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Study on the Effectiveness and Safety of Oral Semaglutide Compared to Placebo in Children and Adolescents with Type 2 Diabetes Using Metformin or Basal Insulin

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Type 2 diabetes in children and teenagers. The study is testing a new medicine called oral semaglutide, which is taken in the form of tablets. The trial will compare the effects of oral semaglutide with a placebo, which is a tablet that looks like the medicine but does not contain the active ingredient. The purpose of the study is to see if oral semaglutide can help control blood sugar levels better than the placebo in young people who are already taking other diabetes medications like metformin or basal insulin.

Participants in the study will take either oral semaglutide or the placebo for a period of up to 52 weeks. The study will monitor changes in blood sugar levels, body weight, and other health indicators over this time. The goal is to determine if oral semaglutide is safe and effective for managing Type 2 diabetes in children and adolescents. The study will also look at how the body processes the medicine and any potential side effects that may occur during the trial.

Throughout the study, participants will have regular check-ups to track their progress and ensure their safety. The trial aims to provide valuable information on the use of oral semaglutide in young people with Type 2 diabetes, potentially offering a new treatment option for managing this condition. The results of this study could help improve the care and treatment of children and teenagers living with diabetes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, informed consent from a parent or legal representative is required, along with the child's assent.
Eligibility is confirmed based on age (10 to <18 years), a diagnosis of type 2 diabetes, and current treatment with metformin and/or basal insulin.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline measurements, including glycosylated hemoglobin (HbA1c) levels, fasting plasma glucose, body mass index (BMI), and other health indicators.
Step 3
Medication administration
Participants receive either oral semaglutide or a placebo. The semaglutide is administered in tablet form, with doses of 3 mg, 7 mg, or 14 mg, depending on the maximum tolerated dose.
The medication is taken orally, and the dosage may be adjusted during the trial based on individual tolerance.
Step 4
Ongoing monitoring
Regular monitoring occurs throughout the trial to assess changes in HbA1c, fasting plasma glucose, BMI, body weight, and other health parameters.
Participants attend scheduled visits for pharmacokinetic sampling and other assessments to evaluate the effects of the medication.
Step 5
Midpoint evaluation
At week 26, a comprehensive evaluation is conducted to measure changes from baseline in various health indicators, including HbA1c and fasting plasma glucose.
The effectiveness of the treatment is assessed, and any necessary adjustments to the medication regimen are made.
Step 6
Final assessment
At week 52, a final assessment is performed to evaluate long-term changes in health indicators and the overall effectiveness of the treatment.
The study concludes with a review of all collected data to determine the impact of oral semaglutide compared to the placebo.

Who can join the trial?

4 criteria

Consent must be given by the parent(s) or a legally acceptable representative, and the child must agree to participate before any trial-related activities begin. These activities include any procedures done as part of the trial to check if the child can join.
The child must be a boy or girl aged between 10 and less than 18 years old on the day they are randomly assigned to a group in the trial.
The child's blood sugar level, measured by a test called **HbA1c**, must be between 6.5% and 11.0%. This test shows the average blood sugar level over the past 2 to 3 months.
The child must have been diagnosed with **type 2 diabetes** according to the guidelines of the American Diabetes Association. They should be treated with a stable dose of **metformin** (a medication to control blood sugar), or a stable dose of metformin and a stable dose of **basal insulin** (a long-acting insulin), or just a stable dose of basal insulin.

Who cannot join the trial?

3 criteria

Patients who are not between the ages of 10 and 18 years old.
Patients who do not have Type 2 diabetes. This is a condition where the body does not use insulin properly, leading to high blood sugar levels.
Patients who are not already being treated with metformin or basal insulin, or both. Metformin is a medication that helps control blood sugar levels, and basal insulin is a type of insulin that works throughout the day to keep blood sugar stable.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Athens Medical Center S.A.
Verified
Thessaloniki, Greece
Krajska zdravotni a.s.
Verified
Teplice, Czechia
Unidade Local De Saúde De Santa Maria, E.P.E.
Verified
Lisbon, Portugal

Trial locations

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Investigated drugs

Oral Semaglutide
is a medication being tested to see if it can help control blood sugar levels in children and adolescents with type 2 diabetes. It is taken by mouth and is being compared to a placebo to see if it works better at managing diabetes when used alongside other treatments like metformin or basal insulin.
Metformin
is a common medication used to help control blood sugar levels in people with type 2 diabetes. It works by decreasing the amount of sugar the liver makes and helps the body respond better to insulin.
Basal Insulin
is a long-acting insulin used to help control blood sugar levels throughout the day and night. It is often used in combination with other diabetes medications to help maintain stable blood sugar levels.

Semaglutide

What is already known about the treatment

Semaglutide – Semaglutide is administered orally and is currently being studied for its effectiveness and safety in treating type 2 diabetes, particularly in children and adolescents. It is a medication that has gained attention in medical literature for its potential to improve blood sugar control. The main therapeutic indication for semaglutide is type 2 diabetes, where it works by mimicking a hormone in the body that helps regulate blood sugar levels. It belongs to the pharmacological class of GLP-1 receptor agonists, which help increase insulin secretion and decrease glucagon release, thereby improving blood sugar control.

Investigated diseases

Type 2 diabetes – This is a chronic condition that affects the way the body processes blood sugar (glucose). In type 2 diabetes, the body either resists the effects of insulin, a hormone that regulates the movement of sugar into cells, or doesn't produce enough insulin to maintain normal glucose levels. Over time, high blood sugar levels can lead to various health issues, including nerve damage, kidney problems, and vision loss. The disease often develops slowly, and individuals may not notice symptoms initially. Common symptoms include increased thirst, frequent urination, hunger, fatigue, and blurred vision. Lifestyle factors such as obesity and inactivity are significant contributors to the development of type 2 diabetes.