RYBELSUS® for Type 2 Diabetes
(REALYSE Trial)

Recruiting in Palo Alto (17 mi)

+45 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Novo Nordisk A/S

No Placebo Group

Prior Safety Data

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.

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.

See 5 more

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.

Treatment Details

Interventions

Oral Glucose-Lowering Medications (Commercially Available) (Drug)
Semaglutide (GLP-1 Receptor Agonist)

Trial OverviewThe 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

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.