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RYBELSUS® for Type 2 Diabetes (REALYSE Trial)

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
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
Must not have
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using contraception.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 1
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing RYBELSUS®, a tablet that lowers blood sugar, in people with type 2 diabetes who need extra treatment. The study will compare RYBELSUS® to other similar tablets over several months. Participants will have regular doctor visits and complete some questionnaires. Pregnant or breastfeeding women cannot join. RYBELSUS® is an oral form of a medication that has been used in injectable form for managing type 2 diabetes.

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am pregnant, breastfeeding, planning to become pregnant, or not using contraception.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Glycosylated hemoglobin A1c (HbA1c)
Secondary study objectives
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
23%
Nausea
14%
Diarrhoea
13%
Decreased appetite
10%
Nasopharyngitis
9%
Vomiting
7%
Upper respiratory tract infection
7%
Constipation
6%
Urinary tract infection
6%
Abdominal discomfort
1%
Diverticulitis
1%
Impaired gastric emptying
1%
Osteoarthritis
1%
Myocardial infarction
1%
Cervical spinal stenosis
1%
Gastrooesophageal reflux disease
1%
Hypertension
1%
Dyspnoea
1%
Postoperative wound infection
1%
Thyroidectomy
1%
Death
1%
Acute kidney injury
1%
Acute myocardial infarction
1%
Ischaemic cerebral infarction
1%
Prostatomegaly
1%
Silent myocardial infarction
1%
Adenocarcinoma of colon
1%
Coronary artery disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Oral Semaglutide 14 mg
Oral Semaglutide 3 mg
Oral Semaglutide 7 mg

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
GLP-1 receptor agonists, such as RYBELSUS®, work by mimicking the incretin hormone GLP-1, which enhances insulin secretion in response to meals, inhibits glucagon release, and slows gastric emptying. This results in better blood sugar control and potential weight loss, which are crucial for managing Type 2 Diabetes. These mechanisms help reduce the risk of hyperglycemia and its associated complications. Other common treatments include metformin, which decreases hepatic glucose production and improves insulin sensitivity, and SGLT2 inhibitors, which promote glucose excretion through urine. Each treatment targets different aspects of glucose metabolism, providing a comprehensive approach to managing the disease.
Cardiovascular effects of GLP-1 receptor agonism.Incretin therapies: highlighting common features and differences in the modes of action of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors.The value of short- and long-acting glucagon-like peptide-1 agonists in the management of type 2 diabetes mellitus: experience with exenatide.

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,547 Previous Clinical Trials
2,442,615 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
57 Previous Clinical Trials
44,077 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
~196 spots leftby Jun 2025