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Glucagon-like peptide-1 receptor agonist

Oral semaglutide for Type 2 Diabetes

Phase 1
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 0 to 24 hours after the 10th dosing (day 10)
Awards & highlights

Study Summary

This trial is testing a new drug, semaglutide, to see if it's effective and safe. Participants will take it for 10 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 0 to 24 hours after the 10th dosing (day 10)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 0 to 24 hours after the 10th dosing (day 10) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the salcaprozate sodium (SNAC) milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,SNAC,D10,milk)
Area under the semaglutide milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,D10,milk)
Secondary outcome measures
Area under the SNAC metabolite E1245 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1245,D10,milk)
Area under the SNAC metabolite E1245 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1245,D10,plasma)
Area under the SNAC metabolite E1246 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1246,D10,milk)
+60 more

Side effects data

From 2021 Phase 3 trial • 1441 Patients • NCT04017832
8%
Upper respiratory tract infection
4%
Diarrhoea
4%
Nausea
3%
Lipase increased
1%
Coronary artery disease
1%
COVID-19 pneumonia
1%
Decreased appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sitagliptin 100 mg
Oral Semaglutide 3 mg
Oral Semaglutide 14 mg
Oral Semaglutide 7 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Oral semaglutideExperimental Treatment1 Intervention
All participants will receive oral semaglutide once daily for a total of 10 days: 3 mg for 5 days followed by 7 mg for 5 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,513 Previous Clinical Trials
2,415,015 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
45,106 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still available slots for participants in this experiment?

"As indicated by the information publicly available on clinicaltrials.gov, this medical trial is currently enrolling participants. The study was initially posted on September 10th 2021, and updated most recently on November 18th 2022."

Answered by AI

How extensive is the population of participants in this research endeavor?

"Indeed, the data hosted on clinicaltrials.gov indicates that this medical experiment is presently accepting participants. This trial was first brought to light on September 10th 2021 and has since been revised as of November 18th 2022. Currently, 14 volunteers are needed from one site for this study."

Answered by AI

To what conditions is Oral semaglutide typically prescribed?

"Oral semaglutide can be a viable choice for those who are looking to manage their weight, reduce caloric intake, or increase physical activity."

Answered by AI

Is this the inaugural trial of its species?

"Investigation of oral semaglutide began in 2018, with a trial funded by Novo Nordisk A/S involving 1387 patients. This drug was granted its Phase 4 approval following the conclusion of this initial research and is now being trialed extensively; 58 distinct studies are occurring across 55 countries and 772 cities."

Answered by AI

Has Oral semaglutide been explored in any prior investigations?

"At this moment, Oral semaglutide is the subject of 58 active clinical trials. 27 of them are in Phase 3 and primarily take place at Loma Linda, California; however 3907 other locations across the globe are also running similar studies."

Answered by AI

Has the U.S. Food & Drug Administration given its stamp of approval to Oral semaglutide?

"The pre-clinical data available suggests that Oral semaglutide is safe, and thus receives a score of 1."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Novo Nordisk Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Research Study to See How Much Semaglutide and SNAC is in the Milk of Healthy, Breastfeeding Women Taking Semaglutide Tablets
2021. "A Research Study to See How Much Semaglutide and SNAC is in the Milk of Healthy, Breastfeeding Women Taking Semaglutide Tablets". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04817644.
~4 spots leftby Apr 2025
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