Pre DiabetesPhase 4SWEETNCT04873050
Treatment to Regress to Normoglycemia in Women with a Recent History of GDM
A Phase 4 study testing Semaglutide Pen Injector [Ozempic] in people with Pre Diabetes and Postpartum Disorder, run by Woman's at 1 site in United States.
Trial summary
The purpose of the study is to determine the efficacy of semaglutide 1mg (Ozempic®) to aid recently postpartum women with dysglycemia and a history of GDM to regress to normoglycemia; thereby filling a gap in efficacious pharmacologic intervention options for clinicians to support postpartum diabetes recovery and… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre Diabetes, Postpartum Disorder
- What is being tested?
- Semaglutide Pen Injector [Ozempic]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2022to 1 Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- 18 - 45 years old (inclusive)
- History of gestational diabetes in most recent pregnancy
- 6 months - 10 years postpartum
- BMI ≥ 25 kg/m2
- Use of long-acting reversible contraception or bilateral tubal ligation
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- 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)
- Willingness to maintain physical activity level throughout study duration
- Willingness to standardize diet for 3 days prior to OGTT
- Ability to provide informed consent before any trial-related activities
Who cannot join
- Body weight > 350lb
- Pregnant or the intention of becoming pregnant or not using adequate contraceptive measures.
- Breastfeeding within 3 months of screening visit 1
- Post-menopausal
- Desiring pregnancy within study participation period or two months after participation ends (i.e. 10 months from enrolment)
- Use of tobacco products within past 6 months
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- Substance or alcohol abuse
- Presence of significant systemic disease including: diabetes mellitus (type 1 or type 2), cardiac disease (e.g. congestive heart failure), renal impairment (e.g. serum creatinine levels ≥ 1.4 mg/dL or eGFR < 60), hepatic disease (including viral hepatitis, toxic hepatic damage, jaundice of unknown aetiology, or abnormal liver function tests), pancreatitis, uncontrolled thyroid disease (e.g. documented abnormal TSH), adrenal disease (including Cushing's syndrome, congenital adrenal hyperplasia), hyperlipidemia (fasting triglycerides > 399mg%), untreated or poorly controlled hypertension (resting blood pressure >159/94 mmHg)
- History of or presence of: eating disorder, malignant disease requiring chemotherapy, or debilitating psychiatric disorder such as psychosis or neurological condition that could confound outcome variables
- History of bariatric surgery
- Use of medications for glucose regulation: insulin (e.g. Humalog, Novolog, Humulin), pramlintide, metiglinides, metformin, thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors within four weeks of screening visit 1
- Use of medications for anti-obesity or weight loss within four weeks of screening visit 1
- Use of medications known to exacerbate glucose dysfunction (such as isotretinoin or corticosteroids) within four weeks of screening visit 1
- Known or suspected allergy to trial medication, excipients, or related products
- 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)
- Current or recent past (within 3 months) participation in another experimental drug trial
- Previous randomization in this trial
- Receipt of any investigational drug within 6 months prior to this trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Woman's Hospital
Baton Rouge, Louisiana, 70817
Elizabeth Sutton, PhD, 225-924-8446, elizabeth.sutton@womans.org
About this study
Official title: A Randomized, Placebo-controlled, Double Blind Trial of Semaglutide 1mg (Ozempic®) on Regression to Normoglycemia in WomEn with a Recent History of Gestational DiabETes Mellitus: the SWEET Study
The purpose of the study is to determine the efficacy of semaglutide 1mg (Ozempic®) to aid recently postpartum women with dysglycemia and a history of GDM to regress to normoglycemia; thereby filling a gap in efficacious pharmacologic intervention options for clinicians to support postpartum diabetes recovery and reduce future risk of T2DM in young women.
