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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
SWEET Trial Summary
This trial will test whether semaglutide 1mg can help postpartum women with a history of gestational diabetes mellitus (GDM) to return to normal blood sugar levels, where there are currently no effective pharmacological options.
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.Check my eligibility
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.See study design
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.
SWEET Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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:Select...
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.
SWEET Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Regression to normoglycemia
Secondary outcome measures
Change in HbA1c
Change in body weight
SWEET 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
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.
Find a Location
Who is running the clinical trial?
Woman'sLead Sponsor
17 Previous Clinical Trials
1,352 Total Patients Enrolled
Novo Nordisk A/SIndustry Sponsor
1,525 Previous Clinical Trials
2,419,634 Total Patients Enrolled
Elizabeth Sutton, PhDPrincipal InvestigatorWoman's Hospital, Louisiana
1 Previous Clinical Trials
500 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used tobacco products in the last 6 months.You weigh more than 350 pounds.I have gone through menopause.You are considered overweight based on your weight and height.I do not have a history of thyroid cancer or MEN 2 in my family.I am between 18 and 45 years old.My blood sugar levels are higher than normal but not high enough to be diabetes.I have taken diabetes medication in the last 4 weeks.I do not have an eating disorder, active cancer needing chemotherapy, or severe mental health issues.I have a significant health condition like diabetes, heart, kidney, liver disease, or high blood pressure.I use long-term birth control or have had my tubes tied.I haven't taken isotretinoin or corticosteroids in the last 4 weeks.I haven't taken weight loss drugs in the last 4 weeks.I am female.You have a history of using drugs or drinking a lot of alcohol.I have had weight loss surgery in the past.You had diabetes during your most recent pregnancy.I gave birth between 6 and 36 months ago.
Research Study Groups:
This trial has the following groups:- Group 1: Semaglutide Pen Injector (Ozempic)
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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