Obesity, Overweight
Conditions
Brief summary
The researchers are doing the study to see if semaglutide may reduce the risk of having cardiovascular events in patients with overweight or obesity and with prior cardiovascular disease. The participant will either get semaglutide (active medicine) or placebo (dummy medicine). Which treatment the participants get is decided by chance. The participant's chance of getting semaglutide or placebo is the same. The participant will get the study medicine in a pen. The participants will need to use the pen to inject the study medicine in a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have up to 25 clinic visits with the study doctor.
Interventions
DRUGSemaglutide
Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Subjects will start semaglutide treatment at 0.24 mg; dose will gradually be increased every 4 weeks up to 2.4 mg.
DRUGPlacebo (semaglutide)
Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Participants will receive placebo at an equivalent dose to semaglutide.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Male or female, age greater than or equal to 45 years at the time of signing informed consent * Body mass index (BMI) greater than or equal to 27 kg/m\^2 * Have established cardiovascular (CV) disease as evidenced by at least one of the following: prior myocardial infarction; prior stroke (ischemic or haemorrhagic stroke); or symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) less than 0.85 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease
Exclusion criteria
Cardiovascular-related: * Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening * Planned coronary, carotid or peripheral artery revascularisation known on the day of screening * Presently classified as being in New York Heart Association (NYHA) Class IV heart failure Glycaemia-related: * HbA1c greater than or equal to 48 mmol/mol (6.5 %) as measured by the central laboratory at screening * History of type 1 or type 2 diabetes (history of gestational diabetes is allowed) * Treatment with glucose-lowering agents within 90 days before screening * Treatment with any glucagon-like-peptide-1 receptor agonist (GLP-1 RA) within 90 days before screening General safety: * History or presence of chronic pancreatitis * Presence of acute pancreatitis within the past 180 days prior to the day of screening * Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma * End stage renal disease or chronic or intermittent haemodialysis or peritoneal dialysis * Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed * Severe psychiatric disorder which in the investigator's opinion could compromise compliance with the protocol * Known or suspected hypersensitivity to trial products or related products * Previous participation in this trial. Participation is defined as randomisation * Receipt of any investigational medicinal product within 30 days before screening * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method * Any disorder, unwillingness or inability, which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke | From randomisation (week 0) up to 240 weeks | Number of participants with first occurrence of composite outcome measure consisted of CV death (undetermined cause of death presumed CV death), non-fatal MI, or non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants From Time of Randomisation to First Occurrence of a Composite Heart Failure (HF) Outcome Measure Consisting of: HF Hospitalisation, Urgent HF Visit or CV Death | From randomisation (week 0) up to 240 weeks | Number of participants with first occurrence of a composite HF outcome measure consisted of HF hospitalisation, urgent HF visit or CV death are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Participants From Time of Randomisation to All-cause Death | From randomisation (week 0) up to 240 weeks | Number of participants with all-cause death are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Participants From Time of Randomisation to First Occurrence of an Expanded Composite CV Outcome Measure Consisting of: CV Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularisation or Unstable Angina Pectoris (UAP) Requiring Hospitalisation | From randomisation (week 0) up to 240 weeks | Number of participants with first occurrence of an expanded composite CV outcome measure consisted of CV death, non-fatal MI, non-fatal stroke, coronary revascularisation or UAP requiring hospitalisation are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Participants From Time of Randomisation to First Occurrence of a Composite Outcome Measure Consisting of: All-cause Death, Non-fatal MI, or Non-fatal Stroke | From randomisation (week 0) up to 240 weeks | Number of participants with first occurrence of a composite outcome measure consisted of all-cause death, non-fatal MI, or non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Participants From Time of Randomisation to First Occurrence of Non-fatal MI | From randomisation (week 0) up to 240 weeks | Number of participants with first occurrence of non-fatal MI are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Participants From Time of Randomisation to First Occurrence of Non-fatal Stroke | From randomisation (week 0) up to 240 weeks | Number of participants with first occurrence of non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Participants From Time of Randomisation to First Occurrence of Coronary Revascularisation | From randomisation (week 0) up to 240 weeks | Number of participants with first occurrence of coronary revascularisation are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Participants From Time of Randomisation to First Occurrence of UAP Requiring Hospitalisation | From randomisation (week 0) up to 240 weeks | Number of participants with first occurrence of UAP requiring hospitalisation are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Participants From Time of Randomisation to First Occurrence of HF Requiring Hospitalisation or Urgent HF Visit | From randomisation (week 0) up to 240 weeks | Number of participants with first occurrence of HF requiring hospitalisation or urgent HF visit are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Participants From Time of Randomisation to First Occurrence of Glycosylated Haemoglobin (HbA1c) Greater Than Equals to (≥) 48 Millimole Per Mole (mmol/Mol) (6.5 Percentage [%]) | From randomisation (week 0) up to 240 weeks | Number of participants with first occurrence of HbA1c ≥ 48 mmol/mol (6.5%) are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Participants From Time of Randomisation to First Occurrence of a 5-component Composite Nephropathy Outcome Measure | From randomisation (week 0) up to 240 weeks | Number of participants with first occurrence of a 5-component composite nephropathy outcome measure consisted of onset of persistent macroalbuminuria (UACR \> 300 milligram per gram \[mg/g\]), persistent 50% reduction in estimated glomerular filtration rate (eGFR) compared with baseline (randomisation), onset of persistent eGFR \< 15 ml/min/1.73m\^2, initiation of chronic renal replacement therapy (dialysis or transplantation) or renal death. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Participants From Time of Randomisation to HbA1c ≥ 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c <39 mmol/Mol [5.7%]) | From randomisation (week 0) up to 240 weeks | Number of participants with HbA1c ≥ 39 mmol/mol (5.7%) are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Participants With HbA1c < 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c ≥ 39 mmol/Mol [5.7%]) | At week 52, week 104 | Number of participants with HbA1c \< 39 mmol/mol (5.7%) are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Participants From Time of Randomisation to CV Death | From randomisation (week 0) up to 240 weeks | Number of participants with CV death are presented. The outcome measure was evalulated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Change in Diastolic Blood Pressure (DBP) | Week 0, week 104 | Change in DBP from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Change in Pulse | Week 0, week 104 | Change in pulse from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline | Week 0, week 104 | Change in hsCRP (milligram per liter \[mg/L\]) from randomisation (week 0) to week 104 presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Change in Total Cholesterol - Ratio to Baseline | Week 0, week 104 | Change in total cholesterol (milligram per deciliter \[mg/dL\]) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline | Week 0, week 104 | Change in HDL (mg/dL) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline | Week 0, week 104 | Change in LDL (mg/dL) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Change in Triglycerides - Ratio to Baseline | Week 0, week 104 | Change in triglycerides (mg/dL) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Change in Body Weight | Week 0, week 104 | Percentage change in body weight from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Change in Waist Circumference | Week 0, week 104 | Change is waist circumference from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Change From Randomisation (Week 0) in Participant Reported Outcome (PRO): EuroQol Five Dimensions Five Level Questionnaire (EQ-5D-5L) Index Score to Week 104 | Week 0, week 104 | EQ-5D-5L is a PRO tool used to estimate impact on participant's health-related quality of life and provides a description of their problems by dimensions (descriptive system). EQ-5D has 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression, and each dimension has 5 levels: not at all, mild, moderate, severe, extreme. Participant marks most appropriate statement in each dimension, resulting in 1-digit number and digits from 5 dimensions can be combined in 5-digit number describing participant's health state. Index score records an average health status according to dimensions using an algorithm, ranges 0-1 with higher score indicates better health status. Outcome measure was evaluated based on data from in-trial observation period (defined as date of randomisation to one of the dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant \[who were lost to follow-up\], date of death). |
