Semaglutide Pen Injector [Ozempic] for Prediabetes

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Woman's Hospital, Baton Rouge, LAPrediabetes+1 MoreSemaglutide Pen Injector [Ozempic] - Drug
Eligibility
18 - 45
Female
What conditions do you have?
Select

Study Summary

This trial will test whether semaglutide 1mg can help postpartum women with a history of gestational diabetes mellitus (GDM) to return to normal blood sugar levels, where there are currently no effective pharmacological options.

Eligible Conditions
  • Postpartum Depression
  • Prediabetes

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: After 24 weeks of full-dose treatment

Week 24
Change in HbA1c
Change in body weight
Regression to normoglycemia

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Semaglutide Pen Injector (Ozempic)
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

102 Total Participants · 2 Treatment Groups

Primary Treatment: Semaglutide Pen Injector [Ozempic] · Has Placebo Group · Phase 4

Semaglutide Pen Injector (Ozempic)
Drug
Experimental Group · 1 Intervention: Semaglutide Pen Injector [Ozempic] · Intervention Types: Drug
Placebo
Drug
ShamComparator Group · 1 Intervention: Placebo semaglutide pen injector · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: after 24 weeks of full-dose treatment

Who is running the clinical trial?

Woman'sLead Sponsor
16 Previous Clinical Trials
1,280 Total Patients Enrolled
Novo Nordisk A/SIndustry Sponsor
1,424 Previous Clinical Trials
2,313,566 Total Patients Enrolled
Elizabeth Sutton, PhDPrincipal InvestigatorWoman's Hospital, Louisiana

Eligibility Criteria

Age 18 - 45 · Female Participants · 11 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a woman.
You must be willing to stay active during the entire study.

Frequently Asked Questions

What is the uppermost limit for participants in this experiment?

"Affirmative. The information accessible on clinicaltrials.gov supports the fact that this research is actively looking for participants, having been posted on January 13th 2022 and recently modified on January 25th 2022. They require 102 volunteers from 1 site to take part in their trial." - Anonymous Online Contributor

Unverified Answer

Has the FDA sanctioned Ozempic for therapeutic use?

"Our team at Power has assessed that semaglutide pen injector [Ozempic] is a highly safe medication, scoring 3 on the 1-3 scale. This decision was based on the fact Ozempic is formally approved for use during Phase 4 trials." - Anonymous Online Contributor

Unverified Answer

Is this the inaugural scientific investigation of its kind?

"Ozempic has been subject to 58 ongoing clinical trials located in 55 countries and 772 cities since the initial Phase 4 Trial sponsored by Novo Nordisk A/S which concluded with 1387 participants back in 2018. Since then, 123 other studies have been conducted for this pen injector drug." - Anonymous Online Contributor

Unverified Answer

Does this clinical trial cater to individuals aged fifty and above?

"This trial is geared towards individuals aged 18 to 45, with 19 clinical trials for minors and 203 specifically targeting patients above the age of 65." - Anonymous Online Contributor

Unverified Answer

Is it feasible for me to be included in this research study?

"This medical trial is looking to enrol 102 people, aged between 18 and 45 years old with impaired glucose tolerance. Candidates must also be female, have a body mass index of 25 kg/m2 or greater, used long-acting reversible contraception or had bilateral tubal ligation; their fasting glucose should lie within 100 - 125mg/dL (inclusive) and the two hour postprandial value needed for inclusion in this study lies between 140 - 199 mg/dL. Furthermore, participants are expected to maintain physical activity levels throughout the duration of the trial as well as standardize dietary intake for three days prior to an oral glucose" - Anonymous Online Contributor

Unverified Answer

Are there still available slots for those interested in participating in this research?

"Right. According to clinicaltrials.gov, this medical study – which was first listed on January 13th 2022 – is actively recruiting participants for the trial. The research plans to enrol 102 patients at one centre." - Anonymous Online Contributor

Unverified Answer

To what therapeutic purpose is Ozempic primarily prescribed?

"Semaglutide Pen Injector [Ozempic] is a popular medication for chronic weight management. Additionally, this drug can be beneficial in addressing other issues such as dietary restriction, physical activity regimens and comorbid conditions connected to obesity." - Anonymous Online Contributor

Unverified Answer

Are there any other experiments that have investigated the efficacy of Semaglutide Pen Injector [Ozempic]?

"A total of 58 clinical trials are currently underway to investigate the effectiveness of Semaglutide Pen Injector [Ozempic], 27 of which have progressed to Phase 3. Though the majority are conducted in Loma Linda, California, there is a grand total of 3907 sites hosting studies for this treatment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.