Efficacy and Safety of Oral Semaglutide Versus Placebo Both in Combination With Metformin and/or Basal Insulin in Children and Adolescents With Type 2 Diabetes
New study tests oral semaglutide for type 2 diabetes in children and teens
Plain English Summary
A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes is a Phase 3 clinical trial sponsored by Novo Nordisk A/S studying Diabetes Mellitus, Type 2. This study tests if a new oral medicine, semaglutide, is effective and safe for children and teenagers with type 2 diabetes. It is for individuals aged 10 to 17 years who have been diagnosed with type 2 diabetes and are currently treated with metformin and/or basal insulin. Participants will take either the new medicine or a placebo (dummy pill) daily for about a year, involving regular clinic visits and phone calls. Alternative treatments for type 2 diabetes in this age group include other oral medications, insulin, and lifestyle changes. The trial aims to enroll 132 participants.
Official Summary
This study compares 2 medicines for type 2 diabetes: semaglutide (new medicine) and a dummy medicine (placebo). Semaglutide will be tested to see how well it works compared to the dummy medicine. The study will also test if semaglutide is safe in children and teenagers. Participants will either get semaglutide or the dummy medicine - which one is decided by chance. Participants will take 1 tablet of the study medicine every morning on an empty stomach. They have to wait 30 minutes before they eat, drink or take any other medication by mouth. The study will last for about 1 year and 3 months (66 weeks). Participants will have 12 clinic visits and 8 phone calls with the study doctor. At all 12 clinic visits, participants will have blood samples taken. Participants will also be asked some questions.
Who Can Participate
Here is what you need to know about eligibility for this trial. Children and teenagers aged 10 to 17 years with a type 2 diabetes diagnosis. Must have an HbA1c between 6.5% and 11.0% and be on stable doses of metformin and/or basal insulin. Cannot have type 1 diabetes, MODY, or specific diabetes-related antibodies. Requires informed consent from a parent or guardian and assent from the child. This trial is studying Diabetes Mellitus, Type 2, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how well the new medicine lowers HbA1c, a key indicator of long-term blood sugar control, meaning it shows how effectively the drug can help manage diabetes over time. The specific primary outcome measures are: Change from baseline in glycosylated haemoglobin (HbA1c) (Week 0, week 26). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial addresses a critical need for effective and safe treatment options for the growing number of children and adolescents diagnosed with type 2 diabetes, a condition historically seen in adults As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Diabetes Mellitus, Type 2, where improved treatment options are needed.
Investor Insight
This trial signals Novo Nordisk's expansion of semaglutide's use into the pediatric diabetes market, a significant and growing area with high unmet needs, potentially leading to a new standard of care Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor about the potential benefits and risks of oral semaglutide compared to your current treatment. Be prepared for regular clinic visits for blood tests and check-ups, and daily medication intake. Understand that participation involves taking a study medication for over a year, with potential for dose adjustments. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: QUADRUPLE
- Enrollment: 132 participants
Interventions
- DRUG: Oral semaglutide — Oral semaglutide treatment for 52 weeks. All participants will be dose-escalated to an individual maximum tolerated dose.
- DRUG: Placebo (semaglutide) — Placebo treatment for 52 weeks.
Primary Outcomes
- Change from baseline in glycosylated haemoglobin (HbA1c) (Week 0, week 26)
Secondary Outcomes
- Change from baseline in fasting plasma glucose (FPG) (Week 0, week 26)
- Change from baseline in body mass index (BMI) standard deviation score (SDS) (Week 0, week 26)
- Change from baseline in glycosylated haemoglobin (HbA1c) (Week 0, week 52)
- Change from baseline in FPG (Week 0, week 52)
- Change from baseline in body weight (Week 0, week 26)
Full Eligibility Criteria
Inclusion 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) * Diagnosed with type 2 diabetes mellitus according to the American Diabetes Association criteria and treated with: * stable metformin dose (stable metformin dose is defined as at least 1000 mg daily or the maximum tolerated dose for 56 days or longer prior to screening) or * stable metformin dose and a stable dose of basal insulin (stable dose of basal insulin is defined as basal insulin treatment equal to or more than 30 days prior to screening, compared to the dose at screening, dose adjustments of ± 25% are allowed) or * stable dose of basal insulin Exclusion Criteria: * Diagnosis of type 1 diabetes * Maturity onset diabetes of the young (MODY) * Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.
Trial Locations
- UAB Ped Endo Children's Hosp, Birmingham, Alabama, United States
- Children's Hospital Los Angeles - Endocrinology, Los Angeles, California, United States
- Yale School Of Medicine, New Haven, Connecticut, United States
- Nemours Chld Clnc Jacksonville, Jacksonville, Florida, United States
- Nemours Children's Health, Pensacola, Florida, United States
- University of South Florida Diabetes Center, Tampa, Florida, United States
- Children's Healthcare Atlanta, Atlanta, Georgia, United States
- Columbus Research Foundation, Columbus, Georgia, United States
- Indiana Uni School of Med-Ped, Indianapolis, Indiana, United States
- University Of Louisville Research Foundation, Louisville, Kentucky, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT04596631?
NCT04596631 is a Phase 3 INTERVENTIONAL study titled "A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes." It is currently completed and is sponsored by Novo Nordisk A/S. The trial targets enrollment of 132 participants.
What conditions does NCT04596631 study?
This trial investigates treatments for Diabetes Mellitus, Type 2. The primary condition under study is Diabetes Mellitus, Type 2.
What treatments are being tested in NCT04596631?
The interventions being studied include: Oral semaglutide (DRUG), Placebo (semaglutide) (DRUG). Oral semaglutide treatment for 52 weeks. All participants will be dose-escalated to an individual maximum tolerated dose.
What does Phase 3 mean for NCT04596631?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT04596631?
This trial is currently "Completed." It started on 2020-11-02. The estimated completion date is 2026-02-03.
Who is sponsoring NCT04596631?
NCT04596631 is sponsored by Novo Nordisk A/S. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04596631?
The trial aims to enroll 132 participants. The trial status is completed.
How is NCT04596631 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT04596631?
The primary outcome measures are: Change from baseline in glycosylated haemoglobin (HbA1c) (Week 0, week 26). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04596631 being conducted?
This trial is being conducted at 20 sites, including Birmingham, Alabama; Los Angeles, California; New Haven, Connecticut; Jacksonville, Florida and 16 more sites (United States).
Where can I find official information about NCT04596631?
The official record for NCT04596631 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04596631. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04596631 testing in simple terms?
This study tests if a new oral medicine, semaglutide, is effective and safe for children and teenagers with type 2 diabetes. It is for individuals aged 10 to 17 years who have been diagnosed with type 2 diabetes and are currently treated with metformin and/or basal insulin.
Why is this trial significant?
This trial addresses a critical need for effective and safe treatment options for the growing number of children and adolescents diagnosed with type 2 diabetes, a condition historically seen in adults As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT04596631?
Common side effects may include nausea, vomiting, diarrhea, and abdominal pain, which are often mild and temporary. There is a risk of developing pancreatitis (inflammation of the pancreas) or gallbladder problems, though these are less common. The long-term effects of this medication in children and adolescents are still being studied. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04596631?
Ask your doctor about the potential benefits and risks of oral semaglutide compared to your current treatment. Be prepared for regular clinic visits for blood tests and check-ups, and daily medication intake. Understand that participation involves taking a study medication for over a year, with potential for dose adjustments. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04596631 signal from an investment perspective?
This trial signals Novo Nordisk's expansion of semaglutide's use into the pediatric diabetes market, a significant and growing area with high unmet needs, potentially leading to a new standard of care This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participants will take either the new medicine or a placebo (dummy pill) daily for about a year, involving regular clinic visits and phone calls. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.