Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes mellitus treated with diet and exercise only.
Interventions
DRUGsemaglutide
Oral administration once daily.
DRUGplacebo
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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male or female, age above or equal to 18 years at the time of signing informed consent.For Japan only: Male or female, age above or equal to 20 years at the time of signing informed consent. For Algeria only: Male or female, age above or equal to 19 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 (glycosylated haemoglobin) between 7.0-9.5% (53-80 mmol/mol) (both inclusive) - Treatment with diet and exercise for at least 30 days prior to day of screening
Exclusion criteria
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) For Japan only: Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives.For Czech Republic only: Adequate contraceptive measures are always one highly reliable method (such as intrauterine device, sterilisation of one of the partners, hormonal birth control methods) plus one supplementary barrier method (such as condom, diaphragm) with a spermicide. In justified cases, this combination may be replaced with a double-barrier method with a spermicide. Total sexual abstinence may also be considered contraception. (Please note: hormonal contraception should always be discussed with a gynaecologist) - 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 or medullary thyroid carcinomas - History of pancreatitis (acute or chronic) - History of major surgical procedures involving the stomach 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 - Subjects presently classified as being in New York Heart Association Class IV. - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Subjects with alanine aminotransferase above 2.5 x upper normal limit - Renal impairment defined as estimated glomerular filtration rate below 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula - Treatment with any medication for the indication of diabetes or obesity in a period of 90 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Week 0, week 26 | Change from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c). The endpoint was evaluated based on data from the in-trial observation period. The in-trial observation period - time period from when a subject was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. The primary endpoint was also analysed based on data from the on-treatment without rescue medication observation period. The on-treatment without rescue medication observation period - time period when a subject was on treatment with trial product, excluding any period after initiation of rescue medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight (kg) | Week 0, week 26 | Change from baseline (week 0) to week 26 in body weight. The endpoint was evaluated based on data from the in-trial observation period. The in-trial observation period - time period from when a subject was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. The primary endpoint was also analysed based on data from the on-treatment without rescue medication observation period. The on-treatment without rescue medication observation period - time period when a subject was on treatment with trial product, excluding any period after initiation of rescue medication. |
| Change in Fasting Plasma Glucose | Week 0, week 26 | Change from baseline (week 0) to week 26 in fasting plasma glucose. The endpoint was evaluated based on data from the in-trial observation period. The in-trial observation period - time period from when a subject was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
| Change in Mean 7-point SMPG Profile | Week 0, week 26 | Change from baseline (week 0) to week 26 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. The results are based on the data from the in-trial observation period. In trial observation period: 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. |
| Change in Mean Postprandial Increment Over All Meals in SMPG | Week 0, week 26 | Change from baseline (week 0) to week 26 in the average of the post-prandial increments over all meals. The results are based on the data from the in-trial observation period. In trial observation period: 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. |
| Change in Fasting Insulin - Ratio to Baseline | Week 0, week 26 | Change from baseline (week 0) to week 26 in fasting insulin (pmol/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: 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 |
| Change in Fasting Pro-insulin - Ratio to Baseline | Week 0, week 26 | Change from baseline (week 0) to week 26 in fasting pro-insulin (pmol/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: 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 |
| Change in Fasting Glucagon - Ratio to Baseline | Week 0, week 26 | Change from baseline (week 0) to week 26 in fasting glucagon (pg/mL) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: 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 |
| Change in HOMA-IR (Insulin Resistance) - Ratio to Baseline | Week 0, week 26 | Change from baseline (week 0) to week 26 in homeostatic model assessment index of insulin resistance (HOMA-IR) (%) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: 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. |
| Change in HOMA-B (Beta-cell Function) - Ratio to Baseline | Week 0, week 26 | Change from baseline (week 0) to week 26 in homeostatic model assessment index of beta-cell function (HOMA-B) (%) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: 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. |
| Change in CRP - Ratio to Baseline | Week 0, week 26 | Change from baseline (week 0) to week 26 in C-reactive protein (CRP) (mg/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: 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. |
| Change in Body Weight (%) | Week 0, week 26 | Change from baseline (week 0) to week 26 in body weight. The results are based on the data from the in-trial observation period. In trial observation period: 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. |
| Change in BMI | Week 0, week 26 | Change from baseline (week 0) to week 26 in body mass index (BMI). 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. |
| Change in Waist Circumference | Week 0, week 26 | Change from baseline (week 0) to week 26 in waist circumference. 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. |
| Change in Fasting Total Cholesterol - Ratio to Baseline | Week 0, week 26 | Change from baseline (week 0) to week 26 in fasting total cholesterol (mmol/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: 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. |
| Change in Fasting LDL Cholesterol - Ratio to Baseline | Week 0, week 26 | Change from baseline (week 0) to week 26 in fasting low-density lipoprotein (LDL) cholesterol (mmol/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: 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. |
| Change in Fasting HDL Cholesterol - Ratio to Baseline | Week 0, week 26 | Change from baseline (week 0) to week 26 in fasting high-density lipoprotein (HDL) cholesterol (mmol/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: 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. |
| Change in Fasting Triglycerides - Ratio to Baseline | Week 0, week 26 | Change from baseline (week 0) to week 26 in triglycerides (mmol/L) is presented as ratio to baseline. 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. |
| Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | Participants who achieved HbA1c \<7.0% (53 mmol/mol) (American Diabetes Association (ADA) target), at week 26 are presented. The results are based on the data from the in-trial observation period. In trial observation period: 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. |
| Participants Who Achieve HbA1c ≤ 6.5 % (48 mmol/Mol) AACE Target (Yes/no) | Week 26 | Participants who achieved HbA1c ≤6.5% (48 mmol/mol) (American Association of Clinical Endocrinologists (AACE) target), at week 26 are presented. The results are based on the data from the in-trial observation period. In trial observation period: 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. |
| Participants Who Achieve Body Weight Loss ≥ 5 % (Yes/no) | Week 26 | Participants who achieved body weight loss more than or equal to 5% of their baseline body weight (yes/no) at week 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
| Participants Who Achieve Body Weight Loss ≥ 10 % (Yes/no) | Week 26 | Participants who achieved body weight loss more than or equal to 10% of their baseline body weight (yes/no) at week 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
| Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG-confirmed Symptomatic Hypoglycaemia) and Without Body Weight Gain (Yes/no) | Week 26 | Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at week 26 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product |
| Participants Who Achieve HbA1c Reduction ≥ 1.0% (10.9 mmol/Mol) and Weight Loss ≥ 3% (Yes/no) | Week 26 | Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at week 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
| Time to Additional Anti-diabetic Medication | Weeks 0-26 | Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the period from week 0 to week 26. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 26), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
| Time to Rescue Medication | Weeks 0-26 | Presented results are the number of participants who had taken rescue medication anytime during the period from week 0 to week 26. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication or premature trial product discontinuation. |
| Number of Treatment-emergent Adverse Events (TEAEs) | Approximately upto week 31 | Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 31 (26-week treatment period + 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in Amylase - Ratio to Baseline | Week 0, week 26 | Change from baseline (week 0) to week 26 in amylase (units/litre (U/L)) is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in Lipase - Ratio to Baseline | Week 0, week 26 | Change from baseline (week 0) to week 26 in lipase (U/L) is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in Pulse Rate | Week 0, week 26 | Change from baseline (week 0) in pulse rate was evaluated at week 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in Systolic Blood Pressure (SBP) | Week 0, week 26 | Change from baseline (week 0) in SBP was evaluated at week 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in Diastolic Blood Pressure (DBP) | Week 0, week 26 | Change from baseline (week 0) in DBP was evaluated at week 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in Electrocardiogram (ECG) Evaluation | Week 0, week 26 | Change from baseline (week 0) in ECG was evaluated at week 26. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26. 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. |
| Change in Physical Examination | Week 0, week 26 | Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Nervous system (central and peripheral); 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head (ears, eyes, nose), throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland. |
| Change in Eye Examination Category | Week 0, week 26 | Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2), and week 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
| Occurrence of Anti-semaglutide Binding Antibodies (Yes/no) | Weeks 0-31 | This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
| Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no) | Weeks 0-31 | This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
| Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no) | Weeks 0-31 | This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
| Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no) | Weeks 0-31 | This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. |
| Anti-semaglutide Binding Antibody Levels | Weeks 0-31 | 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 (week 0 to week 31). 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, 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. |
| Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | Weeks 0-31 | Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 31 (26-weeks treatment period + 5-weeks follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. |
| Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | Weeks 0-31 | Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 31 (26-week treatment period + 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. |
| SNAC Plasma Concentrations | Weeks 0-26 | This outcome measure is only applicable for the oral semaglutide 3 mg, 7 mg and 14 mg treatment arms. Sodium N-\[8-(2-hydroxybenzoyl) amino\]caprylate (SNAC) plasma concentrations were measured after 25 and 40 minutes post-dose at weeks 4, 14 and 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Semaglutide Plasma Concentrations for Population PK Analysis | Weeks 0 - 26 | This outcome measure is only applicable for the oral semaglutide 3 mg, 7 mg and 14 mg treatment arms. Semaglutide plasma concentrations were measured at weeks 4, 8, 14 and 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Week 0, week 26 | SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the sub-domain scores and component summary (PCS and MCS) scores were evaluated at week 26. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period. |
| IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | Week 0, week 26 | The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 22-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. Results are based on the data from the in-trial observation period, which 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. |
| PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | Week 26 | Patient global impression of status (PGI-S) is a 2-item questionnaire used to assess the participant's impression of physical functioning and mental health status during the clinical trial. The PGI-S contains two items evaluated on a 5-point graded response scale. 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. |
| PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | Week 26 | Patient global impression of change (PGI-C) is a 2-item questionnaire used to assess the participant's impression of change from baseline in physical functioning and mental health status. The PGI-C contains two items evaluated on a 7-point graded response scale. 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. |
Countries
Algeria, Bulgaria, Czechia, Italy, Japan, Mexico, Romania, Russia, Serbia, Turkey (Türkiye), United States
Participant flow
Recruitment details
The trial was conducted at 93 sites in 9 countries as follows: Algeria: 4 sites screened/4 sites randomised subjects; Bulgaria: 3/3; Czech Republic: 5 /5; Japan: 6/6; Mexico: 2/2; Russian Federation: 9/9; Serbia: 3/3; Turkey: 7/7; United States: 53/48.
Pre-assignment details
Data presented in participant flow is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Participants by arm
| Arm | Count |
|---|---|
| Oral Semaglutide 3 mg Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 26. | 175 |
| Oral Semaglutide 7 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 26. | 175 |
| Oral Semaglutide 14 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 26. | 175 |
| Placebo Participants were to take placebo tablets once daily for a period of 26 weeks. | 178 |
| Total | 703 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 5 | 7 | 5 | 2 |
| Overall Study | Other | 1 | 2 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 5 | 5 | 4 |
Baseline characteristics
| Characteristic | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 55 Years STANDARD_DEVIATION 11 | 56 Years STANDARD_DEVIATION 11 | 54 Years STANDARD_DEVIATION 11 | 54 Years STANDARD_DEVIATION 11 | 55 Years STANDARD_DEVIATION 11 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 31 Participants | 30 Participants | 29 Participants | 31 Participants | 121 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 11 Participants | 10 Participants | 10 Participants | 37 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 52 Participants | 31 Participants | 46 Participants | 51 Participants | 180 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not applicable | 7 Participants | 11 Participants | 7 Participants | 6 Participants | 31 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 116 Participants | 133 Participants | 122 Participants | 121 Participants | 492 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 2 Participants | 4 Participants | 4 Participants | 12 Participants |
| Race/Ethnicity, Customized White | 135 Participants | 131 Participants | 130 Participants | 132 Participants | 528 Participants |
| Sex: Female, Male Female | 86 Participants | 82 Participants | 89 Participants | 89 Participants | 346 Participants |
| Sex: Female, Male Male | 89 Participants | 93 Participants | 86 Participants | 89 Participants | 357 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 175 | 0 / 175 | 1 / 175 | 0 / 178 |
| other Total, other adverse events | 48 / 175 | 37 / 175 | 45 / 175 | 26 / 178 |
| serious Total, serious adverse events | 5 / 175 | 3 / 175 | 2 / 175 | 8 / 178 |
Outcome results
Primary
Change in HbA1c
Change from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c). The endpoint was evaluated based on data from the in-trial observation period. The in-trial observation period - time period from when a subject was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. The primary endpoint was also analysed based on data from the on-treatment without rescue medication observation period. The on-treatment without rescue medication observation period - time period when a subject was on treatment with trial product, excluding any period after initiation of rescue medication.
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 | On-treatment without rescue medication | -0.9 Percentage of HbA1c | Standard Deviation 1.2 |
| Oral Semaglutide 3 mg | Change in HbA1c | In-trial | -0.9 Percentage of HbA1c | Standard Deviation 1.2 |
| Oral Semaglutide 7 mg | Change in HbA1c | On-treatment without rescue medication | -1.4 Percentage of HbA1c | Standard Deviation 0.9 |
| Oral Semaglutide 7 mg | Change in HbA1c | In-trial | -1.3 Percentage of HbA1c | Standard Deviation 1 |
| Oral Semaglutide 14 mg | Change in HbA1c | On-treatment without rescue medication | -1.6 Percentage of HbA1c | Standard Deviation 1 |
| Oral Semaglutide 14 mg | Change in HbA1c | In-trial | -1.5 Percentage of HbA1c | Standard Deviation 1 |
| Placebo | Change in HbA1c | In-trial | -0.3 Percentage of HbA1c | Standard Deviation 1.2 |
| Placebo | Change in HbA1c | On-treatment without rescue medication | -0.3 Percentage of HbA1c | Standard Deviation 1.2 |
Comparison: The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [-1.3, -0.9]Pattern mixed model
Comparison: The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [-1.1, -0.6]Pattern mixed model
Comparison: The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [-0.8, -0.4]Pattern mixed model
Comparison: The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: <0.000195% CI: [-0.9, -0.5]MMRM
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 region 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: [-1.5, -1]MMRM
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 region 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]MMRM
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 (week 0 to week 31). 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, 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 0-31
Population: Overall number of participants analysed = participants who were found positive for anti-semaglutide antibodies.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Anti-semaglutide Binding Antibody Levels | Week 4 | 15 %B/T | Standard Deviation 13 |
| Oral Semaglutide 3 mg | Anti-semaglutide Binding Antibody Levels | Week 31 | 3 %B/T | Standard Deviation 0 |
| Oral Semaglutide 3 mg | Anti-semaglutide Binding Antibody Levels | Week 8 | 7 %B/T | Standard Deviation 4 |
| Oral Semaglutide 7 mg | Anti-semaglutide Binding Antibody Levels | Week 4 | 2 %B/T | Standard Deviation 0 |
| Oral Semaglutide 7 mg | Anti-semaglutide Binding Antibody Levels | Week 14 | 3 %B/T | Standard Deviation 0 |
Secondary
Change in Amylase - Ratio to Baseline
Change from baseline (week 0) to week 26 in amylase (units/litre (U/L)) is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Amylase - Ratio to Baseline | 1.05 Ratio | Geometric Coefficient of Variation 21.1 |
| Oral Semaglutide 7 mg | Change in Amylase - Ratio to Baseline | 1.09 Ratio | Geometric Coefficient of Variation 21.4 |
| Oral Semaglutide 14 mg | Change in Amylase - Ratio to Baseline | 1.12 Ratio | Geometric Coefficient of Variation 20.2 |
| Placebo | Change in Amylase - Ratio to Baseline | 0.99 Ratio | Geometric Coefficient of Variation 25.5 |
Secondary
Change in BMI
Change from baseline (week 0) to week 26 in body mass index (BMI). 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: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in BMI | -0.6 kg/m^2 | Standard Deviation 1.2 |
| Oral Semaglutide 7 mg | Change in BMI | -0.9 kg/m^2 | Standard Deviation 1.5 |
| Oral Semaglutide 14 mg | Change in BMI | -1.5 kg/m^2 | Standard Deviation 1.5 |
| Placebo | Change in BMI | -0.5 kg/m^2 | Standard Deviation 1.2 |
Secondary
Change in Body Weight (%)
Change from baseline (week 0) to week 26 in body weight. The results are based on the data from the in-trial observation period. In trial observation period: 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: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Body Weight (%) | -1.67 Percentage change | Standard Deviation 4.08 |
| Oral Semaglutide 7 mg | Change in Body Weight (%) | -2.85 Percentage change | Standard Deviation 4.57 |
| Oral Semaglutide 14 mg | Change in Body Weight (%) | -4.71 Percentage change | Standard Deviation 5 |
| Placebo | Change in Body Weight (%) | -1.37 Percentage change | Standard Deviation 3.58 |
Secondary
Change in Body Weight (kg)
Change from baseline (week 0) to week 26 in body weight. The endpoint was evaluated based on data from the in-trial observation period. The in-trial observation period - time period from when a subject was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. The primary endpoint was also analysed based on data from the on-treatment without rescue medication observation period. The on-treatment without rescue medication observation period - time period when a subject was on treatment with trial product, excluding any period after initiation of rescue medication.
