Semaglutide for Prediabetes

Overseen By Norma Perez-Olazaran

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Metformin, Insulin, Corticosteroids, others

Disqualifiers: Diabetes, Pregnancy, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests semaglutide, a medication that may lower blood sugar and support weight loss in people with prediabetes. Researchers examine how this drug interacts with the body at genetic and cellular levels, focusing on Mexican-Americans, to discover better ways to prevent diabetes and related health issues like obesity and heart problems. Suitable participants include those diagnosed with prediabetes who are at high risk of developing diabetes, especially if they face obesity or other metabolic health issues. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

If you are taking medications like metformin, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT-2 inhibitors, thiazolidinediones, insulin, sulfonylureas, meglitinides, alpha-glucosidase inhibitors, or corticosteroids, you will need to stop them for at least 3 months before joining the trial.

What is the safety track record for Semaglutide?

Research has shown that semaglutide is generally safe for use. In studies, about 9% of participants taking semaglutide experienced serious side effects, similar to those taking a placebo (a treatment with no active medicine). This indicates that serious problems with semaglutide are uncommon.

In everyday use, semaglutide has not presented any new safety concerns and is well-tolerated by adults with type 2 diabetes. Additionally, semaglutide has been associated with fewer heart-related issues for people with diabetes. This is also significant for those with prediabetes, as it may help improve heart health.

Overall, semaglutide appears safe for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for prediabetes, which typically involves lifestyle changes or medications like metformin, semaglutide is unique because it targets the GLP-1 receptor to enhance insulin secretion and reduce appetite. This mechanism not only helps control blood sugar levels but also supports weight loss, which is crucial for managing prediabetes. Researchers are excited about semaglutide because it's administered through a once-weekly injection, making it a more convenient option compared to daily medications.

What is the effectiveness track record for Semaglutide in treating prediabetes?

Research has shown that semaglutide, the treatment under study in this trial, can improve how the body processes sugar. In one study, participants who took semaglutide for 68 weeks were more likely to achieve normal blood sugar levels than those who took a placebo. Another study found that semaglutide significantly lowered HbA1c, a measure of average blood sugar over time, and helped some individuals return to normal blood sugar levels. Additionally, semaglutide is known to lower the risk of heart problems in people with diabetes. Overall, semaglutide has shown promising results in controlling blood sugar and improving health in individuals with prediabetes and related conditions. ^{2 4 5 6 7}

Who Is on the Research Team?

Absalon D Gutierrez, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for Mexican-Americans with prediabetes, particularly those at high risk of developing diabetes due to obesity or metabolic issues. Participants must be adults with specific blood and kidney function levels, and women who can have children should use birth control during the study. People taking certain diabetes medications or with a history of serious diseases like pancreatitis, thyroid cancer, or active malignancy cannot join.

Inclusion Criteria

My blood sugar levels indicate I have prediabetes.

I agree to use birth control during the study.

I am at high risk for diabetes due to obesity or unhealthy metabolism.

Exclusion Criteria

I have a history of cancer.

My family has a history of medullary thyroid cancer or MEN2.

I have a serious heart, liver, pancreas, or kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide 0.25 mg subcutaneously weekly for 4 weeks, followed by semaglutide 0.5 mg subcutaneously weekly for 8 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Data Analysis and Model Development

Creation of polygenic prediction models using collected data to predict GLP-1 therapy-associated outcomes

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide

Trial Overview The trial is studying how people respond to Semaglutide—a drug that mimics a hormone important for lowering blood sugar and aiding weight loss—by looking at their genes and gene activity. The goal is to understand why different people react differently to this treatment.

How Is the Trial Designed?

Group I: Semaglutide Experimental Treatment 1 Intervention

Semaglutide 0.25 mg subcutaneously weekly for 4 weeks, followed by semaglutide 0.5 mg subcutaneously weekly for 8 weeks.

Semaglutide is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in United States as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Canada as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Japan as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in United States as Wegovy for:

• Obesity

Approved in United States as Rybelsus for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Published Research Related to This Trial

Semaglutide, a GLP-1 receptor agonist with a long half-life, effectively promotes insulin secretion in a glucose-dependent manner, making it a valuable treatment for type 2 diabetes, approved for use worldwide and in Japan since 2018.

