RYBELSUS® for Type 2 Diabetes

(REALYSE Trial)

No longer recruiting at 48 trial locations

Overseen By Novo Nordisk

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Novo Nordisk A/S

Must be taking: Metformin

Disqualifiers: Pregnancy, Breast-feeding, Safety concerns, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of RYBELSUS® (an oral glucose-lowering medication) in reducing blood sugar in people with type 2 diabetes, compared to other similar medications. Participants will take either RYBELSUS® or another blood sugar-lowering tablet alongside metformin. The trial aims to determine which medication better manages diabetes. This trial may suit individuals currently taking metformin who need additional help managing their blood sugar levels. Participants must have a recent blood sugar level (HbA1c) of 7% or higher and be part of a health plan with pharmacy benefits. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you continue taking metformin. If you are on other diabetes medications, you might need to adjust them, so it's best to discuss this with your doctor.

What is the safety track record for these treatments?

Research has shown that oral semaglutide, the main ingredient in RYBELSUS®, is generally safe and well-tolerated for people with type 2 diabetes. Studies have found that it effectively lowers blood sugar levels. In one study, patients saw an average drop in their HbA1c (a measure of blood sugar) by 1.1%. Another study found that about two-thirds of patients achieved good blood sugar control.

Most people do not experience serious side effects. Some may have mild to moderate issues, such as stomach upset or nausea, but these usually improve over time.

The FDA has tested and approved RYBELSUS® for type 2 diabetes, providing extra assurance about its safety for this condition. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

RYBELSUS® is unique because it offers a new way to manage type 2 diabetes with an oral form of semaglutide, a GLP-1 receptor agonist. Unlike traditional treatments that often require injections, such as insulin or injectable GLP-1 receptor agonists, RYBELSUS® provides the convenience of a pill. This oral delivery method could improve adherence and make diabetes management easier for many patients. Researchers are excited about RYBELSUS® because it effectively lowers blood sugar levels and supports weight loss, two critical factors in managing type 2 diabetes.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research has shown that RYBELSUS® (a tablet form of semaglutide), which participants in this trial may receive, effectively controls blood sugar in people with type 2 diabetes. Studies have demonstrated that it significantly lowers HbA1c levels, a measure of blood sugar over time, and helps many patients reach an HbA1c level of less than 7%, a common treatment goal. One study found that semaglutide reduced HbA1c by 0.90% after six months, along with decreases in fasting blood sugar and body weight. RYBELSUS® is already approved for managing type 2 diabetes, highlighting its proven ability to control blood sugar levels. ^{6 7 8 9 10}

Who Is on the Research Team?

Clinical Transparency (dept. 1452)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My diabetes wasn't controlled by metformin alone, but I may have briefly used other treatments.

My last HbA1c level was 7% or higher.

My doctor thinks I need more medication to control my blood sugar.

Exclusion Criteria

Any disorder which in the investigator's or treatment provider's opinion might jeopardize patient's safety.

I am pregnant, breastfeeding, planning to become pregnant, or not using contraception.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either RYBELSUS® or another oral glucose-lowering medication in addition to metformin

52 weeks

2 visits (in-person), up to 3 contacts (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Oral Glucose-Lowering Medications (Commercially Available)
• Semaglutide

Trial Overview 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.

How Is the Trial Designed?

Group I: oral semaglutide Experimental Treatment 1 Intervention

All participants are given tablets used in addition to metformin.

Group II: other oral glucose lowering medication Active Control 1 Intervention

All participants are given tablets used in addition to metformin.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9889982/

Real world effectiveness of subcutaneous semaglutide in ... After 6 months of treatment with OW semaglutide, HbA1c levels were reduced by 0.90%, FBG by 26 mg/dl, and body weight by 3.43 kg. Systolic blood ...

2. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/1733-P/159240/1733-P-Two-Year-Real-World-Effectiveness-of

Two-Year Real-World Effectiveness of Semaglutide in Patients ... 85-OR: Semaglutide 2.4 mg Improves Patient Reported Outcome Measures of Physical Functioning in Adults with Overweight/Obesity and Type 2 ...

3. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.15911

Semaglutide use in people with obesity and type 2 diabetes ... The median endpoint for HbA1c was 7.10%, with 1310 participants (48.87% of individuals on semaglutide) achieving an HbA1c of less than 7%; 824 ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK603723/

Semaglutide - StatPearls - NCBI Bookshelf The Rybelsus® tablet brand demonstrates efficacy in improving glycemic control in patients with type 2 diabetes mellitus (T2DM).

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2307563

Semaglutide and Cardiovascular Outcomes in Obesity ... In this trial, semaglutide was associated with changes in multiple biomarkers of cardiovascular risk, including blood pressure, waist circumference, glycemic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7384149/

Efficacy, safety and cardiovascular outcomes of once‐daily ... The results of the PIONEER programme suggest that oral semaglutide is efficacious and well tolerated for glycaemic control of T2D.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1871402124000857

Efficacy and safety of oral semaglutide in type 2 diabetes This retrospective cohort study showed −1.1 % HbA1c reduction, −3.5 kg weight loss, −1.1 kg/m2 BMI decrease (p < 0.001 for all), and 32.4 % of patients achieved ...

8. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.15431

Real-world effectiveness and safety of oral semaglutide in ... Oral semaglutide was effective and safe for an unselected population, with one-third reporting weight loss >10% and about two-thirds achieving ...

9. novomedlink.com novomedlink.com/diabetes/products/treatments/rybelsus/efficacy-safety/safety-data.html

Safety data from RYBELSUS ® (semaglutide) clinical trials Find RYBELSUS® (semaglutide) side effect and safety data from clinical trials in adults with type 2 diabetes. Read Important Safety Information, ...

10. diabetesjournals.org diabetesjournals.org/care/article/42/9/1724/36289/PIONEER-1-Randomized-Clinical-Trial-of-the

PIONEER 1: Randomized Clinical Trial of the Efficacy and ... In patients with type 2 diabetes, oral semaglutide monotherapy demonstrated superior and clinically relevant improvements in HbA1c (all doses) ...