Time frame: Week 0, week 26
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Body Weight (kg) | In-trial | -1.5 kg | Standard Deviation 3.3 |
| Oral Semaglutide 3 mg | Change in Body Weight (kg) | On-treatment without rescue medication | -1.8 kg | Standard Deviation 3.3 |
| Oral Semaglutide 7 mg | Change in Body Weight (kg) | On-treatment without rescue medication | -2.8 kg | Standard Deviation 4 |
| Oral Semaglutide 7 mg | Change in Body Weight (kg) | In-trial | -2.6 kg | Standard Deviation 4.1 |
| Oral Semaglutide 14 mg | Change in Body Weight (kg) | In-trial | -4.0 kg | Standard Deviation 4.2 |
| Oral Semaglutide 14 mg | Change in Body Weight (kg) | On-treatment without rescue medication | -4.3 kg | Standard Deviation 4.2 |
| Placebo | Change in Body Weight (kg) | In-trial | -1.4 kg | Standard Deviation 3.5 |
| Placebo | Change in Body Weight (kg) | On-treatment without rescue medication | -1.6 kg | Standard Deviation 3.6 |
Comparison: The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [-3.1, -1.5]Pattern mixed model
Comparison: The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: 0.086695% CI: [-1.9, 0.1]Pattern mixed model
Comparison: The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: 0.869295% CI: [-0.9, 0.8]Pattern mixed model
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 region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: 0.707595% CI: [-1, 0.6]MMRM
Comparison: The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: 0.013895% CI: [-1.8, -0.2]MMRM
Comparison: The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: <0.000195% CI: [-3.4, -1.8]MMRM
Secondary
Change in CRP - Ratio to Baseline
Change from baseline (week 0) to week 26 in C-reactive protein (CRP) (mg/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: 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: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in CRP - Ratio to Baseline | 0.89 Ratio of CRP | Geometric Coefficient of Variation 87.5 |
| Oral Semaglutide 7 mg | Change in CRP - Ratio to Baseline | 0.72 Ratio of CRP | Geometric Coefficient of Variation 118.2 |
| Oral Semaglutide 14 mg | Change in CRP - Ratio to Baseline | 0.81 Ratio of CRP | Geometric Coefficient of Variation 123.7 |
| Placebo | Change in CRP - Ratio to Baseline | 0.99 Ratio of CRP | Geometric Coefficient of Variation 108.3 |
Secondary
Change in Diastolic Blood Pressure (DBP)
Change from baseline (week 0) in DBP was evaluated at week 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Diastolic Blood Pressure (DBP) | -1 mmHg | Standard Deviation 9 |
| Oral Semaglutide 7 mg | Change in Diastolic Blood Pressure (DBP) | -2 mmHg | Standard Deviation 8 |
| Oral Semaglutide 14 mg | Change in Diastolic Blood Pressure (DBP) | -1 mmHg | Standard Deviation 9 |
| Placebo | Change in Diastolic Blood Pressure (DBP) | -1 mmHg | Standard Deviation 9 |
Secondary
Change in Electrocardiogram (ECG) Evaluation
Change from baseline (week 0) in ECG was evaluated at week 26. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26. 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: Week 0, week 26
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 Electrocardiogram (ECG) Evaluation | Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change in Electrocardiogram (ECG) Evaluation | Normal (week 0) to normal (week 26) | 102 Participants |
| Oral Semaglutide 3 mg | Change in Electrocardiogram (ECG) Evaluation | Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change in Electrocardiogram (ECG) Evaluation | Normal (week 0) to abnormal NCS (week 26) | 11 Participants |
| Oral Semaglutide 3 mg | Change in Electrocardiogram (ECG) Evaluation | Abnormal CS (week 0) to abnormal NCS (week 26) | 1 Participants |
| Oral Semaglutide 3 mg | Change in Electrocardiogram (ECG) Evaluation | Normal (week 0) to abnormal CS (week 26) | 1 Participants |
| Oral Semaglutide 3 mg | Change in Electrocardiogram (ECG) Evaluation | Abnormal CS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change in Electrocardiogram (ECG) Evaluation | Abnormal NCS (week 0) to normal (week 26) | 12 Participants |
| Oral Semaglutide 3 mg | Change in Electrocardiogram (ECG) Evaluation | Abnormal NCS (week 0) to abnormal NCS (week 26) | 40 Participants |
| Oral Semaglutide 7 mg | Change in Electrocardiogram (ECG) Evaluation | Abnormal CS (week 0) to normal (week 26) | 1 Participants |
| Oral Semaglutide 7 mg | Change in Electrocardiogram (ECG) Evaluation | Abnormal NCS (week 0) to abnormal NCS (week 26) | 39 Participants |
| Oral Semaglutide 7 mg | Change in Electrocardiogram (ECG) Evaluation | Abnormal CS (week 0) to abnormal CS (week 26) | 1 Participants |
| Oral Semaglutide 7 mg | Change in Electrocardiogram (ECG) Evaluation | Abnormal NCS (week 0) to abnormal CS (week 26) | 1 Participants |
| Oral Semaglutide 7 mg | Change in Electrocardiogram (ECG) Evaluation | Normal (week 0) to abnormal CS (week 26) | 1 Participants |
| Oral Semaglutide 7 mg | Change in Electrocardiogram (ECG) Evaluation | Normal (week 0) to normal (week 26) | 88 Participants |
| Oral Semaglutide 7 mg | Change in Electrocardiogram (ECG) Evaluation | Abnormal NCS (week 0) to normal (week 26) | 12 Participants |
| Oral Semaglutide 7 mg | Change in Electrocardiogram (ECG) Evaluation | Normal (week 0) to abnormal NCS (week 26) | 13 Participants |
| Oral Semaglutide 7 mg | Change in Electrocardiogram (ECG) Evaluation | Abnormal CS (week 0) to abnormal NCS (week 26) | 3 Participants |
| Oral Semaglutide 14 mg | Change in Electrocardiogram (ECG) Evaluation | Normal (week 0) to normal (week 26) | 96 Participants |
| Oral Semaglutide 14 mg | Change in Electrocardiogram (ECG) Evaluation | Normal (week 0) to abnormal NCS (week 26) | 4 Participants |
| Oral Semaglutide 14 mg | Change in Electrocardiogram (ECG) Evaluation | Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change in Electrocardiogram (ECG) Evaluation | Abnormal NCS (week 0) to normal (week 26) | 20 Participants |
| Oral Semaglutide 14 mg | Change in Electrocardiogram (ECG) Evaluation | Abnormal NCS (week 0) to abnormal NCS (week 26) | 39 Participants |
| Oral Semaglutide 14 mg | Change in Electrocardiogram (ECG) Evaluation | Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change in Electrocardiogram (ECG) Evaluation | Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change in Electrocardiogram (ECG) Evaluation | Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change in Electrocardiogram (ECG) Evaluation | Abnormal CS (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change in Electrocardiogram (ECG) Evaluation | Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change in Electrocardiogram (ECG) Evaluation | Abnormal CS (week 0) to abnormal NCS (week 26) | 2 Participants |
| Placebo | Change in Electrocardiogram (ECG) Evaluation | Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Placebo | Change in Electrocardiogram (ECG) Evaluation | Normal (week 0) to abnormal NCS (week 26) | 13 Participants |
| Placebo | Change in Electrocardiogram (ECG) Evaluation | Normal (week 0) to normal (week 26) | 97 Participants |
| Placebo | Change in Electrocardiogram (ECG) Evaluation | Abnormal NCS (week 0) to abnormal NCS (week 26) | 40 Participants |
| Placebo | Change in Electrocardiogram (ECG) Evaluation | Abnormal CS (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change in Electrocardiogram (ECG) Evaluation | Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change in Electrocardiogram (ECG) Evaluation | Abnormal NCS (week 0) to normal (week 26) | 14 Participants |
Secondary
Change in Eye Examination Category
Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2), and week 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time frame: Week 0, week 26
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week -2) | Normal | 109 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week 26) | Normal | 101 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal NCS | 59 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal CS | 5 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal NCS | 58 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week 26) | Normal | 103 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal CS | 5 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week -2) | Normal | 111 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week 26) | Abnormal CS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week 26) | Abnormal NCS | 52 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week 26) | Abnormal CS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week 26) | Abnormal NCS | 55 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week -2) | Normal | 112 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal NCS | 55 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week 26) | Abnormal CS | 4 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal NCS | 59 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal CS | 4 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week 26) | Normal | 94 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week 26) | Abnormal NCS | 55 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week 26) | Abnormal CS | 4 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week -2) | Normal | 116 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal CS | 4 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week 26) | Normal | 93 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week 26) | Abnormal NCS | 56 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week 26) | Abnormal NCS | 54 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week 26) | Abnormal CS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week 26) | Abnormal NCS | 55 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal NCS | 63 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week 26) | Abnormal CS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal NCS | 63 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal CS | 4 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal CS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week 26) | Normal | 98 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week -2) | Normal | 109 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week -2) | Normal | 108 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week 26) | Normal | 99 Participants |
| Placebo | Change in Eye Examination Category | Right eye (week -2) | Normal | 120 Participants |
| Placebo | Change in Eye Examination Category | Right eye (week 26) | Abnormal CS | 3 Participants |
| Placebo | Change in Eye Examination Category | Left eye (week 26) | Abnormal NCS | 54 Participants |
| Placebo | Change in Eye Examination Category | Left eye (week -2) | Normal | 122 Participants |
| Placebo | Change in Eye Examination Category | Left eye (week 26) | Abnormal CS | 3 Participants |
| Placebo | Change in Eye Examination Category | Right eye (week 26) | Abnormal NCS | 53 Participants |
| Placebo | Change in Eye Examination Category | Left eye (week 26) | Normal | 105 Participants |
| Placebo | Change in Eye Examination Category | Right eye (week -2) | Abnormal NCS | 55 Participants |
| Placebo | Change in Eye Examination Category | Right eye (week 26) | Normal | 106 Participants |
| Placebo | Change in Eye Examination Category | Left eye (week -2) | Abnormal NCS | 54 Participants |
