Semaglutide for Prediabetes Post-GDM

(SWEET Trial)

Overseen By Elizabeth Sutton, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Woman's

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

Disqualifiers: Diabetes, Cardiac disease, Renal impairment, 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 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 months

102 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop using medications for glucose regulation, anti-obesity, weight loss, or those known to worsen glucose issues at least four weeks before the first screening visit.

What data supports the effectiveness of the drug semaglutide for prediabetes after gestational diabetes?

Semaglutide, known as Ozempic, has been shown to effectively lower blood sugar levels and promote weight loss in people with type 2 diabetes. It works by helping the body release insulin, which lowers blood sugar, and has also been approved for managing obesity, suggesting potential benefits for prediabetes after gestational diabetes. ^{1 2 3 4 5}

Is semaglutide safe for humans?

Semaglutide has been studied extensively for type 2 diabetes and is generally considered safe, with common side effects being gastrointestinal issues like nausea and vomiting, which tend to decrease over time. However, there is a warning for patients with preexisting diabetic retinopathy, as it may increase the risk of retinopathy complications. ^{1 2 3 5 6}

How is the drug Semaglutide (Ozempic) unique for treating prediabetes after gestational diabetes?

Semaglutide (Ozempic) is unique because it is a once-weekly injection that mimics a natural hormone (GLP-1) to help control blood sugar and promote weight loss, which is different from daily medications or lifestyle changes typically used for managing prediabetes. ^{1 2 3 4 7}

Research Team

Elizabeth Sutton, PhD

Principal Investigator

Woman's Hospital, Louisiana

Eligibility Criteria

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.

Inclusion Criteria

You are considered overweight based on your weight and height.

I am between 18 and 45 years old.

Ability to provide informed consent before any trial-related activities

Exclusion Criteria

You have used tobacco products in the last 6 months.

You weigh more than 350 pounds.

I have gone through menopause.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly injections of semaglutide or placebo for 8 months total, including 2 months of titration and 6 months of full-dose treatment

8 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo semaglutide pen injector
• Semaglutide Pen Injector [Ozempic]

Trial Overview 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.

Participant Groups

Group I: Semaglutide Pen Injector (Ozempic) Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

Weekly injections of placebo for 8 months total

Semaglutide Pen Injector [Ozempic] is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Ozempic for:

• Type 2 diabetes

Approved in United States as Ozempic for:

• Type 2 diabetes
• Obesity

Approved in Canada as Ozempic for:

• Type 2 diabetes

Approved in Japan as Ozempic for:

• Type 2 diabetes

Approved in China as Ozempic for:

• Type 2 diabetes

Approved in Switzerland as Ozempic for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

Woman's

Lead Sponsor

Trials

18

Recruited

1,400+

Novo Nordisk A/S

Industry Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Findings from Research

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]

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]

There has been a significant increase in public interest in Ozempic, a GLP-1 agonist, for weight loss, as evidenced by a growing relative search volume over a 5-year period, particularly after the FDA approval of Wegovy in June 2021.

Ozempic consistently outperformed other GLP-1 agonists like Wegovy and Mounjaro in search popularity, indicating its prominence in discussions about weight management, which suggests that healthcare providers, especially plastic surgeons, need to be aware of its implications for patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Public Interest in the Off-Label Use of Glucagon-Like Peptide 1 Agonists (Ozempic) for Cosmetic Weight Loss: A Google Trends Analysis. Han, SH., Safeek, R., Ockerman, K., et al.[2023]

Semaglutide, a once-weekly injectable GLP-1 receptor agonist for type 2 diabetes, has shown cardiovascular benefits and a safety profile typical of its class, primarily involving gastrointestinal side effects.

While concerns about thyroid and pancreatic safety were not supported by data, there is a notable increase in diabetic retinopathy events and a modest rise in gall bladder issues, indicating the need for caution when starting treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of injectable semaglutide for type 2 diabetes. Peter, R., Bain, SC.[2022]

Semaglutide, a long-acting GLP-1 receptor agonist, has been shown to significantly reduce HbA1c, fasting plasma glucose, body weight, and blood pressure in over 9,000 patients with type 2 diabetes, demonstrating greater efficacy than other GLP-1RAs.

While semaglutide has a low risk of hypoglycemia, it is associated with gastrointestinal side effects, and there is a warning regarding an increased risk of diabetes-related retinopathy in patients with preexisting conditions, necessitating further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical potential of treatment with semaglutide in type 2 diabetes patients. Røder, ME.[2020]

Semaglutide, a GLP-1 receptor agonist, has been shown to effectively lower hemoglobin A1c levels by approximately -1.5% and reduce body weight by about -4.5 kg in phase 3 trials, demonstrating comparable efficacy to dulaglutide.

While semaglutide offers cardiovascular benefits, including a reduced risk of major cardiovascular events, it is associated with an increased risk of retinopathy complications in patients with existing diabetic retinopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide for the Treatment of Type 2 Diabetes Mellitus. Miles, KE., Kerr, JL.[2021]

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]

References

1. Belgium pubmed.ncbi.nlm.nih.gov

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

2. New Zealand pubmed.ncbi.nlm.nih.gov

Semaglutide: First Global Approval. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Public Interest in the Off-Label Use of Glucagon-Like Peptide 1 Agonists (Ozempic) for Cosmetic Weight Loss: A Google Trends Analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Safety of injectable semaglutide for type 2 diabetes. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Clinical potential of treatment with semaglutide in type 2 diabetes patients. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Semaglutide for the Treatment of Type 2 Diabetes Mellitus. [2021]

7. Japan pubmed.ncbi.nlm.nih.gov

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