Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Asia. The aim of this trial is to investigate the dose-response relationship of once-daily dosing of three dose levels (3, 7 and 14 mg) of oral semaglutide versus placebo as monotherapy on glycaemic control in Japanese subjects with type 2 diabetes mellitus
Interventions
DRUGLiraglutide
Subcutaneous (s.c., under the skin) injection once daily
DRUGPlacebo
Oral administration once daily
DRUGSemaglutide
Oral administration once daily
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 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 * Japanese male or female, age above or equal to 20 years at the time of signing informed consent * Diagnosed with type 2 diabetes mellitus for at least 30 days prior to day of screening * HbA1c 6.5%-9.5% (48-80 mmol/mol) (both inclusive) for subjects treated with oral antidiabetic drug as monotherapy and 7.0%-10.0% (53-86 mmol/mol) (both inclusive) for subjects treated with diet and exercise therapy alone * Treatment for at least 30 days prior to day of screening with;- stable daily dose of oral anti-diabetic drug as monotherapy (allowed oral anti-diabetic drugs are: metformin, sulphonylurea, glinide, α-glucosidase inhibitor, dipeptidyl peptidase-4 inhibitor and sodium-glucose cotransporter-2 inhibitor) at a half-maximum approved dose or below according to Japanese labelling in addition to diet and exercise therapy. or - diet and exercise therapy alone
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 measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives * 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, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation * Subject presently classified as being in New York Heart Association (NYHA) Class IV * Planned coronary, carotid or peripheral artery revascularisation known on the day of screening * Subjects with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL) * Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 30 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) * Treatment with once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA), once weekly dipeptidyl peptidase-4 (DPP-4) inhibitor or thiazolidinedione in a period of 90 days before the day of screening * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of below or equal to 14 days * 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 in-situ carcinomas) * Initiation of anti-diabetic medication between the day of screening and the day of randomisation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c (Week 26) | Week 0, week 26 | Change from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c). The endpoint was analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. The endpoint was also evaluated based on data from the in-trial observation period. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight (kg) | Week 0, week 26, week 52 | Change from baseline (week 0) in body weight. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Change in Fasting Plasma Glucose | Week 0, week 26, week 52 | Change from baseline (week 0) in fasting plasma glucose. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile | Week 0, week 26, week 52 | Change from baseline (week 0) in mean 7-point self-measured plasma glucose (SMPG) profile. 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. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Change in Mean Postprandial Increment Over All Meals in SMPG | Week 0, week 26 and week 52 | Change from baseline (week 0) in the average of the post-prandial increments over all meals. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Change in Body Weight (%) | Week 0, week 26 and week 52 | Relative change (%) from baseline (week 0) in body weight (kg). Data based on on-treatment without resue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Change in Body Mass Index | Week 0, week 26 and week 52 | Change from baseline (week 0) in body mass index (BMI). BMI was calculated based on body weight and height based on the formulae: BMI kg/m\^2 = body weight (kg)/(Height (m) x Height (m)). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Change in Waist Circumference | Week 0, week 26 and week 52 | Change from baseline (week 0) in waist circumference. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Change in Total Cholesterol (Ratio to Baseline) | Week 0, week 26 and week 52 | Change from baseline (week 0) in total cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Change in HDL Cholesterol (Ratio to Baseline) | Week 0, week 26 and week 52 | Change from baseline (week 0) in high density lipoprotein (HDL) cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Change in LDL Cholesterol (Ratio to Baseline) | Week 0, week 26 and week 52 | Change from baseline (week 0) in low density lipoprotein (LDL) cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Change in VLDL Cholesterol (Ratio to Baseline) | Week 0, week 26 and week 52 | Change from baseline (week 0) in very low density lipoprotein (VLDL) cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Change in Triglycerides (Ratio to Baseline) | Week 0, week 26 and week 52 | Change from baseline (week 0) in triglycerides (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Change in Fasting Insulin (Ratio to Baseline) | Week 0, week 26 and week 52 | Change from baseline (week 0) in fasting insulin (measured as picomoles per liter \[pmol/L\]) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Change in Fasting C-peptide (Ratio to Baseline) | Week 0, week 26 and week 52 | Change from baseline (week 0) in fasting C-peptide (measured as nanomoles per liter \[nmol/L\]) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Change in Fasting Glucagon (Ratio to Baseline) | Week 0, week 26 and week 52 | Change from baseline (week 0) in fasting glucagon (measured as picograms per milliliter \[pg/mL\]) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Change in Fasting Pro-insulin (Ratio to Baseline) | Week 0, week 26 and week 52 | Change from baseline (week 0) in fasting pro-insulin (measured as pmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline) | Week 0, week 26 and week 52 | Change from baseline (week 0) in fasting pro-insulin/insulin ratio is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline) | Week 0, week 26 and week 52 | Change from baseline (week 0) in insulin resistance (measured as percentage of insulin resistance) by homeostatic model assessment index of insulin resistance (HOMA-IR) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Change in Beta-cell Function (HOMA-B) (Ratio to Baseline) | Week 0, week 26 and week 52 | Change from baseline (week 0) in beta-cell function (measured as percentage of beta-cell function) by homeostatic model assessment index of beta-cell function is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 and week 52 | Participants who achieved HbA1c \<7.0% (53 millimoles per mole \[mmol/mol\]) according to American Diabetes Association (ADA) target, at week 26 and week 52. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 26 and week 52 | Participants who achieved HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists target (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 26 and week 52 | Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 milligrams per deciliter \[mg/dL\]) with symptoms consistent with hypoglycaemia. Number of participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 26 and week 52 | Participants who achieved above or equal to 1% (10.9 mmol/mol) reduction in HbA1c and losing 3% or more of baseline body weight (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 26 and week 52 | Participants losing 5% or more of baseline body weight (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 26 and week 52 | Participants losing 10% or more of baseline body weight (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Time to Additional Anti-diabetic Medication | Weeks 0 - 52 | Presented results are the number of participants who had taken additional anti-diabetic medication anytime from week 0 to week 52. 'Additional anti-diabetic medication': use of new anti-diabetic medication for more than 21 days with the initiation 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 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 from week 0 to week 52. 'Rescue medication': 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 and before last day on trial product. Time to rescue medication was estimated based on data from on-treatment without rescue medication observation period. |
| Number of Treatment-emergent Adverse Events (TEAEs) | Weeks 0 - 57 | A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) with onset in the on-treatment observation period (time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any, and excluding any period after premature trial product discontinuation) assessed up to approximately 57 weeks (52 weeks treatment period + 5 weeks follow-up period). |
| Change in Amylase (Ratio to Baseine) | Week 0, week 26, week 52 | Change in amylase (measured as units per liter \[U/L\]) is presented as ratio to baseline. Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation. |
| Change in Lipase (Ratio to Baseine) | Week 0, week 26, week 52 | Change in lipase (measured as U/L) is presented as ratio to baseline. Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation. |
| Change in Pulse Rate | Week 0, week 26, week 52 | Change from baseline in pulse rate. Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation. |
| Change in Blood Pressure | Week 0, week 26, week 52 | Change from baseline in blood pressure (systolic \[sBP\] and diastolic \[dBP\]). Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation. |
| Change in ECG Evaluation | Week 0, week 26, week 52 | Electrocardiogram (ECG) was evaluated and interpreted by the investigator and categorised as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). The number of participants who had shifted from normal, abnormal NCS or abnormal CS ECG results from baseline (week 0) to week 26, week 52 is presented. Data based on in-trial observation period is presented. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
| Change in Physical Examination | Baseline (Week -8), week 26, week 52 | Physical examination included examination of cardiovascular system, nervous system (central and peripheral), gastrointestinal system including mouth, general appearence, head and neck (head, ears, eyes, nose, throat, neck), lymph node palpation, musculoskeletal system, respiratory system, skin and thyroid gland. Physical examination was performed by the investigator and categorised as normal, abnormal NCS or abnormal CS. Data based on in-trial observation period is presented. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
| Change in Eye Examination Category | Week -8, Week 52 | Eye examination was performed by the investigator and categorised as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Data based on in-trial observation period is presented. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
| Anti-semaglutide Binding Antibodies (Yes/no) | Week 0 - 57 | Number of participants with the presence or absence (yes/no) of anti-semaglutide binding antibodies in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg. Data based on the in-trial observation period was presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
| Anti-semaglutide Neutralising Antibodies (Yes/no) | Week 0 - 57 | Number of participants with the presence or absence (yes/no) of anti-semaglutide neutralising antibodies in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg. Data based on the in-trial observation period is presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
| Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no) | Week 0 - 57 | Number of participants with the presence or absence (yes/no) of anti-semaglutide binding antibodies cross reacting with native GLP-1 in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg. Data based on the in-trial observation period was presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
| Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no) | Week 0 - 57 | Number of participants with the presence or absence (yes/no) of anti-semaglutide neutralising antibodies cross reacting with native GLP-1 in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg. Data based on the in-trial observation period was presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
| Anti-semaglutide Binding Antibody Levels | Weeks 0-57 | This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-57). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
| Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes | Week 0 - 57 | Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data based on on-treatment observation period was presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation. |
| Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes | Weeks 0 - 57 | Number of participants with treatment emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes. Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data based on on-treatment observation period was presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation. |
| Change in HbA1c (Week 52) | Week 0, week 52 | Change from baseline (week 0) to week 52 in HbA1c. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Change in SF-36: Sub-domains | 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™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (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. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores is presented. A positive change score indicates an improvement since baseline. Data based on on-treatment without rescue medication observation period is presented. |
| Change in SF-36: Physical Component Summary (PCS) | Week 0, week 26, week 52 | Change in short form 36 v2.0 acute domain PCS from baseline (week 0) to week 56. SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. It consists of 2 component summary measures that further summarize 8 health domain scales. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. The scores 0-100 (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. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Data based on on-treatment without rescue medication observation period is presented. |
| Change in SF-36: Mental Component Summary (MCS) | Week 0, week 26, week 52 | Change in short form 36 v2.0 acute domain MCS from baseline (week 0) to week 56. SF- 36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The scores 0-100 (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. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Data based on on-treatment without rescue medication observation period is presented. |
| Change From Baseline in DTR-QOL: Total Score | Week 0, week 26, week 52 | Diabetes Therapy-Related QOL (DTR-QOL) questionnaire is a 29-item patient-reported survey of patient health that measures the influence of diabetes treatment on HRQoL on 4 domains on individual scale ranges: Burden on social activities and daily activities, Anxiety and dissatisfaction with treatment, Hypoglycemia and Satisfaction with treatment on a 7-point graded response scale. Higher item scores indicate a higher level of HRQoL for items 1-25. For items 26-29 a higher score indicates a lower level of HRQoL. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100. The total score, after simple addition of the item scores, is converted to 0 - 100 (best-case response = 100; worstcase response = 0). Data based on on-treatment without rescue medication observation period is presented. |
| Change From Baseline in DTR-QOL: Sub-domains | Week 0, week 26, week 52 | DTR-QOL questionnaire is a 29-item patient-reported survey of patient health that measures the the influence of diabetes treatment on HRQoL. DTR-QOL questionnaire measured the HRQoL on 4 domains on individual scale ranges: Burden on social activities and daily activities, Anxiety and dissatisfaction with treatment, Hypoglycemia and Satisfaction with treatment on a 7-point graded response scale. Higher item scores indicate a higher level of HRQoL for items 1-25. For items 26-29 a higher score indicates a lower level of HRQoL. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100. W26 and W52 refer to week 26 and week 52 respectively. Data based on on-treatment without rescue medication observation period was presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Semaglutide Plasma Concentration | Week 26 and week 52 | Semaglutide plasma concentration is presented. Samples for pharmacokinetic (PK) analysis were drawn at any time during the visit except for the visit at week 26 where samples were taken both pre-dose and 60-90 minutes post dosing. This endpoint is applicable only to the reporting groups, Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg. Data based on on-treatment observation period was presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation. |
Countries
Japan
Participant flow
Recruitment details
The trial was conducted at 16 sites in Japan. Japanese participants with type 2 diabetes (T2D) treated with either diet and exercise alone or with oral anti-diabetic drug (OAD) monotherapy for at least 30 days prior to screening were enrolled in the study.
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 received 3.0 mg of oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water. | 49 |
| Oral Semaglutide 7 mg Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 7 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water. | 49 |
| Oral Semaglutide 14 mg Participants received oral semaglutide tablets once daily in the morning in fasted state for 52 weeks. Participants started oral semaglutide at 3 mg and were dose escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to week 52). The oral semaglutide tablet was taken once daily in a fasting state at least 30 min before the first meal of the day with up to half a glass of water. | 48 |
| Liraglutide 0.9 mg Participants received liraglutide for 52 weeks. Liraglutide was administered once-daily as subcutaneous injection (under the skin) in the abdomen, thigh or upper arm and was taken with or without food, preferably at the same time in the morning or evening. Participants initiated liraglutide at 0.3 mg once-daily, and were dose escalated after 1 week to 0.6 mg, and then dose escalated after 1 week to the recommended maximum dose of 0.9 mg. | 48 |
| Placebo Participants received placebo (for oral semaglutide) tablets once daily for 52 weeks. The placebo tablet was taken once daily in the morning in a fasting state at least 30 min before the first meal of the day with up to half a glass of water. | 49 |
| Total | 243 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 0 | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Liraglutide 0.9 mg | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 58 Years STANDARD_DEVIATION 9 | 60 Years STANDARD_DEVIATION 10 | 61 Years STANDARD_DEVIATION 9 | 59 Years STANDARD_DEVIATION 10 | 59 Years STANDARD_DEVIATION 9 | 59 Years STANDARD_DEVIATION 9 |
| Baseline HbA1c | 8.1 Percentage of HbA1c STANDARD_DEVIATION 0.8 | 8.3 Percentage of HbA1c STANDARD_DEVIATION 1 | 8.0 Percentage of HbA1c STANDARD_DEVIATION 0.9 | 8.3 Percentage of HbA1c STANDARD_DEVIATION 0.8 | 8.3 Percentage of HbA1c STANDARD_DEVIATION 1.1 | 8.2 Percentage of HbA1c STANDARD_DEVIATION 0.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 49 Participants | 48 Participants | 48 Participants | 49 Participants | 243 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 49 Participants | 49 Participants | 48 Participants | 48 Participants | 49 Participants | 243 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 8 Participants | 9 Participants | 9 Participants | 52 Participants |
| Sex: Female, Male Male | 36 Participants | 36 Participants | 40 Participants | 39 Participants | 40 Participants | 191 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 49 | 0 / 48 | 0 / 48 | 0 / 49 |
| other Total, other adverse events | 29 / 49 | 21 / 49 | 25 / 48 | 23 / 48 | 27 / 49 |
| serious Total, serious adverse events | 2 / 49 | 3 / 49 | 0 / 48 | 0 / 48 | 3 / 49 |
Outcome results
Primary
Change in HbA1c (Week 26)
Change from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c). The endpoint was analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. The endpoint was also evaluated based on data from the in-trial observation period. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
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) | On-treatment without rescue medication | -1.1 Percentage point of HbA1c | Standard Deviation 0.8 |
| Oral Semaglutide 3 mg | Change in HbA1c (Week 26) | In-trial observation period | -1.1 Percentage point of HbA1c | Standard Deviation 0.8 |
| Oral Semaglutide 7 mg | Change in HbA1c (Week 26) | On-treatment without rescue medication | -1.7 Percentage point of HbA1c | Standard Deviation 0.8 |
| Oral Semaglutide 7 mg | Change in HbA1c (Week 26) | In-trial observation period | -1.6 Percentage point of HbA1c | Standard Deviation 0.8 |
| Oral Semaglutide 14 mg | Change in HbA1c (Week 26) | On-treatment without rescue medication | -1.7 Percentage point of HbA1c | Standard Deviation 0.8 |
| Oral Semaglutide 14 mg | Change in HbA1c (Week 26) | In-trial observation period | -1.7 Percentage point of HbA1c | Standard Deviation 0.9 |
| Liraglutide 0.9 mg | Change in HbA1c (Week 26) | In-trial observation period | -1.4 Percentage point of HbA1c | Standard Deviation 1.1 |
| Liraglutide 0.9 mg | Change in HbA1c (Week 26) | On-treatment without rescue medication | -1.4 Percentage point of HbA1c | Standard Deviation 1.1 |
| Placebo | Change in HbA1c (Week 26) | On-treatment without rescue medication | -0.2 Percentage point of HbA1c | Standard Deviation 0.7 |
| Placebo | Change in HbA1c (Week 26) | In-trial observation period | -0.4 Percentage point of HbA1c | Standard Deviation 1 |
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 and stratification factor 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: [-1.4, -0.8]Mixed model for repeated measurements
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 and stratification factor 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: [-1.7, -1.2]Mixed model for repeated measurements
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 and stratification factor 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: [-2, -1.4]Mixed model for repeated measurements
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 and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: 0.079995% CI: [0, 0.6]Mixed model for repeated measurements
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 and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: 0.394295% CI: [-0.4, 0.2]Mixed model for repeated measurements
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 and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: 0.027295% CI: [-0.6, 0]Mixed model for repeated measurement
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 and stratification factor as categorical fixed effects and baseline HbA1c as a 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, -0.5]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 and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [-1.5, -0.9]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 and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [-1.7, -1.1]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 and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: 0.195895% CI: [-0.1, 0.5]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 and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: 0.186895% CI: [-0.5, 0.1]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 and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: 0.007795% CI: [-0.7, -0.1]Pattern Mixture model
Secondary
Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)
Number of participants with the presence or absence (yes/no) of anti-semaglutide binding antibodies cross reacting with native GLP-1 in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg. Data based on the in-trial observation period was presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time frame: Week 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 | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no) | Yes | 0 Participants |
| Oral Semaglutide 3 mg | Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no) | No | 49 Participants |
| Oral Semaglutide 7 mg | Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no) | Yes | 0 Participants |
| Oral Semaglutide 7 mg | Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no) | No | 49 Participants |
| Oral Semaglutide 14 mg | Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no) | Yes | 1 Participants |
| Oral Semaglutide 14 mg | Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no) | No | 47 Participants |
Secondary
Anti-semaglutide Binding Antibodies (Yes/no)
Number of participants with the presence or absence (yes/no) of anti-semaglutide binding antibodies in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg. Data based on the in-trial observation period was presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time frame: Week 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 | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Anti-semaglutide Binding Antibodies (Yes/no) | Yes | 0 Participants |
| Oral Semaglutide 3 mg | Anti-semaglutide Binding Antibodies (Yes/no) | No | 49 Participants |
| Oral Semaglutide 7 mg | Anti-semaglutide Binding Antibodies (Yes/no) | Yes | 1 Participants |
| Oral Semaglutide 7 mg | Anti-semaglutide Binding Antibodies (Yes/no) | No | 48 Participants |
| Oral Semaglutide 14 mg | Anti-semaglutide Binding Antibodies (Yes/no) | Yes | 1 Participants |
| Oral Semaglutide 14 mg | Anti-semaglutide Binding Antibodies (Yes/no) | No | 47 Participants |
Secondary
Anti-semaglutide Binding Antibody Levels
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-57). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time frame: Weeks 0-57
Population: Overall number of participants analyzed=number of participants who were found positive for anti-semaglutide antibodies.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 7 mg | Anti-semaglutide Binding Antibody Levels | Week 8 | 1.58 %B/T | Standard Deviation 0 |
| Oral Semaglutide 14 mg | Anti-semaglutide Binding Antibody Levels | Week 38 | 2.40 %B/T | Standard Deviation 0 |
| Unknown | Anti-semaglutide Binding Antibody Levels | Week 26 | — %B/T | — |
| Unknown | Anti-semaglutide Binding Antibody Levels | Week 4 | — %B/T | — |
| Unknown | Anti-semaglutide Binding Antibody Levels | Week 57 | — %B/T | — |
| Unknown | Anti-semaglutide Binding Antibody Levels | Week 52 | — %B/T | — |
| Unknown | Anti-semaglutide Binding Antibody Levels | Week 14 | — %B/T | — |
Secondary
Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)
Number of participants with the presence or absence (yes/no) of anti-semaglutide neutralising antibodies cross reacting with native GLP-1 in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg. Data based on the in-trial observation period was presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time frame: Week 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 | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no) | No | 49 Participants |
| Oral Semaglutide 3 mg | Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no) | Yes | 0 Participants |
| Oral Semaglutide 7 mg | Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no) | No | 49 Participants |
| Oral Semaglutide 7 mg | Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no) | Yes | 0 Participants |
| Oral Semaglutide 14 mg | Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no) | Yes | 0 Participants |
| Oral Semaglutide 14 mg | Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no) | No | 48 Participants |
Secondary
Anti-semaglutide Neutralising Antibodies (Yes/no)
Number of participants with the presence or absence (yes/no) of anti-semaglutide neutralising antibodies in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg. Data based on the in-trial observation period is presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time frame: Week 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 | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Anti-semaglutide Neutralising Antibodies (Yes/no) | Yes | 0 Participants |
| Oral Semaglutide 3 mg | Anti-semaglutide Neutralising Antibodies (Yes/no) | No | 49 Participants |
| Oral Semaglutide 7 mg | Anti-semaglutide Neutralising Antibodies (Yes/no) | Yes | 0 Participants |
| Oral Semaglutide 7 mg | Anti-semaglutide Neutralising Antibodies (Yes/no) | No | 49 Participants |
| Oral Semaglutide 14 mg | Anti-semaglutide Neutralising Antibodies (Yes/no) | Yes | 0 Participants |
| Oral Semaglutide 14 mg | Anti-semaglutide Neutralising Antibodies (Yes/no) | No | 48 Participants |
Secondary
Change From Baseline in DTR-QOL: Sub-domains
DTR-QOL questionnaire is a 29-item patient-reported survey of patient health that measures the the influence of diabetes treatment on HRQoL. DTR-QOL questionnaire measured the HRQoL on 4 domains on individual scale ranges: Burden on social activities and daily activities, Anxiety and dissatisfaction with treatment, Hypoglycemia and Satisfaction with treatment on a 7-point graded response scale. Higher item scores indicate a higher level of HRQoL for items 1-25. For items 26-29 a higher score indicates a lower level of HRQoL. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100. W26 and W52 refer to week 26 and week 52 respectively. Data based on on-treatment without rescue medication observation period was presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
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 From Baseline in DTR-QOL: Sub-domains | W26: Burden on social and daily activities | 5.75 Score on a scale | Standard Deviation 20.31 |
| Oral Semaglutide 3 mg | Change From Baseline in DTR-QOL: Sub-domains | W52: Burden on social and daily activities | 9.31 Score on a scale | Standard Deviation 17.06 |
| Oral Semaglutide 3 mg | Change From Baseline in DTR-QOL: Sub-domains | W26: Anxiety and dissatisfaction with treatment | 6.49 Score on a scale | Standard Deviation 18.32 |
| Oral Semaglutide 3 mg | Change From Baseline in DTR-QOL: Sub-domains | W52: Anxiety and dissatisfaction with treatment | 4.93 Score on a scale | Standard Deviation 19.32 |
| Oral Semaglutide 3 mg | Change From Baseline in DTR-QOL: Sub-domains | Week 26: Hypoglycemia | 8.33 Score on a scale | Standard Deviation 23.5 |
| Oral Semaglutide 3 mg | Change From Baseline in DTR-QOL: Sub-domains | Week 52: Hypoglycemia | 5.81 Score on a scale | Standard Deviation 19.07 |
| Oral Semaglutide 3 mg | Change From Baseline in DTR-QOL: Sub-domains | Week 26: Satisfaction with treatment | 8.33 Score on a scale | Standard Deviation 16.39 |
| Oral Semaglutide 3 mg | Change From Baseline in DTR-QOL: Sub-domains | Week 52: Satisfaction with treatment | 4.61 Score on a scale | Standard Deviation 23.47 |
| Oral Semaglutide 7 mg | Change From Baseline in DTR-QOL: Sub-domains | W26: Anxiety and dissatisfaction with treatment | 10.46 Score on a scale | Standard Deviation 15.27 |
| Oral Semaglutide 7 mg | Change From Baseline in DTR-QOL: Sub-domains | Week 52: Hypoglycemia | 1.26 Score on a scale | Standard Deviation 18.51 |
| Oral Semaglutide 7 mg | Change From Baseline in DTR-QOL: Sub-domains | W26: Burden on social and daily activities | 5.87 Score on a scale | Standard Deviation 13.06 |
| Oral Semaglutide 7 mg | Change From Baseline in DTR-QOL: Sub-domains | W52: Anxiety and dissatisfaction with treatment | 5.04 Score on a scale | Standard Deviation 16.52 |
| Oral Semaglutide 7 mg | Change From Baseline in DTR-QOL: Sub-domains | W52: Burden on social and daily activities | 5.49 Score on a scale | Standard Deviation 15.19 |
| Oral Semaglutide 7 mg | Change From Baseline in DTR-QOL: Sub-domains | Week 52: Satisfaction with treatment | 10.85 Score on a scale | Standard Deviation 24.74 |
| Oral Semaglutide 7 mg | Change From Baseline in DTR-QOL: Sub-domains | Week 26: Hypoglycemia | 3.15 Score on a scale | Standard Deviation 18.08 |
| Oral Semaglutide 7 mg | Change From Baseline in DTR-QOL: Sub-domains | Week 26: Satisfaction with treatment | 14.72 Score on a scale | Standard Deviation 23.21 |
| Oral Semaglutide 14 mg | Change From Baseline in DTR-QOL: Sub-domains | Week 26: Satisfaction with treatment | 17.14 Score on a scale | Standard Deviation 25.1 |
| Oral Semaglutide 14 mg | Change From Baseline in DTR-QOL: Sub-domains | Week 52: Satisfaction with treatment | 16.16 Score on a scale | Standard Deviation 26.8 |
| Oral Semaglutide 14 mg | Change From Baseline in DTR-QOL: Sub-domains | W52: Anxiety and dissatisfaction with treatment | 10.52 Score on a scale | Standard Deviation 16.04 |
| Oral Semaglutide 14 mg | Change From Baseline in DTR-QOL: Sub-domains | Week 52: Hypoglycemia | 8.13 Score on a scale | Standard Deviation 20.15 |
| Oral Semaglutide 14 mg | Change From Baseline in DTR-QOL: Sub-domains | W26: Anxiety and dissatisfaction with treatment | 14.68 Score on a scale | Standard Deviation 17.01 |
| Oral Semaglutide 14 mg | Change From Baseline in DTR-QOL: Sub-domains | W52: Burden on social and daily activities | 3.94 Score on a scale | Standard Deviation 19.66 |
| Oral Semaglutide 14 mg | Change From Baseline in DTR-QOL: Sub-domains | W26: Burden on social and daily activities | 7.90 Score on a scale | Standard Deviation 16.55 |
| Oral Semaglutide 14 mg | Change From Baseline in DTR-QOL: Sub-domains | Week 26: Hypoglycemia | 9.19 Score on a scale | Standard Deviation 20.95 |
| Liraglutide 0.9 mg | Change From Baseline in DTR-QOL: Sub-domains | W52: Burden on social and daily activities | 7.60 Score on a scale | Standard Deviation 18.73 |
| Liraglutide 0.9 mg | Change From Baseline in DTR-QOL: Sub-domains | W26: Anxiety and dissatisfaction with treatment | 13.52 Score on a scale | Standard Deviation 20.99 |
| Liraglutide 0.9 mg | Change From Baseline in DTR-QOL: Sub-domains | W52: Anxiety and dissatisfaction with treatment | 7.01 Score on a scale | Standard Deviation 20.45 |
| Liraglutide 0.9 mg | Change From Baseline in DTR-QOL: Sub-domains | Week 26: Hypoglycemia | 3.80 Score on a scale | Standard Deviation 26.53 |
| Liraglutide 0.9 mg | Change From Baseline in DTR-QOL: Sub-domains | Week 52: Hypoglycemia | 4.47 Score on a scale | Standard Deviation 22.94 |
| Liraglutide 0.9 mg | Change From Baseline in DTR-QOL: Sub-domains | Week 52: Satisfaction with treatment | 8.43 Score on a scale | Standard Deviation 22.64 |
| Liraglutide 0.9 mg | Change From Baseline in DTR-QOL: Sub-domains | W26: Burden on social and daily activities | 10.11 Score on a scale | Standard Deviation 17.38 |
| Liraglutide 0.9 mg | Change From Baseline in DTR-QOL: Sub-domains | Week 26: Satisfaction with treatment | 7.13 Score on a scale | Standard Deviation 25.6 |
| Placebo | Change From Baseline in DTR-QOL: Sub-domains | W52: Anxiety and dissatisfaction with treatment | -2.94 Score on a scale | Standard Deviation 22.27 |
| Placebo | Change From Baseline in DTR-QOL: Sub-domains | Week 52: Satisfaction with treatment | -5.39 Score on a scale | Standard Deviation 21.09 |
| Placebo | Change From Baseline in DTR-QOL: Sub-domains | W26: Anxiety and dissatisfaction with treatment | 1.83 Score on a scale | Standard Deviation 17.91 |
| Placebo | Change From Baseline in DTR-QOL: Sub-domains | Week 26: Satisfaction with treatment | -3.25 Score on a scale | Standard Deviation 24.96 |
| Placebo | Change From Baseline in DTR-QOL: Sub-domains | W26: Burden on social and daily activities | 6.91 Score on a scale | Standard Deviation 19.59 |
| Placebo | Change From Baseline in DTR-QOL: Sub-domains | Week 52: Hypoglycemia | 6.00 Score on a scale | Standard Deviation 16.26 |
| Placebo | Change From Baseline in DTR-QOL: Sub-domains | W52: Burden on social and daily activities | 2.90 Score on a scale | Standard Deviation 23.08 |
| Placebo | Change From Baseline in DTR-QOL: Sub-domains | Week 26: Hypoglycemia | 7.42 Score on a scale | Standard Deviation 20.3 |
Secondary
Change From Baseline in DTR-QOL: Total Score
Diabetes Therapy-Related QOL (DTR-QOL) questionnaire is a 29-item patient-reported survey of patient health that measures the influence of diabetes treatment on HRQoL on 4 domains on individual scale ranges: Burden on social activities and daily activities, Anxiety and dissatisfaction with treatment, Hypoglycemia and Satisfaction with treatment on a 7-point graded response scale. Higher item scores indicate a higher level of HRQoL for items 1-25. For items 26-29 a higher score indicates a lower level of HRQoL. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100. The total score, after simple addition of the item scores, is converted to 0 - 100 (best-case response = 100; worstcase response = 0). Data based on on-treatment without rescue medication observation period is presented.
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. On-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in DTR-QOL: Total Score | Week 26 | 6.67 Score on a scale | Standard Deviation 15.81 |
| Oral Semaglutide 3 mg | Change From Baseline in DTR-QOL: Total Score | Week 52 | 6.97 Score on a scale | Standard Deviation 14.47 |
| Oral Semaglutide 7 mg | Change From Baseline in DTR-QOL: Total Score | Week 26 | 7.98 Score on a scale | Standard Deviation 11.47 |
| Oral Semaglutide 7 mg | Change From Baseline in DTR-QOL: Total Score | Week 52 | 5.52 Score on a scale | Standard Deviation 12.29 |
| Oral Semaglutide 14 mg | Change From Baseline in DTR-QOL: Total Score | Week 26 | 11.22 Score on a scale | Standard Deviation 12.99 |
| Oral Semaglutide 14 mg | Change From Baseline in DTR-QOL: Total Score | Week 52 | 8.02 Score on a scale | Standard Deviation 14.09 |
| Liraglutide 0.9 mg | Change From Baseline in DTR-QOL: Total Score | Week 52 | 7.12 Score on a scale | Standard Deviation 15.09 |
| Liraglutide 0.9 mg | Change From Baseline in DTR-QOL: Total Score | Week 26 | 9.77 Score on a scale | Standard Deviation 14.46 |
| Placebo | Change From Baseline in DTR-QOL: Total Score | Week 26 | 4.18 Score on a scale | Standard Deviation 14.13 |
| Placebo | Change From Baseline in DTR-QOL: Total Score | Week 52 | 0.57 Score on a scale | Standard Deviation 16.53 |
Secondary
Change in Amylase (Ratio to Baseine)
Change in amylase (measured as units per liter \[U/L\]) is presented as ratio to baseline. Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation.
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 Baseine) | Week 26 | 1.03 Ratio of amylase | Geometric Coefficient of Variation 20.1 |
| Oral Semaglutide 3 mg | Change in Amylase (Ratio to Baseine) | Week 52 | 1.06 Ratio of amylase | Geometric Coefficient of Variation 18.9 |
| Oral Semaglutide 7 mg | Change in Amylase (Ratio to Baseine) | Week 26 | 1.10 Ratio of amylase | Geometric Coefficient of Variation 20.7 |
| Oral Semaglutide 7 mg | Change in Amylase (Ratio to Baseine) | Week 52 | 1.10 Ratio of amylase | Geometric Coefficient of Variation 17.8 |
| Oral Semaglutide 14 mg | Change in Amylase (Ratio to Baseine) | Week 26 | 1.16 Ratio of amylase | Geometric Coefficient of Variation 30.9 |
| Oral Semaglutide 14 mg | Change in Amylase (Ratio to Baseine) | Week 52 | 1.12 Ratio of amylase | Geometric Coefficient of Variation 18 |
| Liraglutide 0.9 mg | Change in Amylase (Ratio to Baseine) | Week 52 | 1.06 Ratio of amylase | Geometric Coefficient of Variation 18.2 |
| Liraglutide 0.9 mg | Change in Amylase (Ratio to Baseine) | Week 26 | 1.07 Ratio of amylase | Geometric Coefficient of Variation 18.7 |
| Placebo | Change in Amylase (Ratio to Baseine) | Week 26 | 1.02 Ratio of amylase | Geometric Coefficient of Variation 18.9 |
| Placebo | Change in Amylase (Ratio to Baseine) | Week 52 | 1.02 Ratio of amylase | Geometric Coefficient of Variation 16.7 |
Secondary
Change in Beta-cell Function (HOMA-B) (Ratio to Baseline)
Change from baseline (week 0) in beta-cell function (measured as percentage of beta-cell function) by homeostatic model assessment index of beta-cell function is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 0, week 26 and 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 Beta-cell Function (HOMA-B) (Ratio to Baseline) | Week 26 | 1.71 Ratio of beta-cell function | Geometric Coefficient of Variation 38.6 |
| Oral Semaglutide 3 mg | Change in Beta-cell Function (HOMA-B) (Ratio to Baseline) | Week 52 | 1.36 Ratio of beta-cell function | Geometric Coefficient of Variation 40.6 |
| Oral Semaglutide 7 mg | Change in Beta-cell Function (HOMA-B) (Ratio to Baseline) | Week 26 | 1.93 Ratio of beta-cell function | Geometric Coefficient of Variation 41.2 |
| Oral Semaglutide 7 mg | Change in Beta-cell Function (HOMA-B) (Ratio to Baseline) | Week 52 | 1.75 Ratio of beta-cell function | Geometric Coefficient of Variation 47.2 |
| Oral Semaglutide 14 mg | Change in Beta-cell Function (HOMA-B) (Ratio to Baseline) | Week 26 | 1.95 Ratio of beta-cell function | Geometric Coefficient of Variation 42.7 |
| Oral Semaglutide 14 mg | Change in Beta-cell Function (HOMA-B) (Ratio to Baseline) | Week 52 | 1.86 Ratio of beta-cell function | Geometric Coefficient of Variation 35.3 |
| Liraglutide 0.9 mg | Change in Beta-cell Function (HOMA-B) (Ratio to Baseline) | Week 52 | 1.69 Ratio of beta-cell function | Geometric Coefficient of Variation 42.2 |
| Liraglutide 0.9 mg | Change in Beta-cell Function (HOMA-B) (Ratio to Baseline) | Week 26 | 1.89 Ratio of beta-cell function | Geometric Coefficient of Variation 40.2 |
| Placebo | Change in Beta-cell Function (HOMA-B) (Ratio to Baseline) | Week 26 | 1.00 Ratio of beta-cell function | Geometric Coefficient of Variation 32.7 |
| Placebo | Change in Beta-cell Function (HOMA-B) (Ratio to Baseline) | Week 52 | 0.89 Ratio of beta-cell function | Geometric Coefficient of Variation 29.2 |
Secondary
Change in Blood Pressure
Change from baseline in blood pressure (systolic \[sBP\] and diastolic \[dBP\]). Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation.
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 Blood Pressure | Week 26: sBP | -3 Millimeters of mercury (mmHg) | Standard Deviation 13 |
| Oral Semaglutide 3 mg | Change in Blood Pressure | Week 52: sBP | -0 Millimeters of mercury (mmHg) | Standard Deviation 12 |
| Oral Semaglutide 3 mg | Change in Blood Pressure | Week 26: dBP | -0 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Oral Semaglutide 3 mg | Change in Blood Pressure | Week 52: dBP | -1 Millimeters of mercury (mmHg) | Standard Deviation 8 |
| Oral Semaglutide 7 mg | Change in Blood Pressure | Week 26: sBP | -5 Millimeters of mercury (mmHg) | Standard Deviation 12 |
| Oral Semaglutide 7 mg | Change in Blood Pressure | Week 52: dBP | -0 Millimeters of mercury (mmHg) | Standard Deviation 7 |
| Oral Semaglutide 7 mg | Change in Blood Pressure | Week 52: sBP | -1 Millimeters of mercury (mmHg) | Standard Deviation 10 |
| Oral Semaglutide 7 mg | Change in Blood Pressure | Week 26: dBP | -2 Millimeters of mercury (mmHg) | Standard Deviation 7 |
| Oral Semaglutide 14 mg | Change in Blood Pressure | Week 52: dBP | -0 Millimeters of mercury (mmHg) | Standard Deviation 7 |
| Oral Semaglutide 14 mg | Change in Blood Pressure | Week 52: sBP | -1 Millimeters of mercury (mmHg) | Standard Deviation 10 |
| Oral Semaglutide 14 mg | Change in Blood Pressure | Week 26: dBP | 1 Millimeters of mercury (mmHg) | Standard Deviation 6 |
| Oral Semaglutide 14 mg | Change in Blood Pressure | Week 26: sBP | -2 Millimeters of mercury (mmHg) | Standard Deviation 12 |
| Liraglutide 0.9 mg | Change in Blood Pressure | Week 26: sBP | -1 Millimeters of mercury (mmHg) | Standard Deviation 13 |
| Liraglutide 0.9 mg | Change in Blood Pressure | Week 52: sBP | 1 Millimeters of mercury (mmHg) | Standard Deviation 15 |
| Liraglutide 0.9 mg | Change in Blood Pressure | Week 52: dBP | -0 Millimeters of mercury (mmHg) | Standard Deviation 10 |
| Liraglutide 0.9 mg | Change in Blood Pressure | Week 26: dBP | -1 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Placebo | Change in Blood Pressure | Week 52: dBP | -2 Millimeters of mercury (mmHg) | Standard Deviation 8 |
| Placebo | Change in Blood Pressure | Week 26: dBP | -3 Millimeters of mercury (mmHg) | Standard Deviation 10 |
| Placebo | Change in Blood Pressure | Week 52: sBP | -3 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Placebo | Change in Blood Pressure | Week 26: sBP | -4 Millimeters of mercury (mmHg) | Standard Deviation 11 |
Secondary
Change in Body Mass Index
Change from baseline (week 0) in body mass index (BMI). BMI was calculated based on body weight and height based on the formulae: BMI kg/m\^2 = body weight (kg)/(Height (m) x Height (m)). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 0, week 26 and 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 | -0.1 Kilogram per square meter (kg/m^2) | Standard Deviation 0.7 |
| Oral Semaglutide 3 mg | Change in Body Mass Index | Week 52 | 0.0 Kilogram per square meter (kg/m^2) | Standard Deviation 0.9 |
| Oral Semaglutide 7 mg | Change in Body Mass Index | Week 26 | -0.4 Kilogram per square meter (kg/m^2) | Standard Deviation 0.7 |
| Oral Semaglutide 7 mg | Change in Body Mass Index | Week 52 | -0.3 Kilogram per square meter (kg/m^2) | Standard Deviation 0.8 |
| Oral Semaglutide 14 mg | Change in Body Mass Index | Week 26 | -0.9 Kilogram per square meter (kg/m^2) | Standard Deviation 1.1 |
| Oral Semaglutide 14 mg | Change in Body Mass Index | Week 52 | -1.1 Kilogram per square meter (kg/m^2) | Standard Deviation 1.5 |
| Liraglutide 0.9 mg | Change in Body Mass Index | Week 52 | 0.2 Kilogram per square meter (kg/m^2) | Standard Deviation 0.7 |
| Liraglutide 0.9 mg | Change in Body Mass Index | Week 26 | 0.0 Kilogram per square meter (kg/m^2) | Standard Deviation 0.6 |
| Placebo | Change in Body Mass Index | Week 26 | -0.4 Kilogram per square meter (kg/m^2) | Standard Deviation 0.6 |
| Placebo | Change in Body Mass Index | Week 52 | -0.4 Kilogram per square meter (kg/m^2) | Standard Deviation 0.6 |
Secondary
Change in Body Weight (%)
Relative change (%) from baseline (week 0) in body weight (kg). Data based on on-treatment without resue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 0, week 26 and 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 (%) | Week 26 | -0.64 Percentage change | Standard Deviation 2.65 |
| Oral Semaglutide 3 mg | Change in Body Weight (%) | Week 52 | -0.03 Percentage change | Standard Deviation 3.25 |
| Oral Semaglutide 7 mg | Change in Body Weight (%) | Week 26 | -1.63 Percentage change | Standard Deviation 2.78 |
| Oral Semaglutide 7 mg | Change in Body Weight (%) | Week 52 | -1.23 Percentage change | Standard Deviation 3.09 |
| Oral Semaglutide 14 mg | Change in Body Weight (%) | Week 26 | -3.54 Percentage change | Standard Deviation 4.33 |
| Oral Semaglutide 14 mg | Change in Body Weight (%) | Week 52 | -4.42 Percentage change | Standard Deviation 5.91 |
| Liraglutide 0.9 mg | Change in Body Weight (%) | Week 52 | 0.68 Percentage change | Standard Deviation 2.73 |
| Liraglutide 0.9 mg | Change in Body Weight (%) | Week 26 | 0.08 Percentage change | Standard Deviation 2.23 |
| Placebo | Change in Body Weight (%) | Week 26 | -1.58 Percentage change | Standard Deviation 2.27 |
| Placebo | Change in Body Weight (%) | Week 52 | -1.42 Percentage change | Standard Deviation 2.47 |
Secondary
Change in Body Weight (kg)
Change from baseline (week 0) in body weight. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
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 (kg) | Week 26 | -0.4 Kilogram (kg) | Standard Deviation 1.9 |
| Oral Semaglutide 3 mg | Change in Body Weight (kg) | Week 52 | 0.0 Kilogram (kg) | Standard Deviation 2.4 |
| Oral Semaglutide 7 mg | Change in Body Weight (kg) | Week 26 | -1.2 Kilogram (kg) | Standard Deviation 1.9 |
| Oral Semaglutide 7 mg | Change in Body Weight (kg) | Week 52 | -0.8 Kilogram (kg) | Standard Deviation 2.1 |
| Oral Semaglutide 14 mg | Change in Body Weight (kg) | Week 26 | -2.4 Kilogram (kg) | Standard Deviation 3 |
| Oral Semaglutide 14 mg | Change in Body Weight (kg) | Week 52 | -2.9 Kilogram (kg) | Standard Deviation 3.9 |
| Liraglutide 0.9 mg | Change in Body Weight (kg) | Week 52 | 0.5 Kilogram (kg) | Standard Deviation 2 |
| Liraglutide 0.9 mg | Change in Body Weight (kg) | Week 26 | 0.1 Kilogram (kg) | Standard Deviation 1.6 |
| Placebo | Change in Body Weight (kg) | Week 26 | -1.1 Kilogram (kg) | Standard Deviation 1.6 |
| Placebo | Change in Body Weight (kg) | Week 52 | -1.0 Kilogram (kg) | Standard Deviation 1.7 |
Secondary
Change in ECG Evaluation
Electrocardiogram (ECG) was evaluated and interpreted by the investigator and categorised as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). The number of participants who had shifted from normal, abnormal NCS or abnormal CS ECG results from baseline (week 0) to week 26, week 52 is presented. Data based on in-trial observation period is presented. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication 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 | Abnormal CS (week 0) to abnormal CS (week 26) | 0 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) | 2 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal NCS (week 26) | 3 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 26) | 4 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 | Abnormal CS (week 0) to abnormal CS (week 52) | 0 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal CS (week 0) to normal (week 52) | 2 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal CS (week 52) | 0 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal NCS (week 52) | 3 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to normal (week 52) | 3 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 (week 0) to abnormal NCS (week 52) | 0 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 52) | 0 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 52) | 1 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 52) | 37 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to normal (week 26) | 3 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 26) | 34 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal CS (week 0) to normal (week 52) | 0 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 26) | 41 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 26) | 0 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) | 1 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal NCS (week 26) | 5 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) | 2 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 52) | 40 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 52) | 1 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 52) | 0 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to normal (week 52) | 2 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal NCS (week 52) | 4 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal CS (week 52) | 0 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal NCS (week 52) | 0 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal CS (week 52) | 2 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 52) | 3 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 26) | 0 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 | Abnormal CS (week 0) to abnormal NCS (week 52) | 0 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 52) | 0 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 NCS (week 0) to abnormal NCS (week 52) | 5 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to normal (week 52) | 2 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 26) | 39 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal NCS (week 26) | 4 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal CS (week 52) | 0 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 52) | 36 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to normal (week 26) | 3 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal CS (week 52) | 0 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal CS (week 0) to normal (week 52) | 1 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal CS (week 26) | 1 Participants |
| Liraglutide 0.9 mg | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal NCS (week 52) | 0 Participants |
| Liraglutide 0.9 mg | Change in ECG Evaluation | Abnormal CS (week 0) to normal (week 52) | 0 Participants |
| Liraglutide 0.9 mg | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Liraglutide 0.9 mg | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal CS (week 26) | 1 Participants |
| Liraglutide 0.9 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 26) | 38 Participants |
| Liraglutide 0.9 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 52) | 37 Participants |
| Liraglutide 0.9 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Liraglutide 0.9 mg | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal CS (week 52) | 1 Participants |
| Liraglutide 0.9 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 52) | 2 Participants |
| Liraglutide 0.9 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 52) | 0 Participants |
| Liraglutide 0.9 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to normal (week 52) | 2 Participants |
| Liraglutide 0.9 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 26) | 2 Participants |
| Liraglutide 0.9 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal NCS (week 52) | 3 Participants |
| Liraglutide 0.9 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal CS (week 52) | 0 Participants |
| Liraglutide 0.9 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to normal (week 26) | 1 Participants |
| Liraglutide 0.9 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal NCS (week 26) | 4 Participants |
| Liraglutide 0.9 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Liraglutide 0.9 mg | Change in ECG Evaluation | Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Placebo | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 52) | 2 Participants |
| Placebo | Change in ECG Evaluation | Normal (week 0) to normal (week 52) | 39 Participants |
| Placebo | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change in ECG Evaluation | Abnormal NCS (week 0) to normal (week 26) | 1 Participants |
| Placebo | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal CS (week 52) | 0 Participants |
| Placebo | Change in ECG Evaluation | Abnormal CS (week 0) to normal (week 52) | 0 Participants |
| Placebo | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal NCS (week 26) | 1 Participants |
| Placebo | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal NCS (week 26) | 6 Participants |
| Placebo | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal NCS (week 52) | 1 Participants |
| Placebo | Change in ECG Evaluation | Normal (week 0) to normal (week 26) | 39 Participants |
| Placebo | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 26) | 2 Participants |
| Placebo | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change in ECG Evaluation | Abnormal NCS (week 0) to normal (week 52) | 3 Participants |
| Placebo | Change in ECG Evaluation | Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Placebo | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal CS (week 52) | 0 Participants |
| Placebo | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 52) | 0 Participants |
| Placebo | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal NCS (week 52) | 4 Participants |
Secondary
Change in Eye Examination Category
Eye examination was performed by the investigator and categorised as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Data based on in-trial observation period is presented. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time frame: Week -8, 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 Eye Examination Category | Week -8: Right eye- Abnormal NCS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Week 52: Left eye- Normal | 36 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Week 52: Left eye- Abnormal CS | 6 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Week -8: Right eye- Abnormal CS | 5 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Week -8: Left eye- Normal | 39 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Week -8: Left eye- Abnormal CS | 6 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Week 52: Right eye- Abnormal CS | 5 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Week 52: Right eye- Normal | 39 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Week 52: Right eye- Abnormal NCS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Week -8: Left eye- Abnormal NCS | 4 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Week 52: Left eye- Abnormal NCS | 4 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Week -8: Right eye- Normal | 42 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Week 52: Right eye- Normal | 44 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Week -8: Right eye- Abnormal NCS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Week -8: Left eye- Abnormal CS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Week -8: Right eye- Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Week 52: Left eye- Normal | 46 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Week 52: Right eye- Abnormal NCS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Week 52: Right eye- Abnormal CS | 3 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Week -8: Right eye- Normal | 46 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Week -8: Left eye- Normal | 45 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Week 52: Left eye- Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Week 52: Left eye- Abnormal NCS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Week -8: Left eye- Abnormal NCS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Week -8: Right eye- Normal | 36 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Week 52: Left eye- Abnormal NCS | 5 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Week 52: Right eye- Abnormal NCS | 7 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Week 52: Left eye- Abnormal CS | 4 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Week 52: Right eye- Abnormal CS | 4 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Week 52: Right eye- Normal | 36 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Week -8: Left eye- Normal | 37 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Week -8: Right eye- Abnormal NCS | 5 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Week -8: Left eye- Abnormal NCS | 4 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Week -8: Right eye- Abnormal CS | 7 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Week -8: Left eye- Abnormal CS | 7 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Week 52: Left eye- Normal | 38 Participants |
| Liraglutide 0.9 mg | Change in Eye Examination Category | Week -8: Right eye- Abnormal CS | 3 Participants |
| Liraglutide 0.9 mg | Change in Eye Examination Category | Week 52: Right eye- Normal | 39 Participants |
| Liraglutide 0.9 mg | Change in Eye Examination Category | Week 52: Right eye- Abnormal NCS | 5 Participants |
| Liraglutide 0.9 mg | Change in Eye Examination Category | Week 52: Right eye- Abnormal CS | 1 Participants |
