What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes, particularly GLP-1 receptor agonists like Semaglutide, often have side effects including gastrointestinal symptoms such as nausea, vomiting, and diarrhea. These symptoms typically occur during the initial months of therapy. Other potential side effects include weight loss, which can be beneficial, but also the risk of severe acute pancreatitis and thyroid cancer, although these are rare. Patients with severe renal insufficiency, a history of pancreatitis, or a personal or family history of medullary thyroid cancer should avoid these medications.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of Type 2 Diabetes. Liraglutide was approved in 2019 for children aged 10 and older based on the ELLIPSE trial, which demonstrated significant improvements in glycemic control. Exenatide, in its extended-release form (Bydureon BCise), was approved in 2021 for pediatric use following a trial showing improved glycemic control. Dulaglutide was also evaluated in a pediatric trial, showing efficacy and safety. These drugs, like semaglutide, work by enhancing insulin secretion and have shown benefits in glycemic control and weight management.

What other types of research exist?

Promising alternatives to Semaglutide for Type 2 Diabetes patients include: 1) Liraglutide, which has shown significant glycemic control and weight loss benefits in pediatric and adult patients. 2) Dulaglutide, which has demonstrated efficacy in improving glycemic control in adolescents and adults. Both alternatives are GLP-1 receptor agonists with strong clinical trial support and FDA approval for use in children and adults.

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GLP-1 Receptor Agonist

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

Phase 3

Waitlist Available

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.

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I have been diagnosed with MODY.

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I have been diagnosed with type 1 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 57 weeks

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

Diarrhoea

Upper respiratory tract infection

Decreased appetite

Lipase increased

Vomiting

COVID-19

100%

80%

60%

40%

20%

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

0 / 6Eligibility criteria met

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.