Clinical trial NCT05035082: A Research Study Comparing RYBELSUS® to Other Blood Sugar Lowering Tablets in People Living in America With Type 2 Diabetes (REALYSE)
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-09-05
Enrollment: 1262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Glycosylated hemoglobin A1c (HbA1c)
timeFrame: From randomization to year 1
Secondary outcomes:
measure: Patient achieving HbA1c below 7.0% (Yes /No)
timeFrame: Year 1
measure: Patient achieving HbA1c below or equal to 6.5% (Yes/No)
timeFrame: Year 1
measure: Patient achieving HbA1c below 7.0% or at least 1.0%-point reduction in HbA1c (Yes/No)
timeFrame: From randomization to year 1
measure: Patient achieving greater than or equal to 5% reduction in body weight (Yes/No)
timeFrame: From randomization to year 1
measure: 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)
timeFrame: Year 1
measure: Patient achieving HbA1c less than or equal to treatment provider defined individualized target (Yes/No)
timeFrame: Year 1
measure: Relative change in body weight (%)
timeFrame: From randomization to year 1
measure: Change in body weight (lbs)
timeFrame: From randomization to year 1
measure: Time to treatment intensification (add-on) or change (switch)
timeFrame: From randomization to year 1
measure: Diabetes Treatment Satisfaction Questionnaire, change version (DTSQc), Relative treatment satisfaction total score
timeFrame: Year 1
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: FDRC
state: California
city: La Jolla
country: United States
facility: Scripps Whittier Diabetes Inst
state: California
city: Miami
country: United States
facility: Reyes Clinical Research, Inc
state: Florida
city: Marietta
country: United States
facility: DC Research Works
state: Georgia
city: Marietta
country: United States
facility: Urban Family Practice Assoc
state: Georgia
city: Gillespie
country: United States
facility: Macoupin Research Group
state: Illinois
city: Peoria
country: United States
facility: UnityPoint Health-Diabetes Care Center
state: Illinois
city: Skokie
country: United States
facility: Endeavor Health
state: Illinois
city: Burlington
country: United States
facility: Kernodle Clin Dpt-Pvt Diagnost
state: North Carolina
city: Charlotte
country: United States
facility: OnSite Clinical Solutions, LLC_Charlotte
state: North Carolina
city: Garner
country: United States
facility: WakeMed Garner Hlthplx
state: North Carolina
city: Fargo
country: United States
facility: Valley Weight Loss Clinic
state: North Dakota
city: Canton
country: United States
facility: Diab & Endo Assoc of Stark Co
state: Ohio
city: Columbus
country: United States
facility: Central Ohio Clinical Research LLC
state: Ohio
city: Philadelphia
country: United States
facility: Jefferson Endocrinology Assocs
state: Pennsylvania
city: Philadelphia
country: United States
facility: Tristar Clin Investigations, PC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians_Pittsburgh
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Health IMA
state: South Carolina
city: Dallas
country: United States
facility: Baylor Scott & White Res Inst
state: Texas
city: New Braunfels
country: United States
facility: Hill Country Medical Associates
state: Texas
city: San Antonio
country: United States
facility: DCT-Stone Oak
state: Texas
city: Saint George
country: United States
facility: Chrysalis Clinical Research
state: Utah
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References: