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

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: Female

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 reduce future risk of T2DM in young women.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Woman's
• Collaborator: Novo Nordisk A/S

Criteria

Inclusion Criteria:

1. Female

2. 18 - 45 years old (inclusive)

3. History of gestational diabetes in most recent pregnancy

4. 6 - 36 months 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