What is the mechanism of action of this treatment?

GLP-1 receptor agonists, such as Semaglutide, work by mimicking the incretin hormone GLP-1, which enhances glucose-dependent insulin secretion, inhibits glucagon release, slows gastric emptying, and promotes satiety. These mechanisms help to lower blood glucose levels and support weight loss, which are crucial for managing prediabetes and preventing progression to type 2 diabetes. Other common treatments for prediabetes include lifestyle interventions like diet and exercise, which improve insulin sensitivity and glycemic control. The importance of these treatments lies in their ability to address the underlying metabolic dysfunctions in prediabetes, thereby reducing the risk of developing full-blown diabetes and associated complications.

What side effects are associated with this type of intervention?

GLP-1 receptor agonists, such as Semaglutide, are commonly used to treat prediabetes and type 2 diabetes by enhancing glucose-dependent insulin secretion and promoting weight loss. However, they are associated with several side effects, including gastrointestinal symptoms like nausea, vomiting, and diarrhea. There is also a potential risk for pancreatitis and, in rare cases, thyroid C-cell tumors. These medications are generally not recommended for individuals with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of type 2 diabetes, which are also being studied for their potential benefits in prediabetes. Notable drugs in this category include liraglutide, exenatide, dulaglutide, and semaglutide. These medications work by enhancing glucose-dependent insulin secretion, delaying gastric emptying, and regulating postprandial glucagon levels. While their primary approval is for type 2 diabetes, ongoing research is exploring their efficacy in managing prediabetes and preventing the progression to type 2 diabetes.

What other types of research exist?

Promising alternatives to Semaglutide for prediabetes patients in 2024 include: 1) Dulaglutide, another GLP-1 receptor agonist with once-weekly dosing and proven efficacy in glycemic control. 2) DPP-4 inhibitors like Sitagliptin and Linagliptin, which increase insulin release and are generally safe with minimal side effects. 3) SGLT2 inhibitors such as Dapagliflozin and Empagliflozin, which not only improve glycemic control but also offer cardiovascular and renal benefits.

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Glucagon-like peptide-1 (GLP-1) receptor agonist

Semaglutide for Prediabetes Post-GDM (SWEET Trial)

Phase 4

Recruiting

Led By Elizabeth Sutton, PhD

Research Sponsored by Woman's

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 - 45 years old (inclusive)

Dysglycemia as determined by glycemic response to 75g, 2-hour OGTT: either impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT): Fasting glucose 100-125mg/dL (inclusive) and/or 120 minute glucose 140-199mg/dL (inclusive)

Must not have

Post-menopausal

Contraindications to study medications: patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 24 weeks of full-dose treatment

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing semaglutide, a medication that helps control blood sugar, in women who had gestational diabetes and now have high blood sugar levels. These women are at risk of developing type 2 diabetes. The goal is to see if semaglutide can help them return to normal blood sugar levels and reduce their future diabetes risk. Semaglutide is developed for the treatment of type 2 diabetes and has shown benefits in controlling blood sugar and weight loss.

Who is the study for?

This trial is for women aged 18-45 who have had gestational diabetes in their most recent pregnancy, are 6-36 months postpartum, overweight (BMI ≥ 25 kg/m2), and not currently pregnant or breastfeeding. They must be willing to standardize their diet before testing and maintain physical activity levels. Exclusions include allergies to the medication, certain medical conditions like thyroid cancer or heart failure, use of specific drugs affecting glucose levels, and substance abuse.

What is being tested?

The study tests whether semaglutide (Ozempic®) can help women with abnormal blood sugar levels after childbirth return to normal glucose levels. Participants will either receive Ozempic® or a placebo without active medication. The goal is to find an effective treatment option that could reduce the risk of developing type 2 diabetes later on.

What are the potential side effects?

Semaglutide may cause side effects such as nausea, vomiting, diarrhea, abdominal pain, decreased appetite which might lead to weight loss. Some people might also experience changes in insulin sensitivity or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 45 years old.

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My blood sugar levels are higher than normal but not high enough to be diabetes.

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I use long-term birth control or have had my tubes tied.

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I am female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have gone through menopause.

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I do not have a history of thyroid cancer or MEN 2 in my family.

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I do not have an eating disorder, active cancer needing chemotherapy, or severe mental health issues.

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I have a significant health condition like diabetes, heart, kidney, liver disease, or high blood pressure.

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I have had weight loss surgery in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 24 weeks of full-dose treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 24 weeks of full-dose treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 24 weeks of full-dose treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Regression to normoglycemia

Secondary study objectives

Change in HbA1c

Change in body weight

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Semaglutide Pen Injector (Ozempic)Experimental Treatment1 Intervention

Weekly injections of semaglutide for 8 months total (2 months of titration; 6 months of full dose- 1mg/week)

Group II: PlaceboPlacebo Group1 Intervention

Weekly injections of placebo for 8 months total

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Semaglutide Pen Injector [Ozempic]

2021

Completed Phase 4

~90

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

GLP-1 receptor agonists, such as Semaglutide, work by mimicking the incretin hormone GLP-1, which enhances glucose-dependent insulin secretion, inhibits glucagon release, slows gastric emptying, and promotes satiety. These mechanisms help to lower blood glucose levels and support weight loss, which are crucial for managing prediabetes and preventing progression to type 2 diabetes. Other common treatments for prediabetes include lifestyle interventions like diet and exercise, which improve insulin sensitivity and glycemic control. The importance of these treatments lies in their ability to address the underlying metabolic dysfunctions in prediabetes, thereby reducing the risk of developing full-blown diabetes and associated complications.