What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes, particularly GLP-1 receptor agonists like RYBELSUS® (oral semaglutide), often have gastrointestinal side effects such as nausea, vomiting, and diarrhea. Other potential side effects include a risk of thyroid C-cell tumors, as seen in rodent studies, though this risk is not well established in humans. Additionally, GLP-1 receptor agonists can cause weight loss and may have cardiovascular benefits. It is important to note that these medications are not recommended for individuals with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2A or 2B.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of Type 2 Diabetes. Notable approvals include liraglutide, which was approved for pediatric patients aged 10 to 17 years based on the ELLIPSE trial, and extended-release exenatide (Bydureon BCise) for the same age group. Dulaglutide has also been approved for both adults and pediatric patients, demonstrating significant improvements in glycemic control. These drugs, like RYBELSUS®, work by enhancing insulin secretion and lowering blood glucose levels, offering effective options for managing Type 2 Diabetes.

What other types of research exist?

Promising alternatives to RYBELSUS® for Type 2 Diabetes patients include: 1) Dulaglutide (Trulicity®), a once-weekly GLP-1 receptor agonist, which has shown efficacy in combination with other diabetes medications. 2) Albiglutide (Tanzeum™), another GLP-1 receptor agonist, approved for use in combination with other antihyperglycemic agents. 3) Exenatide extended-release (Bydureon BCise), approved for once-weekly use and shown to improve glycemic control in pediatric and adult patients.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 1

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

Vomiting

Upper respiratory tract infection

Constipation

Urinary tract infection

Abdominal discomfort

Impaired gastric emptying

Osteoarthritis

Diverticulitis

Myocardial infarction

Cervical spinal stenosis

Gastrooesophageal reflux disease

Hypertension

Dyspnoea

Postoperative wound infection

Thyroidectomy

Death

Acute kidney injury

Acute myocardial infarction

Ischaemic cerebral infarction

Prostatomegaly

Silent myocardial infarction

Adenocarcinoma of colon

Coronary artery disease

100%

80%

60%

40%

20%

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

0 / 2Eligibility criteria met

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.