Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of oral semaglutide versus placebo in subjects with Type 2 Diabetes Mellitus treated with insulin. All subjects should continue their pre-trial insulin therapy (basal, basal-bolus or premixed regimen including combinations of soluble insulins) throughout the trial. Subjects treated with metformin in addition to insulin treatment must continue their metformin treatment throughout the entire trial.
Interventions
DRUGsemaglutide
Oral semaglutide administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment
DRUGplacebo
Oral semaglutide placebo administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 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 above or equal to 18 years at the time of signing informed consent. For Japan only: Male or female, age above or equal to 20 years at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus 90 days or more prior to the day of screening. - HbA1c (glycosylated haemoglobin) of 7.0-9.5% (53-80 mmol/mol) (both inclusive). - Stable treatment with one of the following insulin regimens (minimum 10 IU/day) 90 or more days prior to the day of screening. Maximum 20% change in total daily dose is acceptable: (1) Basal insulin alone or (2) Basal and bolus insulin in any combination or (3) Premixed insulin including combinations of soluble insulins
Exclusion criteria
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice). For Greece only: adequate contraceptive measures are defined as combined hormonal contraception (containing oestrogen and progesterone), which suppress ovulation (oral, intravaginal, percutaneous), progesterone-only hormonal contraception which suppress ovulation (oral, injectable, implantable), intrauterine device, hormone-releasing intrauterine system, bilateral tubal occlusion, partner with vasectomy, sexual abstinence. For Japan only: Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives. For Canada only: adequate contraceptive measures are defined as combined hormonal contraception (containing oestrogen and progesterone), which suppress ovulation (oral, intravaginal, percutaneous), progesterone-only hormonal contraception which suppress ovulation (oral, injectable, implantable), intrauterine device, hormone-releasing intrauterine system, bilateral tubal occlusion, partner with vasectomy, sexual abstinence - Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol. - Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC). - History of pancreatitis (acute or chronic). - History of major surgical procedures involving the stomach and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). - Any of the following: myocardial infarction (MI), stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation. - Classified as being in New York Heart Association (NYHA) Class IV. - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening. - Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) less than 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI). - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term change of insulin treatment for acute illness for a total of 14 days or less. - Known hypoglycaemic unawareness according to Clarke's questionnaire. - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation. - History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ). - Subjects with alanine aminotransferase (ALT) more than 2.5 x upper normal limit (UNL).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c (Week 26) | Week 0, week 26 | Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period started at the date of the first dose of trial product and includes the period after initiation of rescue medication, if any, and excludes the period after premature trial discontinuation, if any. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c (Week 52) | Week 0, week 52 | Change from baseline (week 0) in HbA1c to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. |
| Change in Body Weight (kg) (Week 52) | Week 0, week 52 | Change from baseline (week 0) in body weight to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. |
| Change in Fasting Plasma Glucose (FPG) | Week 0, week 26, week 52 | Change from baseline (week 0) in FPG to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. |
| Change in Self-measured Plasma Glucose (SMPG) Mean 7-point Profile | Week 0, week 26, week 52 | Change from baseline (week 0) in self-measured plasma glucose (SMPG) mean 7-point profile to week 26 and week 52. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. |
| Change in SMPG Mean Postprandial Increment Over All Meals | Week 0, week 26, week 52 | Change from baseline (week 0) in SMPG mean postprandial increment over all meals to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. |
| Change in Body Weight (Percentage) | Week 0, week 26, week 52 | Relative change from baseline (week 0) in body weight (%) was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. |
| Change in Body Mass Index | Week 0, week 26, week 52 | Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26 and 52. BMI was calculated based on body weight and height based on the formula: BMI kg/m\^2 = body weight (kg)/(Height (m) x Height (m)). Data based on in-trial observation period is presented. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. |
| Change in Waist Circumference | Week 0, week 26, week 52 | Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. |
| Change in Total Cholesterol - Ratio to Baseline | Week 0, week 26, week 52 | Change from baseline in total cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. |
| Change in LDL Cholesterol - Ratio to Baseline | Week 0, week 26, week 52 | Change from baseline in LDL cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. |
| Change in HDL Cholesterol - Ratio to Baseline | Week 0, week 26, week 52 | Change from baseline (week 0) in HDL cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. |
| Change in Triglycerides - Ratio to Baseline | Week 0, week 26, week 52 | Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. |
| Change in Total Daily Insulin Dose | Week 0, week 26, week 52 | Change from baseline in total daily insulin dose to week 26 and week 52 is presented. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. |
| Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no) | Week 26, week 52 | Number of particpants achieving HbA1c \< 7.0 % (53 mmol/mol) according to American Diabetes Association (ADA) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. |
| Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no) | Week 26, week 52 | Number of participants achieving HbA1c ≤ 6.5% (48 mmol/mol) according to American Association of Clinical Endocrinologists (AACE) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. |
| Participants Who Achieve Body Weight Loss ≥5% (Yes/no) | Week 26, week 52 | Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. |
| Participants Who Achieve Body Weight Loss ≥10% (Yes/no) | Week 26, week 52 | Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiatiion of of rescue medication and/or premature trial product discontinuation, if any. |
| Change in Body Weight (Week 26) | Week 0, week 26 | Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also evaluated based on data from the on-treatment without rescue medication observation period. It started at the date of first dose of trial product and excluded the period after initiation of rescue medication and/or premature trial product discontinuation, if any. |
| Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26, week 52 | Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Time to Additional Anti-diabetic Medication | Weeks 0-52 | Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as use of new anti-diabetic medication for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Time to Rescue Medication | Weeks 0-52 | Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 1) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation. |
| Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product | Weeks 0-57 | Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | Weeks 0-57 | Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. |
| Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | Weeks 0-57 | Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. |
| Change in Amylase - Ratio to Baseline | Week 0, week 26, week 52 | Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in Lipase - Ratio to Baseline | Week 0, week 26, week 52 | Change from baseline (week 0) in lipase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication |
| Change in Pulse Rate | Week 0, week 26, week 52 | Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52 Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in SBP and DBP | Week 0, week 26, week 52 | Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at weeks 26 and 52 Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in ECG Evaluation | Week 0, week 26, week 52 | Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. Change from baseline results are presented as shift in findings (normal; abnormal and not clinically significant (NCS); abnormal and clinically significant (CS)) from week 0 to week 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in Physical Examination | Week -2, week 52 | Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2) and weeks 52 presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland. |
| Change in Eye Examination Category | Week -2, week 52 | Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Semaglutide Plasma Concentrations for Population PK Analyses | Weeks 0-52 | This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Semaglutide plasma concentrations were measured at week 4, 14, 26, 38 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Week 0, week 26, week 52 | SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period. |
| Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | Week 0, week 26, week 52 | The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. The items of the IWQOL-Lite-CT pertain to physical functioning (physical, physical function and pain/discomfort) and psychosocial domains and all items employ a 5-point graded response scale (never, rarely, sometimes, usually, always; or not at all true, a little true, moderately true, mostly true, completely true). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. |
| Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Week 0, week 26, week 52 | Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26 and week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of hyperglycaemia and hypoglycaemia, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score has a minimum of 0 and a maximum of 36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. |
| Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26, week 52 | Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
Countries
Canada, France, Greece, India, Japan, Mexico, Poland, Puerto Rico, Russia, United States
Participant flow
Recruitment details
The trial was conducted at 111 sites in 9 countries: Canada (7), France (10), Greece (6), India (9), Japan (18), Mexico (2), Poland (4), Russian Federation (5) and United States (48). Following sites were approved by the IRB/IEC but didn't randomise subjects: France (2), India (1), Japan (1) and United States (3).
Pre-assignment details
Data presented in participant flow is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Participants by arm
| Arm | Count |
|---|---|
| Oral Semaglutide 3 mg Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. | 184 |
| Oral Semaglutide 7 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. | 182 |
| Oral Semaglutide 14 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. | 181 |
| Placebo Participants were to take oral semaglutide placebo tablets once-daily for a period of 52 weeks. | 184 |
| Total | 731 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 3 | 0 |
| Overall Study | Lost to Follow-up | 10 | 3 | 1 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 6 | 2 | 5 |
Baseline characteristics
| Characteristic | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 9 | 60 years STANDARD_DEVIATION 10 | 61 years STANDARD_DEVIATION 10 | 60 years STANDARD_DEVIATION 10 | 61 years STANDARD_DEVIATION 10 |
| HbA1c | 8.2 Percentage of HbA1c STANDARD_DEVIATION 0.7 | 8.2 Percentage of HbA1c STANDARD_DEVIATION 0.7 | 8.2 Percentage of HbA1c STANDARD_DEVIATION 0.7 | 8.2 Percentage of HbA1c STANDARD_DEVIATION 0.7 | 8.2 Percentage of HbA1c STANDARD_DEVIATION 0.7 |
| Race/Ethnicity, Customized American Indian or Alaska native | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 66 Participants | 66 Participants | 66 Participants | 65 Participants | 263 Participants |
| Race/Ethnicity, Customized Black or African American | 15 Participants | 10 Participants | 11 Participants | 13 Participants | 49 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 18 Participants | 24 Participants | 30 Participants | 25 Participants | 97 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Non hispanic or Latino | 154 Participants | 148 Participants | 143 Participants | 150 Participants | 595 Participants |
| Race/Ethnicity, Customized Not applicable | 12 Participants | 10 Participants | 8 Participants | 8 Participants | 39 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 89 Participants | 95 Participants | 94 Participants | 98 Participants | 376 Participants |
| Sex: Female, Male Female | 82 Participants | 79 Participants | 96 Participants | 79 Participants | 336 Participants |
| Sex: Female, Male Male | 102 Participants | 103 Participants | 85 Participants | 105 Participants | 395 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 184 | 0 / 181 | 3 / 181 | 0 / 184 |
| other Total, other adverse events | 77 / 184 | 86 / 181 | 100 / 181 | 73 / 184 |
| serious Total, serious adverse events | 25 / 184 | 19 / 181 | 12 / 181 | 17 / 184 |
Outcome results
Primary
Change in HbA1c (Week 26)
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period started at the date of the first dose of trial product and includes the period after initiation of rescue medication, if any, and excludes the period after premature trial discontinuation, if any.
