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New treatment option for Pre Diabetes
Official title Treatment to Regress to Normoglycemia in Women with a Recent History of GDM
ClinicalTrials.gov ID: NCT04873050
What this study is testing
What is Semaglutide Pen Injector [Ozempic]?
Semaglutide Pen Injector [Ozempic] is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for pre diabetes.
Also referred to as Semaglutide 1mg, Ozempic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- Female
- 18 - 45 years old (inclusive)
- History of gestational diabetes in most recent pregnancy
- 6 months - 10 years postpartum
- BMI ≥ 25 kg/m2
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
- 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 \ 399mg%)...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baton Rouge, Louisiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baton Rouge, Louisiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.