| Liraglutide 0.9 mg | Change in Eye Examination Category | Week -8: Left eye- Normal | 37 Participants |
| Liraglutide 0.9 mg | Change in Eye Examination Category | Week -8: Left eye- Abnormal NCS | 6 Participants |
| Liraglutide 0.9 mg | Change in Eye Examination Category | Week -8: Left eye- Abnormal CS | 5 Participants |
| Liraglutide 0.9 mg | Change in Eye Examination Category | Week 52: Left eye- Normal | 37 Participants |
| Liraglutide 0.9 mg | Change in Eye Examination Category | Week 52: Left eye- Abnormal NCS | 5 Participants |
| Liraglutide 0.9 mg | Change in Eye Examination Category | Week 52: Left eye- Abnormal CS | 3 Participants |
| Liraglutide 0.9 mg | Change in Eye Examination Category | Week -8: Right eye- Normal | 38 Participants |
| Liraglutide 0.9 mg | Change in Eye Examination Category | Week -8: Right eye- Abnormal NCS | 7 Participants |
| Placebo | Change in Eye Examination Category | Week 52: Left eye- Normal | 41 Participants |
| Placebo | Change in Eye Examination Category | Week 52: Right eye- Normal | 44 Participants |
| Placebo | Change in Eye Examination Category | Week -8: Right eye- Normal | 39 Participants |
| Placebo | Change in Eye Examination Category | Week -8: Left eye- Abnormal CS | 5 Participants |
| Placebo | Change in Eye Examination Category | Week -8: Left eye- Abnormal NCS | 5 Participants |
| Placebo | Change in Eye Examination Category | Week -8: Left eye- Normal | 39 Participants |
| Placebo | Change in Eye Examination Category | Week -8: Right eye- Abnormal CS | 6 Participants |
| Placebo | Change in Eye Examination Category | Week -8: Right eye- Abnormal NCS | 4 Participants |
| Placebo | Change in Eye Examination Category | Week 52: Right eye- Abnormal CS | 2 Participants |
| Placebo | Change in Eye Examination Category | Week 52: Right eye- Abnormal NCS | 3 Participants |
| Placebo | Change in Eye Examination Category | Week 52: Left eye- Abnormal CS | 5 Participants |
| Placebo | Change in Eye Examination Category | Week 52: Left eye- Abnormal NCS | 3 Participants |
Secondary
Change in Fasting C-peptide (Ratio to Baseline)
Change from baseline (week 0) in fasting C-peptide (measured as nanomoles per liter \[nmol/L\]) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 0, week 26 and 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 Fasting C-peptide (Ratio to Baseline) | Week 26 | 1.15 Ratio of C-peptide | Geometric Coefficient of Variation 23.2 |
| Oral Semaglutide 3 mg | Change in Fasting C-peptide (Ratio to Baseline) | Week 52 | 1.12 Ratio of C-peptide | Geometric Coefficient of Variation 24.9 |
| Oral Semaglutide 7 mg | Change in Fasting C-peptide (Ratio to Baseline) | Week 26 | 1.24 Ratio of C-peptide | Geometric Coefficient of Variation 32.8 |
| Oral Semaglutide 7 mg | Change in Fasting C-peptide (Ratio to Baseline) | Week 52 | 1.19 Ratio of C-peptide | Geometric Coefficient of Variation 21.9 |
| Oral Semaglutide 14 mg | Change in Fasting C-peptide (Ratio to Baseline) | Week 26 | 1.17 Ratio of C-peptide | Geometric Coefficient of Variation 35 |
| Oral Semaglutide 14 mg | Change in Fasting C-peptide (Ratio to Baseline) | Week 52 | 1.10 Ratio of C-peptide | Geometric Coefficient of Variation 34.2 |
| Liraglutide 0.9 mg | Change in Fasting C-peptide (Ratio to Baseline) | Week 52 | 1.11 Ratio of C-peptide | Geometric Coefficient of Variation 24.1 |
| Liraglutide 0.9 mg | Change in Fasting C-peptide (Ratio to Baseline) | Week 26 | 1.18 Ratio of C-peptide | Geometric Coefficient of Variation 23.3 |
| Placebo | Change in Fasting C-peptide (Ratio to Baseline) | Week 26 | 0.98 Ratio of C-peptide | Geometric Coefficient of Variation 20.7 |
| Placebo | Change in Fasting C-peptide (Ratio to Baseline) | Week 52 | 0.99 Ratio of C-peptide | Geometric Coefficient of Variation 20.6 |
Secondary
Change in Fasting Glucagon (Ratio to Baseline)
Change from baseline (week 0) in fasting glucagon (measured as picograms per milliliter \[pg/mL\]) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 0, week 26 and 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 Fasting Glucagon (Ratio to Baseline) | Week 26 | 0.95 Ratio of glucagon | Geometric Coefficient of Variation 16.3 |
| Oral Semaglutide 3 mg | Change in Fasting Glucagon (Ratio to Baseline) | Week 52 | 0.97 Ratio of glucagon | Geometric Coefficient of Variation 14.7 |
| Oral Semaglutide 7 mg | Change in Fasting Glucagon (Ratio to Baseline) | Week 26 | 0.89 Ratio of glucagon | Geometric Coefficient of Variation 25.1 |
| Oral Semaglutide 7 mg | Change in Fasting Glucagon (Ratio to Baseline) | Week 52 | 0.95 Ratio of glucagon | Geometric Coefficient of Variation 19.1 |
| Oral Semaglutide 14 mg | Change in Fasting Glucagon (Ratio to Baseline) | Week 26 | 0.85 Ratio of glucagon | Geometric Coefficient of Variation 22.9 |
| Oral Semaglutide 14 mg | Change in Fasting Glucagon (Ratio to Baseline) | Week 52 | 0.92 Ratio of glucagon | Geometric Coefficient of Variation 19.8 |
| Liraglutide 0.9 mg | Change in Fasting Glucagon (Ratio to Baseline) | Week 52 | 0.93 Ratio of glucagon | Geometric Coefficient of Variation 18.4 |
| Liraglutide 0.9 mg | Change in Fasting Glucagon (Ratio to Baseline) | Week 26 | 0.91 Ratio of glucagon | Geometric Coefficient of Variation 18.7 |
| Placebo | Change in Fasting Glucagon (Ratio to Baseline) | Week 26 | 0.95 Ratio of glucagon | Geometric Coefficient of Variation 16 |
| Placebo | Change in Fasting Glucagon (Ratio to Baseline) | Week 52 | 0.96 Ratio of glucagon | Geometric Coefficient of Variation 14.2 |
Secondary
Change in Fasting Insulin (Ratio to Baseline)
Change from baseline (week 0) in fasting insulin (measured as picomoles per liter \[pmol/L\]) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 0, week 26 and 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 Fasting Insulin (Ratio to Baseline) | Week 26 | 1.19 Ratio of insulin | Geometric Coefficient of Variation 31.9 |
| Oral Semaglutide 3 mg | Change in Fasting Insulin (Ratio to Baseline) | Week 52 | 1.07 Ratio of insulin | Geometric Coefficient of Variation 32.2 |
| Oral Semaglutide 7 mg | Change in Fasting Insulin (Ratio to Baseline) | Week 26 | 1.27 Ratio of insulin | Geometric Coefficient of Variation 49 |
| Oral Semaglutide 7 mg | Change in Fasting Insulin (Ratio to Baseline) | Week 52 | 1.16 Ratio of insulin | Geometric Coefficient of Variation 38.5 |
| Oral Semaglutide 14 mg | Change in Fasting Insulin (Ratio to Baseline) | Week 26 | 1.10 Ratio of insulin | Geometric Coefficient of Variation 47.5 |
| Oral Semaglutide 14 mg | Change in Fasting Insulin (Ratio to Baseline) | Week 52 | 1.04 Ratio of insulin | Geometric Coefficient of Variation 47.2 |
| Liraglutide 0.9 mg | Change in Fasting Insulin (Ratio to Baseline) | Week 52 | 1.06 Ratio of insulin | Geometric Coefficient of Variation 35.9 |
| Liraglutide 0.9 mg | Change in Fasting Insulin (Ratio to Baseline) | Week 26 | 1.14 Ratio of insulin | Geometric Coefficient of Variation 37.1 |
| Placebo | Change in Fasting Insulin (Ratio to Baseline) | Week 26 | 0.92 Ratio of insulin | Geometric Coefficient of Variation 32.2 |
| Placebo | Change in Fasting Insulin (Ratio to Baseline) | Week 52 | 0.93 Ratio of insulin | Geometric Coefficient of Variation 28.8 |
Secondary
Change in Fasting Plasma Glucose
Change from baseline (week 0) in fasting plasma glucose. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
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 | Week 26 | -1.62 Millimoles per liter (mmol/L) | Standard Deviation 1.74 |
| Oral Semaglutide 3 mg | Change in Fasting Plasma Glucose | Week 52 | -1.13 Millimoles per liter (mmol/L) | Standard Deviation 1.82 |
| Oral Semaglutide 7 mg | Change in Fasting Plasma Glucose | Week 26 | -1.60 Millimoles per liter (mmol/L) | Standard Deviation 1.74 |
| Oral Semaglutide 7 mg | Change in Fasting Plasma Glucose | Week 52 | -1.60 Millimoles per liter (mmol/L) | Standard Deviation 1.22 |
| Oral Semaglutide 14 mg | Change in Fasting Plasma Glucose | Week 26 | -2.37 Millimoles per liter (mmol/L) | Standard Deviation 1.84 |
| Oral Semaglutide 14 mg | Change in Fasting Plasma Glucose | Week 52 | -2.29 Millimoles per liter (mmol/L) | Standard Deviation 1.62 |
| Liraglutide 0.9 mg | Change in Fasting Plasma Glucose | Week 52 | -2.28 Millimoles per liter (mmol/L) | Standard Deviation 2.09 |
| Liraglutide 0.9 mg | Change in Fasting Plasma Glucose | Week 26 | -2.48 Millimoles per liter (mmol/L) | Standard Deviation 1.76 |
| Placebo | Change in Fasting Plasma Glucose | Week 26 | -0.37 Millimoles per liter (mmol/L) | Standard Deviation 1.5 |
| Placebo | Change in Fasting Plasma Glucose | Week 52 | 0.33 Millimoles per liter (mmol/L) | Standard Deviation 1.31 |
Secondary
Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline)
Change from baseline (week 0) in fasting pro-insulin/insulin ratio is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 0, week 26 and 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 Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline) | Week 26 | 0.59 Ratio of pro-insulin/insulin ratio | Geometric Coefficient of Variation 42.7 |
| Oral Semaglutide 3 mg | Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline) | Week 52 | 0.78 Ratio of pro-insulin/insulin ratio | Geometric Coefficient of Variation 39.1 |
| Oral Semaglutide 7 mg | Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline) | Week 26 | 0.54 Ratio of pro-insulin/insulin ratio | Geometric Coefficient of Variation 34.2 |
| Oral Semaglutide 7 mg | Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline) | Week 52 | 0.67 Ratio of pro-insulin/insulin ratio | Geometric Coefficient of Variation 42.2 |
| Oral Semaglutide 14 mg | Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline) | Week 26 | 0.49 Ratio of pro-insulin/insulin ratio | Geometric Coefficient of Variation 42.4 |
| Oral Semaglutide 14 mg | Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline) | Week 52 | 0.56 Ratio of pro-insulin/insulin ratio | Geometric Coefficient of Variation 39.6 |
| Liraglutide 0.9 mg | Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline) | Week 52 | 0.69 Ratio of pro-insulin/insulin ratio | Geometric Coefficient of Variation 39.3 |
| Liraglutide 0.9 mg | Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline) | Week 26 | 0.55 Ratio of pro-insulin/insulin ratio | Geometric Coefficient of Variation 40.3 |
| Placebo | Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline) | Week 26 | 0.92 Ratio of pro-insulin/insulin ratio | Geometric Coefficient of Variation 29.1 |
| Placebo | Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline) | Week 52 | 1.11 Ratio of pro-insulin/insulin ratio | Geometric Coefficient of Variation 29.2 |
Secondary
Change in Fasting Pro-insulin (Ratio to Baseline)
Change from baseline (week 0) in fasting pro-insulin (measured as pmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 0, week 26 and 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 Fasting Pro-insulin (Ratio to Baseline) | Week 26 | 0.69 Ratio of pro-insulin | Geometric Coefficient of Variation 52.7 |
| Oral Semaglutide 3 mg | Change in Fasting Pro-insulin (Ratio to Baseline) | Week 52 | 0.83 Ratio of pro-insulin | Geometric Coefficient of Variation 46.6 |
| Oral Semaglutide 7 mg | Change in Fasting Pro-insulin (Ratio to Baseline) | Week 26 | 0.68 Ratio of pro-insulin | Geometric Coefficient of Variation 56.1 |
| Oral Semaglutide 7 mg | Change in Fasting Pro-insulin (Ratio to Baseline) | Week 52 | 0.78 Ratio of pro-insulin | Geometric Coefficient of Variation 41.7 |
| Oral Semaglutide 14 mg | Change in Fasting Pro-insulin (Ratio to Baseline) | Week 26 | 0.51 Ratio of pro-insulin | Geometric Coefficient of Variation 77.8 |
| Oral Semaglutide 14 mg | Change in Fasting Pro-insulin (Ratio to Baseline) | Week 52 | 0.56 Ratio of pro-insulin | Geometric Coefficient of Variation 68.6 |
| Liraglutide 0.9 mg | Change in Fasting Pro-insulin (Ratio to Baseline) | Week 52 | 0.72 Ratio of pro-insulin | Geometric Coefficient of Variation 49.4 |
| Liraglutide 0.9 mg | Change in Fasting Pro-insulin (Ratio to Baseline) | Week 26 | 0.61 Ratio of pro-insulin | Geometric Coefficient of Variation 49 |
| Placebo | Change in Fasting Pro-insulin (Ratio to Baseline) | Week 26 | 0.85 Ratio of pro-insulin | Geometric Coefficient of Variation 34.6 |
| Placebo | Change in Fasting Pro-insulin (Ratio to Baseline) | Week 52 | 1.04 Ratio of pro-insulin | Geometric Coefficient of Variation 37.9 |
Secondary
Change in HbA1c (Week 52)
Change from baseline (week 0) to week 52 in HbA1c. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
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) | -1.0 Percentage of HbA1c | Standard Deviation 0.9 |
| Oral Semaglutide 7 mg | Change in HbA1c (Week 52) | -1.4 Percentage of HbA1c | Standard Deviation 0.9 |
| Oral Semaglutide 14 mg | Change in HbA1c (Week 52) | -1.5 Percentage of HbA1c | Standard Deviation 0.8 |
| Liraglutide 0.9 mg | Change in HbA1c (Week 52) | -1.3 Percentage of HbA1c | Standard Deviation 1 |
| Placebo | Change in HbA1c (Week 52) | 0.1 Percentage of HbA1c | Standard Deviation 0.7 |
Secondary
Change in HDL Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in high density lipoprotein (HDL) cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 0, week 26 and 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 | 0.97 Ratio of HDL cholesterol | Geometric Coefficient of Variation 13.8 |
| Oral Semaglutide 3 mg | Change in HDL Cholesterol (Ratio to Baseline) | Week 52 | 1.05 Ratio of HDL cholesterol | Geometric Coefficient of Variation 12.2 |
| Oral Semaglutide 7 mg | Change in HDL Cholesterol (Ratio to Baseline) | Week 26 | 0.98 Ratio of HDL cholesterol | Geometric Coefficient of Variation 14.7 |
| Oral Semaglutide 7 mg | Change in HDL Cholesterol (Ratio to Baseline) | Week 52 | 1.01 Ratio of HDL cholesterol | Geometric Coefficient of Variation 14.2 |
| Oral Semaglutide 14 mg | Change in HDL Cholesterol (Ratio to Baseline) | Week 26 | 0.96 Ratio of HDL cholesterol | Geometric Coefficient of Variation 10 |
| Oral Semaglutide 14 mg | Change in HDL Cholesterol (Ratio to Baseline) | Week 52 | 0.99 Ratio of HDL cholesterol | Geometric Coefficient of Variation 12.2 |
| Liraglutide 0.9 mg | Change in HDL Cholesterol (Ratio to Baseline) | Week 52 | 0.98 Ratio of HDL cholesterol | Geometric Coefficient of Variation 11 |
| Liraglutide 0.9 mg | Change in HDL Cholesterol (Ratio to Baseline) | Week 26 | 0.99 Ratio of HDL cholesterol | Geometric Coefficient of Variation 11.5 |
| Placebo | Change in HDL Cholesterol (Ratio to Baseline) | Week 26 | 1.03 Ratio of HDL cholesterol | Geometric Coefficient of Variation 11.7 |
| Placebo | Change in HDL Cholesterol (Ratio to Baseline) | Week 52 | 1.04 Ratio of HDL cholesterol | Geometric Coefficient of Variation 10.5 |
Secondary
Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline)
Change from baseline (week 0) in insulin resistance (measured as percentage of insulin resistance) by homeostatic model assessment index of insulin resistance (HOMA-IR) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 0, week 26 and 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 Insulin Resistance (HOMA-IR) (Ratio to Baseline) | Week 26 | 0.98 Ratio of insulin resistance | Geometric Coefficient of Variation 44.7 |
| Oral Semaglutide 3 mg | Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline) | Week 52 | 0.93 Ratio of insulin resistance | Geometric Coefficient of Variation 44.9 |
| Oral Semaglutide 7 mg | Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline) | Week 26 | 1.02 Ratio of insulin resistance | Geometric Coefficient of Variation 66 |
| Oral Semaglutide 7 mg | Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline) | Week 52 | 0.95 Ratio of insulin resistance | Geometric Coefficient of Variation 42.9 |
| Oral Semaglutide 14 mg | Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline) | Week 26 | 0.83 Ratio of insulin resistance | Geometric Coefficient of Variation 58.5 |
| Oral Semaglutide 14 mg | Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline) | Week 52 | 0.78 Ratio of insulin resistance | Geometric Coefficient of Variation 62 |
| Liraglutide 0.9 mg | Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline) | Week 52 | 0.82 Ratio of insulin resistance | Geometric Coefficient of Variation 51.2 |
| Liraglutide 0.9 mg | Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline) | Week 26 | 0.86 Ratio of insulin resistance | Geometric Coefficient of Variation 46.3 |
| Placebo | Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline) | Week 26 | 0.88 Ratio of insulin resistance | Geometric Coefficient of Variation 43.8 |
| Placebo | Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline) | Week 52 | 0.97 Ratio of insulin resistance | Geometric Coefficient of Variation 38.6 |
Secondary
Change in LDL Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in low density lipoprotein (LDL) cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 0, week 26 and 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 52 | 0.99 Ratio of LDL cholesterol | Geometric Coefficient of Variation 13.1 |
| Oral Semaglutide 3 mg | Change in LDL Cholesterol (Ratio to Baseline) | Week 26 | 0.87 Ratio of LDL cholesterol | Geometric Coefficient of Variation 14.6 |
| Oral Semaglutide 7 mg | Change in LDL Cholesterol (Ratio to Baseline) | Week 26 | 0.89 Ratio of LDL cholesterol | Geometric Coefficient of Variation 22.7 |
| Oral Semaglutide 7 mg | Change in LDL Cholesterol (Ratio to Baseline) | Week 52 | 0.96 Ratio of LDL cholesterol | Geometric Coefficient of Variation 15.5 |
| Oral Semaglutide 14 mg | Change in LDL Cholesterol (Ratio to Baseline) | Week 52 | 0.91 Ratio of LDL cholesterol | Geometric Coefficient of Variation 20.4 |
| Oral Semaglutide 14 mg | Change in LDL Cholesterol (Ratio to Baseline) | Week 26 | 0.85 Ratio of LDL cholesterol | Geometric Coefficient of Variation 18.2 |
| Liraglutide 0.9 mg | Change in LDL Cholesterol (Ratio to Baseline) | Week 26 | 0.91 Ratio of LDL cholesterol | Geometric Coefficient of Variation 13.4 |
| Liraglutide 0.9 mg | Change in LDL Cholesterol (Ratio to Baseline) | Week 52 | 0.95 Ratio of LDL cholesterol | Geometric Coefficient of Variation 12.3 |
| Placebo | Change in LDL Cholesterol (Ratio to Baseline) | Week 26 | 1.03 Ratio of LDL cholesterol | Geometric Coefficient of Variation 19.8 |
| Placebo | Change in LDL Cholesterol (Ratio to Baseline) | Week 52 | 1.06 Ratio of LDL cholesterol | Geometric Coefficient of Variation 23 |
Secondary
Change in Lipase (Ratio to Baseine)
Change in lipase (measured as U/L) is presented as ratio to baseline. Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation.
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 Baseine) | Week 26 | 1.25 Ratio of lipase | Geometric Coefficient of Variation 41.7 |
| Oral Semaglutide 3 mg | Change in Lipase (Ratio to Baseine) | Week 52 | 1.29 Ratio of lipase | Geometric Coefficient of Variation 34.2 |
| Oral Semaglutide 7 mg | Change in Lipase (Ratio to Baseine) | Week 26 | 1.35 Ratio of lipase | Geometric Coefficient of Variation 34.5 |
| Oral Semaglutide 7 mg | Change in Lipase (Ratio to Baseine) | Week 52 | 1.41 Ratio of lipase | Geometric Coefficient of Variation 45.8 |
| Oral Semaglutide 14 mg | Change in Lipase (Ratio to Baseine) | Week 26 | 1.61 Ratio of lipase | Geometric Coefficient of Variation 67.4 |
| Oral Semaglutide 14 mg | Change in Lipase (Ratio to Baseine) | Week 52 | 1.47 Ratio of lipase | Geometric Coefficient of Variation 45.9 |
| Liraglutide 0.9 mg | Change in Lipase (Ratio to Baseine) | Week 52 | 1.60 Ratio of lipase | Geometric Coefficient of Variation 46.8 |
| Liraglutide 0.9 mg | Change in Lipase (Ratio to Baseine) | Week 26 | 1.47 Ratio of lipase | Geometric Coefficient of Variation 52.1 |
| Placebo | Change in Lipase (Ratio to Baseine) | Week 26 | 1.04 Ratio of lipase | Geometric Coefficient of Variation 48.5 |
| Placebo | Change in Lipase (Ratio to Baseine) | Week 52 | 1.03 Ratio of lipase | Geometric Coefficient of Variation 38.7 |
Secondary
Change in Mean Postprandial Increment Over All Meals in SMPG
Change from baseline (week 0) in the average of the post-prandial increments over all meals. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 0, week 26 and 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 Mean Postprandial Increment Over All Meals in SMPG | Week 26 | -0.7 mmol/L | Standard Deviation 2.1 |
| Oral Semaglutide 3 mg | Change in Mean Postprandial Increment Over All Meals in SMPG | Week 52 | -0.5 mmol/L | Standard Deviation 2.4 |
| Oral Semaglutide 7 mg | Change in Mean Postprandial Increment Over All Meals in SMPG | Week 26 | -1.2 mmol/L | Standard Deviation 2.3 |
| Oral Semaglutide 7 mg | Change in Mean Postprandial Increment Over All Meals in SMPG | Week 52 | -0.9 mmol/L | Standard Deviation 2.4 |