| Placebo | Change in Eye Examination Category | Left eye (week -2) | Abnormal CS | 2 Participants |
| Placebo | Change in Eye Examination Category | Right eye (week -2) | Abnormal CS | 3 Participants |
Secondary
Change in Fasting Glucagon - Ratio to Baseline
Change from baseline (week 0) to week 26 in fasting glucagon (pg/mL) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: 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: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Fasting Glucagon - Ratio to Baseline | 1.00 Ratio of fasting glucagon | Geometric Coefficient of Variation 28.2 |
| Oral Semaglutide 7 mg | Change in Fasting Glucagon - Ratio to Baseline | 0.90 Ratio of fasting glucagon | Geometric Coefficient of Variation 27.1 |
| Oral Semaglutide 14 mg | Change in Fasting Glucagon - Ratio to Baseline | 0.89 Ratio of fasting glucagon | Geometric Coefficient of Variation 25.7 |
| Placebo | Change in Fasting Glucagon - Ratio to Baseline | 0.95 Ratio of fasting glucagon | Geometric Coefficient of Variation 25.4 |
Secondary
Change in Fasting HDL Cholesterol - Ratio to Baseline
Change from baseline (week 0) to week 26 in fasting high-density lipoprotein (HDL) cholesterol (mmol/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: 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: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Fasting HDL Cholesterol - Ratio to Baseline | 1.03 Ratio of fasting HDL cholesterol | Geometric Coefficient of Variation 14.6 |
| Oral Semaglutide 7 mg | Change in Fasting HDL Cholesterol - Ratio to Baseline | 1.05 Ratio of fasting HDL cholesterol | Geometric Coefficient of Variation 14.9 |
| Oral Semaglutide 14 mg | Change in Fasting HDL Cholesterol - Ratio to Baseline | 1.02 Ratio of fasting HDL cholesterol | Geometric Coefficient of Variation 14.7 |
| Placebo | Change in Fasting HDL Cholesterol - Ratio to Baseline | 1.03 Ratio of fasting HDL cholesterol | Geometric Coefficient of Variation 14 |
Secondary
Change in Fasting Insulin - Ratio to Baseline
Change from baseline (week 0) to week 26 in fasting insulin (pmol/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: 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: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Fasting Insulin - Ratio to Baseline | 1.12 Ratio of fasting insulin | Geometric Coefficient of Variation 59.2 |
| Oral Semaglutide 7 mg | Change in Fasting Insulin - Ratio to Baseline | 1.07 Ratio of fasting insulin | Geometric Coefficient of Variation 49.2 |
| Oral Semaglutide 14 mg | Change in Fasting Insulin - Ratio to Baseline | 0.98 Ratio of fasting insulin | Geometric Coefficient of Variation 45 |
| Placebo | Change in Fasting Insulin - Ratio to Baseline | 0.97 Ratio of fasting insulin | Geometric Coefficient of Variation 59.2 |
Secondary
Change in Fasting LDL Cholesterol - Ratio to Baseline
Change from baseline (week 0) to week 26 in fasting low-density lipoprotein (LDL) cholesterol (mmol/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: 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: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Fasting LDL Cholesterol - Ratio to Baseline | 0.95 Ratio of fasting LDL cholesterol | Geometric Coefficient of Variation 27.8 |
| Oral Semaglutide 7 mg | Change in Fasting LDL Cholesterol - Ratio to Baseline | 0.97 Ratio of fasting LDL cholesterol | Geometric Coefficient of Variation 28.8 |
| Oral Semaglutide 14 mg | Change in Fasting LDL Cholesterol - Ratio to Baseline | 0.95 Ratio of fasting LDL cholesterol | Geometric Coefficient of Variation 31.6 |
| Placebo | Change in Fasting LDL Cholesterol - Ratio to Baseline | 1.00 Ratio of fasting LDL cholesterol | Geometric Coefficient of Variation 26.2 |
Secondary
Change in Fasting Plasma Glucose
Change from baseline (week 0) to week 26 in fasting plasma glucose. The endpoint was evaluated based on data from the in-trial observation period. The in-trial observation period - time period from when a subject 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 = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Fasting Plasma Glucose | -0.89 mmol/L | Standard Deviation 2.67 |
| Oral Semaglutide 7 mg | Change in Fasting Plasma Glucose | -1.52 mmol/L | Standard Deviation 2.28 |
| Oral Semaglutide 14 mg | Change in Fasting Plasma Glucose | -1.92 mmol/L | Standard Deviation 2.04 |
| Placebo | Change in Fasting Plasma Glucose | -0.18 mmol/L | Standard Deviation 2.37 |
Secondary
Change in Fasting Pro-insulin - Ratio to Baseline
Change from baseline (week 0) to week 26 in fasting pro-insulin (pmol/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: 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: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Fasting Pro-insulin - Ratio to Baseline | 0.84 Ratio of fasting pro-insulin | Geometric Coefficient of Variation 71.5 |
| Oral Semaglutide 7 mg | Change in Fasting Pro-insulin - Ratio to Baseline | 0.74 Ratio of fasting pro-insulin | Geometric Coefficient of Variation 74.3 |
| Oral Semaglutide 14 mg | Change in Fasting Pro-insulin - Ratio to Baseline | 0.62 Ratio of fasting pro-insulin | Geometric Coefficient of Variation 75.5 |
| Placebo | Change in Fasting Pro-insulin - Ratio to Baseline | 0.89 Ratio of fasting pro-insulin | Geometric Coefficient of Variation 76.5 |
Secondary
Change in Fasting Total Cholesterol - Ratio to Baseline
Change from baseline (week 0) to week 26 in fasting total cholesterol (mmol/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: 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: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Fasting Total Cholesterol - Ratio to Baseline | 0.98 Ratio of fasting total cholesterol | Geometric Coefficient of Variation 15.6 |
| Oral Semaglutide 7 mg | Change in Fasting Total Cholesterol - Ratio to Baseline | 0.98 Ratio of fasting total cholesterol | Geometric Coefficient of Variation 18.4 |
| Oral Semaglutide 14 mg | Change in Fasting Total Cholesterol - Ratio to Baseline | 0.96 Ratio of fasting total cholesterol | Geometric Coefficient of Variation 19 |
| Placebo | Change in Fasting Total Cholesterol - Ratio to Baseline | 1.01 Ratio of fasting total cholesterol | Geometric Coefficient of Variation 17.9 |
Secondary
Change in Fasting Triglycerides - Ratio to Baseline
Change from baseline (week 0) to week 26 in triglycerides (mmol/L) is presented as ratio to baseline. 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: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Fasting Triglycerides - Ratio to Baseline | 1.01 Ratio of fasting triglycerides | Geometric Coefficient of Variation 35.8 |
| Oral Semaglutide 7 mg | Change in Fasting Triglycerides - Ratio to Baseline | 0.90 Ratio of fasting triglycerides | Geometric Coefficient of Variation 41.1 |
| Oral Semaglutide 14 mg | Change in Fasting Triglycerides - Ratio to Baseline | 0.91 Ratio of fasting triglycerides | Geometric Coefficient of Variation 37.8 |
| Placebo | Change in Fasting Triglycerides - Ratio to Baseline | 1.00 Ratio of fasting triglycerides | Geometric Coefficient of Variation 39.2 |
Secondary
Change in HOMA-B (Beta-cell Function) - Ratio to Baseline
Change from baseline (week 0) to week 26 in homeostatic model assessment index of beta-cell function (HOMA-B) (%) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: 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: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in HOMA-B (Beta-cell Function) - Ratio to Baseline | 1.40 Ratio of HOMA-B | Geometric Coefficient of Variation 73.2 |
| Oral Semaglutide 7 mg | Change in HOMA-B (Beta-cell Function) - Ratio to Baseline | 1.51 Ratio of HOMA-B | Geometric Coefficient of Variation 60.5 |
| Oral Semaglutide 14 mg | Change in HOMA-B (Beta-cell Function) - Ratio to Baseline | 1.60 Ratio of HOMA-B | Geometric Coefficient of Variation 58.4 |
| Placebo | Change in HOMA-B (Beta-cell Function) - Ratio to Baseline | 1.01 Ratio of HOMA-B | Geometric Coefficient of Variation 61.9 |
Secondary
Change in HOMA-IR (Insulin Resistance) - Ratio to Baseline
Change from baseline (week 0) to week 26 in homeostatic model assessment index of insulin resistance (HOMA-IR) (%) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: 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: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in HOMA-IR (Insulin Resistance) - Ratio to Baseline | 1.00 Ratio of HOMA-IR | Geometric Coefficient of Variation 74.6 |
| Oral Semaglutide 7 mg | Change in HOMA-IR (Insulin Resistance) - Ratio to Baseline | 0.88 Ratio of HOMA-IR | Geometric Coefficient of Variation 66.7 |
| Oral Semaglutide 14 mg | Change in HOMA-IR (Insulin Resistance) - Ratio to Baseline | 0.76 Ratio of HOMA-IR | Geometric Coefficient of Variation 60.4 |
| Placebo | Change in HOMA-IR (Insulin Resistance) - Ratio to Baseline | 0.92 Ratio of HOMA-IR | Geometric Coefficient of Variation 75 |
Secondary
Change in Lipase - Ratio to Baseline
Change from baseline (week 0) to week 26 in lipase (U/L) is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Lipase - Ratio to Baseline | 1.14 Ratio | Geometric Coefficient of Variation 43.8 |
| Oral Semaglutide 7 mg | Change in Lipase - Ratio to Baseline | 1.27 Ratio | Geometric Coefficient of Variation 51.1 |
| Oral Semaglutide 14 mg | Change in Lipase - Ratio to Baseline | 1.33 Ratio | Geometric Coefficient of Variation 45.1 |
| Placebo | Change in Lipase - Ratio to Baseline | 0.99 Ratio | Geometric Coefficient of Variation 54.2 |
Secondary
Change in Mean 7-point SMPG Profile
Change from baseline (week 0) to week 26 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. The results are based on the data from the in-trial observation period. In trial observation period: 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: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Mean 7-point SMPG Profile | -1.8 mmol/L | Standard Deviation 2.3 |
| Oral Semaglutide 7 mg | Change in Mean 7-point SMPG Profile | -2.1 mmol/L | Standard Deviation 2 |
| Oral Semaglutide 14 mg | Change in Mean 7-point SMPG Profile | -2.3 mmol/L | Standard Deviation 2.4 |
| Placebo | Change in Mean 7-point SMPG Profile | -0.5 mmol/L | Standard Deviation 2.6 |
Secondary
Change in Mean Postprandial Increment Over All Meals in SMPG
Change from baseline (week 0) to week 26 in the average of the post-prandial increments over all meals. The results are based on the data from the in-trial observation period. In trial observation period: 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: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Mean Postprandial Increment Over All Meals in SMPG | -0.4 mmol/L | Standard Deviation 2.3 |
| Oral Semaglutide 7 mg | Change in Mean Postprandial Increment Over All Meals in SMPG | -0.8 mmol/L | Standard Deviation 2 |
| Oral Semaglutide 14 mg | Change in Mean Postprandial Increment Over All Meals in SMPG | -1.2 mmol/L | Standard Deviation 2.1 |
| Placebo | Change in Mean Postprandial Increment Over All Meals in SMPG | -0.3 mmol/L | Standard Deviation 2 |
Secondary
Change in Physical Examination
Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Nervous system (central and peripheral); 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head (ears, eyes, nose), throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.