Time frame: Week 0, week 26
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in HbA1c (Week 26) | In-trial | -0.5 Percentage of HbA1c | Standard Deviation 1 |
| Oral Semaglutide 3 mg | Change in HbA1c (Week 26) | On-treatment without rescue medication | -0.6 Percentage of HbA1c | Standard Deviation 1.1 |
| Oral Semaglutide 7 mg | Change in HbA1c (Week 26) | On-treatment without rescue medication | -1.1 Percentage of HbA1c | Standard Deviation 1 |
| Oral Semaglutide 7 mg | Change in HbA1c (Week 26) | In-trial | -1.0 Percentage of HbA1c | Standard Deviation 1.1 |
| Oral Semaglutide 14 mg | Change in HbA1c (Week 26) | In-trial | -1.3 Percentage of HbA1c | Standard Deviation 1.1 |
| Oral Semaglutide 14 mg | Change in HbA1c (Week 26) | On-treatment without rescue medication | -1.4 Percentage of HbA1c | Standard Deviation 0.9 |
| Placebo | Change in HbA1c (Week 26) | In-trial | -0.1 Percentage of HbA1c | Standard Deviation 0.9 |
| Placebo | Change in HbA1c (Week 26) | On-treatment without rescue medication | -0.1 Percentage of HbA1c | Standard Deviation 0.8 |
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [-0.7, -0.3]Pattern mixture model
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [-1.1, -0.7]Pattern mixture model
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [-1.4, -1]Pattern mixture model
Comparison: The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: <0.000195% CI: [-0.7, -0.4]MMRM
Comparison: The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: <0.000195% CI: [-1.2, -0.8]MMRM
Comparison: The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: <0.000195% CI: [-1.6, -1.2]MMRM
Secondary
Change in Amylase - Ratio to Baseline
Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 26, week 52
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Amylase - Ratio to Baseline | Week 26 | 1.08 Ratio of amylase | Geometric Coefficient of Variation 25.4 |
| Oral Semaglutide 3 mg | Change in Amylase - Ratio to Baseline | Week 52 | 1.07 Ratio of amylase | Geometric Coefficient of Variation 24.6 |
| Oral Semaglutide 7 mg | Change in Amylase - Ratio to Baseline | Week 52 | 1.11 Ratio of amylase | Geometric Coefficient of Variation 26.5 |
| Oral Semaglutide 7 mg | Change in Amylase - Ratio to Baseline | Week 26 | 1.12 Ratio of amylase | Geometric Coefficient of Variation 24.7 |
| Oral Semaglutide 14 mg | Change in Amylase - Ratio to Baseline | Week 26 | 1.14 Ratio of amylase | Geometric Coefficient of Variation 26.7 |
| Oral Semaglutide 14 mg | Change in Amylase - Ratio to Baseline | Week 52 | 1.17 Ratio of amylase | Geometric Coefficient of Variation 21.6 |
| Placebo | Change in Amylase - Ratio to Baseline | Week 26 | 1.01 Ratio of amylase | Geometric Coefficient of Variation 20.6 |
| Placebo | Change in Amylase - Ratio to Baseline | Week 52 | 0.99 Ratio of amylase | Geometric Coefficient of Variation 23.5 |
Secondary
Change in Body Mass Index
Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26 and 52. BMI was calculated based on body weight and height based on the formula: BMI kg/m\^2 = body weight (kg)/(Height (m) x Height (m)). Data based on in-trial observation period is presented. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
Time frame: Week 0, week 26, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Body Mass Index | Week 26 | -0.5 kg/m^2 | Standard Deviation 1.1 |
| Oral Semaglutide 3 mg | Change in Body Mass Index | Week 52 | -0.3 kg/m^2 | Standard Deviation 1.4 |
| Oral Semaglutide 7 mg | Change in Body Mass Index | Week 52 | -0.8 kg/m^2 | Standard Deviation 1.8 |
| Oral Semaglutide 7 mg | Change in Body Mass Index | Week 26 | -1.0 kg/m^2 | Standard Deviation 1.7 |
| Oral Semaglutide 14 mg | Change in Body Mass Index | Week 26 | -1.4 kg/m^2 | Standard Deviation 1.5 |
| Oral Semaglutide 14 mg | Change in Body Mass Index | Week 52 | -1.4 kg/m^2 | Standard Deviation 2.1 |
| Placebo | Change in Body Mass Index | Week 26 | -0.2 kg/m^2 | Standard Deviation 0.9 |
| Placebo | Change in Body Mass Index | Week 52 | 0.2 kg/m^2 | Standard Deviation 1.2 |
Secondary
Change in Body Weight (kg) (Week 52)
Change from baseline (week 0) in body weight to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
Time frame: Week 0, week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Body Weight (kg) (Week 52) | -0.9 Kg | Standard Deviation 3.9 |
| Oral Semaglutide 7 mg | Change in Body Weight (kg) (Week 52) | -2.2 Kg | Standard Deviation 5.2 |
| Oral Semaglutide 14 mg | Change in Body Weight (kg) (Week 52) | -3.8 Kg | Standard Deviation 5.8 |
| Placebo | Change in Body Weight (kg) (Week 52) | 0.5 Kg | Standard Deviation 3.2 |
Secondary
Change in Body Weight (Percentage)
Relative change from baseline (week 0) in body weight (%) was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
Time frame: Week 0, week 26, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Body Weight (Percentage) | Week 26 | -1.73 Percentage change | Standard Deviation 3.34 |
| Oral Semaglutide 3 mg | Change in Body Weight (Percentage) | Week 52 | -1.18 Percentage change | Standard Deviation 4.17 |
| Oral Semaglutide 7 mg | Change in Body Weight (Percentage) | Week 52 | -2.54 Percentage change | Standard Deviation 5.77 |
| Oral Semaglutide 7 mg | Change in Body Weight (Percentage) | Week 26 | -3.11 Percentage change | Standard Deviation 5.66 |
| Oral Semaglutide 14 mg | Change in Body Weight (Percentage) | Week 52 | -4.42 Percentage change | Standard Deviation 6.07 |
| Oral Semaglutide 14 mg | Change in Body Weight (Percentage) | Week 26 | -4.30 Percentage change | Standard Deviation 4.57 |
| Placebo | Change in Body Weight (Percentage) | Week 52 | 0.65 Percentage change | Standard Deviation 3.72 |
| Placebo | Change in Body Weight (Percentage) | Week 26 | -0.47 Percentage change | Standard Deviation 3.02 |
Secondary
Change in Body Weight (Week 26)
Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also evaluated based on data from the on-treatment without rescue medication observation period. It started at the date of first dose of trial product and excluded the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
Time frame: Week 0, week 26
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Body Weight (Week 26) | In trial | -1.4 Kg | Standard Deviation 3.1 |
| Oral Semaglutide 3 mg | Change in Body Weight (Week 26) | On-treatment without rescue medication | -1.5 Kg | Standard Deviation 3.1 |
| Oral Semaglutide 7 mg | Change in Body Weight (Week 26) | On-treatment without rescue medication | -3.0 Kg | Standard Deviation 3.7 |
| Oral Semaglutide 7 mg | Change in Body Weight (Week 26) | In trial | -2.6 Kg | Standard Deviation 5.2 |
| Oral Semaglutide 14 mg | Change in Body Weight (Week 26) | In trial | -3.7 Kg | Standard Deviation 4 |
| Oral Semaglutide 14 mg | Change in Body Weight (Week 26) | On-treatment without rescue medication | -3.9 Kg | Standard Deviation 3.6 |
| Placebo | Change in Body Weight (Week 26) | In trial | -0.5 Kg | Standard Deviation 2.5 |
| Placebo | Change in Body Weight (Week 26) | On-treatment without rescue medication | -0.5 Kg | Standard Deviation 2.4 |
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: 0.039295% CI: [-1.8, 0]Pattern mixture model
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: 0.000195% CI: [-3, -1]Pattern mixture model
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [-4.2, -2.3]Pattern mixture model
Comparison: The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: 0.011195% CI: [-1.6, -0.2]MMRM
Comparison: The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: <0.000195% CI: [-3.2, -1.8]MMRM
Comparison: The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: <0.000195% CI: [-4.4, -3]MMRM
Secondary
Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed)
Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26 and week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of hyperglycaemia and hypoglycaemia, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score has a minimum of 0 and a maximum of 36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction.
