Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGsemaglutide
Oral administration The doctor will give a prescription for the medicine and tell how to take it.
DRUGoral glucose-lowering medications (commercially available)
Oral administration The doctor will give a prescription for the medicine and tell how to take it.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycated Haemoglobin (HbA1c) | Week 0, year 1 | Change in HbA1c in percentage from week 0 to year 1 is presented |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Achieving Individualized HbA1c Target Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria (Yes/No) | At year 1 | 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. |
| Participant Achieving HbA1c ≤ Treatment Provider Defined Individualized Target (Yes/No) | At year 1 | 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. |
| Relative Change in Body Weight (%) | Week 0, year 1 | Relative change in body weight from week 0 to year 1 is presented. |
| Change in Body Weight (Lbs) | Week 0, year 1 | Change in body weight in pounds (lbs) from week 0 to year 1 is presented. |
| Time to Treatment Intensification (add-on) or Change (Switch) in Terms of Events | From week 0 to year 1 | Time to treatment intensification (add-on) or change (switch) in terms of events from week 0 to year 1 is presented. |
| Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc), Relative Treatment Satisfaction Total Score | At year 1 | 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). |
| Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) (Yes /No) | At year 1 | 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 %. |
| Participants Achieving HbA1c Less Than or Equal to (≤) 6.5% (Yes/No) | At year 1 | 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%. |
| Participants Achieving Greater Than or Equal to (≥) 5% Reduction in Body Weight (Yes/No) | From week 0 to year 1 | 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. |
| Participants Achieving HbA1c <7.0% or at Least 1.0%-Point Reduction in HbA1c (Yes/No) | From Week 0 to year 1 | 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. |
Countries
United States
Contacts
STUDY_DIRECTORClinical Transparency (dept. 1452)
Novo Nordisk A/S
Participant flow
Recruitment details
The trial was conducted at 25 sites in the United States. One participant is counted in 'Completed' and not in 'Death in Reason for Not Completed' in Participant Flow as they died after completing the study and hence, not counted as non-completer.
Pre-assignment details
Participants were randomized in a 1:1 ratio to receive either oral semaglutide or one other oral glucose-lowering medication, respectively.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 59.7 Years STANDARD_DEVIATION 12 |
| Race/Ethnicity, Customized Asian | 80 Participants |
| Race/Ethnicity, Customized Black or African American | 68 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 91 Participants |
| Race/Ethnicity, Customized Missing Ethnicity | 13 Participants |
| Race/Ethnicity, Customized Missing Race | 6 Participants |
| Race/Ethnicity, Customized Non-Hispanic or Non-Latino | 404 Participants |
| Race/Ethnicity, Customized Other | 21 Participants |
| Race/Ethnicity, Customized White | 366 Participants |
| Sex: Female, Male Female | 237 Participants |
| Sex: Female, Male Male | 550 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 500 | 2 / 492 |
| other Total, other adverse events | 81 / 500 | 46 / 492 |
| serious Total, serious adverse events | 51 / 500 | 55 / 492 |
Outcome results
None listed