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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

Tracking Information
First Submitted Date  ICMJE August 30, 2021
First Posted Date  ICMJE September 5, 2021
Last Update Posted Date April 20, 2023
Actual Study Start Date  ICMJE September 1, 2021
Estimated Primary Completion Date February 7, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2021)		 Change in Glycosylated hemoglobin A1c (HbA1c) [ Time Frame: From randomization to year 1 ]
percentage-points
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2023)
  • Patient achieving HbA1c below 7.0% (Yes /No) [ Time Frame: Year 1 ]
    Count of patient(s)
  • Patient achieving HbA1c below or equal to 6.5% (Yes/No) [ Time Frame: Year 1 ]
    Count of patient(s)
  • 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)
  • 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)
  • 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)
  • Patient achieving HbA1c less than or equal to treatment provider defined individualized target (Yes/No) [ Time Frame: Year 1 ]
    Count of patient(s)
  • Relative change in body weight (%) [ Time Frame: From randomization to year 1 ]
    Percentage
  • Change in body weight (lbs) [ Time Frame: From randomization to year 1 ]
    Lbs
  • Time to treatment intensification (add-on) or change (switch) [ Time Frame: From randomization to year 1 ]
    Days
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2021)
  • Change in HbA1c [ Time Frame: From randomization to year 2 ]
    percentage-points
  • Patient achieving HbA1c below 7.0% (Yes /No) [ Time Frame: Year 1 ]
    Count of patient(s)
  • Patient achieving HbA1c below or equal to 6.5% (Yes/No) [ Time Frame: Year 1 ]
    Count of patient(s)
  • 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)
  • 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)
  • 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)
  • Patient achieving HbA1c less than or equal to physician defined individualized target (Yes/No) [ Time Frame: Year 1 ]
    Count of patient(s)
  • Relative change in body weight (%) [ Time Frame: From randomization to year 1 ]
    Percentage
  • Change in body weight (lbs) [ Time Frame: From randomization to year 1 ]
    Lbs
  • Time to treatment intensification (add-on) or change (switch) [ Time Frame: From randomization to year 2 ]
    Days
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Research Study Comparing RYBELSUS® to Other Blood Sugar Lowering Tablets in People Living in America With Type 2 Diabetes (REALYSE)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: semaglutide
    Oral administration The doctor will give a prescription for the medicine and tell how to take it.
  • Drug: oral glucose-lowering medications (commercially available)
    Oral administration The doctor will give a prescription for the medicine and tell how to take it.
Study Arms  ICMJE
  • Experimental: oral semaglutide
    All participants are given tablets used in addition to metformin.
    Intervention: Drug: semaglutide
  • Active Comparator: other oral glucose lowering medication
    All participants are given tablets used in addition to metformin.
    Intervention: Drug: oral glucose-lowering medications (commercially available)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 11, 2022)		 1262
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2021)		 1900
Estimated Study Completion Date  ICMJE June 9, 2025
Estimated Primary Completion Date February 7, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05035082
Other Study ID Numbers  ICMJE NN9924-4558
U1111-1253-2577 ( Other Identifier: World Health Organization (WHO) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com
Current Responsible Party Novo Nordisk A/S
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Novo Nordisk A/S
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Transparency (dept. 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date April 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP