RYBELSUS® for Type 2 Diabetes

(REALYSE Trial)

Recruiting at 46 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

1262 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Clinical Transparency (dept. 1452)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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