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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05035082

Collaborator

(none)

1,900

Enrollment

Locations

Arms

42.6

Anticipated Duration (Months)

79.2

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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 2 years. Participants will have 3 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, and the last visit is a 2-year follow-up visit. In addition, the study personnel will contact participants up to 3 times per year 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: semaglutide Drug: oral glucose-lowering medications (commercially available)	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1900 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

REALYSE - Long-term 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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Feb 7, 2024

Anticipated Study Completion Date :

Mar 21, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: oral semaglutide All participants are given tablets used in addition to metformin.	Drug: semaglutide Oral administration The doctor will give a prescription for the medicine and tell how to take it. The study will last for about 2 years.
Active Comparator: other oral glucose lowering medication All participants are given tablets used in addition to metformin.	Drug: oral glucose-lowering medications (commercially available) Oral administration The doctor will give a prescription for the medicine and tell how to take it. The study will last for about 2 years.

Arm

Intervention/Treatment

Experimental: oral semaglutide

All participants are given tablets used in addition to metformin.

Drug: semaglutide

Oral administration The doctor will give a prescription for the medicine and tell how to take it. The study will last for about 2 years.

Active Comparator: other oral glucose lowering medication

All participants are given tablets used in addition to metformin.

Drug: oral glucose-lowering medications (commercially available)

Oral administration The doctor will give a prescription for the medicine and tell how to take it. The study will last for about 2 years.

Outcome Measures

Primary Outcome Measures

Change in Glycosylated hemoglobin A1c (HbA1c) [From randomization to year 1]
percentage-points

Secondary Outcome Measures

Change in HbA1c [From randomization to year 2]
percentage-points
Patient achieving HbA1c below 7.0% (Yes /No) [Year 1]
Count of patient(s)
Patient achieving HbA1c below or equal to 6.5% (Yes/No) [Year 1]
Count of patient(s)
Patient achieving HbA1c below 7.0% or at least 1.0%-point reduction in HbA1c (Yes/No) [From randomization to year 1]
Count of patient(s)
Patient achieving greater than or equal to 5% reduction in body weight (Yes/No) [From randomization to year 1]
Count of patient(s)
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) [Year 1]
Count of patient(s)
Patient achieving HbA1c less than or equal to physician defined individualized target (Yes/No) [Year 1]
Count of patient(s)
Relative change in body weight (%) [From randomization to year 1]
Percentage
Change in body weight (lbs) [From randomization to year 1]
Lbs
Time to treatment intensification (add-on) or change (switch) [From randomization to year 2]
Days
Diabetes Treatment Satisfaction Questionnaire, change version (DTSQc), Relative treatment satisfaction total score [Year 1]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key inclusion criteria

Treatment with metformin as monotherapy for a period of at least 90 days prior to eligibility assessment. 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 treating physician.

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 treating physician's opinion might jeopardize patient's safety.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Alhambra	California	United States	91801
2	Novo Nordisk Investigational Site	Costa Mesa	California	United States	92627
3	Novo Nordisk Investigational Site	La Jolla	California	United States	92037
4	Novo Nordisk Investigational Site	Riverside	California	United States	92506
5	Novo Nordisk Investigational Site	Miami	Florida	United States	33175
6	Novo Nordisk Investigational Site	Marietta	Georgia	United States	30060
7	Novo Nordisk Investigational Site	Marietta	Georgia	United States	30067
8	Novo Nordisk Investigational Site	Carlinville	Illinois	United States	62626
9	Novo Nordisk Investigational Site	Peoria	Illinois	United States	61603
10	Novo Nordisk Investigational Site	Skokie	Illinois	United States	60077
11	Novo Nordisk Investigational Site	Burlington	North Carolina	United States	27215
12	Novo Nordisk Investigational Site	Charlotte	North Carolina	United States	28277
13	Novo Nordisk Investigational Site	Garner	North Carolina	United States	27529
14	Novo Nordisk Investigational Site	Fargo	North Dakota	United States	58104
15	Novo Nordisk Investigational Site	Canton	Ohio	United States	44718
16	Novo Nordisk Investigational Site	Columbus	Ohio	United States	43213
17	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	United States	19107-6810
18	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	United States	19114
19	Novo Nordisk Investigational Site	Pittsburgh	Pennsylvania	United States	15236
20	Novo Nordisk Investigational Site	Anderson	South Carolina	United States	29621
21	Novo Nordisk Investigational Site	Dallas	Texas	United States	75210
22	Novo Nordisk Investigational Site	New Braunfels	Texas	United States	78130
23	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78258
24	Novo Nordisk Investigational Site	Saint George	Utah	United States	84790

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT05035082

Other Study ID Numbers:

NN9924-4558
U1111-1253-2577

First Posted:

Sep 5, 2021

Last Update Posted:

Jul 12, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jul 12, 2022