Read the detailed description
The diagnosis of gestational diabetes mellitus (GDM) during pregnancy identifies young women with abnormalities in pancreatic beta cell function that worsen over time, leading to diabetes. It is estimated that between 15% and 70% of women with a history GDM will progress to type 2 diabetes mellitus (T2DM). However, upon an impaired glucose tolerance test result in the early postpartum period, the American College of Obstetricians and Gynecologists only recommend considering referral for management, weight loss and physical activity counseling, considering metformin if testing results are severe enough, and yearly assessment of glycemic status. In many cases, it is possible to reverse diabetes by losing weight in the early stages before permanent, systemic damage occurs. Therefore, there is a dire need for efficacious pharmacologic intervention options in this period of postpartum diabetes recovery to return women to normoglycemia and lower future T2DM risk. Weight loss and medications that mitigate impairments in insulin secretion show the best promise for delaying or preventing T2DM, the dominant form of diabetes that develops after GDM. The primary study objective is "to examine the efficacy of semaglutide 1mg compared to placebo on regression to normoglycemia in women with dysglycemia and a recent history of gestational diabetes mellitus (i.e., 6-36 months postpartum)" to answer the research question of: "Among women with dysglycemia and a recent history of gestational diabetes mellitus, can acute treatment of semaglutide 1mg lead to regression to normoglycemia?"
- Conditions
- Pre Diabetes, Postpartum Disorder
- Being tested
- Semaglutide Pen Injector [Ozempic], Placebo semaglutide pen injector
- Medical subject headings
- Glucose Intolerance, Puerperal Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide Pen Injector [Ozempic]Drug
Also called Semaglutide 1mg, Ozempic
Start injection of semaglutide 0.25mg subcutaneously (SC) once a week for 4 weeks; step up to 0.5 mg SC QD for once a week for 4 weeks to a final dose of 1.0 mg semaglutide SQ weekly for 24 doses
Placebo semaglutide pen injectorDrug
Also called Placebo Semaglutide 1mg, Placebo Ozempic
Start injection of placebo semaglutide 0.25mg subcutaneously (SC) one a week for 4 weeks; step up to 0.5 mg SC QD for once a week for 4 weeks to a final dose of 1.0 mg semaglutide SQ weekly for 24 doses
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide Pen Injector (Ozempic) | Experimental | Weekly injections of semaglutide for 8 months total (2 months of titration; 6 months of full dose- 1mg/week) Receives: Drug: Semaglutide Pen Injector [Ozempic] |
| Placebo | Sham comparator | Weekly injections of placebo for 8 months total Receives: Drug: Placebo semaglutide pen injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression to normoglycemia
Glucose tolerance to be determined by glycemic response to a 75 gram, two-hour oral glucose tolerance test (OGTT). Regression to normoglycemia is defined by fasting glucose <100mg/dL and 120 minute glucose <140 mg/dL
Measured: After 24 weeks of full-dose treatment
Secondary outcomes (2)
Change in HbA1c
Hemoglobin to be determined
Measured: After 24 weeks of full-dose treatment
Change in body weight
Fasted body weight after intervention minus fasted body weight at enrollment
Measured: After 24 weeks of full-dose treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start13 Jan 2022
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Woman's
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Elizabeth F Sutton, PhD, Woman's
- Investigators
- Elizabeth Sutton, PhD, Principal investigator, Woman's Hospital, Louisiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873050
- Sponsor's protocol ID
- RP-21-010
- Acronym
- SWEET
- Status last verified
- Mar 2025
- First submitted
- 29 Apr 2021
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double Blind Trial of Semaglutide 1mg (Ozempic®) on Regression to Normoglycemia in WomEn with a Recent History of Gestational DiabETes Mellitus: the SWEET Study
- ClinicalTrials.gov ID
- NCT04873050
- Acronym / sponsor ID
- SWEET / RP-21-010
- Conditions
- Pre Diabetes, Postpartum Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Woman'sUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the efficacy of semaglutide 1mg (Ozempic®) to aid recently postpartum women with dysglycemia and a history of GDM to regress to normoglycemia; thereby filling a gap in efficacious pharmacologic intervention options for clinicians to support postpartum diabetes recovery and reduce future risk of T2DM in young women.