Time frame: Week 0, week 26
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Normal | 173 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week 26) | Abnormal CS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Normal | 163 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Normal | 163 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal NCS | 12 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal NCS | 11 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 26) | Normal | 155 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Normal | 164 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week 26) | Abnormal NCS | 30 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Normal | 175 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week 26) | Normal | 167 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Normal | 165 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Abnormal CS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Normal | 163 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week -2) | Normal | 143 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week 26) | Normal | 136 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal NCS | 12 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal CS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Normal | 157 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal NCS | 36 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Abnormal NCS | 10 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 26) | Abnormal NCS | 12 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week -2) | Normal | 137 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal NCS | 10 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal CS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week 26) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Normal | 157 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Abnormal NCS | 4 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Abnormal NCS | 10 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Normal | 164 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal NCS | 11 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Normal | 173 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Normal | 153 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week 26) | Abnormal CS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Abnormal NCS | 13 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Abnormal CS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week 26) | Abnormal NCS | 11 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week -2) | Abnormal NCS | 32 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week 26) | Normal | 155 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week 26) | Normal | 138 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week 26) | Abnormal NCS | 29 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Normal | 165 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week 26) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Normal | 169 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Normal | 172 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Normal | 165 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week 26) | Abnormal NCS | 17 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal NCS | 6 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week 26) | Normal | 141 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal NCS | 10 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week 26) | Abnormal NCS | 13 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal NCS | 4 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Normal | 169 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week -2) | Abnormal NCS | 23 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 26) | Normal | 149 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Normal | 154 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 26) | Abnormal NCS | 10 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week 26) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week -2) | Normal | 156 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week 26) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Normal | 175 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week 26) | Normal | 145 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week 26) | Normal | 154 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal NCS | 8 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week 26) | Normal | 159 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Normal | 157 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Normal | 170 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal NCS | 4 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Abnormal NCS | 4 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Abnormal NCS | 5 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Normal | 155 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Normal | 167 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal NCS | 3 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Normal | 157 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week 26) | Abnormal NCS | 5 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Normal | 171 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Normal | 149 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week -2) | Normal | 152 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal NCS | 6 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Abnormal NCS | 9 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal NCS | 18 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week -2) | Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week 26) | Normal | 141 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 26) | Normal | 149 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Normal | 167 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal NCS | 8 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Normal | 155 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Abnormal NCS | 4 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Normal | 168 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal NCS | 7 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Normal | 153 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Abnormal NCS | 6 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Normal | 159 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal NCS | 16 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Normal | 148 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Abnormal NCS | 11 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week -2) | Normal | 153 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week -2) | Abnormal NCS | 20 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week 26) | Abnormal NCS | 17 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week 26) | Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Normal | 165 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal NCS | 10 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 26) | Abnormal NCS | 10 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Normal | 175 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week 26) | Normal | 159 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week 26) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Normal | 167 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal NCS | 8 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week 26) | Normal | 152 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week 26) | Abnormal NCS | 6 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week 26) | Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Normal | 173 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Normal | 159 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week -2) | Normal | 150 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal NCS | 24 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week 26) | Normal | 140 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week 26) | Abnormal NCS | 18 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week 26) | Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Normal | 169 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal NCS | 6 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Normal | 156 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Abnormal NCS | 3 Participants |
| Placebo | Change in Physical Examination | 4) General appearance (week -2) | Normal | 157 Participants |
| Placebo | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Abnormal NCS | 10 Participants |
| Placebo | Change in Physical Examination | 10) Thyroid gland (week 26) | Normal | 165 Participants |
| Placebo | Change in Physical Examination | 7) Musculoskeletal system (week 26) | Abnormal NCS | 10 Participants |
| Placebo | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Normal | 157 Participants |
| Placebo | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 10) Thyroid gland (week -2) | Normal | 176 Participants |
| Placebo | Change in Physical Examination | 7) Musculoskeletal system (week 26) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal NCS | 10 Participants |
| Placebo | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Normal | 168 Participants |
| Placebo | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Abnormal NCS | 8 Participants |
| Placebo | Change in Physical Examination | 6) Lymph node palpation (week 26) | Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Normal | 159 Participants |
| Placebo | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 1) Cardiovascular system (week 26) | Normal | 162 Participants |
| Placebo | Change in Physical Examination | 8) Respiratory system (week 26) | Abnormal NCS | 1 Participants |
| Placebo | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal NCS | 9 Participants |
| Placebo | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal NCS | 2 Participants |
| Placebo | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Normal | 169 Participants |
| Placebo | Change in Physical Examination | 1) Cardiovascular system (week 26) | Abnormal NCS | 4 Participants |
| Placebo | Change in Physical Examination | 6) Lymph node palpation (week -2) | Normal | 178 Participants |
| Placebo | Change in Physical Examination | 9) Skin (week -2) | Normal | 150 Participants |
| Placebo | Change in Physical Examination | 1) Cardiovascular system (week 26) | Abnormal CS | 1 Participants |
| Placebo | Change in Physical Examination | 4) General appearance (week 26) | Normal | 148 Participants |
| Placebo | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal NCS | 6 Participants |
| Placebo | Change in Physical Examination | 10) Thyroid gland (week 26) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 9) Skin (week -2) | Abnormal CS | 1 Participants |
| Placebo | Change in Physical Examination | 1) Cardiovascular system (week -2) | Normal | 172 Participants |
| Placebo | Change in Physical Examination | 9) Skin (week -2) | Abnormal NCS | 27 Participants |
| Placebo | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 9) Skin (week 26) | Normal | 140 Participants |
| Placebo | Change in Physical Examination | 8) Respiratory system (week 26) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 8) Respiratory system (week 26) | Normal | 166 Participants |
| Placebo | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 6) Lymph node palpation (week 26) | Normal | 167 Participants |
| Placebo | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 26) | Abnormal CS | 1 Participants |
| Placebo | Change in Physical Examination | 9) Skin (week 26) | Abnormal NCS | 24 Participants |
| Placebo | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 26) | Abnormal NCS | 11 Participants |
| Placebo | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 6) Lymph node palpation (week 26) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 26) | Normal | 155 Participants |
| Placebo | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal CS | 1 Participants |
| Placebo | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal NCS | 4 Participants |
| Placebo | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Normal | 167 Participants |
| Placebo | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal NCS | 9 Participants |
| Placebo | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Normal | 168 Participants |
| Placebo | Change in Physical Examination | 10) Thyroid gland (week 26) | Abnormal NCS | 2 Participants |
| Placebo | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal NCS | 11 Participants |
| Placebo | Change in Physical Examination | 4) General appearance (week 26) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 4) General appearance (week 26) | Abnormal NCS | 19 Participants |
| Placebo | Change in Physical Examination | 9) Skin (week 26) | Abnormal CS | 3 Participants |
| Placebo | Change in Physical Examination | 4) General appearance (week -2) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 4) General appearance (week -2) | Abnormal NCS | 21 Participants |
| Placebo | Change in Physical Examination | 8) Respiratory system (week -2) | Normal | 174 Participants |
| Placebo | Change in Physical Examination | 7) Musculoskeletal system (week 26) | Normal | 157 Participants |
Secondary
Change in Pulse Rate
Change from baseline (week 0) in pulse rate was evaluated at week 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Pulse Rate | 0 beats/min | Standard Deviation 9 |
| Oral Semaglutide 7 mg | Change in Pulse Rate | 1 beats/min | Standard Deviation 9 |
| Oral Semaglutide 14 mg | Change in Pulse Rate | 3 beats/min | Standard Deviation 9 |
| Placebo | Change in Pulse Rate | 1 beats/min | Standard Deviation 9 |
Secondary
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the sub-domain scores and component summary (PCS and MCS) scores were evaluated at week 26. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.
