Semaglutide for Type 1 Diabetes

Overseen By Mansa Krishnamurthy, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Children's Hospital Medical Center, Cincinnati

Must not be taking: GLP-1 receptor agonists

Disqualifiers: Anaphylaxis, Bariatric surgery, Cancer, Pancreatitis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests semaglutide, a treatment that might slow the progression of type 1 diabetes from stage 1 to stage 2. Researchers aim to determine if semaglutide can protect the insulin-producing cells in the pancreas, potentially delaying the disease's progression. Participants will receive either semaglutide or a placebo. The trial seeks individuals with stage 1 type 1 diabetes who have not progressed to more severe stages affecting blood sugar levels. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that semaglutide is generally well-tolerated, even by those with type 1 diabetes. Studies have found that semaglutide can help control blood sugar levels and aid in weight loss. Some individuals have experienced stomach issues such as nausea, belly pain, and diarrhea. These side effects are common but usually mild and manageable.

Other studies indicate that semaglutide can reduce the need for insulin in people with type 1 diabetes, which is a positive outcome. Although semaglutide is approved for other uses, it is not yet approved specifically for type 1 diabetes.

Overall, semaglutide is considered safe for many, though side effects can occur. Clinical trial participants are closely monitored to address any issues that arise. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for type 1 diabetes?

Semaglutide is unique because it offers a fresh approach to treating Type 1 diabetes. Unlike standard treatments like insulin therapy, semaglutide is a GLP-1 receptor agonist, which primarily helps manage blood sugar by enhancing insulin production in response to meals and slowing gastric emptying. Researchers are excited about semaglutide because it potentially offers better blood sugar control and could also aid in weight management, a significant concern for many people with diabetes. Additionally, its once-weekly injection regimen may improve convenience and adherence compared to the multiple daily doses required with traditional insulin therapy.

What evidence suggests that semaglutide might be an effective treatment for type 1 diabetes?

Research has shown that semaglutide, a type of medication, might help manage type 1 diabetes. In this trial, participants will receive either semaglutide or a placebo. Studies have found that semaglutide can reduce the need for insulin, and some individuals may not require mealtime insulin at all. It also promotes weight loss, which benefits those with type 1 diabetes. Additionally, semaglutide helps control blood sugar levels and reduces the risk of low blood sugar episodes. These benefits suggest that semaglutide might protect pancreatic cells and slow the progression of type 1 diabetes. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

Screening OGTT with impaired or loss of first phase insulin secretion but no dysglycemia to suggest stage 2 or stage 3 type 1 diabetes

I have Stage 1 Type 1 Diabetes.

Exclusion Criteria

My BMI is below the healthy range for my age group.

History of anaphylaxis or allergies to GLP-1 receptor agonists

I have had weight loss (bariatric) surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide or placebo for 12 months to evaluate effects on beta cell function and glucagon secretion

12 months

Regular visits for oral glucose tolerance tests and liver MRI

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide

How Is the Trial Designed?

Group I: Semaglutide or Placebo Treatment Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Randomized to placebo or semaglutide

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40550013/

Semaglutide in Adults with Type 1 Diabetes and Obesity

Results: A significantly greater percentage of patients in the semaglutide group than in the placebo group achieved the primary composite outcome (36% vs. 0%; ...

2.

diabetesjournals.org

diabetesjournals.org/care/article/49/5/718/164128/Effect-of-Semaglutide-on-Insulin-Dose-Reduction-in

Effect of Semaglutide on Insulin Dose Reduction in Adults ...

Semaglutide produced rapid, sustained, and primarily bolus-driven insulin dose reductions, with early effects being largely independent of ...

3.

journals.lww.com

journals.lww.com/md-journal/fulltext/2025/12120/impact_of_semaglutide_use_on_glycemic_and.50.aspx

Impact of semaglutide use on glycemic and metabolic ...

Semaglutide has proven to be a powerful and effective treatment for obesity and T2D, offering positive effects on metabolic issues linked to ...

4.

esmed.org

esmed.org/semaglutide-and-tirzepatide-in-type-1-diabetes-treatment/

Semaglutide and Tirzepatide in Type 1 Diabetes Treatment

Semaglutide treatment was associated with the elimination of prandial insulin in all patients and basal insulin in seven patients and reduced ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0168822724000779

Effect of low dose Semaglutide in people with Type 1 ...

Using Semaglutide 0,5mg in people living with T1D and excess weight might result in a significant weight loss of approximately 11 %, associated with a reduction ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1056872725001175

Evaluating the effect of Semaglutide as add-on therapy on ...

Semaglutide improved glycemic stability and reduced glycemic risk in T1D. HbA1c declined with nearly a 50 % reduction in daily insulin dose.

7.

diabetesjournals.org

diabetesjournals.org/diabetes/article/72/Supplement_1/1801-PUB/150900/1801-PUB-Efficacy-and-Safety-of-Once-Weekly

1801-PUB: Efficacy and Safety of Once-Weekly Semaglutide ...

Weight loss ≥ 5% and ≥ 10% were achieved in 57.1% and 33.3% of cases, respectively. Significant improvements in time in range (+8.8 ± 13.4%) and ...

8.

muhc.ca

muhc.ca/news-and-patient-stories/news/semaglutide-known-ozempic-can-be-beneficial-people-type-1-diabetes

Semaglutide - known as Ozempic - can be beneficial to ...

A first randomized clinical trial shows that semaglutide use in type 1 diabetes is associated with improved glucose management, weight loss and lower insulin ...

9.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK544016/

Results - Clinical Review Report: Semaglutide (Ozempic) - NCBI

The baseline A1C in all trials ranged from 8.0% to 8.7%. The mean duration of diabetes varied across trials and was lowest for SUSTAIN-1 (6.4 years to 6.7 ...