Diabetes Mellitus, Type 2
Conditions
Brief summary
The main purpose of this study is to compare the effects of semaglutide (Ozempic®) with the effects of other treatments for type 2 diabetes in a normal practice setting. The participant will be assigned by chance (like flipping a coin) to one of the following treatment groups: Group 1: semaglutide (Ozempic®) (by injection into skin) Group 2: standard of care antidiabetic medication (oral or injectable). The participant has an equal chance of being in either of the treatment groups. Neither the participant nor the study doctor or study staff will be able to pick which group the participant is in, but the participant will know which study drug the participant has been assigned to. The study doctor will provide the participant with a prescription for the study diabetes medication based on the treatment group the participant is assigned. The participation will last about 2 years.
Interventions
DRUGSemaglutide
Participants will be prescribed commercially available semaglutide s.c. and will be instructed to initiate treatment with semaglutide s.c. according to the approved label. The study doctor will determine the intended maintenance dose of semaglutide, as well as changes to the maintenance dose thereafter.
DRUGStandard of care
Participants will receive standard of care, defined as commercially available oral or injectable antidiabetic medication other than semaglutide. Participants will be prescribed and instructed to initiate commercially available antidiabetic medication according to the approved label and, if relevant for the specific antidiabetic medication, adjusted at the discretion of the study doctor.
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 65 Years
Healthy volunteers
No
Inclusion criteria
- * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study. * Male or female, age 18 years or older at the time of signing informed consent. * Type 2 diabetes mellitus diagnosis. * Treatment with either 1 or 2 oral antidiabetic medications. * Current member of a commercial or Medicare health plan with pharmacy benefits. * Recorded HbAlc value within the last 90 days prior to randomization. * Further intensification with an additional antidiabetic oral or injectable medication is indicated to achieve glycemic target at the discretion of the study physician according to approved labelling.
Exclusion criteria
* Previous randomization in this study * Treatment with more than 2 oral antidiabetic medications, oral semaglutide, or any injectable medication in a period of 30 days before the day of eligibility assessment. Temporary/emergency use of any type of insulin is allowed, as is prior insulin treatment for gestational diabetes. * Contraindications to semaglutide according to the Food and Drug Administration approved label. * Female who is pregnant, breastfeeding or intends to become pregnant * Participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No) | At year 1 | Number of participants who achieved HbA1c less than 7.0 % (53 mmol/mol) at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0 % at year 1; No: number of participants who did not achieve HbA1c less than 7.0 % at year 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0% (53 Millimoles Per Mole [mmol/Mol]) at Year 2 (Yes/No) | At year 2 | Number of participants who achieved HbA1c less than 7.0 % (53 mmol/mol) at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0 % at year 2; No: number of participants who did not achieve HbA1c less than 7.0 % at year 2. |
| Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 2 | Baseline (less than or equal to 90 days prior to randomization at week 0), year 2 | Change in HbA1c from baseline to year 2 is presented in percentage-point. |
| Time to First Study Drug Discontinuation During 2 Years | Week 0 to year 2 | Time to first study drug discontinuation during 2 years is presented. First study drug discontinuation=date of the first time a patient is not taking study drug as defined. |
| Number of Participants Who Attained Individualized HbA1c Target at Year 1 (Yes/No) | At year 1 | Number of participants who attained individualized HbA1c target at year 1 is presented. Study physicians set and documented an individualized HbA1c target for participants prior to randomization based on their clinical judgement and knowledge of the participant. Yes: number of participants who achieved individualized HbA1c target attained at year 1; No: number of participants who did not achieve individualized HbA1c target attained at year 1 |
| Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 1 (Yes/No) | At year 1 | Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) or at least 1% point improvement in HbA1c compared to baseline at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0% or at least 1% point improvement in HbA1c compared to baseline at year 1; No: number of participants who did not achieve HbA1c less than 7.0% or at least 1% point improvement in HbA1c compared to baseline at year 1 |
| Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 1 (Yes/No) | At year 1 | Number of participants who achieved HbA1c target attainment per HEDIS criteria (less than 8.0% if age ≥ 65 years or with defined comorbidities, otherwise less than 7.0%) at year 1 is presented. Yes: Number of participants who achieved HbA1c target attainment per HEDIS criteria at year 1; No: Number of participants who did not achieve HbA1c target attainment per HEDIS criteria at year 1 |
| Change in Body Weight (in Pounds) From Baseline to Year 1 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 | Change in body weight (in pounds) from baseline to year 1 is presented. |
| Percentage Change in Body Weight From Baseline to Year 1 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 | Percentage change in body weight from baseline to year 1 is presented. |
| Change in Systolic Blood Pressure (SBP) From Baseline to Year 1 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 | Change in SBP from baseline to year 1 is presented. |
| Change in Diastolic Blood Pressure (DBP) From Baseline to Year 1 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 | Change in DBP from baseline to year 1 is presented. |
| Time to First Treatment Intensification (Add-on) or Change (Switch) After Randomization During 2 Years | Week 0 to year 2 | Time to first treatment intensification (add-on) or change (switch) after randomization during 2 years is presented. |
| Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence for the First Year of the Study | Week 0 to year 1 | Percentage of MPR for study drug medication adherence for the first year of the study is presented. Medication adherence referred to a participant's conformance to the provider's recommendation with respect to timing, dosage, and frequency of medication taken during the prescribed length of time. The MPR was used to assess adherence. MPR was calculated as follows: MPR (%) = Sum of days supply for all prescription fills\*100/Total number of days in time period. MPR was capped at 100%. MPR was calculated from pharmacy claims data and irrespective of adherence to randomized treatment or changes to antidiabetic treatment. |
| Number of Hypoglycemic Episodes Leading to an Inpatient Admission or Emergency Room (ER) Encounter From Baseline to Year 2 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 | Number of hypoglycemic episodes leading to an inpatient admission or emergency room (ER) encounter from baseline to year 2 is presented. |
| Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc), Total Treatment Satisfaction Score Measured at Year 1 | At year 1 | DTSQc total treatment satisfaction score measured at year 1 is presented. The DTSQc provides a measure of how satisfied participants are with their current diabetes treatment compared with previous treatment. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction. |
| DTSQc, Total Treatment Satisfaction Score Measured at Year 2 | At year 2 | DTSQc total treatment satisfaction score measured at year 2 is presented. The DTSQc provides a measure of how satisfied participants are with their current diabetes treatment compared with previous treatment. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction. |
| Change From Baseline in Short Form 12-Item Version 2 Survey (SF-12 v2), Physical Component Summary (PCS-12) Score at Year 1 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 | Change from baseline in SF-12 v2, PCS-12 score at year 1 is presented. The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items were scored using the scoring software. It contains two summary scores: Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life. |
| Change From Baseline in SF-12 v2, PCS-12 Score at Year 2 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 | Change from baseline in SF-12 v2, PCS-12 score at year 2 is presented. The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items were scored using the scoring software. It contains two summary scores: Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life. |
| Change From Baseline in SF-12 v2, Mental Component Summary (MCS-12) Score at Year 1 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 | Change from baseline in SF-12 v2, MCS-12 score at year 1 is presented. The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items were scored using the scoring software. It contains two summary scores: PCS Score and MCS Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life. |
| Change From Baseline in SF-12 v2, MCS-12 Score at Year 2 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 | Change from baseline in SF-12 v2, MCS-12 score at year 2 is presented. The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items were scored using the scoring software. It contains two summary scores: PCS Score and MCS Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life. |
| Change From Baseline in Work Productivity and Activity Impairment, General Health Questionnaire (WPAI-GH) Absenteeism (Work Time Missed) Score at Year 1 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 | Change from baseline in WPAI-GH Absenteeism (work time missed) score at year 1 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work/reduced on-the-job effectiveness), Work productivity loss (overall work impairment/absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health). |
| Change From Baseline in WPAI-GH Absenteeism (Work Time Missed) Score at Year 2 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 | Change from baseline in WPAI-GH Absenteeism (work time missed) score at year 2 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work/reduced on-the-job effectiveness), Work productivity loss (overall work impairment/absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health). |
| Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 1 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 | Change from baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) score at year 1 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health). |
| Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 2 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 | Change from baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) score at year 2 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health). |
| Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 1 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 | Change from baseline in WPAI-GH work productivity loss (overall work impairment/absenteeism plus presenteeism) score at year 1 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health). |
| Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 2 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 | Change from baseline in WPAI-GH work productivity loss (overall work impairment/absenteeism plus presenteeism) score at year 2 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health). |
| Change From Baseline in WPAI-GH Activity Impairment Score at Year 1 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1 | Change from baseline in WPAI-GH activity impairment score at year 1 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work/reduced on-the-job effectiveness), Work productivity loss (overall work impairment/absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health). |
| Change From Baseline in WPAI-GH Activity Impairment Score at Year 2 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 | Change from baseline in WPAI-GH activity impairment score at year 2 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work/reduced on-the-job effectiveness), Work productivity loss (overall work impairment/absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health). |
| All Cause Healthcare Resource Utilization (HCRU): Mean Number of Inpatient Admissions Per Participant From Baseline to Year 2 | From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 | All cause healthcare resource utilization - mean number of inpatient admissions per participant from baseline to year 2 is presented. |
| All Cause HCRU: Mean Cumulative Length of Stay for Inpatient Admissions Per Participant From Baseline to Year 2 | From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 | All cause HCRU - mean cumulative length of stay for inpatient admissions per participant from baseline to year 2 is presented. Cumulative inpatient length of stay is the sum of the length of stay of all inpatient admissions a participant experiences from baseline to year 2. |
| All Cause HCRU: Mean Number of Emergency Room (ER) Encounters Per Participant From Baseline to Year 2 | From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 | All cause HCRU - mean number of emergency room (ER) encounters per participant from baseline to year 2 is presented. |
| All Cause HCRU: Mean Number of Outpatient Encounters Per Participant From Baseline to Year 2 | From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 | All cause HCRU - mean number of outpatient encounters per participant from baseline to year 2 is presented. Physician outpatient office visit is defined by a medical claim with outpatient place of service and an evaluation and management code. |
| All Cause HCRU: Mean Number of Medication Visits Per Participant From Baseline to Year 2 | From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 | All cause HCRU - mean number of medication visits per participant from baseline to year 2 is presented. |
| All Cause HCRU: Number of Participants With Inpatient Admission (Yes/No) From Baseline to Year 2 | From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 | All cause HCRU - number of participants with inpatient admission from baseline to year 2 is presented. Yes: number of participants who experienced inpatient admission; no: number of participants who did not experience inpatient admission. |
| All Cause HCRU: Number of Participants With ER Encounter (Yes/No) From Baseline to Year 2 | From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 | All cause HCRU - number of participants with ER encounter from baseline to year 2 is presented. Yes: number of participants who experienced ER Encounter; no: number of participants who did not experience ER Encounter. |
| All Cause HCRU: Number of Participants With Outpatient Encounter (Yes/No) From Baseline to Year 2 | From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 | All cause HCRU - number of participants with outpatient encounter from baseline to year 2 is presented. Physician outpatient office visit is defined by a medical claim with outpatient place of service and an evaluation and management code. Yes: number of participants who experienced outpatient encounter; no: number of participants who did not experience outpatient encounter. |
| Diabetes Related HCRU: Mean Number of Diabetes Related Inpatient Admissions Per Participant From Baseline to Year 2 | From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 | Diabetes related HCRU - mean number of diabetes related inpatient admissions per participant from baseline to year 2 is presented. |
| Diabetes Related HCRU: Mean Cumulative Length of Stay for Diabetes Related Inpatient Admissions Per Participant From Baseline to Year 2 | From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 | Diabetes related HCRU - mean cumulative length of stay for diabetes related inpatient admissions per participant from baseline to year 2 is presented. Cumulative inpatient length of stay is the sum of the length of stay of all diabetes related inpatient admissions a participant experiences from baseline to year 2. |
| Diabetes Related HCRU: Mean Number of Diabetes Related ER Encounters Per Participant From Baseline to Year 2 | From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 | Diabetes related HCRU - mean number of diabetes related ER encounters per participant from baseline to year 2 is presented. |
| Diabetes Related HCRU: Mean Number of Diabetes Related Outpatient Encounters Per Participant From Baseline to Year 2 | From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 | Diabetes related HCRU - mean number of diabetes related outpatient encounters per participant from baseline to year 2 is presented. Physician outpatient office visit is defined by a medical claim with outpatient place of service and an evaluation and management code. |
| Diabetes Related HCRU: Mean Number of Diabetes Related Medication Visits Per Participant From Baseline to Year 2 | From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 | Diabetes related HCRU - mean number of diabetes related medication visits per participant from baseline to year 2 is presented. |
| Diabetes Related HCRU: Number of Participants With Diabetes Related Inpatient Admission (Yes/No) From Baseline to Year 2 | From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 | Diabeted related HCRU - number of participants with diabetes related inpatient admission from baseline to year 2 is presented. Yes: number of participants who experienced diabetes related inpatient admission; no: number of participants who did not experience diabetes related inpatient admission. |
| Diabetes Related HCRU: Number of Participants With Diabetes Related ER Encounter (Yes/No) From Baseline to Year 2 | From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 | Diabeted related HCRU - number of participants with diabeted related ER encounter from baseline to year 2 is presented. Yes: number of participants who experienced diabeted related ER encounter; no: number of participants who did not experience diabeted related ER encounter. |
| Diabetes Related HCRU: Number of Participants With Diabetes Related Outpatient Encounter (Yes/No) From Baseline to Year 2 | From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2 | Diabeted related HCRU - number of participants with diabeted related outpatient encounter from baseline to year 2 is presented. Physician outpatient office visit is defined by a medical claim with outpatient place of service and an evaluation and management code. Yes: number of participants who experienced diabeted related outpatient encounter; no: number of participants who did not experience diabeted related outpatient encounter. |
| Number of Participants Who Attained Individualized HbA1c Target at Year 2 (Yes/No) | At year 2 | Number of participants who attained individualized HbA1c target at year 2 is presented. Study physicians set and documented an individualized HbA1c target for participants prior to randomization based on their clinical judgement and knowledge of the participant. Yes: number of participants who achieved individualized HbA1c target attained at year 2; No: number of participants who did not achieve individualized HbA1c target attained at year 2 |
| Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 2 (Yes/No) | At year 2 | Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) or at least 1% point improvement in HbA1c compared to baseline at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0% or at least 1% point improvement in HbA1c compared to baseline at year 2; No: number of participants who did not achieve HbA1c less than 7.0% or at least 1% point improvement in HbA1c compared to baseline at year 2. |
| Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 (Yes/No) | At year 1 | Number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 1 is presented. Yes: number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 1; No: number of participants who did not achieve HbA1c less than 8.0% (64 mmol/mol) at year 1. |
| Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 (Yes/No) | At year 2 | Number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 2 is presented. Yes: number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 2; No: number of participants who did not achieve HbA1c less than 8.0% (64 mmol/mol) at year 2. |
| Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 1 (Yes/No) | At year 1 | Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 1; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 1. |
| Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 2 (Yes/No) | At year 2 | Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 2; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 2. |
| Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 2 (Yes/No) | At year 2 | Number of participants who achieved HbA1c target attainment per HEDIS criteria (less than 8.0% if age ≥ 65 years or with defined comorbidities, otherwise less than 7.0%) at year 2 is presented. Yes: Number of participants who achieved HbA1c target attainment per HEDIS criteria at year 2; No: Number of participants who did not achieve HbA1c target attainment per HEDIS criteria at year 2. |
| Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No) | At year 1 | Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) at year 1 in participants with HbA1c \>9.0% at baseline is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) at year 1 in participants with HbA1c \>9.0% at baseline; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) at year 1 in participants with HbA1c \>9.0% at baseline. |
| Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No) | At year 2 | Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) at year 2 in participants with HbA1c \>9.0% at baseline is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) at year 2 in participants with HbA1c \>9.0% at baseline; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) at year 2 in participants with HbA1c \>9.0% at baseline. |
| Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No) | At year 1 | Number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 1 in participants with HbA1c \>9.0% at baseline is presented. Yes: number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 1 in participants with HbA1c \>9.0% at baseline; No: number of participants who did not achieve HbA1c less than 8.0% (64 mmol/mol) at year 1 in participants with HbA1c \>9.0% at baseline |
| Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No) | At year 2 | Number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 2 in participants with HbA1c \>9.0% at baseline is presented. Yes: number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 2 in participants with HbA1c \>9.0% at baseline; No: number of participants who did not achieve HbA1c less than 8.0% (64 mmol/mol) at year 2 in participants with HbA1c \>9.0% at baseline. |