| Oral Semaglutide 14 mg | Change in Mean Postprandial Increment Over All Meals in SMPG | Week 26 | -2.0 mmol/L | Standard Deviation 2.3 |
| Oral Semaglutide 14 mg | Change in Mean Postprandial Increment Over All Meals in SMPG | Week 52 | -2.0 mmol/L | Standard Deviation 2.1 |
| Liraglutide 0.9 mg | Change in Mean Postprandial Increment Over All Meals in SMPG | Week 52 | -0.6 mmol/L | Standard Deviation 2.2 |
| Liraglutide 0.9 mg | Change in Mean Postprandial Increment Over All Meals in SMPG | Week 26 | -1.1 mmol/L | Standard Deviation 2.1 |
| Placebo | Change in Mean Postprandial Increment Over All Meals in SMPG | Week 26 | -0.5 mmol/L | Standard Deviation 2.4 |
| Placebo | Change in Mean Postprandial Increment Over All Meals in SMPG | Week 52 | -0.1 mmol/L | Standard Deviation 2.4 |
Secondary
Change in Physical Examination
Physical examination included examination of cardiovascular system, nervous system (central and peripheral), gastrointestinal system including mouth, general appearence, head and neck (head, ears, eyes, nose, throat, neck), lymph node palpation, musculoskeletal system, respiratory system, skin and thyroid gland. Physical examination was performed by the investigator and categorised as normal, abnormal NCS or abnormal CS. Data based on in-trial observation period is presented. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time frame: Baseline (Week -8), 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 Physical Examination | Week -8: General appearance- Normal | 47 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Lymph node- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Head and neck- Abnormal NCS | 5 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Thyroid- Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Lymph node- Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Head and neck- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Cardiovascular- Normal | 49 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Lymph node- Normal | 46 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Head and neck- Normal | 43 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Lymph node- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Head and neck- Abnormal NCS | 3 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Nervous system- Normal | 48 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Lymph node- Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Head and neck- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Lymph node- Normal | 46 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Head and neck- Normal | 42 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Thyroid - Normal | 48 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Lymph node- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Head and neck- Abnormal NCS | 4 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Cardiovascular- Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Lymph node- Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Head and neck- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Lymph node- Normal | 49 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Skin- Abnormal CS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Cardiovascular- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Thyroid- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Skin- Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Cardiovascular- Normal | 46 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Skin- Normal | 44 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Cardiovascular- Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Thyroid- Normal | 45 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Skin- Abnormal CS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Cardiovascular- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Nervous system- Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Skin- Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Cardiovascular- Normal | 46 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Skin- Normal | 44 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Cardiovascular- Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Nervous system- Normal | 45 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Cardiovascular- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Skin- Abnormal CS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Nervous system- Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Skin- Abnormal NCS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Nervous system- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Thyroid- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Skin- Normal | 46 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Gastrointestinal sys- Normal | 46 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Nervous system- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Respiratory sys- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Gastrointestinal sys- Abnormal NCS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Respiratory sys- Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Gastrointestinal sys- Abnormal CS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Respiratory sys- Normal | 46 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Gastrointestinal sys - Normal | 44 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Respiratory sys- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Gastrointestinal sys- Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Thyroid- Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Respiratory sys- Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Gastrointestinal sys- Abnormal CS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Nervous system- Normal | 45 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Respiratory sys- Normal | 46 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Gastrointestinal sys- Normal | 43 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Respiratory sys- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Gastrointestinal sys- Abnormal NCS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Respiratory sys- Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Gastrointestinal sys- Abnormal CS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Respiratory sys- Normal | 49 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Head and neck- Normal | 44 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Thyroid- Normal | 45 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Musculoskeletal- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: General appearance- Abnormal NCS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Nervous system- Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Musculoskeletal- Abnormal NCS | 5 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: General appearance- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Musculoskeletal- Normal | 41 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: General appearance- Normal | 44 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Musculoskeletal- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: General appearance- Abnormal NCS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Musculoskeletal- Abnormal NCS | 4 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: General appearance- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Thyroid- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Musculoskeletal- Normal | 42 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: General appearance- Normal | 43 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 26: Nervous system- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Musculoskeletal- Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: General appearance- Abnormal NCS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Musculoskeletal- Abnormal NCS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: General appearance- Abnormal CS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week 52: Thyroid- Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | Week -8: Musculoskeletal- Normal | 47 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: General appearance- Normal | 47 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Head and neck- Normal | 45 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Thyroid- Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Lymph node- Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Gastrointestinal sys- Normal | 47 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Musculoskeletal- Abnormal NCS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Head and neck- Abnormal NCS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Respiratory sys- Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Lymph node- Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Musculoskeletal- Abnormal CS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Musculoskeletal- Abnormal CS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Head and neck- Abnormal CS | 3 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Gastrointestinal sys- Abnormal NCS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Lymph node- Normal | 49 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Nervous system- Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Respiratory sys- Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Head and neck- Normal | 47 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Cardiovascular- Normal | 49 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Lymph node- Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: General appearance- Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: General appearance- Abnormal NCS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Head and neck- Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Gastrointestinal sys- Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Lymph node- Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Cardiovascular- Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Respiratory sys- Normal | 49 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Head and neck- Abnormal CS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Thyroid - Normal | 48 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Lymph node- Normal | 49 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: General appearance- Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Musculoskeletal- Abnormal NCS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Head and neck- Normal | 47 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Gastrointestinal sys - Normal | 47 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Lymph node- Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Thyroid- Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Respiratory sys- Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Head and neck- Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Musculoskeletal- Normal | 44 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Lymph node- Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Musculoskeletal- Normal | 45 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Gastrointestinal sys- Abnormal NCS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Head and neck- Abnormal CS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Cardiovascular- Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Lymph node- Normal | 49 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: General appearance- Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Nervous system- Normal | 48 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Skin- Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Respiratory sys- Abnormal NCS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Nervous system- Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Cardiovascular- Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Musculoskeletal- Normal | 45 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Skin- Abnormal NCS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Gastrointestinal sys- Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: General appearance- Abnormal NCS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Cardiovascular- Normal | 49 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Thyroid- Normal | 48 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Skin- Normal | 47 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Respiratory sys- Normal | 48 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Nervous system- Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Cardiovascular- Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: General appearance- Normal | 47 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Skin- Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Gastrointestinal sys- Normal | 45 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Nervous system- Normal | 48 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Cardiovascular- Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Respiratory sys- Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Skin- Abnormal NCS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Thyroid- Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Musculoskeletal- Abnormal CS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Cardiovascular- Normal | 49 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Nervous system- Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Skin- Normal | 47 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Gastrointestinal sys- Abnormal NCS | 3 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Thyroid- Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Cardiovascular- Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Respiratory sys- Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Nervous system- Normal | 48 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: General appearance- Normal | 48 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Skin- Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Musculoskeletal- Abnormal NCS | 3 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Gastrointestinal sys- Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Nervous system- Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Thyroid- Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Skin- Abnormal NCS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: Thyroid- Normal | 48 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Respiratory sys- Normal | 49 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 52: Nervous system- Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week 26: General appearance- Abnormal NCS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Skin- Normal | 48 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | Week -8: Thyroid- Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Cardiovascular- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Cardiovascular- Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Nervous system- Normal | 48 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Nervous system- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Nervous system- Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Nervous system- Normal | 47 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Nervous system- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Nervous system- Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Cardiovascular- Normal | 48 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Cardiovascular- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Cardiovascular- Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Cardiovascular- Normal | 47 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Cardiovascular- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Cardiovascular- Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Cardiovascular- Normal | 47 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Nervous system- Normal | 47 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Nervous system- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Nervous system- Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Gastrointestinal sys- Normal | 47 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Gastrointestinal sys- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Gastrointestinal sys- Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Gastrointestinal sys - Normal | 45 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Gastrointestinal sys- Abnormal NCS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Gastrointestinal sys- Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Gastrointestinal sys- Normal | 45 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Gastrointestinal sys- Abnormal NCS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Gastrointestinal sys- Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: General appearance- Normal | 47 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: General appearance- Abnormal NCS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: General appearance- Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: General appearance- Normal | 45 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: General appearance- Abnormal NCS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: General appearance- Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: General appearance- Normal | 46 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: General appearance- Abnormal NCS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: General appearance- Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Head and neck- Normal | 44 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Head and neck- Abnormal NCS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Head and neck- Abnormal CS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Head and neck- Normal | 43 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Head and neck- Abnormal NCS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Head and neck- Abnormal CS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Head and neck- Normal | 43 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Head and neck- Abnormal NCS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Head and neck- Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Lymph node- Normal | 48 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Lymph node- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Lymph node- Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Lymph node- Normal | 47 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Lymph node- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Lymph node- Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Lymph node- Normal | 47 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Lymph node- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Lymph node- Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Musculoskeletal- Normal | 47 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Musculoskeletal- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Musculoskeletal- Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Musculoskeletal- Normal | 46 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Musculoskeletal- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Musculoskeletal- Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Musculoskeletal- Normal | 46 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Musculoskeletal- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Musculoskeletal- Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Respiratory sys- Normal | 46 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Respiratory sys- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Respiratory sys- Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Respiratory sys- Normal | 45 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Respiratory sys- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Respiratory sys- Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Respiratory sys- Normal | 45 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Respiratory sys- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Respiratory sys- Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Skin- Normal | 45 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Skin- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Skin- Abnormal CS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Skin- Normal | 44 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Skin- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Skin- Abnormal CS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Skin- Normal | 44 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Skin- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Skin- Abnormal CS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Thyroid - Normal | 48 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Thyroid- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week -8: Thyroid- Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Thyroid- Normal | 47 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Thyroid- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 26: Thyroid- Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Thyroid- Normal | 47 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Thyroid- Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | Week 52: Thyroid- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Gastrointestinal sys- Abnormal CS | 1 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Nervous system- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Cardiovascular- Abnormal NCS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Skin- Normal | 47 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Thyroid- Normal | 45 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Respiratory sys- Normal | 47 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Nervous system- Abnormal NCS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Thyroid- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Skin- Abnormal NCS | 1 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: General appearance- Normal | 44 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Nervous system- Abnormal NCS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Nervous system- Normal | 45 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Gastrointestinal sys- Abnormal NCS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Skin- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: General appearance- Normal | 44 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Respiratory sys- Abnormal NCS | 1 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Cardiovascular- Normal | 45 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Musculoskeletal- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Skin- Normal | 43 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Musculoskeletal- Abnormal CS | 1 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Gastrointestinal sys- Normal | 44 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Cardiovascular- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Nervous system- Normal | 48 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Skin- Abnormal NCS | 1 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: General appearance- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Respiratory sys- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Cardiovascular- Abnormal NCS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Musculoskeletal- Abnormal NCS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Skin- Abnormal CS | 1 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: General appearance- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Gastrointestinal sys- Abnormal CS | 1 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Cardiovascular- Normal | 45 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Thyroid- Normal | 45 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Skin- Normal | 45 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Nervous system- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Respiratory sys- Normal | 44 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Cardiovascular- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: General appearance- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Skin- Abnormal NCS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Musculoskeletal- Normal | 45 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Gastrointestinal sys- Abnormal NCS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Cardiovascular- Abnormal NCS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Thyroid- Abnormal NCS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Skin- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Respiratory sys- Abnormal NCS | 1 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Musculoskeletal- Normal | 43 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Head and neck- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: General appearance- Abnormal NCS | 1 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Lymph node- Normal | 48 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Gastrointestinal sys - Normal | 44 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Thyroid- Abnormal NCS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Head and neck- Abnormal NCS | 1 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Cardiovascular- Normal | 48 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Lymph node- Abnormal NCS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Respiratory sys- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Nervous system- Normal | 45 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Head and neck- Normal | 44 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Cardiovascular- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Lymph node- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Musculoskeletal- Abnormal NCS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Gastrointestinal sys- Abnormal CS | 1 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Head and neck- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Thyroid - Normal | 48 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Lymph node- Normal | 45 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Musculoskeletal- Normal | 48 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Respiratory sys- Normal | 44 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Head and neck- Abnormal NCS | 1 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: General appearance- Abnormal NCS | 1 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Lymph node- Abnormal NCS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: General appearance- Normal | 47 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Gastrointestinal sys- Abnormal NCS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Head and neck- Normal | 44 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: General appearance- Abnormal NCS | 1 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Lymph node- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Respiratory sys- Abnormal NCS | 1 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Musculoskeletal- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Head and neck- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Nervous system- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Lymph node- Normal | 45 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Thyroid- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Gastrointestinal sys- Normal | 47 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Head and neck- Abnormal NCS | 3 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Thyroid- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Lymph node- Abnormal NCS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Nervous system- Abnormal NCS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Respiratory sys- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Head and neck- Normal | 45 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week -8: Thyroid- Abnormal NCS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 52: Lymph node- Abnormal CS | 0 Participants |
| Liraglutide 0.9 mg | Change in Physical Examination | Week 26: Musculoskeletal- Abnormal NCS | 1 Participants |
| Placebo | Change in Physical Examination | Week 52: Lymph node- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week -8: Thyroid- Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | Week -8: Musculoskeletal- Normal | 44 Participants |
| Placebo | Change in Physical Examination | Week 52: General appearance- Abnormal NCS | 3 Participants |
| Placebo | Change in Physical Examination | Week 26: Nervous system- Abnormal NCS | 1 Participants |
| Placebo | Change in Physical Examination | Week -8: Musculoskeletal- Abnormal NCS | 4 Participants |
| Placebo | Change in Physical Examination | Week 52: General appearance- Normal | 46 Participants |
| Placebo | Change in Physical Examination | Week -8: Musculoskeletal- Abnormal CS | 1 Participants |
| Placebo | Change in Physical Examination | Week 26: General appearance- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week 26: Musculoskeletal- Normal | 42 Participants |
| Placebo | Change in Physical Examination | Week 26: General appearance- Abnormal NCS | 3 Participants |
| Placebo | Change in Physical Examination | Week 26: Musculoskeletal- Abnormal NCS | 6 Participants |
| Placebo | Change in Physical Examination | Week 26: General appearance- Normal | 46 Participants |
| Placebo | Change in Physical Examination | Week -8: Thyroid- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week 26: Musculoskeletal- Abnormal CS | 1 Participants |
| Placebo | Change in Physical Examination | Week -8: General appearance- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week 26: Nervous system- Normal | 48 Participants |
| Placebo | Change in Physical Examination | Week 52: Musculoskeletal- Normal | 43 Participants |
| Placebo | Change in Physical Examination | Week -8: General appearance- Abnormal NCS | 3 Participants |
| Placebo | Change in Physical Examination | Week 52: Musculoskeletal- Abnormal NCS | 6 Participants |
| Placebo | Change in Physical Examination | Week -8: General appearance- Normal | 46 Participants |
| Placebo | Change in Physical Examination | Week 52: Thyroid- Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | Week 52: Musculoskeletal- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week 52: Gastrointestinal sys- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week -8: Respiratory sys- Normal | 49 Participants |
| Placebo | Change in Physical Examination | Week 52: Gastrointestinal sys- Abnormal NCS | 2 Participants |
| Placebo | Change in Physical Examination | Week 26: Thyroid- Normal | 49 Participants |
| Placebo | Change in Physical Examination | Week -8: Respiratory sys- Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | Week 52: Gastrointestinal sys- Normal | 47 Participants |
| Placebo | Change in Physical Examination | Week -8: Nervous system- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week -8: Respiratory sys- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week 26: Gastrointestinal sys- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week 26: Respiratory sys- Normal | 49 Participants |
| Placebo | Change in Physical Examination | Week 26: Gastrointestinal sys- Abnormal NCS | 1 Participants |
| Placebo | Change in Physical Examination | Week 52: Cardiovascular- Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | Week 26: Respiratory sys- Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | Week 26: Gastrointestinal sys - Normal | 48 Participants |
| Placebo | Change in Physical Examination | Week 26: Respiratory sys- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week -8: Gastrointestinal sys- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week 26: Thyroid- Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | Week 52: Respiratory sys- Normal | 49 Participants |
| Placebo | Change in Physical Examination | Week -8: Gastrointestinal sys- Abnormal NCS | 1 Participants |
| Placebo | Change in Physical Examination | Week -8: Nervous system- Abnormal NCS | 1 Participants |
| Placebo | Change in Physical Examination | Week 52: Respiratory sys- Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | Week -8: Gastrointestinal sys- Normal | 48 Participants |
| Placebo | Change in Physical Examination | Week 52: Respiratory sys- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week 52: Nervous system- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week -8: Skin- Normal | 45 Participants |
| Placebo | Change in Physical Examination | Week 52: Nervous system- Abnormal NCS | 1 Participants |
| Placebo | Change in Physical Examination | Week -8: Skin- Abnormal NCS | 2 Participants |
| Placebo | Change in Physical Examination | Week 52: Nervous system- Normal | 48 Participants |
| Placebo | Change in Physical Examination | Week 26: Thyroid- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week -8: Skin- Abnormal CS | 2 Participants |
| Placebo | Change in Physical Examination | Week 52: Cardiovascular- Normal | 49 Participants |
| Placebo | Change in Physical Examination | Week -8: Nervous system- Normal | 48 Participants |
| Placebo | Change in Physical Examination | Week 26: Skin- Normal | 45 Participants |
| Placebo | Change in Physical Examination | Week 26: Cardiovascular- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week 26: Skin- Abnormal NCS | 2 Participants |
| Placebo | Change in Physical Examination | Week 26: Cardiovascular- Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | Week 52: Thyroid- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week 26: Skin- Abnormal CS | 2 Participants |
| Placebo | Change in Physical Examination | Week 26: Cardiovascular- Normal | 49 Participants |
| Placebo | Change in Physical Examination | Week 52: Skin- Normal | 46 Participants |
| Placebo | Change in Physical Examination | Week -8: Cardiovascular- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week 52: Thyroid- Normal | 49 Participants |
| Placebo | Change in Physical Examination | Week 52: Skin- Abnormal NCS | 2 Participants |
| Placebo | Change in Physical Examination | Week -8: Cardiovascular- Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | Week 52: Cardiovascular- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week 52: Skin- Abnormal CS | 1 Participants |
| Placebo | Change in Physical Examination | Week 52: Head and neck- Abnormal CS | 2 Participants |
| Placebo | Change in Physical Examination | Week -8: Cardiovascular- Normal | 49 Participants |
| Placebo | Change in Physical Examination | Week -8: Lymph node- Normal | 49 Participants |
| Placebo | Change in Physical Examination | Week 52: Head and neck- Abnormal NCS | 3 Participants |
| Placebo | Change in Physical Examination | Week -8: Lymph node- Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | Week 52: Head and neck- Normal | 44 Participants |
| Placebo | Change in Physical Examination | Week -8: Lymph node- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week 26: Head and neck- Abnormal CS | 2 Participants |
| Placebo | Change in Physical Examination | Week 26: Lymph node- Normal | 49 Participants |
| Placebo | Change in Physical Examination | Week 26: Head and neck- Abnormal NCS | 3 Participants |
| Placebo | Change in Physical Examination | Week -8: Thyroid - Normal | 49 Participants |
| Placebo | Change in Physical Examination | Week 26: Lymph node- Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | Week 26: Head and neck- Normal | 44 Participants |
| Placebo | Change in Physical Examination | Week 26: Nervous system- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week 26: Lymph node- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week -8: Head and neck- Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | Week 52: Lymph node- Normal | 49 Participants |
| Placebo | Change in Physical Examination | Week -8: Head and neck- Abnormal NCS | 3 Participants |
| Placebo | Change in Physical Examination | Week 52: Lymph node- Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | Week -8: Head and neck- Normal | 46 Participants |
| Placebo | Change in Physical Examination | Week 52: General appearance- Abnormal CS | 0 Participants |
Secondary
Change in Pulse Rate
Change from baseline in pulse rate. Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation.
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 per minute (beats/min) | Standard Deviation 7 |
| Oral Semaglutide 3 mg | Change in Pulse Rate | Week 52 | 1 Beats per minute (beats/min) | Standard Deviation 7 |
| Oral Semaglutide 7 mg | Change in Pulse Rate | Week 26 | 2 Beats per minute (beats/min) | Standard Deviation 9 |
| Oral Semaglutide 7 mg | Change in Pulse Rate | Week 52 | 3 Beats per minute (beats/min) | Standard Deviation 7 |
| Oral Semaglutide 14 mg | Change in Pulse Rate | Week 26 | 2 Beats per minute (beats/min) | Standard Deviation 8 |
| Oral Semaglutide 14 mg | Change in Pulse Rate | Week 52 | 4 Beats per minute (beats/min) | Standard Deviation 10 |
| Liraglutide 0.9 mg | Change in Pulse Rate | Week 52 | 2 Beats per minute (beats/min) | Standard Deviation 9 |
| Liraglutide 0.9 mg | Change in Pulse Rate | Week 26 | 2 Beats per minute (beats/min) | Standard Deviation 9 |
| Placebo | Change in Pulse Rate | Week 26 | 0 Beats per minute (beats/min) | Standard Deviation 8 |
| Placebo | Change in Pulse Rate | Week 52 | 0 Beats per minute (beats/min) | Standard Deviation 7 |
Secondary
Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile
Change from baseline (week 0) in mean 7-point self-measured plasma glucose (SMPG) profile. 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. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
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 7-point Profile (SMPG) - Mean 7-point Profile | Week 26 | -2.2 mmol/L | Standard Deviation 2.2 |
| Oral Semaglutide 3 mg | Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile | Week 52 | -1.7 mmol/L | Standard Deviation 1.7 |
| Oral Semaglutide 7 mg | Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile | Week 26 | -2.6 mmol/L | Standard Deviation 1.8 |
| Oral Semaglutide 7 mg | Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile | Week 52 | -2.2 mmol/L | Standard Deviation 1.9 |
| Oral Semaglutide 14 mg | Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile | Week 52 | -3.1 mmol/L | Standard Deviation 2.1 |
| Oral Semaglutide 14 mg | Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile | Week 26 | -3.1 mmol/L | Standard Deviation 2.1 |
| Liraglutide 0.9 mg | Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile | Week 52 | -2.3 mmol/L | Standard Deviation 2.5 |
| Liraglutide 0.9 mg | Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile | Week 26 | -2.8 mmol/L | Standard Deviation 2.1 |
| Placebo | Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile | Week 52 | -0.0 mmol/L | Standard Deviation 1.7 |
| Placebo | Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile | Week 26 | -0.8 mmol/L | Standard Deviation 1.7 |
Secondary
Change in SF-36: Mental Component Summary (MCS)
Change in short form 36 v2.0 acute domain MCS from baseline (week 0) to week 56. SF- 36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The scores 0-100 (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. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Data based on on-treatment without rescue medication observation period is presented.
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. On-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in SF-36: Mental Component Summary (MCS) | Week 26 | -1.81 Score on a scale | Standard Deviation 7.23 |
| Oral Semaglutide 3 mg | Change in SF-36: Mental Component Summary (MCS) | Week 52 | -1.56 Score on a scale | Standard Deviation 6.63 |
| Oral Semaglutide 7 mg | Change in SF-36: Mental Component Summary (MCS) | Week 26 | 0.56 Score on a scale | Standard Deviation 5.62 |
| Oral Semaglutide 7 mg | Change in SF-36: Mental Component Summary (MCS) | Week 52 | -0.58 Score on a scale | Standard Deviation 5.02 |
| Oral Semaglutide 14 mg | Change in SF-36: Mental Component Summary (MCS) | Week 26 | -1.61 Score on a scale | Standard Deviation 4.14 |
| Oral Semaglutide 14 mg | Change in SF-36: Mental Component Summary (MCS) | Week 52 | -1.16 Score on a scale | Standard Deviation 4.8 |
| Liraglutide 0.9 mg | Change in SF-36: Mental Component Summary (MCS) | Week 52 | 0.10 Score on a scale | Standard Deviation 4.44 |
| Liraglutide 0.9 mg | Change in SF-36: Mental Component Summary (MCS) | Week 26 | 0.49 Score on a scale | Standard Deviation 5.09 |
| Placebo | Change in SF-36: Mental Component Summary (MCS) | Week 26 | -2.18 Score on a scale | Standard Deviation 7.42 |
| Placebo | Change in SF-36: Mental Component Summary (MCS) | Week 52 | -1.94 Score on a scale | Standard Deviation 7.43 |
Secondary
Change in SF-36: Physical Component Summary (PCS)
Change in short form 36 v2.0 acute domain PCS from baseline (week 0) to week 56. SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. It consists of 2 component summary measures that further summarize 8 health domain scales. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. The scores 0-100 (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. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Data based on on-treatment without rescue medication observation period is presented.
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. On-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in SF-36: Physical Component Summary (PCS) | Week 26 | -1.33 Score on a scale | Standard Deviation 4.56 |
| Oral Semaglutide 3 mg | Change in SF-36: Physical Component Summary (PCS) | Week 52 | -1.28 Score on a scale | Standard Deviation 6.03 |
| Oral Semaglutide 7 mg | Change in SF-36: Physical Component Summary (PCS) | Week 26 | -0.38 Score on a scale | Standard Deviation 3.28 |
| Oral Semaglutide 7 mg | Change in SF-36: Physical Component Summary (PCS) | Week 52 | -0.12 Score on a scale | Standard Deviation 4.3 |
| Oral Semaglutide 14 mg | Change in SF-36: Physical Component Summary (PCS) | Week 26 | 0.93 Score on a scale | Standard Deviation 3.49 |
| Oral Semaglutide 14 mg | Change in SF-36: Physical Component Summary (PCS) | Week 52 | 0.02 Score on a scale | Standard Deviation 4.05 |
| Liraglutide 0.9 mg | Change in SF-36: Physical Component Summary (PCS) | Week 52 | 0.10 Score on a scale | Standard Deviation 3.42 |
| Liraglutide 0.9 mg | Change in SF-36: Physical Component Summary (PCS) | Week 26 | -0.14 Score on a scale | Standard Deviation 3.21 |
| Placebo | Change in SF-36: Physical Component Summary (PCS) | Week 26 | 0.20 Score on a scale | Standard Deviation 4.11 |
| Placebo | Change in SF-36: Physical Component Summary (PCS) | Week 52 | -0.10 Score on a scale | Standard Deviation 4.03 |
Secondary
Change in SF-36: Sub-domains
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™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (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. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores is presented. A positive change score indicates an improvement since baseline. Data based on on-treatment without rescue medication observation period is presented.
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. On-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in SF-36: Sub-domains | Week 52: Mental Health | -2.41 Score on a scale | Standard Deviation 7.63 |
| Oral Semaglutide 3 mg | Change in SF-36: Sub-domains | Week 52: Vitality | -1.93 Score on a scale | Standard Deviation 6.84 |
| Oral Semaglutide 3 mg | Change in SF-36: Sub-domains | Week 52: General Health | -0.99 Score on a scale | Standard Deviation 5.07 |
| Oral Semaglutide 3 mg | Change in SF-36: Sub-domains | Week 52: Physical Functioning | -0.31 Score on a scale | Standard Deviation 3.63 |
| Oral Semaglutide 3 mg | Change in SF-36: Sub-domains | Week 26: Vitality | -2.85 Score on a scale | Standard Deviation 5.85 |
| Oral Semaglutide 3 mg | Change in SF-36: Sub-domains | Week 26: Physical Functioning | -0.22 Score on a scale | Standard Deviation 2.53 |
| Oral Semaglutide 3 mg | Change in SF-36: Sub-domains | Week 26: Mental Health | -1.90 Score on a scale | Standard Deviation 9 |
| Oral Semaglutide 3 mg | Change in SF-36: Sub-domains | Week 26: Role-Physical | -1.79 Score on a scale | Standard Deviation 4.91 |
| Oral Semaglutide 3 mg | Change in SF-36: Sub-domains | Week 52: Role-Emotional | -0.70 Score on a scale | Standard Deviation 5.94 |
| Oral Semaglutide 3 mg | Change in SF-36: Sub-domains | Week 52: Role-Physical | -2.14 Score on a scale | Standard Deviation 5.94 |
| Oral Semaglutide 3 mg | Change in SF-36: Sub-domains | Week 26: Role-Emotional | -1.60 Score on a scale | Standard Deviation 8.21 |
| Oral Semaglutide 3 mg | Change in SF-36: Sub-domains | Week 26: Bodily Pain | -2.02 Score on a scale | Standard Deviation 8.92 |
| Oral Semaglutide 3 mg | Change in SF-36: Sub-domains | Week 52: Social Functioning | -0.78 Score on a scale | Standard Deviation 4.67 |
| Oral Semaglutide 3 mg | Change in SF-36: Sub-domains | Week 52: Bodily Pain | -2.43 Score on a scale | Standard Deviation 9.02 |
| Oral Semaglutide 3 mg | Change in SF-36: Sub-domains | Week 26: Social Functioning | -0.11 Score on a scale | Standard Deviation 4.25 |
| Oral Semaglutide 3 mg | Change in SF-36: Sub-domains | Week 26: General Health | -2.43 Score on a scale | Standard Deviation 4.49 |
| Oral Semaglutide 7 mg | Change in SF-36: Sub-domains | Week 26: Social Functioning | 0.77 Score on a scale | Standard Deviation 3.94 |
| Oral Semaglutide 7 mg | Change in SF-36: Sub-domains | Week 52: Vitality | -0.82 Score on a scale | Standard Deviation 6.63 |
| Oral Semaglutide 7 mg | Change in SF-36: Sub-domains | Week 26: General Health | 0.52 Score on a scale | Standard Deviation 4.29 |
| Oral Semaglutide 7 mg | Change in SF-36: Sub-domains | Week 26: Role-Emotional | -0.00 Score on a scale | Standard Deviation 6.03 |
| Oral Semaglutide 7 mg | Change in SF-36: Sub-domains | Week 52: General Health | -1.24 Score on a scale | Standard Deviation 5.38 |
| Oral Semaglutide 7 mg | Change in SF-36: Sub-domains | Week 52: Bodily Pain | -0.16 Score on a scale | Standard Deviation 7.78 |
| Oral Semaglutide 7 mg | Change in SF-36: Sub-domains | Week 26: Vitality | -0.48 Score on a scale | Standard Deviation 4.83 |
| Oral Semaglutide 7 mg | Change in SF-36: Sub-domains | Week 52: Mental Health | -0.52 Score on a scale | Standard Deviation 7.38 |
| Oral Semaglutide 7 mg | Change in SF-36: Sub-domains | Week 52: Physical Functioning | 0.30 Score on a scale | Standard Deviation 2.37 |
| Oral Semaglutide 7 mg | Change in SF-36: Sub-domains | Week 26: Bodily Pain | -0.89 Score on a scale | Standard Deviation 5.93 |
| Oral Semaglutide 7 mg | Change in SF-36: Sub-domains | Week 26: Mental Health | 0.77 Score on a scale | Standard Deviation 5.56 |
| Oral Semaglutide 7 mg | Change in SF-36: Sub-domains | Week 52: Role-Physical | 0.15 Score on a scale | Standard Deviation 4.84 |
| Oral Semaglutide 7 mg | Change in SF-36: Sub-domains | Week 52: Social Functioning | -0.58 Score on a scale | Standard Deviation 3.92 |
| Oral Semaglutide 7 mg | Change in SF-36: Sub-domains | Week 26: Role-Physical | 0.00 Score on a scale | Standard Deviation 3.48 |
| Oral Semaglutide 7 mg | Change in SF-36: Sub-domains | Week 26: Physical Functioning | -0.09 Score on a scale | Standard Deviation 1.93 |
| Oral Semaglutide 7 mg | Change in SF-36: Sub-domains | Week 52: Role-Emotional | 0.18 Score on a scale | Standard Deviation 2.63 |
| Oral Semaglutide 14 mg | Change in SF-36: Sub-domains | Week 52: Role-Physical | -0.86 Score on a scale | Standard Deviation 4.69 |
| Oral Semaglutide 14 mg | Change in SF-36: Sub-domains | Week 26: Physical Functioning | 0.04 Score on a scale | Standard Deviation 2.71 |
| Oral Semaglutide 14 mg | Change in SF-36: Sub-domains | Week 52: Physical Functioning | -0.00 Score on a scale | Standard Deviation 3.42 |
| Oral Semaglutide 14 mg | Change in SF-36: Sub-domains | Week 26: Role-Physical | 0.05 Score on a scale | Standard Deviation 3.31 |
| Oral Semaglutide 14 mg | Change in SF-36: Sub-domains | Week 26: Bodily Pain | 1.18 Score on a scale | Standard Deviation 6.21 |
| Oral Semaglutide 14 mg | Change in SF-36: Sub-domains | Week 52: Bodily Pain | 0.03 Score on a scale | Standard Deviation 8.3 |
| Oral Semaglutide 14 mg | Change in SF-36: Sub-domains | Week 26: General Health | 0.41 Score on a scale | Standard Deviation 4.33 |
| Oral Semaglutide 14 mg | Change in SF-36: Sub-domains | Week 52: General Health | -0.47 Score on a scale | Standard Deviation 4 |
| Oral Semaglutide 14 mg | Change in SF-36: Sub-domains | Week 26: Vitality | -1.49 Score on a scale | Standard Deviation 4.93 |
| Oral Semaglutide 14 mg | Change in SF-36: Sub-domains | Week 52: Vitality | -1.06 Score on a scale | Standard Deviation 6.08 |
| Oral Semaglutide 14 mg | Change in SF-36: Sub-domains | Week 26: Social Functioning | -0.45 Score on a scale | Standard Deviation 5.62 |
| Oral Semaglutide 14 mg | Change in SF-36: Sub-domains | Week 52: Social Functioning | 0.00 Score on a scale | Standard Deviation 5.3 |
| Oral Semaglutide 14 mg | Change in SF-36: Sub-domains | Week 26: Role-Emotional | 0.35 Score on a scale | Standard Deviation 5.39 |
| Oral Semaglutide 14 mg | Change in SF-36: Sub-domains | Week 52: Role-Emotional | -0.47 Score on a scale | Standard Deviation 5.86 |
| Oral Semaglutide 14 mg | Change in SF-36: Sub-domains | Week 26: Mental Health | -2.36 Score on a scale | Standard Deviation 6.23 |
| Oral Semaglutide 14 mg | Change in SF-36: Sub-domains | Week 52: Mental Health | -1.69 Score on a scale | Standard Deviation 5.12 |
| Liraglutide 0.9 mg | Change in SF-36: Sub-domains | Week 52: Vitality | -0.13 Score on a scale | Standard Deviation 6.17 |
| Liraglutide 0.9 mg | Change in SF-36: Sub-domains | Week 52: Bodily Pain | 0.98 Score on a scale | Standard Deviation 7.09 |
| Liraglutide 0.9 mg | Change in SF-36: Sub-domains | Week 26: Social Functioning | -0.66 Score on a scale | Standard Deviation 5.12 |
| Liraglutide 0.9 mg | Change in SF-36: Sub-domains | Week 26: Bodily Pain | 0.48 Score on a scale | Standard Deviation 7.09 |
| Liraglutide 0.9 mg | Change in SF-36: Sub-domains | Week 52: Social Functioning | -0.48 Score on a scale | Standard Deviation 4.53 |
| Liraglutide 0.9 mg | Change in SF-36: Sub-domains | Week 52: Role-Physical | -0.59 Score on a scale | Standard Deviation 3.55 |
| Liraglutide 0.9 mg | Change in SF-36: Sub-domains | Week 26: Physical Functioning | 0.09 Score on a scale | Standard Deviation 2.01 |
| Liraglutide 0.9 mg | Change in SF-36: Sub-domains | Week 26: Role-Emotional | -0.09 Score on a scale | Standard Deviation 5.72 |
| Liraglutide 0.9 mg | Change in SF-36: Sub-domains | Week 26: Role-Physical | 0.10 Score on a scale | Standard Deviation 3.51 |
| Liraglutide 0.9 mg | Change in SF-36: Sub-domains | Week 52: Role-Emotional | -0.19 Score on a scale | Standard Deviation 4.67 |
| Liraglutide 0.9 mg | Change in SF-36: Sub-domains | Week 52: Physical Functioning | -0.09 Score on a scale | Standard Deviation 2.11 |
| Liraglutide 0.9 mg | Change in SF-36: Sub-domains | Week 52: General Health | 0.62 Score on a scale | Standard Deviation 6.34 |
| Liraglutide 0.9 mg | Change in SF-36: Sub-domains | Week 52: Mental Health | 0.72 Score on a scale | Standard Deviation 5.82 |
| Liraglutide 0.9 mg | Change in SF-36: Sub-domains | Week 26: Vitality | -0.18 Score on a scale | Standard Deviation 6.07 |
| Liraglutide 0.9 mg | Change in SF-36: Sub-domains | Week 26: General Health | -0.00 Score on a scale | Standard Deviation 5.87 |
| Liraglutide 0.9 mg | Change in SF-36: Sub-domains | Week 26: Mental Health | 1.71 Score on a scale | Standard Deviation 6.7 |
| Placebo | Change in SF-36: Sub-domains | Week 26: Role-Emotional | -1.12 Score on a scale | Standard Deviation 5.8 |
| Placebo | Change in SF-36: Sub-domains | Week 52: Vitality | -1.60 Score on a scale | Standard Deviation 7.55 |
| Placebo | Change in SF-36: Sub-domains | Week 52: Bodily Pain | -0.79 Score on a scale | Standard Deviation 8.1 |
| Placebo | Change in SF-36: Sub-domains | Week 26: Role-Physical | -0.86 Score on a scale | Standard Deviation 5.7 |
| Placebo | Change in SF-36: Sub-domains | Week 26: Mental Health | -2.17 Score on a scale | Standard Deviation 6.81 |
| Placebo | Change in SF-36: Sub-domains | Week 52: General Health | -0.99 Score on a scale | Standard Deviation 6.96 |
| Placebo | Change in SF-36: Sub-domains | Week 26: Social Functioning | -1.20 Score on a scale | Standard Deviation 6.52 |
| Placebo | Change in SF-36: Sub-domains | Week 26: Bodily Pain | -0.19 Score on a scale | Standard Deviation 6.19 |
| Placebo | Change in SF-36: Sub-domains | Week 52: Mental Health | -1.31 Score on a scale | Standard Deviation 6.49 |
| Placebo | Change in SF-36: Sub-domains | Week 26: Physical Functioning | -0.14 Score on a scale | Standard Deviation 2.63 |
| Placebo | Change in SF-36: Sub-domains | Week 26: General Health | -0.08 Score on a scale | Standard Deviation 6.06 |
| Placebo | Change in SF-36: Sub-domains | Week 52: Social Functioning | -1.16 Score on a scale | Standard Deviation 5.72 |
| Placebo | Change in SF-36: Sub-domains | Week 52: Role-Physical | -0.58 Score on a scale | Standard Deviation 3.99 |
| Placebo | Change in SF-36: Sub-domains | Week 52: Role-Emotional | -1.80 Score on a scale | Standard Deviation 8.31 |
| Placebo | Change in SF-36: Sub-domains | Week 52: Physical Functioning | -0.00 Score on a scale | Standard Deviation 2.96 |
| Placebo | Change in SF-36: Sub-domains | Week 26: Vitality | -1.99 Score on a scale | Standard Deviation 9.66 |
Secondary
Change in Total Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in total cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 0, week 26 and 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 26 | 0.92 Ratio of total cholesterol | Geometric Coefficient of Variation 9.6 |
| Oral Semaglutide 3 mg | Change in Total Cholesterol (Ratio to Baseline) | Week 52 | 0.99 Ratio of total cholesterol | Geometric Coefficient of Variation 8.8 |
| Oral Semaglutide 7 mg | Change in Total Cholesterol (Ratio to Baseline) | Week 26 | 0.93 Ratio of total cholesterol | Geometric Coefficient of Variation 14.7 |
| Oral Semaglutide 7 mg | Change in Total Cholesterol (Ratio to Baseline) | Week 52 | 0.95 Ratio of total cholesterol | Geometric Coefficient of Variation 10.6 |
| Oral Semaglutide 14 mg | Change in Total Cholesterol (Ratio to Baseline) | Week 26 | 0.89 Ratio of total cholesterol | Geometric Coefficient of Variation 12.6 |
| Oral Semaglutide 14 mg | Change in Total Cholesterol (Ratio to Baseline) | Week 52 | 0.93 Ratio of total cholesterol | Geometric Coefficient of Variation 13.9 |
| Liraglutide 0.9 mg | Change in Total Cholesterol (Ratio to Baseline) | Week 52 | 0.95 Ratio of total cholesterol | Geometric Coefficient of Variation 9 |
| Liraglutide 0.9 mg | Change in Total Cholesterol (Ratio to Baseline) | Week 26 | 0.94 Ratio of total cholesterol | Geometric Coefficient of Variation 9.6 |
| Placebo | Change in Total Cholesterol (Ratio to Baseline) | Week 26 | 1.00 Ratio of total cholesterol | Geometric Coefficient of Variation 12.3 |
| Placebo | Change in Total Cholesterol (Ratio to Baseline) | Week 52 | 1.01 Ratio of total cholesterol | Geometric Coefficient of Variation 15 |
Secondary
Change in Triglycerides (Ratio to Baseline)
Change from baseline (week 0) in triglycerides (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 0, week 26 and 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 | 1.03 Ratio of triglycerides | Geometric Coefficient of Variation 40.2 |
| Oral Semaglutide 3 mg | Change in Triglycerides (Ratio to Baseline) | Week 52 | 0.86 Ratio of triglycerides | Geometric Coefficient of Variation 32.3 |
| Oral Semaglutide 7 mg | Change in Triglycerides (Ratio to Baseline) | Week 26 | 0.94 Ratio of triglycerides | Geometric Coefficient of Variation 38.3 |
| Oral Semaglutide 7 mg | Change in Triglycerides (Ratio to Baseline) | Week 52 | 0.84 Ratio of triglycerides | Geometric Coefficient of Variation 33.3 |
| Oral Semaglutide 14 mg | Change in Triglycerides (Ratio to Baseline) | Week 26 | 0.93 Ratio of triglycerides | Geometric Coefficient of Variation 36.5 |
| Oral Semaglutide 14 mg | Change in Triglycerides (Ratio to Baseline) | Week 52 | 0.86 Ratio of triglycerides | Geometric Coefficient of Variation 45.4 |
| Liraglutide 0.9 mg | Change in Triglycerides (Ratio to Baseline) | Week 52 | 0.87 Ratio of triglycerides | Geometric Coefficient of Variation 35.5 |
| Liraglutide 0.9 mg | Change in Triglycerides (Ratio to Baseline) | Week 26 | 0.99 Ratio of triglycerides | Geometric Coefficient of Variation 33.5 |
| Placebo | Change in Triglycerides (Ratio to Baseline) | Week 26 | 0.87 Ratio of triglycerides | Geometric Coefficient of Variation 41.7 |
| Placebo | Change in Triglycerides (Ratio to Baseline) | Week 52 | 0.82 Ratio of triglycerides | Geometric Coefficient of Variation 44.7 |
Secondary
Change in VLDL Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in very low density lipoprotein (VLDL) cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 0, week 26 and 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 VLDL Cholesterol (Ratio to Baseline) | Week 26 | 1.02 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 37.7 |
| Oral Semaglutide 3 mg | Change in VLDL Cholesterol (Ratio to Baseline) | Week 52 | 0.86 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 32.3 |
| Oral Semaglutide 7 mg | Change in VLDL Cholesterol (Ratio to Baseline) | Week 26 | 0.94 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 37.2 |
| Oral Semaglutide 7 mg | Change in VLDL Cholesterol (Ratio to Baseline) | Week 52 | 0.84 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 33.3 |
| Oral Semaglutide 14 mg | Change in VLDL Cholesterol (Ratio to Baseline) | Week 26 | 0.93 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 36.4 |
| Oral Semaglutide 14 mg | Change in VLDL Cholesterol (Ratio to Baseline) | Week 52 | 0.86 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 45.3 |
| Liraglutide 0.9 mg | Change in VLDL Cholesterol (Ratio to Baseline) | Week 52 | 0.87 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 35 |
| Liraglutide 0.9 mg | Change in VLDL Cholesterol (Ratio to Baseline) | Week 26 | 0.99 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 33.1 |
| Placebo | Change in VLDL Cholesterol (Ratio to Baseline) | Week 26 | 0.87 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 42.4 |
| Placebo | Change in VLDL Cholesterol (Ratio to Baseline) | Week 52 | 0.81 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 45.6 |
Secondary
Change in Waist Circumference
Change from baseline (week 0) in waist circumference. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 0, week 26 and 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 | 0.5 Centimeters (cm) | Standard Deviation 3.9 |
| Oral Semaglutide 3 mg | Change in Waist Circumference | Week 52 | 0.2 Centimeters (cm) | Standard Deviation 4.5 |
| Oral Semaglutide 7 mg | Change in Waist Circumference | Week 52 | -1.0 Centimeters (cm) | Standard Deviation 2.8 |
| Oral Semaglutide 7 mg | Change in Waist Circumference | Week 26 | -0.6 Centimeters (cm) | Standard Deviation 2.8 |
| Oral Semaglutide 14 mg | Change in Waist Circumference | Week 52 | -2.7 Centimeters (cm) | Standard Deviation 4.8 |
| Oral Semaglutide 14 mg | Change in Waist Circumference | Week 26 | -1.3 Centimeters (cm) | Standard Deviation 3.8 |
| Liraglutide 0.9 mg | Change in Waist Circumference | Week 26 | 0.0 Centimeters (cm) | Standard Deviation 2.7 |
| Liraglutide 0.9 mg | Change in Waist Circumference | Week 52 | 1.0 Centimeters (cm) | Standard Deviation 3.7 |
| Placebo | Change in Waist Circumference | Week 52 | -0.9 Centimeters (cm) | Standard Deviation 3 |
| Placebo | Change in Waist Circumference | Week 26 | -0.5 Centimeters (cm) | Standard Deviation 2.1 |
Secondary
Number of Treatment-emergent Adverse Events (TEAEs)
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) with onset in the on-treatment observation period (time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any, and excluding any period after premature trial product discontinuation) assessed up to approximately 57 weeks (52 weeks treatment period + 5 weeks follow-up period).
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) | 119 Adverse events |
| Oral Semaglutide 7 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 111 Adverse events |
| Oral Semaglutide 14 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 96 Adverse events |
| Liraglutide 0.9 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 116 Adverse events |
| Placebo | Number of Treatment-emergent Adverse Events (TEAEs) | 106 Adverse events |
Secondary
Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes
Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data based on on-treatment observation period was presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation.
Time frame: Week 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 Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes | 0 Episodes |
| Oral Semaglutide 7 mg | Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes | 0 Episodes |
| Oral Semaglutide 14 mg | Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes | 0 Episodes |
| Liraglutide 0.9 mg | Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes | 2 Episodes |
| Placebo | Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes | 0 Episodes |
Secondary
Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no)
Participants who achieved HbA1c \<7.0% (53 millimoles per mole \[mmol/mol\]) according to American Diabetes Association (ADA) target, at week 26 and week 52. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 26 and 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 Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | Yes | 24 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | No | 19 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | Yes | 19 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | No | 19 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | Yes | 33 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | No | 14 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | No | 12 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | Yes | 29 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | No | 8 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | No | 9 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | Yes | 33 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | Yes | 35 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | Yes | 24 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | No | 21 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | No | 21 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | Yes | 20 Participants |
| Placebo | Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | No | 30 Participants |
| Placebo | Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | Yes | 4 Participants |
| Placebo | Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | No | 35 Participants |
| Placebo | Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | Yes | 6 Participants |
Secondary
Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)
Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 milligrams per deciliter \[mg/dL\]) with symptoms consistent with hypoglycaemia. Number of participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 26 and 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 Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 52 | Yes | 12 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 26 | No | 28 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 26 | Yes | 15 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 52 | No | 26 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 26 | Yes | 26 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 52 | No | 19 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 26 | No | 19 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 52 | Yes | 24 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 52 | Yes | 28 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 52 | No | 13 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 26 | Yes | 30 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 26 | No | 14 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 26 | No | 30 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 26 | Yes | 15 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 52 | No | 32 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 52 | Yes | 9 Participants |
| Placebo | Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 52 | Yes | 4 Participants |
| Placebo | Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 26 | No | 37 Participants |
| Placebo | Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 26 | Yes | 4 Participants |
| Placebo | Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 52 | No | 30 Participants |
Secondary
Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No)
Participants who achieved HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists target (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 26 and 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 Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 26 | Yes | 13 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 26 | No | 30 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 52 | Yes | 11 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 52 | No | 27 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 26 | Yes | 24 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 52 | No | 23 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 26 | No | 21 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 52 | Yes | 20 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 52 | No | 17 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 26 | No | 16 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 52 | Yes | 24 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 26 | Yes | 28 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 26 | Yes | 16 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 26 | No | 29 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 52 | No | 30 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 52 | Yes | 11 Participants |
| Placebo | Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 52 | No | 33 Participants |
| Placebo | Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 52 | Yes | 1 Participants |
| Placebo | Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 26 | No | 39 Participants |
| Placebo | Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No) | Week 26 | Yes | 2 Participants |
Secondary
Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3%
Participants who achieved above or equal to 1% (10.9 mmol/mol) reduction in HbA1c and losing 3% or more of baseline body weight (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 26 and 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 Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 26 | Yes | 7 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 26 | No | 36 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 52 | Yes | 8 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 52 | No | 30 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 26 | Yes | 11 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 52 | No | 36 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 26 | No | 34 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 52 | Yes | 7 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 52 | No | 21 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 26 | No | 23 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 52 | Yes | 20 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 26 | Yes | 21 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 26 | Yes | 5 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 26 | No | 40 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 52 | No | 39 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 52 | Yes | 2 Participants |
| Placebo | Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 52 | No | 33 Participants |
| Placebo | Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 52 | Yes | 1 Participants |
| Placebo | Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 26 | No | 38 Participants |
| Placebo | Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3% | Week 26 | Yes | 3 Participants |
Secondary
Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No)
Participants losing 10% or more of baseline body weight (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 26 and 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 Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 26 | Yes | 0 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 26 | No | 43 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 52 | Yes | 0 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 52 | No | 38 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 26 | Yes | 0 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 52 | No | 42 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 26 | No | 45 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 52 | Yes | 1 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 52 | No | 35 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 26 | No | 41 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 52 | Yes | 6 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 26 | Yes | 3 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 26 | Yes | 0 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 26 | No | 45 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 52 | No | 41 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 52 | Yes | 0 Participants |
| Placebo | Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 52 | No | 34 Participants |
| Placebo | Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 52 | Yes | 0 Participants |
| Placebo | Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 26 | No | 41 Participants |
| Placebo | Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No) | Week 26 | Yes | 0 Participants |
Secondary
Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No)
Participants losing 5% or more of baseline body weight (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 26 and 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 Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 26 | Yes | 1 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 26 | No | 42 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 52 | Yes | 1 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 52 | No | 37 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 26 | Yes | 5 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 52 | No | 38 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 26 | No | 40 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 52 | Yes | 5 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 52 | No | 24 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 26 | No | 28 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 52 | Yes | 17 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 26 | Yes | 16 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 26 | Yes | 0 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 26 | No | 45 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 52 | No | 39 Participants |
| Liraglutide 0.9 mg | Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 52 | Yes | 2 Participants |
| Placebo | Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 52 | No | 32 Participants |
| Placebo | Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 52 | Yes | 2 Participants |
| Placebo | Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 26 | No | 38 Participants |
| Placebo | Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No) | Week 26 | Yes | 3 Participants |
Secondary
Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes
Number of participants with treatment emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes. Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data based on on-treatment observation period was presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation.
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 Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes | 0 Participants |
| Oral Semaglutide 7 mg | Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes | 0 Participants |
| Oral Semaglutide 14 mg | Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes | 0 Participants |
| Liraglutide 0.9 mg | Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes | 2 Participants |
| Placebo | Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes | 0 Participants |
Secondary
Semaglutide Plasma Concentration
Semaglutide plasma concentration is presented. Samples for pharmacokinetic (PK) analysis were drawn at any time during the visit except for the visit at week 26 where samples were taken both pre-dose and 60-90 minutes post dosing. This endpoint is applicable only to the reporting groups, Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg. Data based on on-treatment observation period was presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation.
Time frame: Week 26 and week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentration | Week 26 post-dose | 5.3 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 92.9 |
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentration | Week 26 pre-dose | 3.7 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 96.7 |
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentration | Week 52 | 3.2 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 89.1 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentration | Week 26 post-dose | 13.9 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 86.3 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentration | Week 26 pre-dose | 9.5 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 80.1 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentration | Week 52 | 9.2 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 96.9 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentration | Week 26 pre-dose | 20.6 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 92.5 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentration | Week 52 | 20.0 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 148.9 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentration | Week 26 post-dose | 30.7 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 80.9 |
Secondary
Time to Additional Anti-diabetic Medication
Presented results are the number of participants who had taken additional anti-diabetic medication anytime from week 0 to week 52. 'Additional anti-diabetic medication': use of new anti-diabetic medication for more than 21 days with the initiation 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 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 | Up to Week 26 | 3 Participants |
| Oral Semaglutide 3 mg | Time to Additional Anti-diabetic Medication | Up to Week 52 | 8 Participants |
| Oral Semaglutide 7 mg | Time to Additional Anti-diabetic Medication | Up to Week 52 | 6 Participants |
| Oral Semaglutide 7 mg | Time to Additional Anti-diabetic Medication | Up to Week 26 | 3 Participants |
| Oral Semaglutide 14 mg | Time to Additional Anti-diabetic Medication | Up to Week 52 | 4 Participants |
| Oral Semaglutide 14 mg | Time to Additional Anti-diabetic Medication | Up to Week 26 | 1 Participants |
| Liraglutide 0.9 mg | Time to Additional Anti-diabetic Medication | Up to Week 26 | 0 Participants |
| Liraglutide 0.9 mg | Time to Additional Anti-diabetic Medication | Up to Week 52 | 4 Participants |
| Placebo | Time to Additional Anti-diabetic Medication | Up to Week 52 | 15 Participants |
| Placebo | Time to Additional Anti-diabetic Medication | Up to Week 26 | 7 Participants |
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor 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: 0.257995% CI: [0.29, 1.4]Regression, Cox
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor 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: 0.005295% CI: [0.1, 0.66]Regression, Cox
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor 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: 0.025995% CI: [0.11, 0.87]Regression, Cox
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor 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: 0.067495% CI: [0.93, 7.8]Regression, Cox
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor 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: 0.908795% CI: [0.32, 3.54]Regression, Cox
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor 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: 0.649895% CI: [0.38, 4.62]Regression, Cox
Secondary
Time to Rescue Medication
Presented results are the number of participants who had taken rescue medication anytime from week 0 to week 52. 'Rescue medication': 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 and before last day on trial product. Time to rescue medication was estimated based on data from on-treatment without rescue medication observation period.
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 | Up to Week 26 | 2 Participants |
| Oral Semaglutide 3 mg | Time to Rescue Medication | Up to Week 52 | 7 Participants |
| Oral Semaglutide 7 mg | Time to Rescue Medication | Up to Week 26 | 2 Participants |
| Oral Semaglutide 7 mg | Time to Rescue Medication | Up to Week 52 | 5 Participants |
| Oral Semaglutide 14 mg | Time to Rescue Medication | Up to Week 26 | 1 Participants |
| Oral Semaglutide 14 mg | Time to Rescue Medication | Up to Week 52 | 4 Participants |
| Liraglutide 0.9 mg | Time to Rescue Medication | Up to Week 52 | 3 Participants |
| Liraglutide 0.9 mg | Time to Rescue Medication | Up to Week 26 | 0 Participants |
| Placebo | Time to Rescue Medication | Up to Week 26 | 7 Participants |
| Placebo | Time to Rescue Medication | Up to Week 52 | 15 Participants |
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: 0.021995% CI: [0.14, 0.86]Regression, Cox
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: 0.000595% CI: [0.05, 0.44]Regression, Cox
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: 0.009895% CI: [0.07, 0.7]Regression, Cox
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: 0.119395% CI: [0.76, 11.46]Regression, Cox
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: 0.714795% CI: [0.31, 5.56]Regression, Cox
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: 0.376595% CI: [0.44, 8.85]Regression, Cox