| Change From Randomisation (Week 0) in PRO: EuroQol Five Dimensions Visual Analogue Scale (EQ-5D-VAS) to Week 104 | Week 0, week 104 | EQ-5D-5L is a PRO tool used to estimate impact on participant's health-related quality of life and provides a description of their problems by dimensions (descriptive system). EQ-5D has 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression, and each dimension has 5 levels: not at all, mild, moderate, severe, extreme. Participant marks most appropriate statement in each dimension, resulting in 1-digit number and digits from 5 dimensions can be combined in 5-digit number describing participant's health state. VAS component records a participant's overall self-rated health on a range of 0-100 with higher score indicates better self-reported health status. Outcome measure was evaluated based on data from in-trial observation period (defined as date of randomisation to one of the dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant \[who were lost to follow-up\], date of death). |
| Change in HbA1c - Percentage | Week 0, week 104 | Change in HbA1c (percentage) from randomisation (week 0) to week 104 is presented. The outcome measure was evaulated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Change in HbA1c - mmol/Mol | Week 0, week 104 | Change in HbA1c (mmol/mol) from randomisation (week 0) to week 104 is presented. The outcome measure was evaulated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
| Change in Systolic Blood Pressure (SBP) | Week 0, week 104 | Change in SBP from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death. |
Countries
Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Recruitment details
The participants were screened at 811 sites in 41 countries. Out of 811 sites, participants were randomised at 804 sites.
Pre-assignment details
Participants were randomized in a 1:1 ratio to receive treatment with either semaglutide or placebo as an adjunct to standard-of-care.
Participants by arm
| Arm | Count |
|---|---|
| Semaglutide Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period. | 8,803 |
| Placebo Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period. | 8,801 |
| Total | 17,604 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 192 | 188 |
| Overall Study | Withdrawal by Subject | 67 | 96 |
Baseline characteristics
| Characteristic | Semaglutide | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 61.6 Years STANDARD_DEVIATION 8.9 | 61.6 Years STANDARD_DEVIATION 8.8 | 61.6 Years STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 914 Participants | 908 Participants | 1822 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7794 Participants | 7817 Participants | 15611 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 95 Participants | 76 Participants | 171 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 23 Participants | 21 Participants | 44 Participants |
| Race/Ethnicity, Customized Asian | 720 Participants | 727 Participants | 1447 Participants |
| Race/Ethnicity, Customized Black or African American | 348 Participants | 323 Participants | 671 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 3 Participants | 5 Participants | 8 Participants |
| Race/Ethnicity, Customized Not Reported | 95 Participants | 74 Participants | 169 Participants |
| Race/Ethnicity, Customized Other | 227 Participants | 247 Participants | 474 Participants |
| Race/Ethnicity, Customized White | 7387 Participants | 7404 Participants | 14791 Participants |
| Sex: Female, Male Female | 2448 Participants | 2424 Participants | 4872 Participants |
| Sex: Female, Male Male | 6355 Participants | 6377 Participants | 12732 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 371 / 8,803 | 460 / 8,801 |
| other Total, other adverse events | 3,944 / 8,803 | 2,440 / 8,801 |
| serious Total, serious adverse events | 2,941 / 8,803 | 3,204 / 8,801 |
Outcome results
Primary
Participants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke
Number of participants with first occurrence of composite outcome measure consisted of CV death (undetermined cause of death presumed CV death), non-fatal MI, or non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: From randomisation (week 0) up to 240 weeks
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Semaglutide | Participants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke | 569 Participants |
| Placebo | Participants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke | 701 Participants |
Comparison: Data from the in-trial period. The outcome measure was analysed using a Cox proportional hazards model with treatment as categorical fixed factor. Participants without events of interest were censored at the end of their in-trial period.p-value: <0.000195% CI: [0.72, 0.89]Regression, Cox
Secondary
Change From Randomisation (Week 0) in Participant Reported Outcome (PRO): EuroQol Five Dimensions Five Level Questionnaire (EQ-5D-5L) Index Score to Week 104
EQ-5D-5L is a PRO tool used to estimate impact on participant's health-related quality of life and provides a description of their problems by dimensions (descriptive system). EQ-5D has 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression, and each dimension has 5 levels: not at all, mild, moderate, severe, extreme. Participant marks most appropriate statement in each dimension, resulting in 1-digit number and digits from 5 dimensions can be combined in 5-digit number describing participant's health state. Index score records an average health status according to dimensions using an algorithm, ranges 0-1 with higher score indicates better health status. Outcome measure was evaluated based on data from in-trial observation period (defined as date of randomisation to one of the dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant \[who were lost to follow-up\], date of death).