Detailed description
The diagnosis of gestational diabetes mellitus (GDM) during pregnancy identifies young women with abnormalities in pancreatic beta cell function that worsen over time, leading to diabetes. It is estimated that between 15% and 70% of women with a history GDM will progress to type 2 diabetes mellitus (T2DM). However, upon an impaired glucose tolerance test result in the early postpartum period, the American College of Obstetricians and Gynecologists only recommend considering referral for management, weight loss and physical activity counseling, considering metformin if testing results are severe enough, and yearly assessment of glycemic status. In many cases, it is possible to reverse diabetes by losing weight in the early stages before permanent, systemic damage occurs. Therefore, there is a dire need for efficacious pharmacologic intervention options in this period of postpartum diabetes recovery to return women to normoglycemia and lower future T2DM risk. Weight loss and medications that mitigate impairments in insulin secretion show the best promise for delaying or preventing T2DM, the dominant form of diabetes that develops after GDM. The primary study objective is "to examine the efficacy of semaglutide 1mg compared to placebo on regression to normoglycemia in women with dysglycemia and a recent history of gestational diabetes mellitus (i.e., 6-36 months postpartum)" to answer the research question of: "Among women with dysglycemia and a recent history of gestational diabetes mellitus, can acute treatment of semaglutide 1mg lead to regression to normoglycemia?"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide Pen Injector (Ozempic) | Experimental | Drug: Semaglutide Pen Injector [Ozempic]Weekly injections of semaglutide for 8 months total (2 months of titration; 6 months of full dose- 1mg/week) |
| Placebo | Sham comparator | Drug: Placebo semaglutide pen injectorWeekly injections of placebo for 8 months total |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Female
- 18 - 45 years old (inclusive)
- History of gestational diabetes in most recent pregnancy
- 6 months - 10 years postpartum
- BMI ≥ 25 kg/m2
Key exclusion criteria (18 listed)
- Body weight > 350lb
- Pregnant or the intention of becoming pregnant or not using adequate contraceptive measures.
- Breastfeeding within 3 months of screening visit 1
- Post-menopausal
- Desiring pregnancy within study participation period or two months after participation ends (i.e. 10 months from enrolment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide Pen Injector [Ozempic]Also: Semaglutide 1mg, OzempicStart injection of semaglutide 0.25mg subcutaneously (SC) once a week for 4 weeks; step up to 0.5 mg SC QD for once a week for 4 weeks to a final dose of 1.0 mg semaglutide SQ weekly for 24 doses | Drug | Semaglutide Pen Injector (Ozempic) |
| Placebo semaglutide pen injectorAlso: Placebo Semaglutide 1mg, Placebo OzempicStart injection of placebo semaglutide 0.25mg subcutaneously (SC) one a week for 4 weeks; step up to 0.5 mg SC QD for once a week for 4 weeks to a final dose of 1.0 mg semaglutide SQ weekly for 24 doses | Drug | Placebo |
Primary outcome
Regression to normoglycemia
Time frame: After 24 weeks of full-dose treatment
Glucose tolerance to be determined by glycemic response to a 75 gram, two-hour oral glucose tolerance test (OGTT). Regression to normoglycemia is defined by fasting glucose <100mg/dL and 120 minute glucose <140 mg/dL
2 secondary outcomes
Change in HbA1c
Time frame: After 24 weeks of full-dose treatment
Change in body weight
Time frame: After 24 weeks of full-dose treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Sutton, PhD principal investigator
Woman's Hospital, Louisiana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide Pen Injector [Ozempic] in people with Pre Diabetes and Postpartum Disorder, run by Woman's at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Briasha Jones, MPH (225-924-8446, briasha.jones@womans.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression to normoglycemia (time frame: After 24 weeks of full-dose treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.