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
16
Locations
2
Arms
42.6
Anticipated Duration (Months)
118.8
Patients Per Site
2.8
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 DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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

  1. Change in Glycosylated hemoglobin A1c (HbA1c) [From randomization to year 1]

    percentage-points

Secondary Outcome Measures

  1. Change in HbA1c [From randomization to year 2]

    percentage-points

  2. Patient achieving HbA1c below 7.0% (Yes /No) [Year 1]

    Count of patient(s)

  3. Patient achieving HbA1c below or equal to 6.5% (Yes/No) [Year 1]

    Count of patient(s)

  4. 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)

  5. Patient achieving greater than or equal to 5% reduction in body weight (Yes/No) [From randomization to year 1]

    Count of patient(s)

  6. 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)

  7. Patient achieving HbA1c less than or equal to physician defined individualized target (Yes/No) [Year 1]

    Count of patient(s)

  8. Relative change in body weight (%) [From randomization to year 1]

    Percentage

  9. Change in body weight (lbs) [From randomization to year 1]

    Lbs

  10. Time to treatment intensification (add-on) or change (switch) [From randomization to year 2]

    Days

  11. 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:
No

Key inclusion criteria

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

  • 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

SiteCityStateCountryPostal Code
1Novo Nordisk Investigational SiteAlhambraCaliforniaUnited States91801
2Novo Nordisk Investigational SiteCosta MesaCaliforniaUnited States92627
3Novo Nordisk Investigational SiteMiamiFloridaUnited States33175
4Novo Nordisk Investigational SiteMariettaGeorgiaUnited States30067
5Novo Nordisk Investigational SiteGillespieIllinoisUnited States62033
6Novo Nordisk Investigational SitePeoriaIllinoisUnited States61603
7Novo Nordisk Investigational SiteSkokieIllinoisUnited States60077
8Novo Nordisk Investigational SiteBurlingtonNorth CarolinaUnited States27215
9Novo Nordisk Investigational SiteCharlotteNorth CarolinaUnited States28277
10Novo Nordisk Investigational SiteGarnerNorth CarolinaUnited States27529
11Novo Nordisk Investigational SiteFargoNorth DakotaUnited States58104
12Novo Nordisk Investigational SitePhiladelphiaPennsylvaniaUnited States19107-6810
13Novo Nordisk Investigational SitePhiladelphiaPennsylvaniaUnited States19114
14Novo Nordisk Investigational SiteAndersonSouth CarolinaUnited States29621
15Novo Nordisk Investigational SiteSan AntonioTexasUnited States78258
16Novo Nordisk Investigational SiteSaint GeorgeUtahUnited States84790

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:
Nov 19, 2021
Last Verified:
Nov 1, 2021
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:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021