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Glucagon-like peptide-1 receptor agonist

Semaglutide for Type 2 Diabetes

Phase 4
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 baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Awards & highlights

Study Summary

This trial is comparing the effects of semaglutide to other type 2 diabetes treatments in a normal practice setting. The participant will be randomly assigned to one of two groups-- either semaglutide or standard of care antidiabetic medication-- and will not know which they are receiving. The study will last approximately two years.

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No)
Secondary outcome measures
All Cause HCRU: Cumulative Length of Stay for Inpatient Admissions From Baseline to Year 2
All Cause HCRU: Number of Emergency Room (ER) Encounters From Baseline to Year 2
All Cause HCRU: Number of Medications From Baseline to Year 2
+65 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SemaglutideExperimental Treatment1 Intervention
Participants will receive semaglutide subcutaneously (s.c.) in addition to metformin monotherapy as treatment intensification in the course of routine clinical practice. Participants will be followed for 2 years, regardless of changes in antidiabetic treatment over the course of the study.
Group II: Standard of careActive Control1 Intervention
Participants will receive standard of care in addition to metformin monotherapy as treatment intensification in the course of routine clinical practice. Participants will be followed for 2 years, regardless of changes in antidiabetic treatment over the course of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,413,790 Total Patients Enrolled
Clinical Reporting Anchor and Disclosure (1452)Study DirectorNovo Nordisk A/S
104 Previous Clinical Trials
101,976 Total Patients Enrolled

Frequently Asked Questions

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

What maladies have been ameliorated by Semaglutide treatment?

"Semaglutide has been prescribed to address weight management and associated comorbidities, such as those that result from a reduced-calorie diet or exercise."

Answered by AI

Could you elucidate on any other investigations undertaken regarding Semaglutide?

"Currently, there are 58 active clinical trials investigating Semaglutide. Out of those studies, 27 have entered Phase 3 and the most prevalent location for such research is Loma Linda, California with 3907 other sites running similar investigations."

Answered by AI

Is eligibility for the trial restricted to those over 60 years of age?

"To enroll in this clinical trial, patients must fall within the age range of 18-65 years. For those who do not meet these requirements, there are 199 studies available for minors and 1125 trials designated to elderly care."

Answered by AI

Can individuals currently enroll in this clinical experiment?

"Sadly, this medical trial is not recruiting participants at the moment. It was initially announced on July 13th 2018 and has been modified most recently on November 11th 2022. However, if you are looking for other avenues of research participation, there are currently 1,391 clinical studies accepting candidates with Type 2 diabetes Mellitus and 58 trials eager to recruit patients taking Semaglutide."

Answered by AI

How extensively has this trial been implemented among medical facilities?

"As of now, this trial is welcoming participants at a total of 100 sites located in Springfield, Williamsburg, Las Vegas and various other cities. If you are interested in taking part then it would be prudent to select the closest site to minimize any travelling requirements."

Answered by AI

What qualifications must a person meet to be eligible for this research trial?

"This diabetes mellitus, type 2 clinical trial is recruiting up to 1387 participants of ages 18 and 65."

Answered by AI

Is this a groundbreaking clinical trial?

"Currently, 58 experiments involving Semaglutide are taking place in 772 cities and 55 nations. Initially launched by Novo Nordisk A/S back in 2018, the Phase 4 trial included 1387 people; since then, 247 assessments have been concluded successfully."

Answered by AI

How many study participants are enrolled in this research endeavor?

"This clinical trial has since been closed for patient recruitment, with its posting dating back to July 13th 2018 and the last update made on November 11th 2022. For those looking for alternative studies, there are currently 1,391 trials recruiting diabetes mellitus type 2 patients and 58 other trials accepting participants that require Semaglutide treatments."

Answered by AI

Has Semaglutide been cleared by the FDA for public use?

"We rate Semaglutide's safety at 3, as it has already been approved by the FDA and is currently in Phase 4 clinical trials."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Virginia
California
Other
How old are they?
65+
18 - 65
What site did they apply to?
Novo Nordisk Investigational Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0
3+

Why did patients apply to this trial?

Bristol va tn are close to me. Want to lower my numbers and lose some weight.
PatientReceived no prior treatments
Looking for drug that will help with weight loss. I’m taking 3 drugs to control my type 2. I’m super frustrated with this disease and I feel defeated. I’ll try anything.
PatientReceived 2+ prior treatments
Ive have used Metformin, Victoza and Glimperide. These medications work in combination but I am looking for a solution using one medication.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Trial
2018. "Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03596450.
~189 spots leftby Apr 2025
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