Time frame: Week 0, week 104
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Randomisation (Week 0) in Participant Reported Outcome (PRO): EuroQol Five Dimensions Five Level Questionnaire (EQ-5D-5L) Index Score to Week 104 | 0.01 score on a scale | Standard Deviation 0.14 |
| Placebo | Change From Randomisation (Week 0) in Participant Reported Outcome (PRO): EuroQol Five Dimensions Five Level Questionnaire (EQ-5D-5L) Index Score to Week 104 | -0.01 score on a scale | Standard Deviation 0.14 |
Secondary
Change From Randomisation (Week 0) in PRO: EuroQol Five Dimensions Visual Analogue Scale (EQ-5D-VAS) to Week 104
EQ-5D-5L is a PRO tool used to estimate impact on participant's health-related quality of life and provides a description of their problems by dimensions (descriptive system). EQ-5D has 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression, and each dimension has 5 levels: not at all, mild, moderate, severe, extreme. Participant marks most appropriate statement in each dimension, resulting in 1-digit number and digits from 5 dimensions can be combined in 5-digit number describing participant's health state. VAS component records a participant's overall self-rated health on a range of 0-100 with higher score indicates better self-reported health status. Outcome measure was evaluated based on data from in-trial observation period (defined as date of randomisation to one of the dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant \[who were lost to follow-up\], date of death).
Time frame: Week 0, week 104
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Randomisation (Week 0) in PRO: EuroQol Five Dimensions Visual Analogue Scale (EQ-5D-VAS) to Week 104 | 2.38 score on a scale | Standard Deviation 15.38 |
| Placebo | Change From Randomisation (Week 0) in PRO: EuroQol Five Dimensions Visual Analogue Scale (EQ-5D-VAS) to Week 104 | 0.77 score on a scale | Standard Deviation 15.79 |
Secondary
Change in Body Weight
Percentage change in body weight from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: Week 0, week 104
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Body Weight | -9.39 percentage change in body weight | Standard Deviation 8.62 |
| Placebo | Change in Body Weight | -0.87 percentage change in body weight | Standard Deviation 6.08 |
Secondary
Change in Diastolic Blood Pressure (DBP)
Change in DBP from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: Week 0, week 104
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Diastolic Blood Pressure (DBP) | -1.1 mmHg | Standard Deviation 10.4 |
| Placebo | Change in Diastolic Blood Pressure (DBP) | -0.4 mmHg | Standard Deviation 10.4 |
Secondary
Change in HbA1c - mmol/Mol
Change in HbA1c (mmol/mol) from randomisation (week 0) to week 104 is presented. The outcome measure was evaulated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: Week 0, week 104
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in HbA1c - mmol/Mol | -3.38 mmol/mol | Standard Deviation 4.06 |
| Placebo | Change in HbA1c - mmol/Mol | 0.10 mmol/mol | Standard Deviation 3.94 |
Secondary
Change in HbA1c - Percentage
Change in HbA1c (percentage) from randomisation (week 0) to week 104 is presented. The outcome measure was evaulated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: Week 0, week 104
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in HbA1c - Percentage | -0.31 Percentage of HbA1c | Standard Deviation 0.37 |
| Placebo | Change in HbA1c - Percentage | 0.01 Percentage of HbA1c | Standard Deviation 0.36 |
Secondary
Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline
Change in HDL (mg/dL) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: Week 0, week 104
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline | 1.05 ratio of HDL | Geometric Coefficient of Variation 17.39 |
| Placebo | Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline | 1.01 ratio of HDL | Geometric Coefficient of Variation 16.69 |
Secondary
Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
Change in hsCRP (milligram per liter \[mg/L\]) from randomisation (week 0) to week 104 presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: Week 0, week 104
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline | 0.61 ratio of hsCRP | Geometric Coefficient of Variation 149.53 |