Time frame: Week 0, week 26, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably low blood sugars: wk 52 | 0.04 Score on a scale | Standard Deviation 1.9 |
| Oral Semaglutide 3 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably high blood sugars: wk 52 | -0.70 Score on a scale | Standard Deviation 2.02 |
| Oral Semaglutide 3 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Recommending treatment to others: wk 52 | 0.32 Score on a scale | Standard Deviation 1.47 |
| Oral Semaglutide 3 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Total treatment satisfaction: wk 26 | 2.12 Score on a scale | Standard Deviation 5.38 |
| Oral Semaglutide 3 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Convenience of treatment: wk 26 | 0.51 Score on a scale | Standard Deviation 1.25 |
| Oral Semaglutide 3 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Recommending treatment to others: wk 26 | 0.20 Score on a scale | Standard Deviation 1.5 |
| Oral Semaglutide 3 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with understading of diabetes: wk 26 | 0.24 Score on a scale | Standard Deviation 1.31 |
| Oral Semaglutide 3 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with treatment: wk 26 | 0.47 Score on a scale | Standard Deviation 1.27 |
| Oral Semaglutide 3 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Convenience of treatment: wk 52 | 0.38 Score on a scale | Standard Deviation 1.5 |
| Oral Semaglutide 3 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Total treatmemt satisfaction: wk 52 | 2.14 Score on a scale | Standard Deviation 6.02 |
| Oral Semaglutide 3 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably low blood sugars: wk 26 | 0.07 Score on a scale | Standard Deviation 1.97 |
| Oral Semaglutide 3 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction to continue present treatment: wk 52 | 0.41 Score on a scale | Standard Deviation 1.27 |
| Oral Semaglutide 3 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Flexibility of treatment: wk 26 | 0.31 Score on a scale | Standard Deviation 1.43 |
| Oral Semaglutide 3 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with understading of diabetes: wk 52 | 0.25 Score on a scale | Standard Deviation 1.4 |
| Oral Semaglutide 3 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably high blood sugars: wk 26 | -0.62 Score on a scale | Standard Deviation 1.89 |
| Oral Semaglutide 3 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with treatment: wk 52 | 0.53 Score on a scale | Standard Deviation 1.42 |
| Oral Semaglutide 3 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Flexibility of treatment: wk 52 | 0.25 Score on a scale | Standard Deviation 1.6 |
| Oral Semaglutide 3 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction to continue present treatment: wk 26 | 0.40 Score on a scale | Standard Deviation 1.3 |
| Oral Semaglutide 7 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Flexibility of treatment: wk 52 | 0.42 Score on a scale | Standard Deviation 1.58 |
| Oral Semaglutide 7 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with understading of diabetes: wk 26 | 0.31 Score on a scale | Standard Deviation 1.4 |
| Oral Semaglutide 7 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Recommending treatment to others: wk 52 | 0.63 Score on a scale | Standard Deviation 1.55 |
| Oral Semaglutide 7 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with understading of diabetes: wk 52 | 0.35 Score on a scale | Standard Deviation 1.45 |
| Oral Semaglutide 7 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably high blood sugars: wk 52 | -1.15 Score on a scale | Standard Deviation 1.95 |
| Oral Semaglutide 7 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Recommending treatment to others: wk 26 | 0.66 Score on a scale | Standard Deviation 1.79 |
| Oral Semaglutide 7 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably low blood sugars: wk 26 | -0.06 Score on a scale | Standard Deviation 1.7 |
| Oral Semaglutide 7 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Total treatment satisfaction: wk 26 | 3.00 Score on a scale | Standard Deviation 7.36 |
| Oral Semaglutide 7 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably low blood sugars: wk 52 | -0.10 Score on a scale | Standard Deviation 1.74 |
| Oral Semaglutide 7 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with treatment: wk 52 | 0.51 Score on a scale | Standard Deviation 1.45 |
| Oral Semaglutide 7 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Convenience of treatment: wk 26 | 0.50 Score on a scale | Standard Deviation 1.68 |
| Oral Semaglutide 7 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with treatment: wk 26 | 0.59 Score on a scale | Standard Deviation 1.49 |
| Oral Semaglutide 7 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction to continue present treatment: wk 52 | 0.56 Score on a scale | Standard Deviation 1.58 |
| Oral Semaglutide 7 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Convenience of treatment: wk 52 | 0.52 Score on a scale | Standard Deviation 1.54 |
| Oral Semaglutide 7 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably high blood sugars: wk 26 | -1.23 Score on a scale | Standard Deviation 1.98 |
| Oral Semaglutide 7 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Flexibility of treatment: wk 26 | 0.37 Score on a scale | Standard Deviation 1.66 |
| Oral Semaglutide 7 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction to continue present treatment: wk 26 | 0.57 Score on a scale | Standard Deviation 1.65 |
| Oral Semaglutide 7 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Total treatmemt satisfaction: wk 52 | 2.99 Score on a scale | Standard Deviation 6.8 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably high blood sugars: wk 26 | -1.29 Score on a scale | Standard Deviation 1.96 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with treatment: wk 26 | 0.63 Score on a scale | Standard Deviation 1.5 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with treatment: wk 52 | 0.78 Score on a scale | Standard Deviation 1.53 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably high blood sugars: wk 52 | -1.34 Score on a scale | Standard Deviation 2.13 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably low blood sugars: wk 26 | 0.13 Score on a scale | Standard Deviation 2.08 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably low blood sugars: wk 52 | -0.06 Score on a scale | Standard Deviation 2.04 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Convenience of treatment: wk 26 | 0.50 Score on a scale | Standard Deviation 1.43 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Convenience of treatment: wk 52 | 0.44 Score on a scale | Standard Deviation 1.7 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Flexibility of treatment: wk 26 | 0.40 Score on a scale | Standard Deviation 1.43 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Flexibility of treatment: wk 52 | 0.46 Score on a scale | Standard Deviation 1.53 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with understading of diabetes: wk 26 | 0.27 Score on a scale | Standard Deviation 1.22 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with understading of diabetes: wk 52 | 0.34 Score on a scale | Standard Deviation 1.28 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Recommending treatment to others: wk 26 | 0.53 Score on a scale | Standard Deviation 1.53 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Recommending treatment to others: wk 52 | 0.65 Score on a scale | Standard Deviation 1.62 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction to continue present treatment: wk 26 | 0.58 Score on a scale | Standard Deviation 1.39 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction to continue present treatment: wk 52 | 0.65 Score on a scale | Standard Deviation 1.52 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Total treatment satisfaction: wk 26 | 2.90 Score on a scale | Standard Deviation 5.95 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Total treatmemt satisfaction: wk 52 | 3.32 Score on a scale | Standard Deviation 6.78 |
| Placebo | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Flexibility of treatment: wk 52 | 0.23 Score on a scale | Standard Deviation 1.54 |
| Placebo | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Flexibility of treatment: wk 26 | 0.23 Score on a scale | Standard Deviation 1.34 |
| Placebo | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with treatment: wk 26 | 0.18 Score on a scale | Standard Deviation 1.4 |
| Placebo | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction to continue present treatment: wk 26 | 0.09 Score on a scale | Standard Deviation 1.24 |
| Placebo | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Convenience of treatment: wk 52 | 0.19 Score on a scale | Standard Deviation 1.5 |
| Placebo | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Convenience of treatment: wk 26 | 0.20 Score on a scale | Standard Deviation 1.49 |
| Placebo | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Total treatmemt satisfaction: wk 52 | 0.67 Score on a scale | Standard Deviation 5.92 |
| Placebo | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction to continue present treatment: wk 52 | 0.03 Score on a scale | Standard Deviation 1.35 |
| Placebo | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably low blood sugars: wk 52 | -0.02 Score on a scale | Standard Deviation 1.8 |
| Placebo | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably low blood sugars: wk 26 | -0.15 Score on a scale | Standard Deviation 1.91 |
| Placebo | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with treatment: wk 52 | 0.20 Score on a scale | Standard Deviation 1.17 |
| Placebo | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Total treatment satisfaction: wk 26 | 0.76 Score on a scale | Standard Deviation 5.52 |
| Placebo | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably high blood sugars: wk 52 | -0.41 Score on a scale | Standard Deviation 1.91 |
| Placebo | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Recommending treatment to others: wk 26 | 0.02 Score on a scale | Standard Deviation 1.4 |
| Placebo | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with understading of diabetes: wk 52 | 0.03 Score on a scale | Standard Deviation 1.18 |
| Placebo | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with understading of diabetes: wk 26 | 0.04 Score on a scale | Standard Deviation 0.94 |
| Placebo | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably high blood sugars: wk 26 | -0.28 Score on a scale | Standard Deviation 1.85 |
| Placebo | Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed) | Recommending treatment to others: wk 52 | -0.01 Score on a scale | Standard Deviation 1.34 |
Secondary
Change in ECG Evaluation
Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. Change from baseline results are presented as shift in findings (normal; abnormal and not clinically significant (NCS); abnormal and clinically significant (CS)) from week 0 to week 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 26, week 52
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to Abnormal NCS (week 26) | 10 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to Normal (week 52) | 95 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal CS (week 0) to Abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to Abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to Normal (week 26) | 101 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal CS (week 0) to Abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal CS (week 0) to Normal (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal CS to Normal (Week 52) | 0 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal NCS to Abnormal CS (Week 52) | 0 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to Abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal CS to Abnormal CS (Week 52) | 0 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal NCS to Abnormal NCS (Week 52) | 50 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal NCS to Normal (Week 52) | 13 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to Normal (week 26) | 22 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal CS to Abnormal NCS (Week 52) | 0 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to Abnormal CS (week 52) | 2 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to Abnormal NCS (week 52) | 14 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to Abnormal NCS (week 26) | 44 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to Abnormal NCS (week 26) | 42 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to Normal (week 26) | 98 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to Abnormal NCS (week 26) | 12 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to Abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to Normal (week 26) | 17 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal CS to Abnormal NCS (Week 52) | 0 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to Abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal CS (week 0) to Normal (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal CS (week 0) to Abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal CS (week 0) to Abnormal CS (week 26) | 4 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to