Time frame: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical Functioning | 0.14 Score on a scale | Standard Deviation 6.25 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social Functioning | 0.21 Score on a scale | Standard Deviation 9.15 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality | -0.08 Score on a scale | Standard Deviation 8.1 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary | -0.07 Score on a scale | Standard Deviation 8.08 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role-Physical | -0.41 Score on a scale | Standard Deviation 6.62 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General Health | 0.97 Score on a scale | Standard Deviation 8.08 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental Health | 0.04 Score on a scale | Standard Deviation 7.62 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary | 0.52 Score on a scale | Standard Deviation 6.04 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily Pain | 1.17 Score on a scale | Standard Deviation 9.02 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role-Emotional | -0.05 Score on a scale | Standard Deviation 9.89 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily Pain | -0.67 Score on a scale | Standard Deviation 9.37 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social Functioning | 1.00 Score on a scale | Standard Deviation 7.64 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General Health | 0.92 Score on a scale | Standard Deviation 7.51 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality | 0.77 Score on a scale | Standard Deviation 7.83 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role-Emotional | -0.63 Score on a scale | Standard Deviation 9.27 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical Functioning | 1.18 Score on a scale | Standard Deviation 6.36 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary | -0.00 Score on a scale | Standard Deviation 8 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role-Physical | -0.08 Score on a scale | Standard Deviation 7.04 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary | 0.61 Score on a scale | Standard Deviation 5.86 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental Health | 0.06 Score on a scale | Standard Deviation 8.51 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social Functioning | 0.88 Score on a scale | Standard Deviation 7.94 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role-Emotional | 0.85 Score on a scale | Standard Deviation 9.49 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary | 0.89 Score on a scale | Standard Deviation 5.66 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary | 0.67 Score on a scale | Standard Deviation 8.4 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical Functioning | 1.05 Score on a scale | Standard Deviation 5.75 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role-Physical | 0.79 Score on a scale | Standard Deviation 6.86 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily Pain | -0.14 Score on a scale | Standard Deviation 9.61 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General Health | 2.07 Score on a scale | Standard Deviation 6.88 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality | 0.40 Score on a scale | Standard Deviation 8.21 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental Health | 0.67 Score on a scale | Standard Deviation 8.74 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General Health | 0.18 Score on a scale | Standard Deviation 7.53 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily Pain | 0.40 Score on a scale | Standard Deviation 8.77 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social Functioning | 0.18 Score on a scale | Standard Deviation 8.37 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary | -0.90 Score on a scale | Standard Deviation 9.08 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental Health | -0.25 Score on a scale | Standard Deviation 9.64 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role-Physical | -0.25 Score on a scale | Standard Deviation 6.73 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary | 0.65 Score on a scale | Standard Deviation 5.44 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical Functioning | 0.66 Score on a scale | Standard Deviation 6.18 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role-Emotional | -1.28 Score on a scale | Standard Deviation 10.02 |
| Placebo | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality | -0.47 Score on a scale | Standard Deviation 8.02 |
Secondary
Change in Systolic Blood Pressure (SBP)
Change from baseline (week 0) in SBP was evaluated at week 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Systolic Blood Pressure (SBP) | -3 mmHg | Standard Deviation 14 |
| Oral Semaglutide 7 mg | Change in Systolic Blood Pressure (SBP) | -5 mmHg | Standard Deviation 13 |
| Oral Semaglutide 14 mg | Change in Systolic Blood Pressure (SBP) | -5 mmHg | Standard Deviation 14 |
| Placebo | Change in Systolic Blood Pressure (SBP) | -3 mmHg | Standard Deviation 14 |
Secondary
Change in Waist Circumference
Change from baseline (week 0) to week 26 in waist circumference. 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: Week 0, week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Waist Circumference | -2.0 cm | Standard Deviation 4.8 |
| Oral Semaglutide 7 mg | Change in Waist Circumference | -2.3 cm | Standard Deviation 5 |
| Oral Semaglutide 14 mg | Change in Waist Circumference | -4.1 cm | Standard Deviation 4.9 |
| Placebo | Change in Waist Circumference | -0.9 cm | Standard Deviation 4.4 |
Secondary
IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire)
The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 22-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. Results are based on the data from the in-trial observation period, which 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: Week 0, week 26
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 21) Self-conscious about weight | -0.10 Score on a scale | Standard Deviation 0.92 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 8) Feel judged by others | -0.01 Score on a scale | Standard Deviation 1 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 11) Feel bad or upset in pictures | -0.16 Score on a scale | Standard Deviation 1.07 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 1) Trouble bending over | -0.17 Score on a scale | Standard Deviation 1.09 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 7) Less confident | -0.22 Score on a scale | Standard Deviation 1.05 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 12) Feel down or depressed | -0.22 Score on a scale | Standard Deviation 1.07 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 17) Not as physically active | -0.09 Score on a scale | Standard Deviation 1.06 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 2) Tired/winded walking up stairs | -0.13 Score on a scale | Standard Deviation 1.03 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 19) Worried about health | -0.32 Score on a scale | Standard Deviation 1.35 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 22) Frustrated/upset with self | -0.12 Score on a scale | Standard Deviation 0.91 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 4) Uncomfortable in small seats | -0.09 Score on a scale | Standard Deviation 1.08 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 18) Unable to walk far/quickly | -0.08 Score on a scale | Standard Deviation 1.09 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 9) Less important/worthy of respect | -0.05 Score on a scale | Standard Deviation 0.83 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 20) Limited self-esteem | -0.03 Score on a scale | Standard Deviation 1.04 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 15) Less productive | -0.09 Score on a scale | Standard Deviation 1 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 5) Bodily pain | -0.27 Score on a scale | Standard Deviation 1.1 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 14) Avoid social gatherings | 0.05 Score on a scale | Standard Deviation 0.76 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 3) Difficulty standing | -0.12 Score on a scale | Standard Deviation 1.34 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 13) Less interested in sex | -0.14 Score on a scale | Standard Deviation 1.24 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 6) Self-conscious eating in social settings | 0.00 Score on a scale | Standard Deviation 0.97 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 10) Frustrated shopping for clothes | -0.08 Score on a scale | Standard Deviation 0.95 |
| Oral Semaglutide 3 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 16) Lack energy to do things I would like to do | -0.14 Score on a scale | Standard Deviation 1.06 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 5) Bodily pain | -0.08 Score on a scale | Standard Deviation 1.11 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 7) Less confident | -0.29 Score on a scale | Standard Deviation 0.98 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 16) Lack energy to do things I would like to do | -0.20 Score on a scale | Standard Deviation 1.11 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 13) Less interested in sex | 0.04 Score on a scale | Standard Deviation 1.07 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 8) Feel judged by others | -0.23 Score on a scale | Standard Deviation 0.92 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 10) Frustrated shopping for clothes | -0.10 Score on a scale | Standard Deviation 0.96 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 11) Feel bad or upset in pictures | -0.20 Score on a scale | Standard Deviation 0.91 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 18) Unable to walk far/quickly | -0.29 Score on a scale | Standard Deviation 1.26 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 20) Limited self-esteem | -0.09 Score on a scale | Standard Deviation 1.1 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 22) Frustrated/upset with self | -0.25 Score on a scale | Standard Deviation 1.02 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 17) Not as physically active | -0.41 Score on a scale | Standard Deviation 1.26 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 21) Self-conscious about weight | -0.12 Score on a scale | Standard Deviation 1.06 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 9) Less important/worthy of respect | -0.04 Score on a scale | Standard Deviation 0.79 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 1) Trouble bending over | -0.12 Score on a scale | Standard Deviation 1.07 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 3) Difficulty standing | -0.22 Score on a scale | Standard Deviation 1.4 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 2) Tired/winded walking up stairs | -0.16 Score on a scale | Standard Deviation 1.04 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 15) Less productive | -0.13 Score on a scale | Standard Deviation 0.97 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 4) Uncomfortable in small seats | -0.05 Score on a scale | Standard Deviation 1.2 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 19) Worried about health | -0.49 Score on a scale | Standard Deviation 1.39 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 12) Feel down or depressed | -0.18 Score on a scale | Standard Deviation 0.88 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 14) Avoid social gatherings | -0.07 Score on a scale | Standard Deviation 0.69 |