Oral semaglutide (Rybelsus®) is the first GLP-1 receptor agonist available in pill form, showing continuous benefits in glycemic control for patients with type 2 diabetes across various stages, as demonstrated in multiple global clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New drug for type 2 diabetes: introduction of oral Semaglutide (Rybelsus® tablets), an oral GLP-1 receptor agonist]. Miyasaka, K.[2022]

Oral semaglutide (Rybelsus®) has been shown to provide better glycaemic control and promote weight loss in patients with type 2 diabetes (T2DM) compared to standard oral glucose-lowering medications, based on data from the PIONEER clinical trial program involving 9543 patients.

The safety profile of oral semaglutide is similar to other GLP-1 receptor agonists, and it demonstrated cardiovascular safety comparable to placebo in high-risk patients, making it a viable option for T2DM management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. Paquot, N.[2022]

In a study of 20 patients with type 2 diabetes in Slovenia, oral semaglutide significantly reduced HbA1c levels and fasting plasma glucose, indicating its efficacy in improving glycaemic control.

Patients reported high satisfaction with the treatment, and while some experienced mild gastrointestinal side effects, the overall safety profile was considered good, suggesting that oral semaglutide is a promising option for diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and patient satisfaction with oral semaglutide: first single-centre clinical experience. Janić, M., Jovanović, M., Janež, A., et al.[2023]

Semaglutide (Ozempic®) is a new subcutaneous treatment for type 2 diabetes that effectively lowers blood glucose levels by stimulating insulin release and also helps reduce body weight.

The once-weekly injection has been approved in the US, Puerto Rico, and Canada, and is also under review in other countries, with ongoing clinical development for additional conditions like obesity and liver diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide: First Global Approval. Dhillon, S.[2019]

In a meta-analysis of 23 randomized trials involving 22,096 patients with type 2 diabetes, semaglutide was not found to significantly increase the overall risk of diabetic retinopathy (DR) compared to control groups.

However, the analysis indicated that semaglutide was associated with a higher risk of DR in specific subgroups, particularly in patients aged 60 years or older and those with a diabetes duration of 10 years or more, suggesting that caution is warranted in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide and Diabetic Retinopathy Risk in Patients with Type 2 Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials. Wang, F., Mao, Y., Wang, H., et al.[2022]

Semaglutide, marketed as Rybelsus, is the first oral glucagon-like peptide receptor agonist approved by the FDA in 2019 for treating type 2 diabetes, highlighting its innovative delivery method.

This medication, taken once daily, aids in glucose control and weight management, potentially leading to improved health outcomes for individuals with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. Blakely, KK., Weaver, K.[2021]

Semaglutide (Ozempic®) is an effective once-weekly treatment for type 2 diabetes, showing superior glucose-lowering effects and greater weight loss compared to other GLP-1 receptor agonists in Phase III clinical trials.

It is approved for use in Belgium for patients with type 2 diabetes who have not achieved adequate control with other antidiabetic therapies, particularly in those with a body mass index of 30 kg/m² or higher.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. Scheen, AJ.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9862484/

Changes in Glucose Metabolism and Glycemic Status With ... 68 weeks' treatment with semaglutide versus placebo led to significant improvements in glucose metabolism and a higher likelihood of normoglycemia.

2. diabetesjournals.org diabetesjournals.org/care/article/47/8/1350/156833/Effect-of-Semaglutide-on-Regression-and

Effect of Semaglutide on Regression and Progression of ... Major glycemic outcomes were HbA1c and proportions achieving biochemical normoglycemia (HbA1c <5.7%) and progressing to biochemical diabetes ( ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40990044/

Effectiveness of oral semaglutide versus empagliflozin for ... HbA1c reduction was significantly greater with oral semaglutide than with empagliflozin (mean difference - 0.35%, p <0.001). Weight loss over ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2307563

Semaglutide and Cardiovascular Outcomes in Obesity ... Semaglutide, a glucagon-like peptide-1 receptor agonist, has been shown to reduce the risk of adverse cardiovascular events in patients with diabetes.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213858724001827

Efficacy and safety of once-weekly semaglutide 2·4 mg ... Semaglutide 2·4 mg provided superior reduction in bodyweight and reversion to normoglycaemia versus placebo in participants with obesity and prediabetes.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39089293/

Efficacy and safety of once-weekly semaglutide 2·4 mg ... Serious adverse events occurred in 12 (9%) participants receiving semaglutide 2·4 mg versus six (9%) receiving placebo. Adverse events leading ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39118222/

Real-world safety profile of once-weekly semaglutide in ... No new safety concerns were identified, highlighting that OW semaglutide is well tolerated by adults with T2D and in subpopulations in routine clinical ...