectorNovo Nordisk A/S
104 Previous Clinical Trials
103,126 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
~8 spots leftby Feb 2025