| Oral Semaglutide 7 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 6) Self-conscious eating in social settings | 0.01 Score on a scale | Standard Deviation 1.15 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 17) Not as physically active | -0.04 Score on a scale | Standard Deviation 1.11 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 8) Feel judged by others | -0.20 Score on a scale | Standard Deviation 0.93 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 10) Frustrated shopping for clothes | -0.19 Score on a scale | Standard Deviation 0.92 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 11) Feel bad or upset in pictures | -0.23 Score on a scale | Standard Deviation 0.99 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 16) Lack energy to do things I would like to do | -0.14 Score on a scale | Standard Deviation 1.01 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 20) Limited self-esteem | -0.07 Score on a scale | Standard Deviation 1.02 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 21) Self-conscious about weight | 0.01 Score on a scale | Standard Deviation 1.08 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 1) Trouble bending over | -0.13 Score on a scale | Standard Deviation 0.96 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 2) Tired/winded walking up stairs | -0.23 Score on a scale | Standard Deviation 1.02 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 3) Difficulty standing | -0.08 Score on a scale | Standard Deviation 1.18 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 4) Uncomfortable in small seats | -0.09 Score on a scale | Standard Deviation 1.04 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 5) Bodily pain | -0.06 Score on a scale | Standard Deviation 1.05 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 6) Self-conscious eating in social settings | -0.11 Score on a scale | Standard Deviation 0.96 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 7) Less confident | -0.35 Score on a scale | Standard Deviation 1 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 9) Less important/worthy of respect | -0.11 Score on a scale | Standard Deviation 0.74 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 12) Feel down or depressed | -0.24 Score on a scale | Standard Deviation 0.86 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 13) Less interested in sex | -0.03 Score on a scale | Standard Deviation 1.11 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 14) Avoid social gatherings | -0.04 Score on a scale | Standard Deviation 0.63 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 15) Less productive | -0.10 Score on a scale | Standard Deviation 0.97 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 18) Unable to walk far/quickly | 0.02 Score on a scale | Standard Deviation 0.99 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 19) Worried about health | -0.42 Score on a scale | Standard Deviation 1.27 |
| Oral Semaglutide 14 mg | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 22) Frustrated/upset with self | -0.14 Score on a scale | Standard Deviation 1.08 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 5) Bodily pain | -0.14 Score on a scale | Standard Deviation 1.07 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 21) Self-conscious about weight | -0.05 Score on a scale | Standard Deviation 0.91 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 14) Avoid social gatherings | -0.02 Score on a scale | Standard Deviation 0.58 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 4) Uncomfortable in small seats | 0.03 Score on a scale | Standard Deviation 1.33 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 3) Difficulty standing | -0.01 Score on a scale | Standard Deviation 1.28 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 10) Frustrated shopping for clothes | -0.14 Score on a scale | Standard Deviation 1.09 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 15) Less productive | -0.07 Score on a scale | Standard Deviation 0.8 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 16) Lack energy to do things I would like to do | -0.03 Score on a scale | Standard Deviation 1.01 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 1) Trouble bending over | -0.08 Score on a scale | Standard Deviation 1.06 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 20) Limited self-esteem | -0.09 Score on a scale | Standard Deviation 0.89 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 2) Tired/winded walking up stairs | -0.11 Score on a scale | Standard Deviation 0.96 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 19) Worried about health | -0.30 Score on a scale | Standard Deviation 1.39 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 8) Feel judged by others | -0.13 Score on a scale | Standard Deviation 0.9 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 18) Unable to walk far/quickly | -0.19 Score on a scale | Standard Deviation 1.21 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 17) Not as physically active | -0.08 Score on a scale | Standard Deviation 1.22 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 11) Feel bad or upset in pictures | -0.14 Score on a scale | Standard Deviation 1.07 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 12) Feel down or depressed | -0.16 Score on a scale | Standard Deviation 1.01 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 9) Less important/worthy of respect | -0.15 Score on a scale | Standard Deviation 0.77 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 7) Less confident | -0.20 Score on a scale | Standard Deviation 1.07 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 22) Frustrated/upset with self | 0.02 Score on a scale | Standard Deviation 0.91 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 13) Less interested in sex | -0.06 Score on a scale | Standard Deviation 1.16 |
| Placebo | IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire) | 6) Self-conscious eating in social settings | -0.10 Score on a scale | Standard Deviation 1.08 |
Secondary
Number of Treatment-emergent Adverse Events (TEAEs)
Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 31 (26-week treatment period + 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Approximately upto week 31
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) | 290 Events |
| Oral Semaglutide 7 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 258 Events |
| Oral Semaglutide 14 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 304 Events |
| Placebo | Number of Treatment-emergent Adverse Events (TEAEs) | 263 Events |
Secondary
Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product
Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 31 (26-weeks treatment period + 5-weeks follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time frame: Weeks 0-31
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 During Exposure to Trial Product | 5 Episodes |
| Oral Semaglutide 7 mg | Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | 2 Episodes |
| Oral Semaglutide 14 mg | Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | 1 Episodes |
| Placebo | Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | 1 Episodes |
Secondary
Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time frame: Weeks 0-31
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 3 mg | Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no) | 2 Participants |
| Oral Semaglutide 7 mg | Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no) | 1 Participants |
| Oral Semaglutide 14 mg | Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no) | 0 Participants |
Secondary
Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time frame: Weeks 0-31
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 3 mg | Occurrence of Anti-semaglutide Binding Antibodies (Yes/no) | 2 Participants |
| Oral Semaglutide 7 mg | Occurrence of Anti-semaglutide Binding Antibodies (Yes/no) | 1 Participants |
| Oral Semaglutide 14 mg | Occurrence of Anti-semaglutide Binding Antibodies (Yes/no) | 0 Participants |
Secondary
Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time frame: Weeks 0-31
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 3 mg | Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no) | 0 Participants |
| Oral Semaglutide 7 mg | Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no) | 0 Participants |
| Oral Semaglutide 14 mg | Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no) | 0 Participants |
Secondary
Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time frame: Weeks 0-31
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 3 mg | Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no) | 1 Participants |
| Oral Semaglutide 7 mg | Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no) | 0 Participants |
| Oral Semaglutide 14 mg | Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no) | 0 Participants |
Secondary
Participants Who Achieve Body Weight Loss ≥ 10 % (Yes/no)
Participants who achieved body weight loss more than or equal to 10% of their baseline body weight (yes/no) at week 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time frame: Week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Participants Who Achieve Body Weight Loss ≥ 10 % (Yes/no) | Yes | 4 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Body Weight Loss ≥ 10 % (Yes/no) | No | 164 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Body Weight Loss ≥ 10 % (Yes/no) | No | 147 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Body Weight Loss ≥ 10 % (Yes/no) | Yes | 13 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Body Weight Loss ≥ 10 % (Yes/no) | Yes | 23 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Body Weight Loss ≥ 10 % (Yes/no) | No | 137 Participants |
| Placebo | Participants Who Achieve Body Weight Loss ≥ 10 % (Yes/no) | Yes | 2 Participants |
| Placebo | Participants Who Achieve Body Weight Loss ≥ 10 % (Yes/no) | No | 166 Participants |
Secondary
Participants Who Achieve Body Weight Loss ≥ 5 % (Yes/no)
Participants who achieved body weight loss more than or equal to 5% of their baseline body weight (yes/no) at week 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time frame: Week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Participants Who Achieve Body Weight Loss ≥ 5 % (Yes/no) | Yes | 33 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Body Weight Loss ≥ 5 % (Yes/no) | No | 135 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Body Weight Loss ≥ 5 % (Yes/no) | No | 117 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Body Weight Loss ≥ 5 % (Yes/no) | Yes | 43 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Body Weight Loss ≥ 5 % (Yes/no) | No | 94 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Body Weight Loss ≥ 5 % (Yes/no) | Yes | 66 Participants |
| Placebo | Participants Who Achieve Body Weight Loss ≥ 5 % (Yes/no) | Yes | 25 Participants |
| Placebo | Participants Who Achieve Body Weight Loss ≥ 5 % (Yes/no) | No | 143 Participants |
Secondary
Participants Who Achieve HbA1c ≤ 6.5 % (48 mmol/Mol) AACE Target (Yes/no)
Participants who achieved HbA1c ≤6.5% (48 mmol/mol) (American Association of Clinical Endocrinologists (AACE) target), at week 26 are presented. The results are based on the data from the in-trial observation period. In trial observation period: 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: Week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c ≤ 6.5 % (48 mmol/Mol) AACE Target (Yes/no) | Yes | 60 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c ≤ 6.5 % (48 mmol/Mol) AACE Target (Yes/no) | No | 107 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c ≤ 6.5 % (48 mmol/Mol) AACE Target (Yes/no) | No | 84 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c ≤ 6.5 % (48 mmol/Mol) AACE Target (Yes/no) | Yes | 76 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c ≤ 6.5 % (48 mmol/Mol) AACE Target (Yes/no) | Yes | 102 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c ≤ 6.5 % (48 mmol/Mol) AACE Target (Yes/no) | No | 58 Participants |
| Placebo | Participants Who Achieve HbA1c ≤ 6.5 % (48 mmol/Mol) AACE Target (Yes/no) | Yes | 30 Participants |
| Placebo | Participants Who Achieve HbA1c ≤ 6.5 % (48 mmol/Mol) AACE Target (Yes/no) | No | 138 Participants |
Secondary
Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) ADA Target (Yes/no)
Participants who achieved HbA1c \<7.0% (53 mmol/mol) (American Diabetes Association (ADA) target), at week 26 are presented. The results are based on the data from the in-trial observation period. In trial observation period: 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: Week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) ADA Target (Yes/no) | No | 75 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) ADA Target (Yes/no) | Yes | 92 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) ADA Target (Yes/no) | No | 50 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) ADA Target (Yes/no) | Yes | 110 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) ADA Target (Yes/no) | Yes | 123 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) ADA Target (Yes/no) | No | 37 Participants |
| Placebo | Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) ADA Target (Yes/no) | No | 116 Participants |
| Placebo | Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) ADA Target (Yes/no) | Yes | 52 Participants |
Secondary
Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG-confirmed Symptomatic Hypoglycaemia) and Without Body Weight Gain (Yes/no)
Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at week 26 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product
Time frame: Week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG-confirmed Symptomatic Hypoglycaemia) and Without Body Weight Gain (Yes/no) | Yes | 62 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG-confirmed Symptomatic Hypoglycaemia) and Without Body Weight Gain (Yes/no) | No | 105 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG-confirmed Symptomatic Hypoglycaemia) and Without Body Weight Gain (Yes/no) | No | 69 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG-confirmed Symptomatic Hypoglycaemia) and Without Body Weight Gain (Yes/no) | Yes | 91 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG-confirmed Symptomatic Hypoglycaemia) and Without Body Weight Gain (Yes/no) | Yes | 110 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG-confirmed Symptomatic Hypoglycaemia) and Without Body Weight Gain (Yes/no) | No | 50 Participants |
