A Research Study Comparing RYBELSUS® to Other Blood Sugar Lowering Tablets in People Living in America With Type 2 Diabetes (REALYSE)
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: oral glucose-lowering medications (commercially available)
- Registration Number
- NCT05035082
- Lead Sponsor
- Novo Nordisk A/S
- 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 available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1262
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description oral semaglutide semaglutide All participants are given tablets used in addition to metformin. other oral glucose lowering medication oral glucose-lowering medications (commercially available) All participants are given tablets used in addition to metformin.
- Primary Outcome Measures
Name Time Method Change in Glycosylated hemoglobin A1c (HbA1c) From randomization to year 1 percentage-points
- Secondary Outcome Measures
Name Time Method 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 greater than or equal to 5% reduction in body weight (Yes/No) From randomization to year 1 Count of patient(s)
Relative change in body weight (%) From randomization to year 1 Percentage
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 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)
Change in body weight (lbs) From randomization to year 1 Lbs
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)
Patient achieving HbA1c less than or equal to treatment provider defined individualized target (Yes/No) Year 1 Count of patient(s)
Time to treatment intensification (add-on) or change (switch) From randomization to year 1 Days
Trial Locations
- Locations (22)
WakeMed Garner Hlthplx
🇺🇸Garner, North Carolina, United States
FDRC
🇺🇸Costa Mesa, California, United States
Scripps Whittier Diabetes Inst
🇺🇸La Jolla, California, United States
Reyes Clinical Research, Inc
🇺🇸Miami, Florida, United States
DC Research Works
🇺🇸Marietta, Georgia, United States
Urban Family Practice Assoc
🇺🇸Marietta, Georgia, United States
Macoupin Research Group
🇺🇸Gillespie, Illinois, United States
UnityPoint Health-Diabetes Care Center
🇺🇸Peoria, Illinois, United States
Endeavor Health
🇺🇸Skokie, Illinois, United States
Kernodle Clin Dpt-Pvt Diagnost
🇺🇸Burlington, North Carolina, United States
OnSite Clinical Solutions, LLC_Charlotte
🇺🇸Charlotte, North Carolina, United States
Valley Weight Loss Clinic
🇺🇸Fargo, North Dakota, United States
Diab & Endo Assoc of Stark Co
🇺🇸Canton, Ohio, United States
Central Ohio Clinical Research LLC
🇺🇸Columbus, Ohio, 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
AnMed Health IMA
🇺🇸Anderson, South Carolina, United States
Baylor Scott & White Res Inst
🇺🇸Dallas, Texas, United States
Hill Country Medical Associates
🇺🇸New Braunfels, Texas, United States
DCT-Stone Oak
🇺🇸San Antonio, Texas, United States
Chrysalis Clinical Research
🇺🇸Saint George, Utah, United States