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Glucagon-like peptide-1 (GLP-1) receptor agonist

Oral semaglutide for Type 2 Diabetes (PIONEER PLUS Trial)

Phase 3
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 week 12, week 52
Awards & highlights

PIONEER PLUS Trial Summary

This trial is testing if semaglutide, a drug used to treat type 2 diabetes, is effective when given in different doses. Participants will take the drug for 68 weeks.

Eligible Conditions
  • Type 2 Diabetes

PIONEER PLUS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12, week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12, week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52)
Secondary outcome measures
Change From Baseline in BMI (Week 68)
Change From Baseline in Body Mass Index (BMI) (Week 52)
Change From Baseline in Body Weight (Week 52)
+35 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

PIONEER PLUS Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Oral semaglutide 50 mgExperimental Treatment1 Intervention
Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12), 25 mg (week 13-16) and 50 mg (week 17-68).
Group II: Oral semaglutide 25 mgExperimental Treatment1 Intervention
Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12) and 25 mg (week 13-68).
Group III: Oral semaglutide 14 mgActive Control1 Intervention
Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8) and 14 mg (week 9-68).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral semaglutide
2021
Completed Phase 3
~6570

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,513 Previous Clinical Trials
2,413,423 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
43,514 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 similar drugs to Oral semaglutide that have been through clinical trials?

"The first year that oral semaglutide was studied was 2018 and it took place at the Novo Nordisk Investigational Site. As of now, 123 clinical trials have been completed with 59 more currently underway. The majority of these active trials are located in Carlinville, Illinois."

Answered by AI

When will the FDA be releasing their decision on semaglutide?

"Oral semaglutide has demonstrated efficacy in clinical trials and has a good safety profile, so our team at Power gives it a score of 3."

Answered by AI

How many sites are running this clinical trial?

"The 4 clinics presently recruiting patients for this trial are in Carlinville, West Hills, and Calgary. There may be other locations too. If you are considering participating in this trial, try to select the clinic that is closest to you to cut down on travel time."

Answered by AI

What are the main conditions that doctors are using Oral semaglutide to treat?

"Oral semaglutide is used to manage chronic weight and can help patients who are on a reduced-calorie diet and exercising to lose weight by also treating at least one weight-related comorbid condition."

Answered by AI

What is the projected total number of participants for this research project?

"This particular clinical trial is no longer recruiting patients. The original posting was on January 15th, 2021 and the last edit was on September 21st, 2022. 1446 other studies are currently enrolling patients with type 2 diabetes mellitus and 59 studies are enrolling patients for oral semaglutide."

Answered by AI

Is this study still looking for participants?

"No, this particular clinical trial is no longer searching for participants. However, as of September 21st, 2022, there are 1446 trials for diabetes mellitus, type 2 and 59 studies for Oral semaglutide that are still enrolling patients."

Answered by AI

What other research is similar to this trial?

"As of now, 59 clinical trials for Oral semaglutide are ongoing in 55 countries and 711 cities. In 2018, the first trial was conducted and completed its Phase 4 approval stage that year. The trial was sponsored by Novo Nordisk A/S, involved 1387 participants, and since its completion, 123 more studies have been completed."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Oklahoma
Illinois
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 responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes
2021. "Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04707469.
~378 spots leftby Apr 2025
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