Using semaglutide to help women with a history of gestational diabetes return to normal blood sugar levels

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

This study is testing if a medication called semaglutide can help women who had gestational diabetes and currently have blood sugar issues get back to normal levels after giving birth.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Woman's (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Baton Rouge, Louisiana)
• Trial ID: NCT04873050 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of semaglutide 1mg (Ozempic®) in helping postpartum women who have experienced gestational diabetes mellitus (GDM) and currently have dysglycemia to achieve normoglycemia. The research focuses on women aged 18 to 45 who are between 6 months and 10 years postpartum and have specific glycemic impairments. Participants will be randomly assigned to receive either semaglutide or a placebo, with the goal of determining if the medication can effectively reverse dysglycemia and reduce the risk of developing type 2 diabetes in the future. The study aims to fill a critical gap in pharmacologic options for managing postpartum diabetes recovery.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-45 with a recent history of gestational diabetes and current dysglycemia.

Not a fit: Patients who are pregnant, breastfeeding, or have a body weight over 350 pounds may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of type 2 diabetes in women with a history of gestational diabetes.

How similar studies have performed: Other studies have shown promise in using pharmacologic interventions for managing postpartum diabetes, but this specific approach with semaglutide is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Female
2. 18 - 45 years old (inclusive)
3. History of gestational diabetes in most recent pregnancy
4. 6 months - 10 years postpartum
5. BMI ≥ 25 kg/m2
6. Use of long-acting reversible contraception or bilateral tubal ligation
7. Dysglycemia as determined by glycemic response to 75g, 2-hour OGTT: either impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT):

   1. Fasting glucose 100-125mg/dL (inclusive) and/or
   2. 120 minute glucose 140-199mg/dL (inclusive)
8. Willingness to maintain physical activity level throughout study duration
9. Willingness to standardize diet for 3 days prior to OGTT
10. Ability to provide informed consent before any trial-related activities

Exclusion Criteria:

1. Body weight \> 350lb
2. Pregnant or the intention of becoming pregnant or not using adequate contraceptive measures.
3. Breastfeeding within 3 months of screening visit 1
4. Post-menopausal
5. Desiring pregnancy within study participation period or two months after participation ends (i.e. 10 months from enrolment)
6. Use of tobacco products within past 6 months
7. Substance or alcohol abuse
8. 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)
9. 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
10. History of bariatric surgery
11. 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
12. Use of medications for anti-obesity or weight loss within four weeks of screening visit 1
13. Use of medications known to exacerbate glucose dysfunction (such as isotretinoin or corticosteroids) within four weeks of screening visit 1
14. Known or suspected allergy to trial medication, excipients, or related products
15. 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)
16. Current or recent past (within 3 months) participation in another experimental drug trial
17. Previous randomization in this trial
18. Receipt of any investigational drug within 6 months prior to this trial

Where this trial is running

Baton Rouge, Louisiana

• Woman's Hospital — Baton Rouge, Louisiana, United States (RECRUITING)

Study contacts

• Principal investigator: Elizabeth Sutton, PhD — Woman's Hospital, Louisiana
• Study coordinator: Briasha Jones, MPH

Conditions: Pre Diabetes, Postpartum Disorder