| Placebo | Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline | 1.00 ratio of hsCRP | Geometric Coefficient of Variation 133.25 |
Secondary
Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline
Change in LDL (mg/dL) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: Week 0, week 104
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline | 0.95 ratio of LDL | Geometric Coefficient of Variation 37.43 |
| Placebo | Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline | 0.97 ratio of LDL | Geometric Coefficient of Variation 37.83 |
Secondary
Change in Pulse
Change in pulse from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: Week 0, week 104
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Pulse | 3.8 beats per mintue (bpm) | Standard Deviation 11 |
| Placebo | Change in Pulse | 0.9 beats per mintue (bpm) | Standard Deviation 10.7 |
Secondary
Change in Systolic Blood Pressure (SBP)
Change in SBP from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: Week 0, week 104
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Systolic Blood Pressure (SBP) | -3.8 Millimetre of mercury (mmHg) | Standard Deviation 16.4 |
| Placebo | Change in Systolic Blood Pressure (SBP) | -0.6 Millimetre of mercury (mmHg) | Standard Deviation 16 |
Secondary
Change in Total Cholesterol - Ratio to Baseline
Change in total cholesterol (milligram per deciliter \[mg/dL\]) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: Week 0, week 104
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Total Cholesterol - Ratio to Baseline | 0.95 ratio of total cholesterol | Geometric Coefficient of Variation 21.54 |
| Placebo | Change in Total Cholesterol - Ratio to Baseline | 0.98 ratio of total cholesterol | Geometric Coefficient of Variation 21.24 |
Secondary
Change in Triglycerides - Ratio to Baseline
Change in triglycerides (mg/dL) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: Week 0, week 104
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Triglycerides - Ratio to Baseline | 0.82 ratio of triglycerides | Geometric Coefficient of Variation 46.33 |
| Placebo | Change in Triglycerides - Ratio to Baseline | 0.97 ratio of triglycerides | Geometric Coefficient of Variation 44.31 |
Secondary
Change in Waist Circumference
Change is waist circumference from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: Week 0, week 104
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change in Waist Circumference | -7.5 centimeter (cm) | Standard Deviation 9.4 |
| Placebo | Change in Waist Circumference | -1.0 centimeter (cm) | Standard Deviation 7.3 |
Secondary
Participants From Time of Randomisation to All-cause Death
Number of participants with all-cause death are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: From randomisation (week 0) up to 240 weeks
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Semaglutide | Participants From Time of Randomisation to All-cause Death | 375 Participants |
| Placebo | Participants From Time of Randomisation to All-cause Death | 458 Participants |
Secondary
Participants From Time of Randomisation to CV Death
Number of participants with CV death are presented. The outcome measure was evalulated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: From randomisation (week 0) up to 240 weeks
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Semaglutide | Participants From Time of Randomisation to CV Death | 223 Participants |
| Placebo | Participants From Time of Randomisation to CV Death | 262 Participants |
Secondary
Participants From Time of Randomisation to First Occurrence of a 5-component Composite Nephropathy Outcome Measure
Number of participants with first occurrence of a 5-component composite nephropathy outcome measure consisted of onset of persistent macroalbuminuria (UACR \> 300 milligram per gram \[mg/g\]), persistent 50% reduction in estimated glomerular filtration rate (eGFR) compared with baseline (randomisation), onset of persistent eGFR \< 15 ml/min/1.73m\^2, initiation of chronic renal replacement therapy (dialysis or transplantation) or renal death. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: From randomisation (week 0) up to 240 weeks
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Semaglutide | Participants From Time of Randomisation to First Occurrence of a 5-component Composite Nephropathy Outcome Measure | 155 Participants |
