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RYBELSUS® for Type 2 Diabetes (REALYSE Trial)

Phase 4
Recruiting
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
HbA1c greater than or equal to 7% within last 90 days prior to the day of screening or to be taken before randomization.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 1
Awards & highlights

REALYSE Trial Summary

This trial is testing the effectiveness of RYBELSUS®, a new diabetes medication, against other existing diabetes medications. The study will last for two years and compare blood sugar lowering among participants taking RYBELSUS® to those taking other blood sugar lowering tablets.

Who is the study for?
This trial is for people living in America with type 2 diabetes who are already taking metformin but need additional treatment to control their blood sugar. Participants must have an HbA1c level of at least 7% and be covered by a health plan that includes pharmacy benefits. Women who are pregnant, breastfeeding, or planning to become pregnant cannot participate.Check my eligibility
What is being tested?
The study compares RYBELSUS® (semaglutide) with other oral glucose-lowering medications over about one year. Patients will either receive RYBELSUS® or another blood sugar lowering tablet as decided randomly. The goal is to see how well RYBELSUS® works compared to the alternatives when added to metformin therapy.See study design
What are the potential side effects?
Possible side effects include digestive issues like nausea and diarrhea, potential risk of low blood sugar levels (hypoglycemia), headache, fatigue, and allergic reactions. Specific side effects may vary based on the individual medication given.

REALYSE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My last HbA1c level was 7% or higher.

REALYSE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and year 1 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 in Glycosylated hemoglobin A1c (HbA1c)
Secondary outcome measures
Change in body weight (lbs)
Diabetes Treatment Satisfaction Questionnaire, change version (DTSQc), Relative treatment satisfaction total score
Patient achieving HbA1c below 7.0% (Yes /No)
+7 more

Side effects data

From 2018 Phase 3 trial • 731 Patients • NCT03021187
17%
Nausea
12%
Nasopharyngitis
12%
Diarrhoea
10%
Decreased appetite
8%
Vomiting
8%
Constipation
6%
Abdominal discomfort
3%
Urinary tract infection
3%
Upper respiratory tract infection
2%
Hypertension
1%
Orthostatic hypotension
1%
Coronary artery stenosis
1%
Pneumonia
1%
Acute myocardial infarction
1%
Aortic stenosis
1%
Cardiac failure
1%
Cardiac failure chronic
1%
Dyspnoea
1%
Hip arthroplasty
1%
Non-cardiac chest pain
1%
Peripheral arterial occlusive disease
1%
Transient ischaemic attack
1%
Vaginal prolapse
1%
Ventricular tachycardia
1%
Vulval cancer
1%
Brain stem infarction
1%
Breast cancer
1%
Cholelithiasis
1%
Diabetic foot
1%
Pneumonia pneumococcal
1%
Postoperative thoracic procedure complication
1%
White matter lesion
1%
Systemic inflammatory response syndrome
1%
Hysterectomy
1%
Lacunar infarction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Semaglutide 7 mg
Placebo
Oral Semaglutide 3 mg
Oral Semaglutide 14 mg

REALYSE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: oral semaglutideExperimental Treatment1 Intervention
All participants are given tablets used in addition to metformin.
Group II: other oral glucose lowering medicationActive Control1 Intervention
All participants are given tablets used in addition to metformin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
semaglutide
2012
Completed Phase 3
~4890

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,413,806 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
43,858 Total Patients Enrolled

Media Library

Oral Glucose-Lowering Medications (Commercially Available) Clinical Trial Eligibility Overview. Trial Name: NCT05035082 — Phase 4
Type 2 Diabetes Research Study Groups: oral semaglutide, other oral glucose lowering medication
Type 2 Diabetes Clinical Trial 2023: Oral Glucose-Lowering Medications (Commercially Available) Highlights & Side Effects. Trial Name: NCT05035082 — Phase 4
Oral Glucose-Lowering Medications (Commercially Available) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05035082 — Phase 4
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05035082 — Phase 4

Frequently Asked Questions

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

Has semaglutide been investigated in other scientific investigations?

"In 2018, semaglutide was first studied at Novo Nordisk Investigational Site. Currently, 123 completed trials have been recorded and 58 additional studies are in progress. Notably, many of the active clinical trials take place in Gillespie, Illinois."

Answered by AI

How many participants have been enrolled in this research project?

"Affirmative. Per the information on clinicaltrials.gov, this clinical trial is currently seeking suitable candidates to participate in their study which was first posted on September 1st 2021 and edited most recently on November 11th 2022. The trial requires 1262 participants from a total of 22 locations."

Answered by AI

What is the number of venues where this clinical experiment is taking place?

"22 different medical sites, including those in Gillespie, Miami and Fargo are participating in this trial. It is highly recommended to select the closest location possible to avoid extensive travel when enrolling."

Answered by AI

Is enrollment for this investigation available at the present time?

"Yes, the information present on clinicaltrials.gov suggests that this research is actively seeking participants. It was initially posted on September 1st 2021 and most recently updated November 11th 2022; currently recruiting for 1262 study members from 22 distinct locations."

Answered by AI

Has semaglutide been given the go-ahead by United States regulatory authorities?

"Due to Phase 4 status, semaglutide scored a 3 on the safety scale constructed by Power. This signified that this medication is currently authorised for patient use."

Answered by AI

Is this research endeavor pioneering in its approach?

"Research into semaglutide has been conducted since 2018, starting with a study funded by Novo Nordisk A/S. After the Phase 4 drug approval in 2018 following that first trial of 1387 people, there are now 58 active studies spanning 55 different nation and 772 cities worldwide."

Answered by AI

What medical conditions is semaglutide primarily employed to address?

"Semaglutide may prove effective in treating long-term weight management issues, caloric restriction diets, and physical activity."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Illinois
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Novo Nordisk Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
1
0

Why did patients apply to this trial?

Want to get lower A1C. Trying to lower A1c to below 7. It is poosible something better for my diabetes.
PatientReceived 2+ prior treatments
I’m interested in furthering diabetes treatment. I do not have insurance and I need to lower my a1c.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

I'm sure if I'm chosen, you will provide me with complete details as to how and when the study will be done before asking more detailed questions. One quick question though, is there any compensation for time and travel and keeping logs while in the clinical trial?
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 24 hours
Recent research and studies
clinicaltrials.govStudy
A Research Study Comparing RYBELSUS® to Other Blood Sugar Lowering Tablets in People Living in America With Type 2 Diabetes (REALYSE)
2021. "A Research Study Comparing RYBELSUS® to Other Blood Sugar Lowering Tablets in People Living in America With Type 2 Diabetes (REALYSE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05035082.
All > Diabetes Type 2
~365 spots leftby Jun 2025
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