| Percentage Change in Body Weight From Baseline to Year 2 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 | Percentage change in body weight from baseline to year 2 is presented. |
| Change in Body Weight (in Pounds) From Baseline to Year 2 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 | Change in body weight (in pounds) from baseline to year 2 is presented. |
| Change in Systolic Blood Pressure (SBP) From Baseline to Year 2 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 | Change in SBP from baseline to year 2 is presented. |
| Change in Diastolic Blood Pressure (DBP) From Baseline to Year 2 | Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2 | Change in DBP from baseline to year 2 is presented. |
| Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 1 (Yes/No) | Week 0 to year 1 | Number of participants who reported hypoglycemia leading to inpatient admission or ER encounter during year 1 is presented. Yes: number of participants who reported hypoglycemia leading to inpatient admission or ER encounter during year 1; No: number of participants who did not report hypoglycemia leading to inpatient admission or ER encounter during year 1. |
| Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 1 | Baseline (less than or equal to 90 days prior to randomization at week 0), year 1 | Change in HbA1c from baseline to year 1 is presented in %-point. |
| Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and Body Weight Loss of ≥ 5% Versus Baseline at Year 1 (Yes/No) | At year 1 | Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 1; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 1 |
| Number of Participants With Absolute HbA1c Reduction of ≥ 0.5% Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and a Body Weight Loss of ≥ 5% Versus Baseline at Year 1 (Yes/No) | At year 1 | Number of participants who achieved absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 1 is presented. Yes: number of participants who achieved absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 1; No: number of participants who did not achieve absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 1. |
| Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and Body Weight Loss of ≥ 5% Versus Baseline at Year 2 (Yes/No) | At year 2 | Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 2; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 2. |
| Number of Participants With Absolute HbA1c Reduction of ≥ 0.5% Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and a Body Weight Loss of ≥ 5% Versus Baseline at Year 2 (Yes/No) | At year 2 | Number of participants who achieved absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 2 is presented. Yes: number of participants who achieved absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 2; No: number of participants who did not achieve absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 2. |
| Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and No Body Weight Gain Versus Baseline at Year 1 (Yes/No) | At year 1 | Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 1; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 1. |
| Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and No Body Weight Gain Versus Baseline at Year 2 (Yes/No) | At year 2 | Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 2; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 2. |
| Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence For The Two Years of The Study | Week 0 to year 2 | Percentage of MPR for study drug medication adherence for the two years of the study is presented. Medication adherence referred to a participant's conformance to the provider's recommendation with respect to timing, dosage, and frequency of medication taken during the prescribed length of time. The MPR was used to assess adherence. MPR was calculated as follows: MPR (%) = Sum of days supply for all prescription fills\*100/Total number of days in time period. MPR was capped at 100%. MPR was calculated from pharmacy claims data and irrespective of adherence to randomized treatment or changes to antidiabetic treatment. |
| Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 2 (Yes/No) | Week 0 to year 2 | Number of participants who reported hypoglycemia leading to inpatient admission or ER encounter during year 2 is presented. Yes: number of participants who reported hypoglycemia leading to inpatient admission or ER encounter during year 2; No: number of participants who did not report hypoglycemia leading to inpatient admission or ER encounter during year 2. |
Countries
Canada, United States
Participant flow
Recruitment details
The trial was conducted at 138 sites in the United States.
Pre-assignment details
A total of 1,278 participants were randomized 1:1 to receive either semaglutide or standard of care (SOC).
Participants by arm
| Arm | Count |
|---|---|
| Semaglutide Participants received semaglutide subcutaneous (s.c.) injection once weekly in addition to up to 2 oral antidiabetic medications as treatment intensification for 2 years. Medication dose and dose escalation was at the discretion of the study physician according to routine practice for medications for glycemic control in participants. | 644 |
| Standard of Care Participants received standard of care (any commercially available oral or injectable antidiabetic medication, excluding semaglutide) in addition to up to 2 oral antidiabetic medications as treatment intensification for 2 years. Medication dose and dose escalation was at the discretion of the study physician according to routine practice for medications for glycemic control in participants. | 634 |
| Total | 1,278 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Accidentally Randomized | 2 | 0 |
| Overall Study | Adverse Event | 14 | 7 |
| Overall Study | Death | 9 | 9 |
| Overall Study | Lost to Follow-up | 50 | 56 |
| Overall Study | Other reasons | 48 | 53 |
| Overall Study | Pregnancy | 2 | 0 |
| Overall Study | Protocol Violation | 18 | 26 |
| Overall Study | Withdrawal by Subject | 38 | 36 |
Baseline characteristics
| Characteristic | Semaglutide | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 57.47 years STANDARD_DEVIATION 11.305 | 57.24 years STANDARD_DEVIATION 10.982 | 57.36 years STANDARD_DEVIATION 11.142 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 57 Participants | 57 Participants | 114 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 586 Participants | 577 Participants | 1163 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native, Asian | 16 Participants | 27 Participants | 43 Participants |
| Race/Ethnicity, Customized Black or African American | 90 Participants | 99 Participants | 189 Participants |
| Race/Ethnicity, Customized Missing | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 17 Participants | 19 Participants | 36 Participants |
| Race/Ethnicity, Customized White | 517 Participants | 487 Participants | 1004 Participants |
| Sex: Female, Male Female | 309 Participants | 276 Participants | 585 Participants |
| Sex: Female, Male Male | 334 Participants | 358 Participants | 692 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 634 | 9 / 621 |
| other Total, other adverse events | 0 / 634 | 0 / 621 |
| serious Total, serious adverse events | 38 / 634 | 39 / 621 |
Outcome results
Primary
Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No)
Number of participants who achieved HbA1c less than 7.0 % (53 mmol/mol) at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0 % at year 1; No: number of participants who did not achieve HbA1c less than 7.0 % at year 1.
Time frame: At year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No) | Yes | 244 Participants |
| Semaglutide | Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No) | No | 186 Participants |
| Standard of Care | Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No) | Yes | 226 Participants |
| Standard of Care | Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No) | No | 236 Participants |
Comparison: Estimate and p-value are based on logistic regression model with logit link function, treatment as categorical effect, and baseline HbA1c as covariate.p-value: 0.03395% CI: [1.03, 1.79]Regression, Logistic
Secondary
All Cause HCRU: Mean Cumulative Length of Stay for Inpatient Admissions Per Participant From Baseline to Year 2
All cause HCRU - mean cumulative length of stay for inpatient admissions per participant from baseline to year 2 is presented. Cumulative inpatient length of stay is the sum of the length of stay of all inpatient admissions a participant experiences from baseline to year 2.
Time frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for HCRU at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not. It is only calculated for participants with at least one inpatient admission.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | All Cause HCRU: Mean Cumulative Length of Stay for Inpatient Admissions Per Participant From Baseline to Year 2 | 4.7 Days | Standard Deviation 3.4 |
| Standard of Care | All Cause HCRU: Mean Cumulative Length of Stay for Inpatient Admissions Per Participant From Baseline to Year 2 | 7.7 Days | Standard Deviation 12.1 |
Secondary
All Cause HCRU: Mean Number of Emergency Room (ER) Encounters Per Participant From Baseline to Year 2
All cause HCRU - mean number of emergency room (ER) encounters per participant from baseline to year 2 is presented.
Time frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for HCRU at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | All Cause HCRU: Mean Number of Emergency Room (ER) Encounters Per Participant From Baseline to Year 2 | 0.72 ER encounters | Standard Deviation 2.01 |
| Standard of Care | All Cause HCRU: Mean Number of Emergency Room (ER) Encounters Per Participant From Baseline to Year 2 | 0.29 ER encounters | Standard Deviation 0.77 |
Secondary
All Cause HCRU: Mean Number of Medication Visits Per Participant From Baseline to Year 2
All cause HCRU - mean number of medication visits per participant from baseline to year 2 is presented.
Time frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for HCRU at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | All Cause HCRU: Mean Number of Medication Visits Per Participant From Baseline to Year 2 | 7.4 medication visits | Standard Deviation 43.1 |
| Standard of Care | All Cause HCRU: Mean Number of Medication Visits Per Participant From Baseline to Year 2 | 2.9 medication visits | Standard Deviation 5.2 |
Secondary
All Cause HCRU: Mean Number of Outpatient Encounters Per Participant From Baseline to Year 2
All cause HCRU - mean number of outpatient encounters per participant from baseline to year 2 is presented. Physician outpatient office visit is defined by a medical claim with outpatient place of service and an evaluation and management code.
Time frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for HCRU at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | All Cause HCRU: Mean Number of Outpatient Encounters Per Participant From Baseline to Year 2 | 18.7 outpatient encounters | Standard Deviation 17.7 |
| Standard of Care | All Cause HCRU: Mean Number of Outpatient Encounters Per Participant From Baseline to Year 2 | 16.5 outpatient encounters | Standard Deviation 13.2 |
Secondary
All Cause HCRU: Number of Participants With ER Encounter (Yes/No) From Baseline to Year 2
All cause HCRU - number of participants with ER encounter from baseline to year 2 is presented. Yes: number of participants who experienced ER Encounter; no: number of participants who did not experience ER Encounter.
