A Research Study Comparing RYBELSUS® to Other Blood Sugar Lowering Tablets in People Living in America With Type 2 Diabetes (REALYSE)

Diabetes Mellitus, Type 2 Clinical Trial

— REALYSE  

Official title:

REALYSE - Comparative Effectiveness of Once-daily Oral Semaglutide Versus Any Other Oral Glucose-lowering Medication in a Real-world Adult Population With Type 2 Diabetes on Metformin Monotherapy in US Based Health Care Systems - a Pragmatic Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05035082
• Other study ID #: NN9924-4558
• Secondary ID: U1111-1253-2577
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 1, 2021
• Est. completion date: June 9, 2025

Study information

• Verified date: May 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is comparing the medicine RYBELSUS® to other medicines in people with type 2 diabetes who need extra treatment. All medicines used in this study are tablets which lower blood sugar in people with type 2 diabetes. The purpose of the study is to see how well RYBELSUS® is at lowering blood sugar compared to other tablets when used in addition to metformin. Participants doctor will give participants either RYBELSUS® or any other blood sugar lowering tablets - which treatment participants get is decided by chance. The doctor treating participants diabetes will give participants a prescription for the medicine and tell how to take it. The study will last for about 1 year. Participants will have 2 planned visits with their doctor which are part of the usual routine diabetes management: the first visit is when participants are included in the study, the second visit is a 1-year follow-up visit. In addition, the study personnel will contact participants up to 3 times during this period and to follow-up on information from participant doctors visits. Participant will be asked to respond 3 times to 4 questionnaires via their personal smartphone or tablet or paper if participant do not have access to one during the study. All clinic visits are part of the usual routine diabetes management and are covered by participants health insurance plan. The study team will collect information from these visits recorded in the medical chart. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1262
• Est. completion date: June 9, 2025
• Est. primary completion date: June 9, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key inclusion criteria

• Treatment with metformin as monotherapy prior to eligibility assessment that has failed to result in adequate glycemic control at the discretion of the investigator or treatment provider. However, prior short-term treatment with an oral glucose lowering agent or insulin for up to 14 consecutive days in addition to metformin is allowed if discontinued prior to screening.

• Current member of a health plan which includes pharmacy benefits.

• HbA1c greater than or equal to 7% within last 90 days prior to the day of screening or to be taken before randomization.

• Further intensification with an additional glucose-lowering oral agent including oral semaglutide is indicated according to approved prescribing information to achieve glycemic target at the discretion of the treatment provider.

Key exclusion criteria:

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using contraception.

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• semaglutide
Oral administration The doctor will give a prescription for the medicine and tell how to take it.
• oral glucose-lowering medications (commercially available)
Oral administration The doctor will give a prescription for the medicine and tell how to take it.

Locations

Country	Name	City	State
United States	AnMed Health IMA	Anderson	South Carolina
United States	Kernodle Clin Dpt-Pvt Diagnost	Burlington	North Carolina
United States	Diab & Endo Assoc of Stark Co	Canton	Ohio
United States	OnSite Clinical Solutions, LLC_Charlotte	Charlotte	North Carolina
United States	Central Ohio Clinical Research LLC	Columbus	Ohio
United States	FDRC	Costa Mesa	California
United States	Baylor Scott & White Res Inst	Dallas	Texas
United States	Valley Weight Loss Clinic	Fargo	North Dakota
United States	WakeMed Garner Hlthplx	Garner	North Carolina
United States	Clinical Research of Gastonia	Gastonia	North Carolina
United States	Macoupin Research Group	Gillespie	Illinois
United States	Scripps Whittier Diabetes Inst	La Jolla	California
United States	DC Research Works	Marietta	Georgia
United States	Urban Family Practice Assoc	Marietta	Georgia
United States	Reyes Clinical Research, Inc	Miami	Florida
United States	Hill Country Medical Associates	New Braunfels	Texas
United States	UnityPoint Health-Diabetes Care Center	Peoria	Illinois
United States	Jefferson Endocrinology Assocs	Philadelphia	Pennsylvania
United States	Tristar Clin Investigations, PC	Philadelphia	Pennsylvania
United States	Preferred Primary Care Physicians_Pittsburgh	Pittsburgh	Pennsylvania
United States	Raincross Medical Group	Riverside	California
United States	Chrysalis Clinical Research	Saint George	Utah
United States	DCT-Stone Oak	San Antonio	Texas
United States	NorthShore Univ Hlth Sys	Skokie	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycosylated hemoglobin A1c (HbA1c)	percentage-points	From randomization to year 1
Secondary	Patient achieving HbA1c below 7.0% (Yes /No)	Count of patient(s)	Year 1
Secondary	Patient achieving HbA1c below or equal to 6.5% (Yes/No)	Count of patient(s)	Year 1
Secondary	Patient achieving HbA1c below 7.0% or at least 1.0%-point reduction in HbA1c (Yes/No)	Count of patient(s)	From randomization to year 1
Secondary	Patient achieving greater than or equal to 5% reduction in body weight (Yes/No)	Count of patient(s)	From randomization to year 1
Secondary	Patient achieving individualized HbA1c target per Healthcare Effectiveness Data and Information Set (HEDIS) criteria (below 8.0% if age greater than or equal to 65 years or with defined comorbidities or otherwise below 7.0%) (Yes/No)	Count of patient(s)	Year 1
Secondary	Patient achieving HbA1c less than or equal to treatment provider defined individualized target (Yes/No)	Count of patient(s)	Year 1
Secondary	Relative change in body weight (%)	Percentage	From randomization to year 1
Secondary	Change in body weight (lbs)	Lbs	From randomization to year 1
Secondary	Time to treatment intensification (add-on) or change (switch)	Days	From randomization to year 1
Secondary	Diabetes Treatment Satisfaction Questionnaire, change version (DTSQc), Relative treatment satisfaction total score	Score on a scale (The Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) will be used to measure the change in patient satisfaction with their diabetes treatment. It consists of a six-item scale assessing treatment satisfaction and two items assessing perceived frequency of hyperglycaemia and hypoglycaemia. The DTSQc items are on a scale from 3 to -3. If they experience no change, then 0 is chosen. Higher score indicate higher satisfaction with their current treatment)	Year 1