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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: semaglutide
* Drug: oral glucose-lowering medications (commercially available)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oral semaglutide<br>All participants are given tablets used in addition to metformin. | Drug: semaglutide<br>* Oral administration The doctor will give a prescription for the medicine and tell how to take it.<br>|
| Active Comparator: other oral glucose lowering medication<br>All participants are given tablets used in addition to metformin. | Drug: oral glucose-lowering medications (commercially available)<br>* Oral administration The doctor will give a prescription for the medicine and tell how to take it.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycosylated hemoglobin A1c (HbA1c) | percentage-points | From randomization to year 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient achieving HbA1c below 7.0% (Yes /No) | Count of patient(s) | Year 1 | 
| Patient achieving HbA1c below or equal to 6.5% (Yes/No) | Count of patient(s) | Year 1 | 
| Patient achieving HbA1c below 7.0% or at least 1.0%-point reduction in HbA1c (Yes/No) | Count of patient(s) | From randomization to year 1 | 
| Patient achieving greater than or equal to 5% reduction in body weight (Yes/No) | Count of patient(s) | From randomization to year 1 | 
| 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) | Count of patient(s) | Year 1 | 
| Patient achieving HbA1c less than or equal to treatment provider defined individualized target (Yes/No) | Count of patient(s) | Year 1 | 
| Relative change in body weight (%) | Percentage | From randomization to year 1 | 
| Change in body weight (lbs) | Lbs | From randomization to year 1 | 
| Time to treatment intensification (add-on) or change (switch) | Days | From randomization to year 1 | 
| Diabetes Treatment Satisfaction Questionnaire, change version (DTSQc), Relative treatment satisfaction total score | 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) | Year 1 |