Time frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for HCRU at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | All Cause HCRU: Number of Participants With ER Encounter (Yes/No) From Baseline to Year 2 | Yes | 24 Participants |
| Semaglutide | All Cause HCRU: Number of Participants With ER Encounter (Yes/No) From Baseline to Year 2 | No | 77 Participants |
| Standard of Care | All Cause HCRU: Number of Participants With ER Encounter (Yes/No) From Baseline to Year 2 | No | 81 Participants |
| Standard of Care | All Cause HCRU: Number of Participants With ER Encounter (Yes/No) From Baseline to Year 2 | Yes | 21 Participants |
Secondary
All Cause HCRU: Number of Participants With Inpatient Admission (Yes/No) From Baseline to Year 2
All cause HCRU - number of participants with inpatient admission from baseline to year 2 is presented. Yes: number of participants who experienced inpatient admission; no: number of participants who did not experience inpatient admission.
Time frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for HCRU at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | All Cause HCRU: Number of Participants With Inpatient Admission (Yes/No) From Baseline to Year 2 | Yes | 16 Participants |
| Semaglutide | All Cause HCRU: Number of Participants With Inpatient Admission (Yes/No) From Baseline to Year 2 | No | 85 Participants |
| Standard of Care | All Cause HCRU: Number of Participants With Inpatient Admission (Yes/No) From Baseline to Year 2 | Yes | 16 Participants |
| Standard of Care | All Cause HCRU: Number of Participants With Inpatient Admission (Yes/No) From Baseline to Year 2 | No | 86 Participants |
Secondary
All Cause HCRU: Number of Participants With Outpatient Encounter (Yes/No) From Baseline to Year 2
All cause HCRU - number of participants with outpatient encounter from baseline to year 2 is presented. Physician outpatient office visit is defined by a medical claim with outpatient place of service and an evaluation and management code. Yes: number of participants who experienced outpatient encounter; no: number of participants who did not experience outpatient encounter.
Time frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for HCRU at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | All Cause HCRU: Number of Participants With Outpatient Encounter (Yes/No) From Baseline to Year 2 | Yes | 97 Participants |
| Semaglutide | All Cause HCRU: Number of Participants With Outpatient Encounter (Yes/No) From Baseline to Year 2 | No | 4 Participants |
| Standard of Care | All Cause HCRU: Number of Participants With Outpatient Encounter (Yes/No) From Baseline to Year 2 | Yes | 101 Participants |
| Standard of Care | All Cause HCRU: Number of Participants With Outpatient Encounter (Yes/No) From Baseline to Year 2 | No | 1 Participants |
Secondary
All Cause Healthcare Resource Utilization (HCRU): Mean Number of Inpatient Admissions Per Participant From Baseline to Year 2
All cause healthcare resource utilization - mean number of inpatient admissions per participant from baseline to year 2 is presented.
Time frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for HCRU at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | All Cause Healthcare Resource Utilization (HCRU): Mean Number of Inpatient Admissions Per Participant From Baseline to Year 2 | 0.20 inpatient admissions | Standard Deviation 0.55 |
| Standard of Care | All Cause Healthcare Resource Utilization (HCRU): Mean Number of Inpatient Admissions Per Participant From Baseline to Year 2 | 0.25 inpatient admissions | Standard Deviation 0.9 |
Secondary
Change From Baseline in SF-12 v2, MCS-12 Score at Year 2
Change from baseline in SF-12 v2, MCS-12 score at year 2 is presented. The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items were scored using the scoring software. It contains two summary scores: PCS Score and MCS Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life.
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for SF-12 at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline in SF-12 v2, MCS-12 Score at Year 2 | 2.4 Scores on a scale | Standard Deviation 8.43 |
| Standard of Care | Change From Baseline in SF-12 v2, MCS-12 Score at Year 2 | 0.2 Scores on a scale | Standard Deviation 9.31 |
Secondary
Change From Baseline in SF-12 v2, Mental Component Summary (MCS-12) Score at Year 1
Change from baseline in SF-12 v2, MCS-12 score at year 1 is presented. The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items were scored using the scoring software. It contains two summary scores: PCS Score and MCS Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life.
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for SF-12 at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline in SF-12 v2, Mental Component Summary (MCS-12) Score at Year 1 | 2.4 Scores on a scale | Standard Deviation 8.54 |
| Standard of Care | Change From Baseline in SF-12 v2, Mental Component Summary (MCS-12) Score at Year 1 | 1.1 Scores on a scale | Standard Deviation 8.17 |
Secondary
Change From Baseline in SF-12 v2, PCS-12 Score at Year 2
Change from baseline in SF-12 v2, PCS-12 score at year 2 is presented. The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items were scored using the scoring software. It contains two summary scores: Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life.
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for SF-12 at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline in SF-12 v2, PCS-12 Score at Year 2 | 2.6 Scores on a scale | Standard Deviation 8.68 |
| Standard of Care | Change From Baseline in SF-12 v2, PCS-12 Score at Year 2 | 2.4 Scores on a scale | Standard Deviation 7.99 |
Secondary
Change From Baseline in Short Form 12-Item Version 2 Survey (SF-12 v2), Physical Component Summary (PCS-12) Score at Year 1
Change from baseline in SF-12 v2, PCS-12 score at year 1 is presented. The SF-12 v2 is a 12-item generic health-related quality of life measure that assesses physical and mental functioning. The items were scored using the scoring software. It contains two summary scores: Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score. The scores are norm-scored such that the scores range from 0-100 with a mean of 50 and standard deviation of 10. A higher score is associated with better quality of life and a lower score, poorer quality of life.
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for SF-12 at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline in Short Form 12-Item Version 2 Survey (SF-12 v2), Physical Component Summary (PCS-12) Score at Year 1 | 2.8 Scores on a scale | Standard Deviation 8.2 |
| Standard of Care | Change From Baseline in Short Form 12-Item Version 2 Survey (SF-12 v2), Physical Component Summary (PCS-12) Score at Year 1 | 2.3 Scores on a scale | Standard Deviation 7.6 |
Secondary
Change From Baseline in Work Productivity and Activity Impairment, General Health Questionnaire (WPAI-GH) Absenteeism (Work Time Missed) Score at Year 1
Change from baseline in WPAI-GH Absenteeism (work time missed) score at year 1 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work/reduced on-the-job effectiveness), Work productivity loss (overall work impairment/absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health).
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for WPAI-GH at the dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline in Work Productivity and Activity Impairment, General Health Questionnaire (WPAI-GH) Absenteeism (Work Time Missed) Score at Year 1 | -1.5 Scores on a scale | Standard Deviation 21.39 |
| Standard of Care | Change From Baseline in Work Productivity and Activity Impairment, General Health Questionnaire (WPAI-GH) Absenteeism (Work Time Missed) Score at Year 1 | 0.9 Scores on a scale | Standard Deviation 14.39 |
Secondary
Change From Baseline in WPAI-GH Absenteeism (Work Time Missed) Score at Year 2
Change from baseline in WPAI-GH Absenteeism (work time missed) score at year 2 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work/reduced on-the-job effectiveness), Work productivity loss (overall work impairment/absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health).
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for WPAI-GH at the dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline in WPAI-GH Absenteeism (Work Time Missed) Score at Year 2 | -2.1 Scores on a scale | Standard Deviation 22.86 |
| Standard of Care | Change From Baseline in WPAI-GH Absenteeism (Work Time Missed) Score at Year 2 | 0.0 Scores on a scale | Standard Deviation 14.15 |
Secondary
Change From Baseline in WPAI-GH Activity Impairment Score at Year 1
Change from baseline in WPAI-GH activity impairment score at year 1 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work/reduced on-the-job effectiveness), Work productivity loss (overall work impairment/absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health).
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for WPAI-GH at the dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline in WPAI-GH Activity Impairment Score at Year 1 | -6.7 Scores on a scale | Standard Deviation 27.91 |
| Standard of Care | Change From Baseline in WPAI-GH Activity Impairment Score at Year 1 | -3.7 Scores on a scale | Standard Deviation 27.15 |
Secondary
Change From Baseline in WPAI-GH Activity Impairment Score at Year 2
Change from baseline in WPAI-GH activity impairment score at year 2 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work/reduced on-the-job effectiveness), Work productivity loss (overall work impairment/absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health).
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for WPAI-GH at the dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline in WPAI-GH Activity Impairment Score at Year 2 | -5.8 Scores on a scale | Standard Deviation 27.51 |
| Standard of Care | Change From Baseline in WPAI-GH Activity Impairment Score at Year 2 | -3.1 Scores on a scale | Standard Deviation 28.03 |
Secondary
Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 1
Change from baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) score at year 1 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health).
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for WPAI-GH at the dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 1 | -5.1 Scores on a scale | Standard Deviation 24.31 |
| Standard of Care | Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 1 | -4.5 Scores on a scale | Standard Deviation 22.25 |
Secondary
Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 2
Change from baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) score at year 2 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health).
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for WPAI-GH at the dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 2 | -6.0 Scores on a scale | Standard Deviation 24.3 |
| Standard of Care | Change From Baseline in WPAI-GH Presenteeism (Impairment at Work/Reduced On-the-job Effectiveness) Score at Year 2 | -3.8 Scores on a scale | Standard Deviation 24.89 |
Secondary
Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 1
Change from baseline in WPAI-GH work productivity loss (overall work impairment/absenteeism plus presenteeism) score at year 1 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health).
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for WPAI-GH at the dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 1 | -4.8 Scores on a scale | Standard Deviation 25.64 |
| Standard of Care | Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 1 | -4.5 Scores on a scale | Standard Deviation 24.79 |
Secondary
Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 2
Change from baseline in WPAI-GH work productivity loss (overall work impairment/absenteeism plus presenteeism) score at year 2 is presented. The WPAI-GH yields four types of scores: Absenteeism (work time missed), Presenteesism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes (percent work time missed due to health, percent impairment while working due to health, percent overall work impairment due to health, percent activity impairment due to health).
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for WPAI-GH at the dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 2 | -6.4 Scores on a scale | Standard Deviation 25.18 |
| Standard of Care | Change From Baseline in WPAI-GH Work Productivity Loss (Overall Work Impairment/Absenteeism Plus Presenteeism) Score at Year 2 | -4.0 Scores on a scale | Standard Deviation 25.89 |
Secondary
Change in Body Weight (in Pounds) From Baseline to Year 1
Change in body weight (in pounds) from baseline to year 1 is presented.
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Body Weight (in Pounds) From Baseline to Year 1 | -9.8 Pounds (lbs) | Standard Deviation 21.15 |
| Standard of Care | Change in Body Weight (in Pounds) From Baseline to Year 1 | -5.4 Pounds (lbs) | Standard Deviation 20.7 |
Secondary
Change in Body Weight (in Pounds) From Baseline to Year 2
Change in body weight (in pounds) from baseline to year 2 is presented.
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Body Weight (in Pounds) From Baseline to Year 2 | -11.1 lbs | Standard Deviation 24.65 |
| Standard of Care | Change in Body Weight (in Pounds) From Baseline to Year 2 | -6.8 lbs | Standard Deviation 18.54 |
Secondary
Change in Diastolic Blood Pressure (DBP) From Baseline to Year 1
Change in DBP from baseline to year 1 is presented.
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Diastolic Blood Pressure (DBP) From Baseline to Year 1 | -1.6 mmHg | Standard Deviation 10.08 |
| Standard of Care | Change in Diastolic Blood Pressure (DBP) From Baseline to Year 1 | -0.9 mmHg | Standard Deviation 9.79 |
Secondary
Change in Diastolic Blood Pressure (DBP) From Baseline to Year 2
Change in DBP from baseline to year 2 is presented.
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Diastolic Blood Pressure (DBP) From Baseline to Year 2 | -1.9 mmHg | Standard Deviation 10.58 |
| Standard of Care | Change in Diastolic Blood Pressure (DBP) From Baseline to Year 2 | -1.4 mmHg | Standard Deviation 9.92 |
Secondary
Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 1
Change in HbA1c from baseline to year 1 is presented in %-point.
Time frame: Baseline (less than or equal to 90 days prior to randomization at week 0), year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 1 | -1.46 Percentage-point of HbA1c | Standard Deviation 1.669 |
| Standard of Care | Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 1 | -1.14 Percentage-point of HbA1c | Standard Deviation 1.707 |
Secondary
Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 2
Change in HbA1c from baseline to year 2 is presented in percentage-point.
Time frame: Baseline (less than or equal to 90 days prior to randomization at week 0), year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 2 | -1.45 Percentage-point of HbA1c | Standard Deviation 1.723 |
| Standard of Care | Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 2 | -0.98 Percentage-point of HbA1c | Standard Deviation 1.767 |
Secondary
Change in Systolic Blood Pressure (SBP) From Baseline to Year 1
Change in SBP from baseline to year 1 is presented.
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Systolic Blood Pressure (SBP) From Baseline to Year 1 | -2.3 Millimeters of mercury (mmHg) | Standard Deviation 16.4 |
| Standard of Care | Change in Systolic Blood Pressure (SBP) From Baseline to Year 1 | -1.8 Millimeters of mercury (mmHg) | Standard Deviation 16.34 |
Secondary
Change in Systolic Blood Pressure (SBP) From Baseline to Year 2
Change in SBP from baseline to year 2 is presented.
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Systolic Blood Pressure (SBP) From Baseline to Year 2 | -3.0 mmHg | Standard Deviation 17.03 |
| Standard of Care | Change in Systolic Blood Pressure (SBP) From Baseline to Year 2 | -2.8 mmHg | Standard Deviation 16.91 |
Secondary
Diabetes Related HCRU: Mean Cumulative Length of Stay for Diabetes Related Inpatient Admissions Per Participant From Baseline to Year 2
Diabetes related HCRU - mean cumulative length of stay for diabetes related inpatient admissions per participant from baseline to year 2 is presented. Cumulative inpatient length of stay is the sum of the length of stay of all diabetes related inpatient admissions a participant experiences from baseline to year 2.
Time frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Population: FAS: all randomized participants analyzed according to treatment group they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for the outcome measure. Analysis is based only on participants with available data for diabetes related HCRU at dedicated study visit including measurements irrespective of whether participants discontinued study drug/not. It is only calculated for participants with at least 1 diabetes related inpatient admission.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Diabetes Related HCRU: Mean Cumulative Length of Stay for Diabetes Related Inpatient Admissions Per Participant From Baseline to Year 2 | 4.7 Days | Standard Deviation 2.9 |
| Standard of Care | Diabetes Related HCRU: Mean Cumulative Length of Stay for Diabetes Related Inpatient Admissions Per Participant From Baseline to Year 2 | 8.9 Days | Standard Deviation 12.1 |
Secondary
Diabetes Related HCRU: Mean Number of Diabetes Related ER Encounters Per Participant From Baseline to Year 2
Diabetes related HCRU - mean number of diabetes related ER encounters per participant from baseline to year 2 is presented.
Time frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for diabetes related HCRU at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Diabetes Related HCRU: Mean Number of Diabetes Related ER Encounters Per Participant From Baseline to Year 2 | 0.50 ER encounters | Standard Deviation 1.49 |
| Standard of Care | Diabetes Related HCRU: Mean Number of Diabetes Related ER Encounters Per Participant From Baseline to Year 2 | 0.17 ER encounters | Standard Deviation 0.47 |
Secondary
Diabetes Related HCRU: Mean Number of Diabetes Related Inpatient Admissions Per Participant From Baseline to Year 2
Diabetes related HCRU - mean number of diabetes related inpatient admissions per participant from baseline to year 2 is presented.
Time frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for diabetes related HCRU at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Diabetes Related HCRU: Mean Number of Diabetes Related Inpatient Admissions Per Participant From Baseline to Year 2 | 0.13 inpatient admissions | Standard Deviation 0.37 |
| Standard of Care | Diabetes Related HCRU: Mean Number of Diabetes Related Inpatient Admissions Per Participant From Baseline to Year 2 | 0.19 inpatient admissions | Standard Deviation 0.7 |
Secondary
Diabetes Related HCRU: Mean Number of Diabetes Related Medication Visits Per Participant From Baseline to Year 2
Diabetes related HCRU - mean number of diabetes related medication visits per participant from baseline to year 2 is presented.
Time frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for diabetes related HCRU at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Diabetes Related HCRU: Mean Number of Diabetes Related Medication Visits Per Participant From Baseline to Year 2 | 1.4 medication visits | Standard Deviation 2.8 |
| Standard of Care | Diabetes Related HCRU: Mean Number of Diabetes Related Medication Visits Per Participant From Baseline to Year 2 | 1.1 medication visits | Standard Deviation 1.9 |
Secondary
Diabetes Related HCRU: Mean Number of Diabetes Related Outpatient Encounters Per Participant From Baseline to Year 2
Diabetes related HCRU - mean number of diabetes related outpatient encounters per participant from baseline to year 2 is presented. Physician outpatient office visit is defined by a medical claim with outpatient place of service and an evaluation and management code.
Time frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for diabetes related HCRU at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Diabetes Related HCRU: Mean Number of Diabetes Related Outpatient Encounters Per Participant From Baseline to Year 2 | 9.8 outpatient encounters | Standard Deviation 12.9 |
| Standard of Care | Diabetes Related HCRU: Mean Number of Diabetes Related Outpatient Encounters Per Participant From Baseline to Year 2 | 8.1 outpatient encounters | Standard Deviation 5.8 |
Secondary
Diabetes Related HCRU: Number of Participants With Diabetes Related ER Encounter (Yes/No) From Baseline to Year 2
Diabeted related HCRU - number of participants with diabeted related ER encounter from baseline to year 2 is presented. Yes: number of participants who experienced diabeted related ER encounter; no: number of participants who did not experience diabeted related ER encounter.
Time frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for diabetes related HCRU at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Diabetes Related HCRU: Number of Participants With Diabetes Related ER Encounter (Yes/No) From Baseline to Year 2 | Yes | 18 Participants |
| Semaglutide | Diabetes Related HCRU: Number of Participants With Diabetes Related ER Encounter (Yes/No) From Baseline to Year 2 | No | 83 Participants |
| Standard of Care | Diabetes Related HCRU: Number of Participants With Diabetes Related ER Encounter (Yes/No) From Baseline to Year 2 | Yes | 13 Participants |
| Standard of Care | Diabetes Related HCRU: Number of Participants With Diabetes Related ER Encounter (Yes/No) From Baseline to Year 2 | No | 89 Participants |
Secondary
Diabetes Related HCRU: Number of Participants With Diabetes Related Inpatient Admission (Yes/No) From Baseline to Year 2
Diabeted related HCRU - number of participants with diabetes related inpatient admission from baseline to year 2 is presented. Yes: number of participants who experienced diabetes related inpatient admission; no: number of participants who did not experience diabetes related inpatient admission.
Time frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for diabetes related HCRU at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Diabetes Related HCRU: Number of Participants With Diabetes Related Inpatient Admission (Yes/No) From Baseline to Year 2 | Yes | 12 Participants |
| Semaglutide | Diabetes Related HCRU: Number of Participants With Diabetes Related Inpatient Admission (Yes/No) From Baseline to Year 2 | No | 89 Participants |
| Standard of Care | Diabetes Related HCRU: Number of Participants With Diabetes Related Inpatient Admission (Yes/No) From Baseline to Year 2 | Yes | 12 Participants |
| Standard of Care | Diabetes Related HCRU: Number of Participants With Diabetes Related Inpatient Admission (Yes/No) From Baseline to Year 2 | No | 90 Participants |
Secondary
Diabetes Related HCRU: Number of Participants With Diabetes Related Outpatient Encounter (Yes/No) From Baseline to Year 2
Diabeted related HCRU - number of participants with diabeted related outpatient encounter from baseline to year 2 is presented. Physician outpatient office visit is defined by a medical claim with outpatient place of service and an evaluation and management code. Yes: number of participants who experienced diabeted related outpatient encounter; no: number of participants who did not experience diabeted related outpatient encounter.
Time frame: From baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for diabetes related HCRU at dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Diabetes Related HCRU: Number of Participants With Diabetes Related Outpatient Encounter (Yes/No) From Baseline to Year 2 | Yes | 95 Participants |
| Semaglutide | Diabetes Related HCRU: Number of Participants With Diabetes Related Outpatient Encounter (Yes/No) From Baseline to Year 2 | No | 6 Participants |
| Standard of Care | Diabetes Related HCRU: Number of Participants With Diabetes Related Outpatient Encounter (Yes/No) From Baseline to Year 2 | Yes | 97 Participants |
| Standard of Care | Diabetes Related HCRU: Number of Participants With Diabetes Related Outpatient Encounter (Yes/No) From Baseline to Year 2 | No | 5 Participants |
Secondary
Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc), Total Treatment Satisfaction Score Measured at Year 1
DTSQc total treatment satisfaction score measured at year 1 is presented. The DTSQc provides a measure of how satisfied participants are with their current diabetes treatment compared with previous treatment. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction.
Time frame: At year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for DTSQ at the dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc), Total Treatment Satisfaction Score Measured at Year 1 | 13.5 Scores on a scale | Standard Deviation 5.28 |
| Standard of Care | Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc), Total Treatment Satisfaction Score Measured at Year 1 | 12.8 Scores on a scale | Standard Deviation 5.82 |
Secondary
DTSQc, Total Treatment Satisfaction Score Measured at Year 2
DTSQc total treatment satisfaction score measured at year 2 is presented. The DTSQc provides a measure of how satisfied participants are with their current diabetes treatment compared with previous treatment. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction.
Time frame: At year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure. Analysis is based only on participants with available data for DTSQ at the dedicated study visit including measurements irrespective of whether participants discontinued study drug or not.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | DTSQc, Total Treatment Satisfaction Score Measured at Year 2 | 13.2 Scores on a scale | Standard Deviation 6.24 |
| Standard of Care | DTSQc, Total Treatment Satisfaction Score Measured at Year 2 | 12.2 Scores on a scale | Standard Deviation 5.87 |
Secondary
Number of Hypoglycemic Episodes Leading to an Inpatient Admission or Emergency Room (ER) Encounter From Baseline to Year 2
Number of hypoglycemic episodes leading to an inpatient admission or emergency room (ER) encounter from baseline to year 2 is presented.
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0) to year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide | Number of Hypoglycemic Episodes Leading to an Inpatient Admission or Emergency Room (ER) Encounter From Baseline to Year 2 | 2 Episodes |
| Standard of Care | Number of Hypoglycemic Episodes Leading to an Inpatient Admission or Emergency Room (ER) Encounter From Baseline to Year 2 | 1 Episodes |
Secondary
Number of Participants Who Attained Individualized HbA1c Target at Year 1 (Yes/No)
Number of participants who attained individualized HbA1c target at year 1 is presented. Study physicians set and documented an individualized HbA1c target for participants prior to randomization based on their clinical judgement and knowledge of the participant. Yes: number of participants who achieved individualized HbA1c target attained at year 1; No: number of participants who did not achieve individualized HbA1c target attained at year 1
Time frame: At year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants Who Attained Individualized HbA1c Target at Year 1 (Yes/No) | Yes | 216 Participants |
| Semaglutide | Number of Participants Who Attained Individualized HbA1c Target at Year 1 (Yes/No) | No | 214 Participants |
| Standard of Care | Number of Participants Who Attained Individualized HbA1c Target at Year 1 (Yes/No) | Yes | 170 Participants |
| Standard of Care | Number of Participants Who Attained Individualized HbA1c Target at Year 1 (Yes/No) | No | 292 Participants |
Secondary
Number of Participants Who Attained Individualized HbA1c Target at Year 2 (Yes/No)
Number of participants who attained individualized HbA1c target at year 2 is presented. Study physicians set and documented an individualized HbA1c target for participants prior to randomization based on their clinical judgement and knowledge of the participant. Yes: number of participants who achieved individualized HbA1c target attained at year 2; No: number of participants who did not achieve individualized HbA1c target attained at year 2
Time frame: At year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants Who Attained Individualized HbA1c Target at Year 2 (Yes/No) | Yes | 182 Participants |
| Semaglutide | Number of Participants Who Attained Individualized HbA1c Target at Year 2 (Yes/No) | No | 192 Participants |
| Standard of Care | Number of Participants Who Attained Individualized HbA1c Target at Year 2 (Yes/No) | Yes | 129 Participants |
| Standard of Care | Number of Participants Who Attained Individualized HbA1c Target at Year 2 (Yes/No) | No | 245 Participants |
Secondary
Number of Participants With Absolute HbA1c Reduction of ≥ 0.5% Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and a Body Weight Loss of ≥ 5% Versus Baseline at Year 1 (Yes/No)
Number of participants who achieved absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 1 is presented. Yes: number of participants who achieved absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 1; No: number of participants who did not achieve absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 1.
Time frame: At year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With Absolute HbA1c Reduction of ≥ 0.5% Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and a Body Weight Loss of ≥ 5% Versus Baseline at Year 1 (Yes/No) | Yes | 162 Participants |
| Semaglutide | Number of Participants With Absolute HbA1c Reduction of ≥ 0.5% Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and a Body Weight Loss of ≥ 5% Versus Baseline at Year 1 (Yes/No) | No | 248 Participants |
| Standard of Care | Number of Participants With Absolute HbA1c Reduction of ≥ 0.5% Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and a Body Weight Loss of ≥ 5% Versus Baseline at Year 1 (Yes/No) | Yes | 79 Participants |
| Standard of Care | Number of Participants With Absolute HbA1c Reduction of ≥ 0.5% Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and a Body Weight Loss of ≥ 5% Versus Baseline at Year 1 (Yes/No) | No | 346 Participants |
Secondary
Number of Participants With Absolute HbA1c Reduction of ≥ 0.5% Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and a Body Weight Loss of ≥ 5% Versus Baseline at Year 2 (Yes/No)
Number of participants who achieved absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 2 is presented. Yes: number of participants who achieved absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 2; No: number of participants who did not achieve absolute HbA1c reduction of ≥ 0.5% without experiencing hypoglycemia leading to inpatient admission or ER encounter and a body weight loss of ≥ 5% versus baseline at year 2.
Time frame: At year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With Absolute HbA1c Reduction of ≥ 0.5% Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and a Body Weight Loss of ≥ 5% Versus Baseline at Year 2 (Yes/No) | Yes | 136 Participants |
| Semaglutide | Number of Participants With Absolute HbA1c Reduction of ≥ 0.5% Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and a Body Weight Loss of ≥ 5% Versus Baseline at Year 2 (Yes/No) | No | 213 Participants |
| Standard of Care | Number of Participants With Absolute HbA1c Reduction of ≥ 0.5% Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and a Body Weight Loss of ≥ 5% Versus Baseline at Year 2 (Yes/No) | Yes | 89 Participants |
| Standard of Care | Number of Participants With Absolute HbA1c Reduction of ≥ 0.5% Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and a Body Weight Loss of ≥ 5% Versus Baseline at Year 2 (Yes/No) | No | 262 Participants |
Secondary
Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0% (53 Millimoles Per Mole [mmol/Mol]) at Year 2 (Yes/No)
Number of participants who achieved HbA1c less than 7.0 % (53 mmol/mol) at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0 % at year 2; No: number of participants who did not achieve HbA1c less than 7.0 % at year 2.
Time frame: At year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0% (53 Millimoles Per Mole [mmol/Mol]) at Year 2 (Yes/No) | Yes | 209 Participants |
| Semaglutide | Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0% (53 Millimoles Per Mole [mmol/Mol]) at Year 2 (Yes/No) | No | 165 Participants |
| Standard of Care | Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0% (53 Millimoles Per Mole [mmol/Mol]) at Year 2 (Yes/No) | Yes | 162 Participants |
| Standard of Care | Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0% (53 Millimoles Per Mole [mmol/Mol]) at Year 2 (Yes/No) | No | 212 Participants |
Secondary
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 1 (Yes/No)
Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 1; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 1.
Time frame: At year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 1 (Yes/No) | Yes | 229 Participants |
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 1 (Yes/No) | No | 201 Participants |
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 1 (Yes/No) | Data missing | 0 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 1 (Yes/No) | Yes | 206 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 1 (Yes/No) | No | 254 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 1 (Yes/No) | Data missing | 2 Participants |
Secondary
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 2 (Yes/No)
Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 2; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) and no further antidiabetic medication intensification after randomization at year 2.
Time frame: At year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 2 (Yes/No) | No | 188 Participants |
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 2 (Yes/No) | Yes | 186 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 2 (Yes/No) | No | 238 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) and No Further Antidiabetic Medication Intensification After Randomization at Year 2 (Yes/No) | Yes | 135 Participants |
Secondary
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No)
Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) at year 1 in participants with HbA1c \>9.0% at baseline is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) at year 1 in participants with HbA1c \>9.0% at baseline; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) at year 1 in participants with HbA1c \>9.0% at baseline.
Time frame: At year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No) | Yes | 41 Participants |
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No) | No | 90 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No) | Yes | 42 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No) | No | 80 Participants |
Secondary
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No)
Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) at year 2 in participants with HbA1c \>9.0% at baseline is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) at year 2 in participants with HbA1c \>9.0% at baseline; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) at year 2 in participants with HbA1c \>9.0% at baseline.
Time frame: At year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No) | Yes | 41 Participants |
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No) | No | 73 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No) | Yes | 28 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No) | No | 70 Participants |
Secondary
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 1 (Yes/No)
Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) or at least 1% point improvement in HbA1c compared to baseline at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0% or at least 1% point improvement in HbA1c compared to baseline at year 1; No: number of participants who did not achieve HbA1c less than 7.0% or at least 1% point improvement in HbA1c compared to baseline at year 1
Time frame: At year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 1 (Yes/No) | Yes | 321 Participants |
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 1 (Yes/No) | No | 109 Participants |
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 1 (Yes/No) | Data missing | 0 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 1 (Yes/No) | Yes | 301 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 1 (Yes/No) | No | 160 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 1 (Yes/No) | Data missing | 1 Participants |
Secondary
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 2 (Yes/No)
Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) or at least 1% point improvement in HbA1c compared to baseline at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0% or at least 1% point improvement in HbA1c compared to baseline at year 2; No: number of participants who did not achieve HbA1c less than 7.0% or at least 1% point improvement in HbA1c compared to baseline at year 2.
Time frame: At year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 2 (Yes/No) | Yes | 274 Participants |
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 2 (Yes/No) | No | 100 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 2 (Yes/No) | Yes | 228 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) or At Least 1% Point Improvement in HbA1c Compared to Baseline at Year 2 (Yes/No) | No | 145 Participants |
Secondary
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and Body Weight Loss of ≥ 5% Versus Baseline at Year 1 (Yes/No)
Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 1; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 1
Time frame: At year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and Body Weight Loss of ≥ 5% Versus Baseline at Year 1 (Yes/No) | Yes | 128 Participants |
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and Body Weight Loss of ≥ 5% Versus Baseline at Year 1 (Yes/No) | No | 282 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and Body Weight Loss of ≥ 5% Versus Baseline at Year 1 (Yes/No) | Yes | 68 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and Body Weight Loss of ≥ 5% Versus Baseline at Year 1 (Yes/No) | No | 358 Participants |
Secondary
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and Body Weight Loss of ≥ 5% Versus Baseline at Year 2 (Yes/No)
Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 2; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and body weight loss of ≥ 5% versus baseline at year 2.
Time frame: At year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and Body Weight Loss of ≥ 5% Versus Baseline at Year 2 (Yes/No) | Yes | 108 Participants |
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and Body Weight Loss of ≥ 5% Versus Baseline at Year 2 (Yes/No) | No | 241 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and Body Weight Loss of ≥ 5% Versus Baseline at Year 2 (Yes/No) | Yes | 76 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and Body Weight Loss of ≥ 5% Versus Baseline at Year 2 (Yes/No) | No | 276 Participants |
Secondary
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and No Body Weight Gain Versus Baseline at Year 1 (Yes/No)
Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 1 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 1; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 1.
Time frame: At year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and No Body Weight Gain Versus Baseline at Year 1 (Yes/No) | Yes | 199 Participants |
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and No Body Weight Gain Versus Baseline at Year 1 (Yes/No) | No | 211 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and No Body Weight Gain Versus Baseline at Year 1 (Yes/No) | Yes | 159 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and No Body Weight Gain Versus Baseline at Year 1 (Yes/No) | No | 267 Participants |
Secondary
Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and No Body Weight Gain Versus Baseline at Year 2 (Yes/No)
Number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 2 is presented. Yes: number of participants who achieved HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 2; No: number of participants who did not achieve HbA1c less than 7.0% (53 mmol/mol) without experiencing hypoglycemia leading to inpatient admission or ER encounter and no body weight gain versus baseline at year 2.
Time frame: At year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and No Body Weight Gain Versus Baseline at Year 2 (Yes/No) | Yes | 159 Participants |
| Semaglutide | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and No Body Weight Gain Versus Baseline at Year 2 (Yes/No) | No | 190 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and No Body Weight Gain Versus Baseline at Year 2 (Yes/No) | Yes | 118 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 7.0% (53 mmol/Mol) Without Experiencing Hypoglycemia Leading to Inpatient Admission or ER Encounter and No Body Weight Gain Versus Baseline at Year 2 (Yes/No) | No | 234 Participants |
Secondary
Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No)
Number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 1 in participants with HbA1c \>9.0% at baseline is presented. Yes: number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 1 in participants with HbA1c \>9.0% at baseline; No: number of participants who did not achieve HbA1c less than 8.0% (64 mmol/mol) at year 1 in participants with HbA1c \>9.0% at baseline
Time frame: At year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No) | Yes | 77 Participants |
| Semaglutide | Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No) | No | 54 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No) | Yes | 67 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 in Participants With HbA1c >9.0% at Baseline (Yes/No) | No | 55 Participants |
Secondary
Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 (Yes/No)
Number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 1 is presented. Yes: number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 1; No: number of participants who did not achieve HbA1c less than 8.0% (64 mmol/mol) at year 1.
Time frame: At year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 (Yes/No) | Yes | 344 Participants |
| Semaglutide | Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 (Yes/No) | No | 86 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 (Yes/No) | Yes | 344 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 1 (Yes/No) | No | 118 Participants |
Secondary
Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No)
Number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 2 in participants with HbA1c \>9.0% at baseline is presented. Yes: number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 2 in participants with HbA1c \>9.0% at baseline; No: number of participants who did not achieve HbA1c less than 8.0% (64 mmol/mol) at year 2 in participants with HbA1c \>9.0% at baseline.
Time frame: At year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No) | Yes | 70 Participants |
| Semaglutide | Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No) | No | 44 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No) | Yes | 53 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 in Participants With HbA1c >9.0% at Baseline (Yes/No) | No | 45 Participants |
Secondary
Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 (Yes/No)
Number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 2 is presented. Yes: number of participants who achieved HbA1c less than 8.0% (64 mmol/mol) at year 2; No: number of participants who did not achieve HbA1c less than 8.0% (64 mmol/mol) at year 2.
Time frame: At year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 (Yes/No) | Yes | 293 Participants |
| Semaglutide | Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 (Yes/No) | No | 81 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 (Yes/No) | Yes | 271 Participants |
| Standard of Care | Number of Participants With HbA1c Less Than 8.0% (64 mmol/Mol) at Year 2 (Yes/No) | No | 103 Participants |
Secondary
Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 1 (Yes/No)
Number of participants who achieved HbA1c target attainment per HEDIS criteria (less than 8.0% if age ≥ 65 years or with defined comorbidities, otherwise less than 7.0%) at year 1 is presented. Yes: Number of participants who achieved HbA1c target attainment per HEDIS criteria at year 1; No: Number of participants who did not achieve HbA1c target attainment per HEDIS criteria at year 1
Time frame: At year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 1 (Yes/No) | Yes | 64 Participants |
| Semaglutide | Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 1 (Yes/No) | No | 31 Participants |
| Standard of Care | Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 1 (Yes/No) | Yes | 53 Participants |
| Standard of Care | Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 1 (Yes/No) | No | 45 Participants |
Secondary
Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 2 (Yes/No)
Number of participants who achieved HbA1c target attainment per HEDIS criteria (less than 8.0% if age ≥ 65 years or with defined comorbidities, otherwise less than 7.0%) at year 2 is presented. Yes: Number of participants who achieved HbA1c target attainment per HEDIS criteria at year 2; No: Number of participants who did not achieve HbA1c target attainment per HEDIS criteria at year 2.
Time frame: At year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 2 (Yes/No) | Yes | 43 Participants |
| Semaglutide | Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 2 (Yes/No) | No | 20 Participants |
| Standard of Care | Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 2 (Yes/No) | Yes | 29 Participants |
| Standard of Care | Number of Participants With HbA1c Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria at Year 2 (Yes/No) | No | 23 Participants |
Secondary
Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 1 (Yes/No)
Number of participants who reported hypoglycemia leading to inpatient admission or ER encounter during year 1 is presented. Yes: number of participants who reported hypoglycemia leading to inpatient admission or ER encounter during year 1; No: number of participants who did not report hypoglycemia leading to inpatient admission or ER encounter during year 1.
Time frame: Week 0 to year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 1 (Yes/No) | Yes | 0 Participants |
| Semaglutide | Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 1 (Yes/No) | No | 644 Participants |
| Standard of Care | Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 1 (Yes/No) | Yes | 0 Participants |
| Standard of Care | Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 1 (Yes/No) | No | 634 Participants |
Secondary
Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 2 (Yes/No)
Number of participants who reported hypoglycemia leading to inpatient admission or ER encounter during year 2 is presented. Yes: number of participants who reported hypoglycemia leading to inpatient admission or ER encounter during year 2; No: number of participants who did not report hypoglycemia leading to inpatient admission or ER encounter during year 2.
Time frame: Week 0 to year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 2 (Yes/No) | Yes | 1 Participants |
| Semaglutide | Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 2 (Yes/No) | No | 643 Participants |
| Standard of Care | Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 2 (Yes/No) | Yes | 1 Participants |
| Standard of Care | Number of Participants With Reported Hypoglycemia Leading to Inpatient Admission or ER Encounter During Year 2 (Yes/No) | No | 633 Participants |
Secondary
Percentage Change in Body Weight From Baseline to Year 1
Percentage change in body weight from baseline to year 1 is presented.
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Percentage Change in Body Weight From Baseline to Year 1 | -3.93 Percentage change in body weight | Standard Deviation 11.092 |
| Standard of Care | Percentage Change in Body Weight From Baseline to Year 1 | -2.02 Percentage change in body weight | Standard Deviation 8.924 |
Secondary
Percentage Change in Body Weight From Baseline to Year 2
Percentage change in body weight from baseline to year 2 is presented.
Time frame: Baseline (less than or equal to 4 weeks prior to the randomization at week 0), year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Percentage Change in Body Weight From Baseline to Year 2 | -4.47 Percentage change in body weight | Standard Deviation 12.204 |
| Standard of Care | Percentage Change in Body Weight From Baseline to Year 2 | -2.68 Percentage change in body weight | Standard Deviation 7.988 |
Secondary
Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence for the First Year of the Study
Percentage of MPR for study drug medication adherence for the first year of the study is presented. Medication adherence referred to a participant's conformance to the provider's recommendation with respect to timing, dosage, and frequency of medication taken during the prescribed length of time. The MPR was used to assess adherence. MPR was calculated as follows: MPR (%) = Sum of days supply for all prescription fills\*100/Total number of days in time period. MPR was capped at 100%. MPR was calculated from pharmacy claims data and irrespective of adherence to randomized treatment or changes to antidiabetic treatment.
Time frame: Week 0 to year 1
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence for the First Year of the Study | 53.1 Percentage of MPR | Standard Deviation 40.9 |
| Standard of Care | Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence for the First Year of the Study | 55.8 Percentage of MPR | Standard Deviation 41.2 |
Secondary
Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence For The Two Years of The Study
Percentage of MPR for study drug medication adherence for the two years of the study is presented. Medication adherence referred to a participant's conformance to the provider's recommendation with respect to timing, dosage, and frequency of medication taken during the prescribed length of time. The MPR was used to assess adherence. MPR was calculated as follows: MPR (%) = Sum of days supply for all prescription fills\*100/Total number of days in time period. MPR was capped at 100%. MPR was calculated from pharmacy claims data and irrespective of adherence to randomized treatment or changes to antidiabetic treatment.
Time frame: Week 0 to year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence For The Two Years of The Study | 57.9 Percentage of MPR | Standard Deviation 40.5 |
| Standard of Care | Percentage of Medication Possession Ratio (MPR) for Study Drug Medication Adherence For The Two Years of The Study | 55.7 Percentage of MPR | Standard Deviation 38.3 |
Secondary
Time to First Study Drug Discontinuation During 2 Years
Time to first study drug discontinuation during 2 years is presented. First study drug discontinuation=date of the first time a patient is not taking study drug as defined.
Time frame: Week 0 to year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Time to First Study Drug Discontinuation During 2 Years | 1.36 Years | Standard Deviation 0.853 |
| Standard of Care | Time to First Study Drug Discontinuation During 2 Years | 1.54 Years | Standard Deviation 0.719 |
Secondary
Time to First Treatment Intensification (Add-on) or Change (Switch) After Randomization During 2 Years
Time to first treatment intensification (add-on) or change (switch) after randomization during 2 years is presented.
Time frame: Week 0 to year 2
Population: FAS included all randomized participants analyzed according to the treatment group to which they were assigned at randomization. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Time to First Treatment Intensification (Add-on) or Change (Switch) After Randomization During 2 Years | 1.55 Years | Standard Deviation 0.731 |
| Standard of Care | Time to First Treatment Intensification (Add-on) or Change (Switch) After Randomization During 2 Years | 1.43 Years | Standard Deviation 0.742 |