| Placebo | Participants From Time of Randomisation to First Occurrence of a 5-component Composite Nephropathy Outcome Measure | 198 Participants |
Secondary
Participants From Time of Randomisation to First Occurrence of a Composite Heart Failure (HF) Outcome Measure Consisting of: HF Hospitalisation, Urgent HF Visit or CV Death
Number of participants with first occurrence of a composite HF outcome measure consisted of HF hospitalisation, urgent HF visit or CV death are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: From randomisation (week 0) up to 240 weeks
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Semaglutide | Participants From Time of Randomisation to First Occurrence of a Composite Heart Failure (HF) Outcome Measure Consisting of: HF Hospitalisation, Urgent HF Visit or CV Death | 300 Participants |
| Placebo | Participants From Time of Randomisation to First Occurrence of a Composite Heart Failure (HF) Outcome Measure Consisting of: HF Hospitalisation, Urgent HF Visit or CV Death | 361 Participants |
Secondary
Participants From Time of Randomisation to First Occurrence of a Composite Outcome Measure Consisting of: All-cause Death, Non-fatal MI, or Non-fatal Stroke
Number of participants with first occurrence of a composite outcome measure consisted of all-cause death, non-fatal MI, or non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: From randomisation (week 0) up to 240 weeks
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Semaglutide | Participants From Time of Randomisation to First Occurrence of a Composite Outcome Measure Consisting of: All-cause Death, Non-fatal MI, or Non-fatal Stroke | 710 Participants |
| Placebo | Participants From Time of Randomisation to First Occurrence of a Composite Outcome Measure Consisting of: All-cause Death, Non-fatal MI, or Non-fatal Stroke | 877 Participants |
Secondary
Participants From Time of Randomisation to First Occurrence of an Expanded Composite CV Outcome Measure Consisting of: CV Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularisation or Unstable Angina Pectoris (UAP) Requiring Hospitalisation
Number of participants with first occurrence of an expanded composite CV outcome measure consisted of CV death, non-fatal MI, non-fatal stroke, coronary revascularisation or UAP requiring hospitalisation are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: From randomisation (week 0) up to 240 weeks
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Semaglutide | Participants From Time of Randomisation to First Occurrence of an Expanded Composite CV Outcome Measure Consisting of: CV Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularisation or Unstable Angina Pectoris (UAP) Requiring Hospitalisation | 873 Participants |
| Placebo | Participants From Time of Randomisation to First Occurrence of an Expanded Composite CV Outcome Measure Consisting of: CV Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularisation or Unstable Angina Pectoris (UAP) Requiring Hospitalisation | 1074 Participants |
Secondary
Participants From Time of Randomisation to First Occurrence of Coronary Revascularisation
Number of participants with first occurrence of coronary revascularisation are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: From randomisation (week 0) up to 240 weeks
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Semaglutide | Participants From Time of Randomisation to First Occurrence of Coronary Revascularisation | 473 Participants |
| Placebo | Participants From Time of Randomisation to First Occurrence of Coronary Revascularisation | 608 Participants |
Secondary
Participants From Time of Randomisation to First Occurrence of Glycosylated Haemoglobin (HbA1c) Greater Than Equals to (≥) 48 Millimole Per Mole (mmol/Mol) (6.5 Percentage [%])
Number of participants with first occurrence of HbA1c ≥ 48 mmol/mol (6.5%) are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: From randomisation (week 0) up to 240 weeks
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants with HbA1c less than (\<) 48 mmol/mol (6.5%) at screening. Participants with ≥ 48 mmol/mol (6.5%) at screening were excluded from this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Semaglutide | Participants From Time of Randomisation to First Occurrence of Glycosylated Haemoglobin (HbA1c) Greater Than Equals to (≥) 48 Millimole Per Mole (mmol/Mol) (6.5 Percentage [%]) | 306 Participants |