Normal (week 52) | 91 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to Abnormal NCS (week 52) | 15 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to Abnormal CS (week 52) | 2 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal NCS to Normal (Week 52) | 17 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal NCS to Abnormal NCS (Week 52) | 40 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal NCS to Abnormal CS (Week 52) | 1 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal CS to Normal (Week 52) | 0 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal CS to Abnormal CS (Week 52) | 4 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal CS (week 0) to Abnormal CS (week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to Abnormal NCS (week 26) | 47 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to Normal (week 52) | 85 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to Abnormal NCS (week 52) | 20 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to Normal (week 26) | 16 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal CS to Abnormal NCS (Week 52) | 2 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to Abnormal CS (week 52) | 1 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal NCS to Normal (Week 52) | 19 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to Abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to Normal (week 26) | 90 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal NCS to Abnormal NCS (Week 52) | 42 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal NCS to Abnormal CS (Week 52) | 0 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to Abnormal NCS (week 26) | 17 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal CS (week 0) to Normal (week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to Abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal CS to Abnormal CS (Week 52) | 1 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal CS (week 0) to Abnormal NCS (week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal CS to Normal (Week 52) | 0 Participants |
| Placebo | Change in ECG Evaluation | Abnormal CS (week 0) to Abnormal CS (week 26) | 1 Participants |
| Placebo | Change in ECG Evaluation | Abnormal CS (week 0) to Normal (week 26) | 1 Participants |
| Placebo | Change in ECG Evaluation | Abnormal CS to Normal (Week 52) | 0 Participants |
| Placebo | Change in ECG Evaluation | Abnormal NCS to Abnormal NCS (Week 52) | 47 Participants |
| Placebo | Change in ECG Evaluation | Normal (week 0) to Normal (week 52) | 84 Participants |
| Placebo | Change in ECG Evaluation | Abnormal NCS (week 0) to Normal (week 26) | 19 Participants |
| Placebo | Change in ECG Evaluation | Normal (week 0) to Normal (week 26) | 93 Participants |
| Placebo | Change in ECG Evaluation | Normal (week 0) to Abnormal NCS (week 26) | 12 Participants |
| Placebo | Change in ECG Evaluation | Normal (week 0) to Abnormal NCS (week 52) | 17 Participants |
| Placebo | Change in ECG Evaluation | Abnormal CS to Abnormal CS (Week 52) | 1 Participants |
| Placebo | Change in ECG Evaluation | Abnormal CS (week 0) to Abnormal NCS (week 26) | 0 Participants |
| Placebo | Change in ECG Evaluation | Abnormal NCS to Abnormal CS (Week 52) | 1 Participants |
| Placebo | Change in ECG Evaluation | Normal (week 0) to Abnormal CS (week 52) | 1 Participants |
| Placebo | Change in ECG Evaluation | Normal (week 0) to Abnormal CS (week 26) | 0 Participants |
| Placebo | Change in ECG Evaluation | Abnormal CS to Abnormal NCS (Week 52) | 1 Participants |
| Placebo | Change in ECG Evaluation | Abnormal NCS (week 0) to Abnormal CS (week 26) | 0 Participants |
| Placebo | Change in ECG Evaluation | Abnormal NCS to Normal (Week 52) | 21 Participants |
| Placebo | Change in ECG Evaluation | Abnormal NCS (week 0) to Abnormal NCS (week 26) | 51 Participants |
Secondary
Change in Eye Examination Category
Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week -2, week 52
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week 52) | Normal | 79 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal CS | 23 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal NCS | 76 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week -2) | Normal | 89 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal CS | 23 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal CS | 19 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week 52) | Normal | 83 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal NCS | 76 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal NCS | 67 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal NCS | 65 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal CS | 22 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week -2) | Normal | 85 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal NCS | 64 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week -2) | Normal | 104 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week 52) | Normal | 102 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal CS | 13 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week 52) | Normal | 99 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal NCS | 63 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week -2) | Normal | 102 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal CS | 14 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal NCS | 51 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal CS | 14 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal CS | 14 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal NCS | 54 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal NCS | 64 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week -2) | Normal | 99 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal NCS | 64 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal CS | 18 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week 52) | Normal | 92 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal NCS | 52 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal CS | 18 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week -2) | Normal | 99 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal CS | 18 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week 52) | Normal | 97 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal NCS | 51 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal CS | 15 Participants |
| Placebo | Change in Eye Examination Category | Left eye (week 52) | Abnormal CS | 25 Participants |
| Placebo | Change in Eye Examination Category | Left eye (week 52) | Abnormal NCS | 53 Participants |
| Placebo | Change in Eye Examination Category | Left eye (week -2) | Normal | 108 Participants |
| Placebo | Change in Eye Examination Category | Right eye (week 52) | Normal | 90 Participants |
| Placebo | Change in Eye Examination Category | Left eye (week 52) | Normal | 88 Participants |
| Placebo | Change in Eye Examination Category | Left eye (week -2) | Abnormal CS | 21 Participants |
| Placebo | Change in Eye Examination Category | Right eye (week 52) | Abnormal CS | 26 Participants |
| Placebo | Change in Eye Examination Category | Right eye (week 52) | Abnormal NCS | 50 Participants |
| Placebo | Change in Eye Examination Category | Right eye (week -2) | Abnormal NCS | 58 Participants |
| Placebo | Change in Eye Examination Category | Right eye (week -2) | Normal | 106 Participants |
| Placebo | Change in Eye Examination Category | Left eye (week -2) | Abnormal NCS | 55 Participants |
| Placebo | Change in Eye Examination Category | Right eye (week -2) | Abnormal CS | 20 Participants |
Secondary
Change in Fasting Plasma Glucose (FPG)
Change from baseline (week 0) in FPG to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
Time frame: Week 0, week 26, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Fasting Plasma Glucose (FPG) | Week 26 | -0.45 mmol/L | Standard Deviation 3.35 |
| Oral Semaglutide 3 mg | Change in Fasting Plasma Glucose (FPG) | Week 52 | -0.81 mmol/L | Standard Deviation 3.21 |
| Oral Semaglutide 7 mg | Change in Fasting Plasma Glucose (FPG) | Week 52 | -1.12 mmol/L | Standard Deviation 2.91 |
| Oral Semaglutide 7 mg | Change in Fasting Plasma Glucose (FPG) | Week 26 | -1.14 mmol/L | Standard Deviation 3.08 |
| Oral Semaglutide 14 mg | Change in Fasting Plasma Glucose (FPG) | Week 26 | -1.36 mmol/L | Standard Deviation 2.72 |
| Oral Semaglutide 14 mg | Change in Fasting Plasma Glucose (FPG) | Week 52 | -1.60 mmol/L | Standard Deviation 2.65 |
| Placebo | Change in Fasting Plasma Glucose (FPG) | Week 26 | 0.51 mmol/L | Standard Deviation 2.84 |
| Placebo | Change in Fasting Plasma Glucose (FPG) | Week 52 | -0.09 mmol/L | Standard Deviation 2.97 |
Secondary
Change in HbA1c (Week 52)
Change from baseline (week 0) in HbA1c to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
Time frame: Week 0, week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in HbA1c (Week 52) | -0.6 Percentage of HbA1c | Standard Deviation 1 |
| Oral Semaglutide 7 mg | Change in HbA1c (Week 52) | -0.9 Percentage of HbA1c | Standard Deviation 1.1 |
| Oral Semaglutide 14 mg | Change in HbA1c (Week 52) | -1.2 Percentage of HbA1c | Standard Deviation 1 |
| Placebo | Change in HbA1c (Week 52) | -0.2 Percentage of HbA1c | Standard Deviation 0.8 |
Secondary
Change in HDL Cholesterol - Ratio to Baseline
Change from baseline (week 0) in HDL cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
Time frame: Week 0, week 26, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in HDL Cholesterol - Ratio to Baseline | Week 26 | 1.00 Ratio of HDL cholesterol | Geometric Coefficient of Variation 13.5 |
| Oral Semaglutide 3 mg | Change in HDL Cholesterol - Ratio to Baseline | Week 52 | 1.01 Ratio of HDL cholesterol | Geometric Coefficient of Variation 14.4 |
| Oral Semaglutide 7 mg | Change in HDL Cholesterol - Ratio to Baseline | Week 52 | 0.98 Ratio of HDL cholesterol | Geometric Coefficient of Variation 13.4 |
| Oral Semaglutide 7 mg | Change in HDL Cholesterol - Ratio to Baseline | Week 26 | 0.98 Ratio of HDL cholesterol | Geometric Coefficient of Variation 13.5 |
| Oral Semaglutide 14 mg | Change in HDL Cholesterol - Ratio to Baseline | Week 26 | 0.98 Ratio of HDL cholesterol | Geometric Coefficient of Variation 16.7 |
| Oral Semaglutide 14 mg | Change in HDL Cholesterol - Ratio to Baseline | Week 52 | 1.01 Ratio of HDL cholesterol | Geometric Coefficient of Variation 14.3 |
| Placebo | Change in HDL Cholesterol - Ratio to Baseline | Week 26 | 1.01 Ratio of HDL cholesterol | Geometric Coefficient of Variation 13 |
| Placebo | Change in HDL Cholesterol - Ratio to Baseline | Week 52 | 1.00 Ratio of HDL cholesterol | Geometric Coefficient of Variation 13.9 |
Secondary
Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains
The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. The items of the IWQOL-Lite-CT pertain to physical functioning (physical, physical function and pain/discomfort) and psychosocial domains and all items employ a 5-point graded response scale (never, rarely, sometimes, usually, always; or not at all true, a little true, moderately true, mostly true, completely true). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
Time frame: Week 0, week 26, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 5) IWQOL-Lite-CT Total (Week 26) | 1.74 Score on a scale | Standard Deviation 13.37 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 4) Pain/discomfort (Week 26) | 3.30 Score on a scale | Standard Deviation 22.52 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 3) Physical function(Week 26) | 1.88 Score on a scale | Standard Deviation 18.64 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 1) Psychosocial (Week 26) | 1.45 Score on a scale | Standard Deviation 13.89 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 3) Physical function(Week 52) | 3.45 Score on a scale | Standard Deviation 19.79 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 5) IWQOL-Lite-CT Total (Week 52) | 2.35 Score on a scale | Standard Deviation 14.5 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 1) Psychosocial (Week 52) | 1.96 Score on a scale | Standard Deviation 14.89 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 4) Pain/discomfort (Week 52) | 2.23 Score on a scale | Standard Deviation 24.48 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 2) Physical (Week 26) | 2.29 Score on a scale | Standard Deviation 17.3 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 2) Physical (Week 52) | 3.10 Score on a scale | Standard Deviation 18.81 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 5) IWQOL-Lite-CT Total (Week 26) | -0.45 Score on a scale | Standard Deviation 12.47 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 1) Psychosocial (Week 52) | -0.92 Score on a scale | Standard Deviation 13.2 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 5) IWQOL-Lite-CT Total (Week 52) | -0.79 Score on a scale | Standard Deviation 12.47 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 3) Physical function(Week 26) | -0.35 Score on a scale | Standard Deviation 16.28 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 4) Pain/discomfort (Week 26) | -1.45 Score on a scale | Standard Deviation 21.22 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 3) Physical function(Week 52) | -0.59 Score on a scale | Standard Deviation 15.85 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 2) Physical (Week 52) | -0.53 Score on a scale | Standard Deviation 15.3 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 1) Psychosocial (Week 26) | -0.32 Score on a scale | Standard Deviation 13.58 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 2) Physical (Week 26) | -0.66 Score on a scale | Standard Deviation 15.2 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 4) Pain/discomfort (Week 52) | -0.37 Score on a scale | Standard Deviation 20.88 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 2) Physical (Week 52) | 2.50 Score on a scale | Standard Deviation 15.33 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 5) IWQOL-Lite-CT Total (Week 52) | 4.35 Score on a scale | Standard Deviation 13.82 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 1) Psychosocial (Week 26) | 4.10 Score on a scale | Standard Deviation 14.24 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 1) Psychosocial (Week 52) | 5.35 Score on a scale | Standard Deviation 15.89 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 2) Physical (Week 26) | 2.15 Score on a scale | Standard Deviation 14.66 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 5) IWQOL-Lite-CT Total (Week 26) | 3.41 Score on a scale | Standard Deviation 12.19 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 3) Physical function(Week 26) | 2.51 Score on a scale | Standard Deviation 15.94 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 3) Physical function(Week 52) | 2.59 Score on a scale | Standard Deviation 16.02 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 4) Pain/discomfort (Week 26) | 1.23 Score on a scale | Standard Deviation 22.86 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 4) Pain/discomfort (Week 52) | 2.28 Score on a scale | Standard Deviation 22.12 |
| Placebo | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 2) Physical (Week 52) | -1.24 Score on a scale | Standard Deviation 16.36 |
| Placebo | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 2) Physical (Week 26) | -1.75 Score on a scale | Standard Deviation 13.28 |
| Placebo | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 5) IWQOL-Lite-CT Total (Week 52) | -0.73 Score on a scale | Standard Deviation 13.5 |
| Placebo | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 4) Pain/discomfort (Week 26) | -1.85 Score on a scale | Standard Deviation 21.51 |
| Placebo | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 1) Psychosocial (Week 52) | -0.46 Score on a scale | Standard Deviation 14.46 |
| Placebo | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 1) Psychosocial (Week 26) | -0.49 Score on a scale | Standard Deviation 11.62 |
| Placebo | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 5) IWQOL-Lite-CT Total (Week 26) | -0.94 Score on a scale | Standard Deviation 10.4 |
| Placebo | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 3) Physical function(Week 26) | -1.70 Score on a scale | Standard Deviation 15.12 |
| Placebo | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 4) Pain/discomfort (Week 52) | -1.88 Score on a scale | Standard Deviation 22.48 |
| Placebo | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 3) Physical function(Week 52) | -0.98 Score on a scale | Standard Deviation 17.33 |
Secondary
Change in LDL Cholesterol - Ratio to Baseline
Change from baseline in LDL cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
Time frame: Week 0, week 26, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in LDL Cholesterol - Ratio to Baseline | Week 26 | 0.98 Ratio of LDL cholesterol | Geometric Coefficient of Variation 27.1 |
| Oral Semaglutide 3 mg | Change in LDL Cholesterol - Ratio to Baseline | Week 52 | 0.97 Ratio of LDL cholesterol | Geometric Coefficient of Variation 29.2 |
| Oral Semaglutide 7 mg | Change in LDL Cholesterol - Ratio to Baseline | Week 52 | 0.96 Ratio of LDL cholesterol | Geometric Coefficient of Variation 29.4 |
| Oral Semaglutide 7 mg | Change in LDL Cholesterol - Ratio to Baseline | Week 26 | 0.93 Ratio of LDL cholesterol | Geometric Coefficient of Variation 30.2 |
| Oral Semaglutide 14 mg | Change in LDL Cholesterol - Ratio to Baseline | Week 26 | 0.93 Ratio of LDL cholesterol | Geometric Coefficient of Variation 24.5 |
| Oral Semaglutide 14 mg | Change in LDL Cholesterol - Ratio to Baseline | Week 52 | 0.95 Ratio of LDL cholesterol | Geometric Coefficient of Variation 27.6 |
| Placebo | Change in LDL Cholesterol - Ratio to Baseline | Week 26 | 1.03 Ratio of LDL cholesterol | Geometric Coefficient of Variation 25.9 |
| Placebo | Change in LDL Cholesterol - Ratio to Baseline | Week 52 | 1.00 Ratio of LDL cholesterol | Geometric Coefficient of Variation 28.3 |
Secondary
Change in Lipase - Ratio to Baseline
Change from baseline (week 0) in lipase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication
Time frame: Week 0, week 26, week 52
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Lipase - Ratio to Baseline | Week 26 | 1.14 Ratio of lipase | Geometric Coefficient of Variation 56.7 |
| Oral Semaglutide 3 mg | Change in Lipase - Ratio to Baseline | Week 52 | 1.09 Ratio of lipase | Geometric Coefficient of Variation 57.5 |
| Oral Semaglutide 7 mg | Change in Lipase - Ratio to Baseline | Week 52 | 1.25 Ratio of lipase | Geometric Coefficient of Variation 59.8 |
| Oral Semaglutide 7 mg | Change in Lipase - Ratio to Baseline | Week 26 | 1.34 Ratio of lipase | Geometric Coefficient of Variation 59.1 |
| Oral Semaglutide 14 mg | Change in Lipase - Ratio to Baseline | Week 26 | 1.35 Ratio of lipase | Geometric Coefficient of Variation 65.1 |
| Oral Semaglutide 14 mg | Change in Lipase - Ratio to Baseline | Week 52 | 1.35 Ratio of lipase | Geometric Coefficient of Variation 49.6 |
| Placebo | Change in Lipase - Ratio to Baseline | Week 26 | 0.99 Ratio of lipase | Geometric Coefficient of Variation 47.1 |
| Placebo | Change in Lipase - Ratio to Baseline | Week 52 | 0.99 Ratio of lipase | Geometric Coefficient of Variation 53.3 |
Secondary
Change in Physical Examination
Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2) and weeks 52 presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.
Time frame: Week -2, week 52
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Normal | 163 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Normal | 166 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal NCS | 17 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal NCS | 20 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal NCS | 9 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal NCS | 7 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal CS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Abnormal NCS | 25 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Abnormal CS | 3 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week 52) | Normal | 152 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week -2) | Normal | 159 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Normal | 160 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Normal | 173 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week -2) | Abnormal NCS | 25 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal CS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal CS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Abnormal NCS | 11 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Normal | 149 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week 52) | Normal | 151 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Normal | 172 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal NCS | 27 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week 52) | Abnormal NCS | 23 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Normal | 171 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Normal | 166 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Normal | 157 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Normal | 177 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Normal | 158 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week -2) | Normal | 156 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Normal | 168 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Normal | 173 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Normal | 184 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal NCS | 15 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Normal | 182 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal CS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal NCS | 11 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal NCS | 13 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal NCS | 18 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Normal | 161 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal CS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal NCS | 26 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Abnormal NCS | 13 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal NCS | 8 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Normal | 181 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Normal | 170 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal NCS | 4 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal NCS | 5 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Normal | 177 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Normal | 170 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Normal | 150 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal NCS | 10 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Normal | 160 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Abnormal NCS | 20 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Abnormal NCS | 9 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal NCS | 5 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Normal | 176 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Normal | 175 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Normal | 158 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal NCS | 6 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal NCS | 26 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Normal | 164 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal NCS | 6 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal NCS | 12 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week 52) | Normal | 144 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal NCS | 15 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week -2) | Normal | 162 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Normal | 165 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week -2) | Abnormal NCS | 18 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week -2) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal NCS | 28 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week 52) | Normal | 148 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Normal | 166 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week 52) | Abnormal NCS | 21 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week -2) | Normal | 153 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week 52) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Normal | 173 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Normal | 157 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal NCS | 8 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal NCS | 6 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Normal | 164 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal NCS | 24 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Abnormal NCS | 6 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Normal | 164 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Normal | 157 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal NCS | 24 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Normal | 145 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal NCS | 24 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Normal | 158 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal NCS | 21 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Normal | 147 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Abnormal NCS | 22 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Normal | 177 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal NCS | 4 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Normal | 166 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal NCS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week -2) | Normal | 160 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week -2) | Abnormal NCS | 21 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week 52) | Normal | 153 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week 52) | Abnormal NCS | 17 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Normal | 172 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal NCS | 7 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Normal | 165 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Abnormal NCS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Normal | 181 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Normal | 170 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Normal | 169 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal NCS | 9 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Normal | 170 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal CS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Normal | 159 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Abnormal NCS | 8 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Abnormal CS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Normal | 180 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week -2) | Normal | 159 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal NCS | 22 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week 52) | Normal | 151 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal NCS | 18 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Normal | 176 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal NCS | 5 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Normal | 168 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Abnormal CS | 2 Participants |
