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

Novo Nordisk A/S1,018 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,018

Conditions

Diabetes Mellitus, Type 2

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (25)

Stewart Medical Group

Alhambra, California, United States

FDRC

Costa Mesa, California, United States

Scripps Whittier Diabetes Inst

La Jolla, California, United States

Raincross Medical Group

Riverside, 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

...and 15 more locations

Outcomes

Primary Outcomes

Change in Glycated Haemoglobin (HbA1c)

Change in HbA1c in percentage from week 0 to year 1 is presented

Time frame: Week 0, year 1

Secondary Outcomes

Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) (Yes /No)

Participants achieving HbA1c \< 7.0% (Yes /No) at year 1 is presented. 'Yes' defines participants who achieved HbA1c \< 7.0% and 'No' defines participants who did not achieve HbA1c \< 7.0 %.

Time frame: At year 1

Participants Achieving HbA1c Less Than or Equal to (≤) 6.5% (Yes/No)

Participants achieving HbA1c ≤ 6.5% (Yes/No) at year 1 is presented. 'Yes' defines participants who achieved HbA1c ≤ 6.5% and 'No' defines participants who did not achieve HbA1c ≤ 6.5%.

Time frame: At year 1

Participants Achieving HbA1c <7.0% or at Least 1.0%-Point Reduction in HbA1c (Yes/No)

Participants achieving HbA1c \< 7.0% or at least 1.0%-point reduction in HbA1c (Yes/No) from week 0 to year 1 is presented. 'Yes' defines participants who achieved HbA1c \< 7.0% or reduction of at least 1.0%-point in HbA1c and 'No' defines participants who did not achieve HbA1c \< 7.0% or reduction of at least 1.0%-point in HbA1c.

Time frame: From Week 0 to year 1

Participants Achieving Greater Than or Equal to (≥) 5% Reduction in Body Weight (Yes/No)

Participants achieving ≥ 5% reduction in body weight (Yes/No) from week 0 to year 1 is presented. 'Yes' defines participants who achieved ≥ 5% reduction in body weight and 'No' defines participants who did not achieve ≥ 5% reduction in body weight.

Time frame: From week 0 to year 1

Participant Achieving Individualized HbA1c Target Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria (Yes/No)

Participants achieving individualized HbA1c target per HEDIS criteria (\< 8.0% if age ≥ 65 years or with defined comorbidities or otherwise \< 7.0%) (Yes/No) at year 1 is presented. 'Yes' defines participants who achieved individualized HbA1c target per HEDIS criteria and 'No' defines participants who did not achieve individualized HbA1c target per HEDIS criteria.

Time frame: At year 1

Participant Achieving HbA1c ≤ Treatment Provider Defined Individualized Target (Yes/No)

Participant achieving HbA1c ≤ treatment provider defined individualized target (Yes/No) at year 1 is presented. 'Yes' defines participant who achieved HbA1c ≤ treatment provider defined individualized target and 'No' defines participant who did not achieve HbA1c ≤ treatment provider defined individualized target.

Time frame: At year 1

Relative Change in Body Weight (%)

Relative change in body weight from week 0 to year 1 is presented.

Time frame: Week 0, year 1

Change in Body Weight (Lbs)

Change in body weight in pounds (lbs) from week 0 to year 1 is presented.

Time frame: Week 0, year 1

Time to Treatment Intensification (add-on) or Change (Switch) in Terms of Events

Time to treatment intensification (add-on) or change (switch) in terms of events from week 0 to year 1 is presented.

Time frame: From week 0 to year 1

Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc), Relative Treatment Satisfaction Total Score

DTSQc relative treatment satisfaction total score measured at year 1 is presented. DTSQc are used to evaluate patient satisfaction with treatment. The measure consists of 8 items, 6 of which assess treatment satisfaction. Scores from the 6 treatment satisfaction items are summed to a total treatment satisfaction score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).

Time frame: At year 1

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

Overview

Conditions

Interventions

Eligibility

Locations (25)

Outcomes

Primary Outcomes

Secondary Outcomes