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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05035082
Recruitment Status : Recruiting
First Posted : September 5, 2021
Last Update Posted : April 20, 2023
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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 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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : February 7, 2024
Estimated Study Completion Date : June 9, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines
Drug Information available for: Semaglutide

Arms and Interventions
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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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Glycosylated hemoglobin A1c (HbA1c) [ Time Frame: From randomization to year 1 ]
    percentage-points


Secondary Outcome Measures :
  1. Patient achieving HbA1c below 7.0% (Yes /No) [ Time Frame: Year 1 ]
    Count of patient(s)

  2. Patient achieving HbA1c below or equal to 6.5% (Yes/No) [ Time Frame: Year 1 ]
    Count of patient(s)

  3. Patient achieving HbA1c below 7.0% or at least 1.0%-point reduction in HbA1c (Yes/No) [ Time Frame: From randomization to year 1 ]
    Count of patient(s)

  4. Patient achieving greater than or equal to 5% reduction in body weight (Yes/No) [ Time Frame: From randomization to year 1 ]
    Count of patient(s)

  5. 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) [ Time Frame: Year 1 ]
    Count of patient(s)

  6. Patient achieving HbA1c less than or equal to treatment provider defined individualized target (Yes/No) [ Time Frame: Year 1 ]
    Count of patient(s)

  7. Relative change in body weight (%) [ Time Frame: From randomization to year 1 ]
    Percentage

  8. Change in body weight (lbs) [ Time Frame: From randomization to year 1 ]
    Lbs

  9. Time to treatment intensification (add-on) or change (switch) [ Time Frame: From randomization to year 1 ]
    Days

  10. Diabetes Treatment Satisfaction Questionnaire, change version (DTSQc), Relative treatment satisfaction total score [ Time Frame: 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
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05035082


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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United States, California
Novo Nordisk Investigational Site Suspended
Alhambra, California, United States, 91801
Novo Nordisk Investigational Site Recruiting
Costa Mesa, California, United States, 92627
Novo Nordisk Investigational Site Recruiting
La Jolla, California, United States, 92037
Novo Nordisk Investigational Site Recruiting
Riverside, California, United States, 92506
United States, Florida
Novo Nordisk Investigational Site Recruiting
Miami, Florida, United States, 33175
United States, Georgia
Novo Nordisk Investigational Site Recruiting
Marietta, Georgia, United States, 30060
Novo Nordisk Investigational Site Recruiting
Marietta, Georgia, United States, 30067
United States, Illinois
Novo Nordisk Investigational Site Recruiting
Gillespie, Illinois, United States, 62033
Novo Nordisk Investigational Site Recruiting
Peoria, Illinois, United States, 61603
Novo Nordisk Investigational Site Recruiting
Skokie, Illinois, United States, 60077
United States, North Carolina
Novo Nordisk Investigational Site Completed
Burlington, North Carolina, United States, 27215
Novo Nordisk Investigational Site Recruiting
Charlotte, North Carolina, United States, 28277
Novo Nordisk Investigational Site Recruiting
Garner, North Carolina, United States, 27529
Novo Nordisk Investigational Site Recruiting
Gastonia, North Carolina, United States, 28054
United States, North Dakota
Novo Nordisk Investigational Site Recruiting
Fargo, North Dakota, United States, 58104
United States, Ohio
Novo Nordisk Investigational Site Recruiting
Canton, Ohio, United States, 44718
Novo Nordisk Investigational Site Recruiting
Columbus, Ohio, United States, 43213
United States, Pennsylvania
Novo Nordisk Investigational Site Recruiting
Philadelphia, Pennsylvania, United States, 19107-6810
Novo Nordisk Investigational Site Recruiting
Philadelphia, Pennsylvania, United States, 19114
Novo Nordisk Investigational Site Recruiting
Pittsburgh, Pennsylvania, United States, 15236
United States, South Carolina
Novo Nordisk Investigational Site Recruiting
Anderson, South Carolina, United States, 29621
United States, Texas
Novo Nordisk Investigational Site Recruiting
Dallas, Texas, United States, 75246
Novo Nordisk Investigational Site Recruiting
New Braunfels, Texas, United States, 78130
Novo Nordisk Investigational Site Recruiting
San Antonio, Texas, United States, 78258
United States, Utah
Novo Nordisk Investigational Site Recruiting
Saint George, Utah, United States, 84790
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency (dept. 1452) Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT05035082    
Other Study ID Numbers: NN9924-4558
U1111-1253-2577 ( Other Identifier: World Health Organization (WHO) )
First Posted: September 5, 2021    Key Record Dates
Last Update Posted: April 20, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases