Leveraging Semaglutide for Preservation of Beta Cell Function and Restoration of Alpha Cell Function
Study Evaluates Semaglutide for Type 1 Diabetes
Plain English Summary
GLP-1 RA for Stage 1 Type 1 Diabetes is a Phase 2 clinical trial sponsored by Children's Hospital Medical Center, Cincinnati studying Stage 1 Diabetes Mellitus, Type 1. Tests how semaglutide affects beta and alpha cells in early Type 1 Diabetes. For individuals with early Type 1 Diabetes (Stage 1). Participation involves taking semaglutide or placebo for 12 months and regular check-ups. No other treatments like GLP-1 agonists or bariatric surgery allowed. The trial aims to enroll 15 participants.
Official Summary
This study seeks to evaluate the hormone responses of insulin, c-peptide, glucagon, and incretins to semaglutide, a GLP-1 receptor agonist therapy, in individuals with stage 1 type 1 diabetes. The goal of this study is to see if semaglutide can protect beta cell function in this group of people and delay the progression to stage 2 type 1 diabetes.
Who Can Participate
Here is what you need to know about eligibility for this trial. Eligible if you have early Type 1 Diabetes and no signs of more advanced stages. Not eligible if you have had an allergic reaction to GLP-1 agonists or had bariatric surgery. Not eligible if you have a history of certain cancers or pancreatitis. Not eligible if you are pregnant, breastfeeding, or planning to become pregnant. This trial is studying Stage 1 Diabetes Mellitus, Type 1, so participants generally need a confirmed diagnosis.
What They're Measuring
Measures like C-peptide levels will show if semaglutide helps protect beta cells and delay progression to more advanced diabetes. The specific primary outcome measures are: C-peptide area under the curve (12 months); C-peptide area under the curve (AUC) (12 months). 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 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial aims to fill a gap in treating early Type 1 Diabetes by potentially preserving beta cell function. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Stage 1 Diabetes Mellitus, Type 1, where improved treatment options are needed.
Investor Insight
Market size for Type 1 Diabetes treatments is large, with few options for early-stage management, making this trial significant. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if you have early Type 1 Diabetes and if this study is right for you. You will take either semaglutide or a placebo for 12 months and have regular check-ups. The trial is being conducted at 1 site. 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: TRIPLE
- Enrollment: 15 participants
Interventions
- DRUG: Semaglutide — Study participants will be randomized to either placebo or semaglutide treatment for 12 months
- DRUG: Placebo — Randomized to either placebo or semaglutide.
Primary Outcomes
- C-peptide area under the curve (12 months)
- C-peptide area under the curve (AUC) (12 months)
Secondary Outcomes
- Stimulated incretin levels (12 months)
- Glucagon secretion (12 months)
Full Eligibility Criteria
Inclusion Criteria: * Stage 1 Type 1 Diabetes * Screening OGTT with impaired or loss of first phase insulin secretion but no dysglycemia to suggest stage 2 or stage 3 type 1 diabetes Exclusion Criteria: * History of anaphylaxis or allergies to GLP-1 receptor agonists * Already on a GLP-1 receptor agonist * History of bariatric surgery * Personal or family history of cancer such as medullary thyroid cancer * Personal history of pancreatitis or pathogenic variants associated with increased risk of pancreatitis * Severe hypoglycemia within 3 months of study enrollment * Pregnant, breastfeeding, or the intention of becoming pregnant or not using adequate contraceptive measures * Adult individuals with BMI \< 18.5 kg/m2 and pediatric participants with BMI \< 5th percentile
Trial Locations
- Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Frequently Asked Questions
What is clinical trial NCT07430332?
NCT07430332 is a Phase 2 INTERVENTIONAL study titled "GLP-1 RA for Stage 1 Type 1 Diabetes." It is currently not yet recruiting and is sponsored by Children's Hospital Medical Center, Cincinnati. The trial targets enrollment of 15 participants.
What conditions does NCT07430332 study?
This trial investigates treatments for Stage 1 Diabetes Mellitus, Type 1. The primary condition under study is Stage 1 Diabetes Mellitus, Type 1.
What treatments are being tested in NCT07430332?
The interventions being studied include: Semaglutide (DRUG), Placebo (DRUG). Study participants will be randomized to either placebo or semaglutide treatment for 12 months
What does Phase 2 mean for NCT07430332?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT07430332?
This trial is currently "Not Yet Recruiting." It started on 2027-09-01. The estimated completion date is 2030-01-01.
Who is sponsoring NCT07430332?
NCT07430332 is sponsored by Children's Hospital Medical Center, Cincinnati. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07430332?
The trial aims to enroll 15 participants. The trial has not yet started recruiting.
How is NCT07430332 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs triple 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 NCT07430332?
The primary outcome measures are: C-peptide area under the curve (12 months); C-peptide area under the curve (AUC) (12 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07430332 being conducted?
This trial is being conducted at 1 site, including Cincinnati, Ohio (United States).
Where can I find official information about NCT07430332?
The official record for NCT07430332 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07430332. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07430332 testing in simple terms?
Tests how semaglutide affects beta and alpha cells in early Type 1 Diabetes. For individuals with early Type 1 Diabetes (Stage 1).
Why is this trial significant?
This trial aims to fill a gap in treating early Type 1 Diabetes by potentially preserving beta cell function.
What are the potential risks of participating in NCT07430332?
Possible side effects include nausea, vomiting, and diarrhea. Monitor for any changes in blood sugar levels and report them to your doctor. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07430332?
Ask your doctor if you have early Type 1 Diabetes and if this study is right for you. You will take either semaglutide or a placebo for 12 months and have regular check-ups. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07430332 signal from an investment perspective?
Market size for Type 1 Diabetes treatments is large, with few options for early-stage management, making this trial significant. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participation involves taking semaglutide or placebo for 12 months and regular check-ups. 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
More Stage 1 Diabetes Mellitus, Type 1 Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.