| Placebo | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Abnormal NCS | 5 Participants |
| Placebo | Change in Physical Examination | 8) Respiratory system (week 52) | Normal | 173 Participants |
| Placebo | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Normal | 166 Participants |
| Placebo | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal CS | 1 Participants |
| Placebo | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal NCS | 14 Participants |
| Placebo | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal NCS | 5 Participants |
| Placebo | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Normal | 178 Participants |
| Placebo | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal CS | 2 Participants |
| Placebo | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 4) General appearance (week 52) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 4) General appearance (week 52) | Abnormal NCS | 21 Participants |
| Placebo | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal CS | 1 Participants |
| Placebo | Change in Physical Examination | 9) Skin (week -2) | Normal | 162 Participants |
| Placebo | Change in Physical Examination | 4) General appearance (week 52) | Normal | 152 Participants |
| Placebo | Change in Physical Examination | 4) General appearance (week -2) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal NCS | 12 Participants |
| Placebo | Change in Physical Examination | 9) Skin (week -2) | Abnormal NCS | 21 Participants |
| Placebo | Change in Physical Examination | 4) General appearance (week -2) | Abnormal NCS | 22 Participants |
| Placebo | Change in Physical Examination | 4) General appearance (week -2) | Normal | 162 Participants |
| Placebo | Change in Physical Examination | 1) Cardiovascular system (week -2) | Normal | 170 Participants |
| Placebo | Change in Physical Examination | 9) Skin (week -2) | Abnormal CS | 1 Participants |
| Placebo | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal CS | 1 Participants |
| Placebo | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal NCS | 1 Participants |
| Placebo | Change in Physical Examination | 10) Thyroid gland (week 52) | Normal | 166 Participants |
| Placebo | Change in Physical Examination | 9) Skin (week 52) | Normal | 155 Participants |
| Placebo | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Normal | 171 Participants |
| Placebo | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 1) Cardiovascular system (week 52) | Normal | 160 Participants |
| Placebo | Change in Physical Examination | 9) Skin (week 52) | Abnormal NCS | 18 Participants |
| Placebo | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal NCS | 4 Participants |
| Placebo | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Normal | 180 Participants |
| Placebo | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 9) Skin (week 52) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Abnormal NCS | 18 Participants |
| Placebo | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal CS | 1 Participants |
| Placebo | Change in Physical Examination | 10) Thyroid gland (week -2) | Normal | 177 Participants |
| Placebo | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Normal | 155 Participants |
| Placebo | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Normal | 164 Participants |
| Placebo | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal NCS | 6 Participants |
| Placebo | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Abnormal NCS | 8 Participants |
| Placebo | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal NCS | 9 Participants |
| Placebo | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal NCS | 5 Participants |
| Placebo | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Abnormal CS | 1 Participants |
| Placebo | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Normal | 175 Participants |
| Placebo | Change in Physical Examination | 6) Lymph node palpation (week 52) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal NCS | 21 Participants |
| Placebo | Change in Physical Examination | 8) Respiratory system (week -2) | Normal | 184 Participants |
| Placebo | Change in Physical Examination | 6) Lymph node palpation (week 52) | Abnormal NCS | 1 Participants |
| Placebo | Change in Physical Examination | 6) Lymph node palpation (week 52) | Normal | 172 Participants |
| Placebo | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Normal | 163 Participants |
| Placebo | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | 6) Lymph node palpation (week -2) | Normal | 184 Participants |
Secondary
Change in Pulse Rate
Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52 Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 26, week 52
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Pulse Rate | Week 26 | 1 Beats/minute | Standard Deviation 9 |
| Oral Semaglutide 3 mg | Change in Pulse Rate | Week 52 | -0 Beats/minute | Standard Deviation 8 |
| Oral Semaglutide 7 mg | Change in Pulse Rate | Week 52 | 1 Beats/minute | Standard Deviation 9 |
| Oral Semaglutide 7 mg | Change in Pulse Rate | Week 26 | 2 Beats/minute | Standard Deviation 9 |
| Oral Semaglutide 14 mg | Change in Pulse Rate | Week 26 | 3 Beats/minute | Standard Deviation 10 |
| Oral Semaglutide 14 mg | Change in Pulse Rate | Week 52 | 2 Beats/minute | Standard Deviation 10 |
| Placebo | Change in Pulse Rate | Week 26 | -0 Beats/minute | Standard Deviation 9 |
| Placebo | Change in Pulse Rate | Week 52 | 0 Beats/minute | Standard Deviation 9 |
Secondary
Change in SBP and DBP
Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at weeks 26 and 52 Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 26, week 52
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in SBP and DBP | SBP: Week 26 | -1 mmHg | Standard Deviation 12 |
| Oral Semaglutide 3 mg | Change in SBP and DBP | SBP: Week 52 | -1 mmHg | Standard Deviation 12 |
| Oral Semaglutide 3 mg | Change in SBP and DBP | DBP: Week 26 | -0 mmHg | Standard Deviation 8 |
| Oral Semaglutide 3 mg | Change in SBP and DBP | DBP: Week 52 | -1 mmHg | Standard Deviation 8 |
| Oral Semaglutide 7 mg | Change in SBP and DBP | DBP: Week 52 | -2 mmHg | Standard Deviation 9 |
| Oral Semaglutide 7 mg | Change in SBP and DBP | DBP: Week 26 | -1 mmHg | Standard Deviation 10 |
| Oral Semaglutide 7 mg | Change in SBP and DBP | SBP: Week 52 | -3 mmHg | Standard Deviation 16 |
| Oral Semaglutide 7 mg | Change in SBP and DBP | SBP: Week 26 | -3 mmHg | Standard Deviation 17 |
| Oral Semaglutide 14 mg | Change in SBP and DBP | DBP: Week 26 | -1 mmHg | Standard Deviation 9 |
| Oral Semaglutide 14 mg | Change in SBP and DBP | DBP: Week 52 | -2 mmHg | Standard Deviation 9 |
| Oral Semaglutide 14 mg | Change in SBP and DBP | SBP: Week 52 | -6 mmHg | Standard Deviation 14 |
| Oral Semaglutide 14 mg | Change in SBP and DBP | SBP: Week 26 | -5 mmHg | Standard Deviation 14 |
| Placebo | Change in SBP and DBP | SBP: Week 52 | 0 mmHg | Standard Deviation 14 |
| Placebo | Change in SBP and DBP | SBP: Week 26 | 1 mmHg | Standard Deviation 14 |
| Placebo | Change in SBP and DBP | DBP: Week 52 | -0 mmHg | Standard Deviation 8 |
| Placebo | Change in SBP and DBP | DBP: Week 26 | 0 mmHg | Standard Deviation 8 |
Secondary
Change in Self-measured Plasma Glucose (SMPG) Mean 7-point Profile
Change from baseline (week 0) in self-measured plasma glucose (SMPG) mean 7-point profile to week 26 and week 52. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
Time frame: Week 0, week 26, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Self-measured Plasma Glucose (SMPG) Mean 7-point Profile | Week 26 | -1.2 mmol/L | Standard Deviation 2.3 |
| Oral Semaglutide 3 mg | Change in Self-measured Plasma Glucose (SMPG) Mean 7-point Profile | Week 52 | -1.6 mmol/L | Standard Deviation 2.5 |
| Oral Semaglutide 7 mg | Change in Self-measured Plasma Glucose (SMPG) Mean 7-point Profile | Week 52 | -1.7 mmol/L | Standard Deviation 2.4 |
| Oral Semaglutide 7 mg | Change in Self-measured Plasma Glucose (SMPG) Mean 7-point Profile | Week 26 | -1.8 mmol/L | Standard Deviation 2.4 |
| Oral Semaglutide 14 mg | Change in Self-measured Plasma Glucose (SMPG) Mean 7-point Profile | Week 26 | -2.0 mmol/L | Standard Deviation 2.2 |
| Oral Semaglutide 14 mg | Change in Self-measured Plasma Glucose (SMPG) Mean 7-point Profile | Week 52 | -2.0 mmol/L | Standard Deviation 2.1 |
| Placebo | Change in Self-measured Plasma Glucose (SMPG) Mean 7-point Profile | Week 26 | -0.3 mmol/L | Standard Deviation 2.7 |
| Placebo | Change in Self-measured Plasma Glucose (SMPG) Mean 7-point Profile | Week 52 | -0.9 mmol/L | Standard Deviation 2.4 |
Secondary
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.
Time frame: Week 0, week 26, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (Week 52) | -0.48 Score on a scale | Standard Deviation 8.69 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (Week 52) | 0.11 Score on a scale | Standard Deviation 9.73 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role Physical (Week 52) | 0.00 Score on a scale | Standard Deviation 8.46 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (Week 26) | -1.41 Score on a scale | Standard Deviation 9.29 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (Week 26) | -0.94 Score on a scale | Standard Deviation 11.2 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (Week 26) | 0.53 Score on a scale | Standard Deviation 7.58 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (Week 52) | 0.77 Score on a scale | Standard Deviation 10.61 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (Week 52) | 0.51 Score on a scale | Standard Deviation 8.27 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 10) Mental component summary (Week 26) | -1.41 Score on a scale | Standard Deviation 9.5 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily Pain (Week 26) | -0.02 Score on a scale | Standard Deviation 9.75 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily Pain (Week 52) | -0.40 Score on a scale | Standard Deviation 9.78 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 9) Physical component summary (Week 52) | 0.26 Score on a scale | Standard Deviation 6.78 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General Health (Week 26) | 1.43 Score on a scale | Standard Deviation 6.75 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 10) Mental component summary (Week 52) | -0.09 Score on a scale | Standard Deviation 8.45 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General Health (Week 52) | 0.92 Score on a scale | Standard Deviation 6.27 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role Physical (Week 26) | -0.32 Score on a scale | Standard Deviation 8.64 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 9) Physical component summary (Week 26) | 0.94 Score on a scale | Standard Deviation 6.2 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (Week 26) | -0.56 Score on a scale | Standard Deviation 7.73 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (Week 52) | -0.53 Score on a scale | Standard Deviation 8.24 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (Week 26) | -0.31 Score on a scale | Standard Deviation 8.86 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (Week 52) | -0.74 Score on a scale | Standard Deviation 9.91 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (Week 26) | 0.34 Score on a scale | Standard Deviation 8.65 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 10) Mental component summary (Week 26) | -0.55 Score on a scale | Standard Deviation 7.91 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (Week 26) | -0.82 Score on a scale | Standard Deviation 7.58 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily Pain (Week 52) | 0.56 Score on a scale | Standard Deviation 9.7 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (Week 52) | -0.61 Score on a scale | Standard Deviation 10.09 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (Week 26) | 0.52 Score on a scale | Standard Deviation 6.61 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 10) Mental component summary (Week 52) | -0.89 Score on a scale | Standard Deviation 9.66 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (Week 52) | -1.43 Score on a scale | Standard Deviation 7.68 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (Week 26) | 0.62 Score on a scale | Standard Deviation 9.94 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General Health (Week 26) | 0.70 Score on a scale | Standard Deviation 7.23 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (Week 52) | -0.34 Score on a scale | Standard Deviation 10.58 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (Week 26) | -1.27 Score on a scale | Standard Deviation 6.7 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role Physical (Week 52) | -0.76 Score on a scale | Standard Deviation 7.88 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 9) Physical component summary (Week 26) | 0.75 Score on a scale | Standard Deviation 6.27 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role Physical (Week 26) | -0.43 Score on a scale | Standard Deviation 8.45 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General Health (Week 52) | 0.75 Score on a scale | Standard Deviation 7 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily Pain (Week 26) | 1.47 Score on a scale | Standard Deviation 8.98 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (Week 52) | -0.40 Score on a scale | Standard Deviation 6.69 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 9) Physical component summary (Week 52) | 0.12 Score on a scale | Standard Deviation 6.24 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (Week 26) | 0.24 Score on a scale | Standard Deviation 9.78 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (Week 26) | -0.07 Score on a scale | Standard Deviation 6.75 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (Week 52) | -0.32 Score on a scale | Standard Deviation 7.55 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role Physical (Week 26) | 0.04 Score on a scale | Standard Deviation 6.81 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role Physical (Week 52) | -0.87 Score on a scale | Standard Deviation 7.97 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily Pain (Week 26) | -0.18 Score on a scale | Standard Deviation 7.76 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily Pain (Week 52) | -0.21 Score on a scale | Standard Deviation 8.22 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General Health (Week 26) | 1.26 Score on a scale | Standard Deviation 6.11 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General Health (Week 52) | 1.38 Score on a scale | Standard Deviation 6.04 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (Week 26) | 0.14 Score on a scale | Standard Deviation 8.01 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (Week 52) | 0.70 Score on a scale | Standard Deviation 8.4 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (Week 26) | -0.51 Score on a scale | Standard Deviation 9.25 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (Week 52) | 0.03 Score on a scale | Standard Deviation 8.73 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (Week 52) | 0.09 Score on a scale | Standard Deviation 9.91 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (Week 26) | 0.99 Score on a scale | Standard Deviation 8.5 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (Week 52) | 0.89 Score on a scale | Standard Deviation 8.39 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 9) Physical component summary (Week 26) | -0.02 Score on a scale | Standard Deviation 4.81 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 9) Physical component summary (Week 52) | -0.36 Score on a scale | Standard Deviation 6.09 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 10) Mental component summary (Week 26) | 0.49 Score on a scale | Standard Deviation 8.72 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 10) Mental component summary (Week 52) | 0.82 Score on a scale | Standard Deviation 8.57 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (Week 52) | -1.09 Score on a scale | Standard Deviation 7.12 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (Week 26) | -1.69 Score on a scale | Standard Deviation 7.18 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 10) Mental component summary (Week 26) | -2.16 Score on a scale | Standard Deviation 7.45 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (Week 52) | -1.30 Score on a scale | Standard Deviation 8 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General Health (Week 52) | -1.43 Score on a scale | Standard Deviation 6.95 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General Health (Week 26) | -0.36 Score on a scale | Standard Deviation 6.35 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (Week 52) | -0.77 Score on a scale | Standard Deviation 6.31 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 9) Physical component summary (Week 26) | -0.05 Score on a scale | Standard Deviation 6.07 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily Pain (Week 52) | -0.64 Score on a scale | Standard Deviation 11.23 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily Pain (Week 26) | -0.72 Score on a scale | Standard Deviation 9.88 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (Week 26) | -0.82 Score on a scale | Standard Deviation 7.25 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 9) Physical component summary (Week 52) | -0.41 Score on a scale | Standard Deviation 6.54 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role Physical (Week 52) | -0.93 Score on a scale | Standard Deviation 8.28 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (Week 26) | -1.50 Score on a scale | Standard Deviation 9.08 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role Physical (Week 26) | -0.39 Score on a scale | Standard Deviation 7.19 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (Week 52) | -2.78 Score on a scale | Standard Deviation 10.81 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (Week 52) | -1.74 Score on a scale | Standard Deviation 8.7 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (Week 26) | -1.10 Score on a scale | Standard Deviation 8.03 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 10) Mental component summary (Week 52) | -2.19 Score on a scale | Standard Deviation 8.23 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (Week 26) | -2.32 Score on a scale | Standard Deviation 7.57 |
Secondary
Change in SMPG Mean Postprandial Increment Over All Meals
Change from baseline (week 0) in SMPG mean postprandial increment over all meals to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
Time frame: Week 0, week 26, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in SMPG Mean Postprandial Increment Over All Meals | Week 26 | -0.3 mmol/L | Standard Deviation 2.3 |
| Oral Semaglutide 3 mg | Change in SMPG Mean Postprandial Increment Over All Meals | Week 52 | -0.3 mmol/L | Standard Deviation 2.3 |
| Oral Semaglutide 7 mg | Change in SMPG Mean Postprandial Increment Over All Meals | Week 52 | -0.7 mmol/L | Standard Deviation 2.3 |
| Oral Semaglutide 7 mg | Change in SMPG Mean Postprandial Increment Over All Meals | Week 26 | -0.8 mmol/L | Standard Deviation 2.6 |
| Oral Semaglutide 14 mg | Change in SMPG Mean Postprandial Increment Over All Meals | Week 26 | -1.2 mmol/L | Standard Deviation 2.5 |
| Oral Semaglutide 14 mg | Change in SMPG Mean Postprandial Increment Over All Meals | Week 52 | -0.7 mmol/L | Standard Deviation 2.3 |
| Placebo | Change in SMPG Mean Postprandial Increment Over All Meals | Week 26 | -0.1 mmol/L | Standard Deviation 2.8 |
| Placebo | Change in SMPG Mean Postprandial Increment Over All Meals | Week 52 | -0.3 mmol/L | Standard Deviation 2.4 |
Secondary
Change in Total Cholesterol - Ratio to Baseline
Change from baseline in total cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
Time frame: Week 0, week 26, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Total Cholesterol - Ratio to Baseline | Week 52 | 0.98 Ratio of total cholesterol | Geometric Coefficient of Variation 18.2 |
| Oral Semaglutide 3 mg | Change in Total Cholesterol - Ratio to Baseline | Week 26 | 0.99 Ratio of total cholesterol | Geometric Coefficient of Variation 15.5 |
| Oral Semaglutide 7 mg | Change in Total Cholesterol - Ratio to Baseline | Week 52 | 0.97 Ratio of total cholesterol | Geometric Coefficient of Variation 19.2 |
| Oral Semaglutide 7 mg | Change in Total Cholesterol - Ratio to Baseline | Week 26 | 0.95 Ratio of total cholesterol | Geometric Coefficient of Variation 18.7 |
| Oral Semaglutide 14 mg | Change in Total Cholesterol - Ratio to Baseline | Week 26 | 0.95 Ratio of total cholesterol | Geometric Coefficient of Variation 17.3 |
| Oral Semaglutide 14 mg | Change in Total Cholesterol - Ratio to Baseline | Week 52 | 0.95 Ratio of total cholesterol | Geometric Coefficient of Variation 18.1 |
| Placebo | Change in Total Cholesterol - Ratio to Baseline | Week 26 | 1.03 Ratio of total cholesterol | Geometric Coefficient of Variation 15.4 |
| Placebo | Change in Total Cholesterol - Ratio to Baseline | Week 52 | 1.00 Ratio of total cholesterol | Geometric Coefficient of Variation 17.6 |
Secondary
Change in Total Daily Insulin Dose
Change from baseline in total daily insulin dose to week 26 and week 52 is presented. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
Time frame: Week 0, week 26, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Total Daily Insulin Dose | Week 26 | -5 Units/day | Standard Deviation 22 |
| Oral Semaglutide 3 mg | Change in Total Daily Insulin Dose | Week 52 | 1 Units/day | Standard Deviation 26 |
| Oral Semaglutide 7 mg | Change in Total Daily Insulin Dose | Week 52 | -8 Units/day | Standard Deviation 64 |
| Oral Semaglutide 7 mg | Change in Total Daily Insulin Dose | Week 26 | -9 Units/day | Standard Deviation 21 |
| Oral Semaglutide 14 mg | Change in Total Daily Insulin Dose | Week 26 | -8 Units/day | Standard Deviation 19 |
| Oral Semaglutide 14 mg | Change in Total Daily Insulin Dose | Week 52 | -5 Units/day | Standard Deviation 19 |
| Placebo | Change in Total Daily Insulin Dose | Week 26 | -2 Units/day | Standard Deviation 15 |
| Placebo | Change in Total Daily Insulin Dose | Week 52 | 8 Units/day | Standard Deviation 24 |
Secondary
Change in Triglycerides - Ratio to Baseline
Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
Time frame: Week 0, week 26, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Triglycerides - Ratio to Baseline | Week 26 | 0.97 Ratio of triglycerides | Geometric Coefficient of Variation 41.5 |
| Oral Semaglutide 3 mg | Change in Triglycerides - Ratio to Baseline | Week 52 | 0.93 Ratio of triglycerides | Geometric Coefficient of Variation 48.7 |
| Oral Semaglutide 7 mg | Change in Triglycerides - Ratio to Baseline | Week 52 | 0.94 Ratio of triglycerides | Geometric Coefficient of Variation 34.9 |
| Oral Semaglutide 7 mg | Change in Triglycerides - Ratio to Baseline | Week 26 | 0.92 Ratio of triglycerides | Geometric Coefficient of Variation 33 |
| Oral Semaglutide 14 mg | Change in Triglycerides - Ratio to Baseline | Week 26 | 0.91 Ratio of triglycerides | Geometric Coefficient of Variation 44.8 |
| Oral Semaglutide 14 mg | Change in Triglycerides - Ratio to Baseline | Week 52 | 0.86 Ratio of triglycerides | Geometric Coefficient of Variation 43.7 |
| Placebo | Change in Triglycerides - Ratio to Baseline | Week 26 | 0.99 Ratio of triglycerides | Geometric Coefficient of Variation 34.9 |
| Placebo | Change in Triglycerides - Ratio to Baseline | Week 52 | 0.97 Ratio of triglycerides | Geometric Coefficient of Variation 39.2 |
Secondary
Change in Waist Circumference
Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
Time frame: Week 0, week 26, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Waist Circumference | Week 26 | -0.9 cm | Standard Deviation 4.1 |
| Oral Semaglutide 3 mg | Change in Waist Circumference | Week 52 | -0.8 cm | Standard Deviation 4.8 |
| Oral Semaglutide 7 mg | Change in Waist Circumference | Week 52 | -2.3 cm | Standard Deviation 5.1 |
| Oral Semaglutide 7 mg | Change in Waist Circumference | Week 26 | -2.3 cm | Standard Deviation 5.1 |
| Oral Semaglutide 14 mg | Change in Waist Circumference | Week 26 | -3.6 cm | Standard Deviation 4.9 |
| Oral Semaglutide 14 mg | Change in Waist Circumference | Week 52 | -4.0 cm | Standard Deviation 6.8 |
| Placebo | Change in Waist Circumference | Week 26 | -0.6 cm | Standard Deviation 3.6 |
| Placebo | Change in Waist Circumference | Week 52 | 0.3 cm | Standard Deviation 4.1 |
Secondary
Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product
Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Weeks 0-57
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide 3 mg | Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product | 626 Events |
| Oral Semaglutide 7 mg | Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product | 555 Events |
| Oral Semaglutide 14 mg | Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product | 586 Events |
| Placebo | Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product | 464 Events |
Secondary
Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes
Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time frame: Weeks 0-57
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide 3 mg | Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 196 Episodes |
| Oral Semaglutide 7 mg | Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 180 Episodes |
| Oral Semaglutide 14 mg | Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 147 Episodes |
| Placebo | Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 156 Episodes |
Secondary
Participants Who Achieve Body Weight Loss ≥10% (Yes/no)
Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiatiion of of rescue medication and/or premature trial product discontinuation, if any.
