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
1,020
Oral administration The doctor will give a prescription for the medicine and tell how to take it.
Oral administration The doctor will give a prescription for the medicine and tell how to take it.
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
Change in Glycosylated hemoglobin A1c (HbA1c)
percentage-points
Time frame: From randomization to year 1
Patient achieving HbA1c below 7.0% (Yes /No)
Count of patient(s)
Time frame: Year 1
Patient achieving HbA1c below or equal to 6.5% (Yes/No)
Count of patient(s)
Time frame: Year 1
Patient achieving HbA1c below 7.0% or at least 1.0%-point reduction in HbA1c (Yes/No)
Count of patient(s)
Time frame: From randomization to year 1
Patient achieving greater than or equal to 5% reduction in body weight (Yes/No)
Count of patient(s)
Time frame: 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)
Time frame: Year 1
Patient achieving HbA1c less than or equal to treatment provider defined individualized target (Yes/No)
Count of patient(s)
Time frame: Year 1
Relative change in body weight (%)
Percentage
Time frame: From randomization to year 1
Change in body weight (lbs)
Lbs
Time frame: From randomization to year 1
Time to treatment intensification (add-on) or change (switch)
Days
Time frame: 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)
Time frame: Year 1
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