NCT04873050 · Woman's
Treatment to Regress to Normoglycemia in Women with a Recent History of GDM
(SWEET)
What this study is about
The purpose of the study is to determine the effectiveness 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
Exclusion criteria
- 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
- 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
Where
- Baton Rouge, Louisiana
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 13, 2025 · Source of record for eligibility and locations