| Placebo | Participants From Time of Randomisation to First Occurrence of Glycosylated Haemoglobin (HbA1c) Greater Than Equals to (≥) 48 Millimole Per Mole (mmol/Mol) (6.5 Percentage [%]) | 1059 Participants |
Secondary
Participants From Time of Randomisation to First Occurrence of HF Requiring Hospitalisation or Urgent HF Visit
Number of participants with first occurrence of HF requiring hospitalisation or urgent HF visit are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: From randomisation (week 0) up to 240 weeks
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Semaglutide | Participants From Time of Randomisation to First Occurrence of HF Requiring Hospitalisation or Urgent HF Visit | 97 Participants |
| Placebo | Participants From Time of Randomisation to First Occurrence of HF Requiring Hospitalisation or Urgent HF Visit | 122 Participants |
Secondary
Participants From Time of Randomisation to First Occurrence of Non-fatal MI
Number of participants with first occurrence of non-fatal MI are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: From randomisation (week 0) up to 240 weeks
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Semaglutide | Participants From Time of Randomisation to First Occurrence of Non-fatal MI | 234 Participants |
| Placebo | Participants From Time of Randomisation to First Occurrence of Non-fatal MI | 322 Participants |
Secondary
Participants From Time of Randomisation to First Occurrence of Non-fatal Stroke
Number of participants with first occurrence of non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: From randomisation (week 0) up to 240 weeks
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Semaglutide | Participants From Time of Randomisation to First Occurrence of Non-fatal Stroke | 154 Participants |
| Placebo | Participants From Time of Randomisation to First Occurrence of Non-fatal Stroke | 165 Participants |
Secondary
Participants From Time of Randomisation to First Occurrence of UAP Requiring Hospitalisation
Number of participants with first occurrence of UAP requiring hospitalisation are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: From randomisation (week 0) up to 240 weeks
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Semaglutide | Participants From Time of Randomisation to First Occurrence of UAP Requiring Hospitalisation | 109 Participants |
| Placebo | Participants From Time of Randomisation to First Occurrence of UAP Requiring Hospitalisation | 124 Participants |
Secondary
Participants From Time of Randomisation to HbA1c ≥ 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c <39 mmol/Mol [5.7%])
Number of participants with HbA1c ≥ 39 mmol/mol (5.7%) are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: From randomisation (week 0) up to 240 weeks
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants with HbA1c \<39 mmol/mol (5.7%) at screening.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Semaglutide | Participants From Time of Randomisation to HbA1c ≥ 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c <39 mmol/Mol [5.7%]) | 623 Participants |
| Placebo | Participants From Time of Randomisation to HbA1c ≥ 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c <39 mmol/Mol [5.7%]) | 1501 Participants |
Secondary
Participants With HbA1c < 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c ≥ 39 mmol/Mol [5.7%])
Number of participants with HbA1c \< 39 mmol/mol (5.7%) are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Time frame: At week 52, week 104
Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants with HbA1c ≥ 39 mmol/mol (5.7%) at screening. And, number analyzed = number of participants who contributed to the analysis at that particular timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide | Participants With HbA1c < 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c ≥ 39 mmol/Mol [5.7%]) | Week 52 | 3363 Participants |
| Semaglutide | Participants With HbA1c < 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c ≥ 39 mmol/Mol [5.7%]) | Week 104 | 3271 Participants |
| Placebo | Participants With HbA1c < 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c ≥ 39 mmol/Mol [5.7%]) | Week 52 | 955 Participants |
| Placebo | Participants With HbA1c < 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c ≥ 39 mmol/Mol [5.7%]) | Week 104 | 978 Participants |