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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the drug semaglutide (Ozempic) can help women who had gestational diabetes during pregnancy normalize their blood sugar levels after giving birth. The goal is to determine if this treatment reduces the risk of developing type 2 diabetes later in life. Participants will receive either semaglutide or a placebo through weekly injections for eight months. Suitable candidates for this trial have had gestational diabetes, are 6 months to 10 years postpartum, have a BMI of 25 or higher, and experience blood sugar issues. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment benefits more patients.

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 is the safety track record for semaglutide?

Research has shown that semaglutide, the treatment under study, is generally well-tolerated. In one study, some patients experienced complications with diabetic eye disease, occurring in 3.0% of those taking semaglutide compared to 1.8% of those on a placebo. However, this affected only a small number of participants.

Another study demonstrated that semaglutide helped individuals achieve normal blood sugar levels. Despite some risks, the FDA has approved semaglutide for treating type 2 diabetes, indicating a certain level of safety for similar conditions. It is important to consider possible side effects and consult a healthcare provider to understand the risks and benefits. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for prediabetes, which often includes lifestyle changes and oral medications like metformin, semaglutide is unique because it is a GLP-1 receptor agonist that works by mimicking a hormone that helps regulate blood sugar levels and appetite. This injectable treatment could offer better blood sugar control and weight management, which are crucial for individuals who have had gestational diabetes mellitus (GDM) and are now facing prediabetes. Researchers are excited about semaglutide because it not only targets blood sugar levels more effectively but also supports weight loss, addressing two major concerns for those at risk of developing type 2 diabetes.

What evidence suggests that semaglutide might be an effective treatment for prediabetes post-GDM?

Research shows that semaglutide can improve how the body processes sugar. In this trial, participants will receive either semaglutide or a placebo. Previous studies found that people taking semaglutide had significantly better blood sugar levels than those taking a placebo, which contains no active medicine. More participants on semaglutide reached normal blood sugar levels, crucial for managing conditions like prediabetes. It also reduced hemoglobin A1c levels, a measure of long-term blood sugar control, by about 1.5%. Additionally, semaglutide users lost weight, aiding in blood sugar control. These findings suggest that semaglutide could help women who have had gestational diabetes return to normal blood sugar levels after giving birth and lower their risk of developing type 2 diabetes. ^{1 2 6 7 8}

Who Is on the Research Team?

Elizabeth Sutton, PhD

Principal Investigator

Woman's Hospital, Louisiana

Are You a Good Fit for This Trial?

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.

Ability to provide informed consent before any trial-related activities

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

Exclusion Criteria

You have used tobacco products in the last 6 months.

You weigh more than 350 pounds.

I have gone through menopause.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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, 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 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 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]

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]

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 (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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12499737/

New developments in GLP-1 agonist therapy for ... Some GLP-1, such as liraglutide and exenatide, have shown potential outcomes in non-pregnant populations for improving blood glucose levels and ...

4. withpower.com withpower.com/trial/phase-4-puerperal-disorders-7-2021-23b4f

Semaglutide for Prediabetes Post-GDM (SWEET Trial) 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 ...

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

Evaluating the effect of Semaglutide as add-on therapy ... Semaglutide improved glycemic stability and reduced glycemic risk in T1D. HbA1c declined with nearly a 50 % reduction in daily insulin dose.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12141256/

Pregnancy outcomes following first trimester exposure to ... Thirteen women were exposed to semaglutide in first trimester. One infant had significant cardiac anomalies in the setting of very poor maternal ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa1607141

Semaglutide and Cardiovascular Outcomes in Patients ... Microvascular Outcomes​​ Diabetic retinopathy complications occurred in 50 patients (3.0%) in the semaglutide group and 29 (1.8%) in the placebo ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05569772

NCT05569772 | Semaglutide for the Treatment of Glucose ... Outcomes: The primary endpoint is the development of T2DM by 160 weeks defined by fasting glycaemia, OGTT and/or HbA1c according to the ADA criteria. Important ...