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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)

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 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.

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

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

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

0 / 4Eligibility criteria met

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

1,514 Previous Clinical Trials

2,414,966 Total Patients Enrolled

Elizabeth Sutton, PhDPrincipal InvestigatorWoman's Hospital, Louisiana

1 Previous Clinical Trials

500 Total Patients Enrolled

Media Library

Semaglutide Pen Injector [Ozempic] (Glucagon-like peptide-1 (GLP-1) receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04873050 — Phase 4

Prediabetes Research Study Groups: Semaglutide Pen Injector (Ozempic), Placebo

Prediabetes Clinical Trial 2023: Semaglutide Pen Injector [Ozempic] Highlights & Side Effects. Trial Name: NCT04873050 — Phase 4

Semaglutide Pen Injector [Ozempic] (Glucagon-like peptide-1 (GLP-1) receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04873050 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the uppermost limit for participants in this experiment?

"Affirmative. The information accessible on clinicaltrials.gov supports the fact that this research is actively looking for participants, having been posted on January 13th 2022 and recently modified on January 25th 2022. They require 102 volunteers from 1 site to take part in their trial."

Answered by AI

Has the FDA sanctioned Ozempic for therapeutic use?

"Our team at Power has assessed that semaglutide pen injector [Ozempic] is a highly safe medication, scoring 3 on the 1-3 scale. This decision was based on the fact Ozempic is formally approved for use during Phase 4 trials."

Answered by AI

Is this the inaugural scientific investigation of its kind?

"Ozempic has been subject to 58 ongoing clinical trials located in 55 countries and 772 cities since the initial Phase 4 Trial sponsored by Novo Nordisk A/S which concluded with 1387 participants back in 2018. Since then, 123 other studies have been conducted for this pen injector drug."

Answered by AI

Does this clinical trial cater to individuals aged fifty and above?

"This trial is geared towards individuals aged 18 to 45, with 19 clinical trials for minors and 203 specifically targeting patients above the age of 65."

Answered by AI

Is it feasible for me to be included in this research study?

"This medical trial is looking to enrol 102 people, aged between 18 and 45 years old with impaired glucose tolerance. Candidates must also be female, have a body mass index of 25 kg/m2 or greater, used long-acting reversible contraception or had bilateral tubal ligation; their fasting glucose should lie within 100 - 125mg/dL (inclusive) and the two hour postprandial value needed for inclusion in this study lies between 140 - 199 mg/dL. Furthermore, participants are expected to maintain physical activity levels throughout the duration of the trial as well as standardize dietary intake for three days prior to an oral glucose"

Answered by AI

Are there still available slots for those interested in participating in this research?

"Right. According to clinicaltrials.gov, this medical study – which was first listed on January 13th 2022 – is actively recruiting participants for the trial. The research plans to enrol 102 patients at one centre."

Answered by AI

To what therapeutic purpose is Ozempic primarily prescribed?

"Semaglutide Pen Injector [Ozempic] is a popular medication for chronic weight management. Additionally, this drug can be beneficial in addressing other issues such as dietary restriction, physical activity regimens and comorbid conditions connected to obesity."

Answered by AI

Are there any other experiments that have investigated the efficacy of Semaglutide Pen Injector [Ozempic]?

"A total of 58 clinical trials are currently underway to investigate the effectiveness of Semaglutide Pen Injector [Ozempic], 27 of which have progressed to Phase 3. Though the majority are conducted in Loma Linda, California, there is a grand total of 3907 sites hosting studies for this treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment to Regress to Normoglycemia in Women With a Recent History of GDM

Elizabeth F Sutton, PhD 2022. "Treatment to Regress to Normoglycemia in Women With a Recent History of GDM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04873050.

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