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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 1,018
- Locations
- 37
- Primary Endpoint
- Change in Glycated Haemoglobin (HbA1c)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Arms & Interventions
other oral glucose lowering medication
All participants are given tablets used in addition to metformin.
Intervention: oral glucose-lowering medications (commercially available) (Drug)
oral semaglutide
All participants are given tablets used in addition to metformin.
Intervention: semaglutide (Drug)
Outcomes
Primary Outcomes
Change in Glycated Haemoglobin (HbA1c)
Time Frame: Week 0, year 1
Change in HbA1c in percentage from week 0 to year 1 is presented
Secondary Outcomes
- Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) (Yes /No)(At year 1)
- Participants Achieving HbA1c Less Than or Equal to (≤) 6.5% (Yes/No)(At year 1)
- Participants Achieving HbA1c <7.0% or at Least 1.0%-Point Reduction in HbA1c (Yes/No)(From Week 0 to year 1)
- Participants Achieving Greater Than or Equal to (≥) 5% Reduction in Body Weight (Yes/No)(From week 0 to year 1)
- Participant Achieving Individualized HbA1c Target Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria (Yes/No)(At year 1)
- Participant Achieving HbA1c ≤ Treatment Provider Defined Individualized Target (Yes/No)(At year 1)
- Relative Change in Body Weight (%)(Week 0, year 1)
- Change in Body Weight (Lbs)(Week 0, year 1)
- Time to Treatment Intensification (add-on) or Change (Switch) in Terms of Events(From week 0 to year 1)
- Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc), Relative Treatment Satisfaction Total Score(At year 1)