Time frame: Week 26, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Participants Who Achieve Body Weight Loss ≥10% (Yes/no) | Week 26 | Yes | 2 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Body Weight Loss ≥10% (Yes/no) | Week 26 | No | 175 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Body Weight Loss ≥10% (Yes/no) | Week 52 | Yes | 4 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Body Weight Loss ≥10% (Yes/no) | Week 52 | No | 170 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Body Weight Loss ≥10% (Yes/no) | Week 52 | No | 154 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Body Weight Loss ≥10% (Yes/no) | Week 52 | Yes | 17 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Body Weight Loss ≥10% (Yes/no) | Week 26 | No | 162 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Body Weight Loss ≥10% (Yes/no) | Week 26 | Yes | 12 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Body Weight Loss ≥10% (Yes/no) | Week 52 | Yes | 21 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Body Weight Loss ≥10% (Yes/no) | Week 52 | No | 149 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Body Weight Loss ≥10% (Yes/no) | Week 26 | No | 154 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Body Weight Loss ≥10% (Yes/no) | Week 26 | Yes | 19 Participants |
| Placebo | Participants Who Achieve Body Weight Loss ≥10% (Yes/no) | Week 26 | No | 176 Participants |
| Placebo | Participants Who Achieve Body Weight Loss ≥10% (Yes/no) | Week 26 | Yes | 1 Participants |
| Placebo | Participants Who Achieve Body Weight Loss ≥10% (Yes/no) | Week 52 | No | 172 Participants |
| Placebo | Participants Who Achieve Body Weight Loss ≥10% (Yes/no) | Week 52 | Yes | 1 Participants |
Secondary
Participants Who Achieve Body Weight Loss ≥5% (Yes/no)
Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
Time frame: Week 26, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Participants Who Achieve Body Weight Loss ≥5% (Yes/no) | Week 52 | Yes | 30 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Body Weight Loss ≥5% (Yes/no) | Week 26 | Yes | 23 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Body Weight Loss ≥5% (Yes/no) | Week 52 | No | 144 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Body Weight Loss ≥5% (Yes/no) | Week 26 | No | 154 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Body Weight Loss ≥5% (Yes/no) | Week 26 | Yes | 53 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Body Weight Loss ≥5% (Yes/no) | Week 52 | Yes | 48 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Body Weight Loss ≥5% (Yes/no) | Week 26 | No | 121 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Body Weight Loss ≥5% (Yes/no) | Week 52 | No | 123 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Body Weight Loss ≥5% (Yes/no) | Week 52 | Yes | 67 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Body Weight Loss ≥5% (Yes/no) | Week 26 | Yes | 67 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Body Weight Loss ≥5% (Yes/no) | Week 26 | No | 106 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Body Weight Loss ≥5% (Yes/no) | Week 52 | No | 103 Participants |
| Placebo | Participants Who Achieve Body Weight Loss ≥5% (Yes/no) | Week 26 | Yes | 5 Participants |
| Placebo | Participants Who Achieve Body Weight Loss ≥5% (Yes/no) | Week 26 | No | 172 Participants |
| Placebo | Participants Who Achieve Body Weight Loss ≥5% (Yes/no) | Week 52 | No | 164 Participants |
| Placebo | Participants Who Achieve Body Weight Loss ≥5% (Yes/no) | Week 52 | Yes | 9 Participants |
Secondary
Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no)
Number of participants achieving HbA1c ≤ 6.5% (48 mmol/mol) according to American Association of Clinical Endocrinologists (AACE) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
Time frame: Week 26, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no) | Week 26 | Yes | 24 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no) | Week 26 | No | 152 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no) | Week 52 | Yes | 20 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no) | Week 52 | No | 153 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no) | Week 26 | No | 129 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no) | Week 52 | Yes | 33 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no) | Week 52 | No | 136 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no) | Week 26 | Yes | 45 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no) | Week 52 | Yes | 65 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no) | Week 26 | No | 99 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no) | Week 52 | No | 103 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no) | Week 26 | Yes | 74 Participants |
| Placebo | Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no) | Week 52 | No | 168 Participants |
| Placebo | Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no) | Week 26 | No | 170 Participants |
| Placebo | Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no) | Week 26 | Yes | 6 Participants |
| Placebo | Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no) | Week 52 | Yes | 4 Participants |
Secondary
Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)
Number of particpants achieving HbA1c \< 7.0 % (53 mmol/mol) according to American Diabetes Association (ADA) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.
Time frame: Week 26, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no) | Week 26 | Yes | 50 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no) | Week 26 | No | 126 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no) | Week 52 | Yes | 50 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no) | Week 52 | No | 123 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no) | Week 26 | No | 100 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no) | Week 52 | Yes | 67 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no) | Week 52 | No | 102 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no) | Week 26 | Yes | 74 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no) | Week 52 | Yes | 91 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no) | Week 26 | No | 72 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no) | Week 52 | No | 77 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no) | Week 26 | Yes | 101 Participants |
| Placebo | Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no) | Week 52 | No | 156 Participants |
| Placebo | Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no) | Week 26 | No | 164 Participants |
| Placebo | Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no) | Week 26 | Yes | 12 Participants |
| Placebo | Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no) | Week 52 | Yes | 16 Participants |
Secondary
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)
Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 26, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | Yes | 32 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | No | 144 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | Yes | 27 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | No | 146 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | No | 127 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | Yes | 43 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | No | 126 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | Yes | 47 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | Yes | 61 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | No | 97 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | No | 107 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | Yes | 76 Participants |
| Placebo | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | No | 164 Participants |
| Placebo | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | No | 172 Participants |
| Placebo | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | Yes | 4 Participants |
| Placebo | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | Yes | 8 Participants |
Secondary
Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)
Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 26, week 52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | Yes | 28 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | No | 148 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | Yes | 20 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | No | 153 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | No | 123 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | Yes | 37 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | No | 132 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | Yes | 51 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | Yes | 64 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | No | 97 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | No | 104 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | Yes | 76 Participants |
| Placebo | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | No | 167 Participants |
| Placebo | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | No | 169 Participants |
| Placebo | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | Yes | 7 Participants |
| Placebo | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | Yes | 5 Participants |
Secondary
Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes
Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time frame: Weeks 0-57
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 3 mg | Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 52 Participants |
| Oral Semaglutide 7 mg | Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 47 Participants |
| Oral Semaglutide 14 mg | Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 48 Participants |
| Placebo | Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 54 Participants |
Secondary
Semaglutide Plasma Concentrations for Population PK Analyses
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Semaglutide plasma concentrations were measured at week 4, 14, 26, 38 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Weeks 0-52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentrations for Population PK Analyses | Week 52 | 2.4 nmol/L | Geometric Coefficient of Variation 126 |
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentrations for Population PK Analyses | Week 26 | 2.7 nmol/L | Geometric Coefficient of Variation 124.7 |
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentrations for Population PK Analyses | Week 4 | 2.9 nmol/L | Geometric Coefficient of Variation 111.2 |
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentrations for Population PK Analyses | Week 14 | 2.9 nmol/L | Geometric Coefficient of Variation 106.9 |
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentrations for Population PK Analyses | Week 38 | 2.5 nmol/L | Geometric Coefficient of Variation 123.8 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentrations for Population PK Analyses | Week 14 | 7.5 nmol/L | Geometric Coefficient of Variation 143.2 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentrations for Population PK Analyses | Week 52 | 5.8 nmol/L | Geometric Coefficient of Variation 160.5 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentrations for Population PK Analyses | Week 38 | 6.9 nmol/L | Geometric Coefficient of Variation 139.7 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentrations for Population PK Analyses | Week 26 | 7.2 nmol/L | Geometric Coefficient of Variation 141.4 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentrations for Population PK Analyses | Week 4 | 2.9 nmol/L | Geometric Coefficient of Variation 116.4 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentrations for Population PK Analyses | Week 52 | 11.9 nmol/L | Geometric Coefficient of Variation 210.4 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentrations for Population PK Analyses | Week 4 | 2.9 nmol/L | Geometric Coefficient of Variation 98.1 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentrations for Population PK Analyses | Week 26 | 12.6 nmol/L | Geometric Coefficient of Variation 203.9 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentrations for Population PK Analyses | Week 38 | 10.8 nmol/L | Geometric Coefficient of Variation 238.3 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentrations for Population PK Analyses | Week 14 | 14.5 nmol/L | Geometric Coefficient of Variation 172.7 |
Secondary
Time to Additional Anti-diabetic Medication
Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as use of new anti-diabetic medication for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Weeks 0-52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Time to Additional Anti-diabetic Medication | Week 0-26 | 9 Participants |
| Oral Semaglutide 3 mg | Time to Additional Anti-diabetic Medication | Week 0-52 | 61 Participants |
| Oral Semaglutide 7 mg | Time to Additional Anti-diabetic Medication | Week 0-52 | 45 Participants |
| Oral Semaglutide 7 mg | Time to Additional Anti-diabetic Medication | Week 0-26 | 8 Participants |
| Oral Semaglutide 14 mg | Time to Additional Anti-diabetic Medication | Week 0-26 | 8 Participants |
| Oral Semaglutide 14 mg | Time to Additional Anti-diabetic Medication | Week 0-52 | 44 Participants |
| Placebo | Time to Additional Anti-diabetic Medication | Week 0-26 | 11 Participants |
| Placebo | Time to Additional Anti-diabetic Medication | Week 0-52 | 75 Participants |
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.p-value: 0.062795% CI: [0.53, 1.02]Regression, Cox
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.p-value: 0.008395% CI: [0.44, 0.89]Regression, Cox
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.p-value: 0.001995% CI: [0.4, 0.81]Regression, Cox
Secondary
Time to Rescue Medication
Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 1) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Time frame: Weeks 0-52
Population: Overall number of participants analyzed = FAS which comprised all randomised participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Time to Rescue Medication | Week 0-26 | 5 Participants |
| Oral Semaglutide 3 mg | Time to Rescue Medication | Week 0-52 | 54 Participants |
| Oral Semaglutide 7 mg | Time to Rescue Medication | Week 0-52 | 33 Participants |
| Oral Semaglutide 7 mg | Time to Rescue Medication | Week 0-26 | 2 Participants |
| Oral Semaglutide 14 mg | Time to Rescue Medication | Week 0-26 | 4 Participants |
| Oral Semaglutide 14 mg | Time to Rescue Medication | Week 0-52 | 31 Participants |
| Placebo | Time to Rescue Medication | Week 0-26 | 9 Participants |
| Placebo | Time to Rescue Medication | Week 0-52 | 67 Participants |
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: 0.12195% CI: [0.53, 1.08]Regression, Cox
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: 0.000795% CI: [0.32, 0.74]Regression, Cox
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: 0.000695% CI: [0.31, 0.73]Regression, Cox