| Placebo | Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG-confirmed Symptomatic Hypoglycaemia) and Without Body Weight Gain (Yes/no) | Yes | 39 Participants |
| Placebo | Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG-confirmed Symptomatic Hypoglycaemia) and Without Body Weight Gain (Yes/no) | No | 129 Participants |
Secondary
Participants Who Achieve HbA1c Reduction ≥ 1.0% (10.9 mmol/Mol) and Weight Loss ≥ 3% (Yes/no)
Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at week 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time frame: Week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Reduction ≥ 1.0% (10.9 mmol/Mol) and Weight Loss ≥ 3% (Yes/no) | No | 137 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Reduction ≥ 1.0% (10.9 mmol/Mol) and Weight Loss ≥ 3% (Yes/no) | Yes | 30 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Reduction ≥ 1.0% (10.9 mmol/Mol) and Weight Loss ≥ 3% (Yes/no) | No | 101 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Reduction ≥ 1.0% (10.9 mmol/Mol) and Weight Loss ≥ 3% (Yes/no) | Yes | 59 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Reduction ≥ 1.0% (10.9 mmol/Mol) and Weight Loss ≥ 3% (Yes/no) | Yes | 81 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Reduction ≥ 1.0% (10.9 mmol/Mol) and Weight Loss ≥ 3% (Yes/no) | No | 79 Participants |
| Placebo | Participants Who Achieve HbA1c Reduction ≥ 1.0% (10.9 mmol/Mol) and Weight Loss ≥ 3% (Yes/no) | No | 150 Participants |
| Placebo | Participants Who Achieve HbA1c Reduction ≥ 1.0% (10.9 mmol/Mol) and Weight Loss ≥ 3% (Yes/no) | Yes | 18 Participants |
Secondary
Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product
Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 31 (26-week treatment period + 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time frame: Weeks 0-31
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 | Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | 5 Participants |
| Oral Semaglutide 7 mg | Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | 2 Participants |
| Oral Semaglutide 14 mg | Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | 1 Participants |
| Placebo | Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | 1 Participants |
Secondary
PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire)
Patient global impression of change (PGI-C) is a 2-item questionnaire used to assess the participant's impression of change from baseline in physical functioning and mental health status. The PGI-C contains two items evaluated on a 7-point graded response scale. 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: Week 26
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | Much worse | 1 Participants |
| Oral Semaglutide 3 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | Much better | 36 Participants |
| Oral Semaglutide 3 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | A little worse | 6 Participants |
| Oral Semaglutide 3 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | Moderately better | 23 Participants |
| Oral Semaglutide 3 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | Moderately worse | 0 Participants |
| Oral Semaglutide 3 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | Moderately worse | 1 Participants |
| Oral Semaglutide 3 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | Moderately better | 18 Participants |
| Oral Semaglutide 3 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | Much worse | 0 Participants |
| Oral Semaglutide 3 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | A little worse | 5 Participants |
| Oral Semaglutide 3 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | A little better | 45 Participants |
| Oral Semaglutide 3 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | A little better | 38 Participants |
| Oral Semaglutide 3 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | No difference | 56 Participants |
| Oral Semaglutide 3 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | No difference | 60 Participants |
| Oral Semaglutide 3 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | Much better | 45 Participants |
| Oral Semaglutide 7 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | No difference | 53 Participants |
| Oral Semaglutide 7 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | Moderately better | 27 Participants |
| Oral Semaglutide 7 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | Moderately worse | 2 Participants |
| Oral Semaglutide 7 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | A little worse | 2 Participants |
| Oral Semaglutide 7 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | Much worse | 0 Participants |
| Oral Semaglutide 7 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | Much better | 44 Participants |
| Oral Semaglutide 7 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | Moderately better | 28 Participants |
| Oral Semaglutide 7 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | Much worse | 0 Participants |
| Oral Semaglutide 7 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | A little better | 42 Participants |
| Oral Semaglutide 7 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | Moderately worse | 0 Participants |
| Oral Semaglutide 7 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | Much better | 40 Participants |
| Oral Semaglutide 7 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | No difference | 44 Participants |
| Oral Semaglutide 7 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | A little worse | 2 Participants |
| Oral Semaglutide 7 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | A little better | 32 Participants |
| Oral Semaglutide 14 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | A little worse | 3 Participants |
| Oral Semaglutide 14 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | Moderately worse | 0 Participants |
| Oral Semaglutide 14 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | A little better | 37 Participants |
| Oral Semaglutide 14 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | Much better | 50 Participants |
| Oral Semaglutide 14 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | Much worse | 1 Participants |
| Oral Semaglutide 14 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | Moderately worse | 0 Participants |
| Oral Semaglutide 14 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | A little worse | 3 Participants |
| Oral Semaglutide 14 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | No difference | 36 Participants |
| Oral Semaglutide 14 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | Moderately better | 32 Participants |
| Oral Semaglutide 14 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | Much worse | 1 Participants |
| Oral Semaglutide 14 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | No difference | 29 Participants |
| Oral Semaglutide 14 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | A little better | 48 Participants |
| Oral Semaglutide 14 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | Moderately better | 31 Participants |
| Oral Semaglutide 14 mg | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | Much better | 47 Participants |
| Placebo | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | A little worse | 3 Participants |
| Placebo | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | A little worse | 2 Participants |
| Placebo | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | Moderately worse | 1 Participants |
| Placebo | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | Moderately better | 31 Participants |
| Placebo | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | No difference | 66 Participants |
| Placebo | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | A little better | 39 Participants |
| Placebo | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | A little better | 36 Participants |
| Placebo | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | Much worse | 0 Participants |
| Placebo | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | Much better | 29 Participants |
| Placebo | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | No difference | 63 Participants |
| Placebo | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | Moderately worse | 1 Participants |
| Placebo | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning change | Much worse | 1 Participants |
| Placebo | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | Much better | 30 Participants |
| Placebo | PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional change | Moderately better | 32 Participants |
Secondary
PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire)
Patient global impression of status (PGI-S) is a 2-item questionnaire used to assess the participant's impression of physical functioning and mental health status during the clinical trial. The PGI-S contains two items evaluated on a 5-point graded response scale. 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: Week 26
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional status | Poor | 10 Participants |
| Oral Semaglutide 3 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning status | Poor | 6 Participants |
| Oral Semaglutide 3 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning status | Fair | 50 Participants |
| Oral Semaglutide 3 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning status | Excellent | 14 Participants |
| Oral Semaglutide 3 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning status | Good | 67 Participants |
| Oral Semaglutide 3 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional status | Good | 62 Participants |
| Oral Semaglutide 3 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional status | Fair | 41 Participants |
| Oral Semaglutide 3 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional status | Very good | 32 Participants |
| Oral Semaglutide 3 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning status | Very good | 30 Participants |
| Oral Semaglutide 3 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional status | Excellent | 22 Participants |
| Oral Semaglutide 7 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional status | Excellent | 11 Participants |
| Oral Semaglutide 7 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning status | Very good | 38 Participants |
| Oral Semaglutide 7 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional status | Very good | 48 Participants |
| Oral Semaglutide 7 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning status | Poor | 11 Participants |
| Oral Semaglutide 7 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional status | Poor | 7 Participants |
| Oral Semaglutide 7 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning status | Good | 53 Participants |
| Oral Semaglutide 7 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional status | Good | 51 Participants |
| Oral Semaglutide 7 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning status | Fair | 51 Participants |
| Oral Semaglutide 7 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional status | Fair | 41 Participants |
| Oral Semaglutide 7 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning status | Excellent | 4 Participants |
| Oral Semaglutide 14 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning status | Good | 56 Participants |
| Oral Semaglutide 14 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning status | Excellent | 15 Participants |
| Oral Semaglutide 14 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional status | Poor | 9 Participants |
| Oral Semaglutide 14 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional status | Fair | 38 Participants |
| Oral Semaglutide 14 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional status | Good | 55 Participants |
| Oral Semaglutide 14 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional status | Very good | 33 Participants |
| Oral Semaglutide 14 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional status | Excellent | 24 Participants |
| Oral Semaglutide 14 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning status | Poor | 11 Participants |
| Oral Semaglutide 14 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning status | Fair | 45 Participants |
| Oral Semaglutide 14 mg | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning status | Very good | 32 Participants |
| Placebo | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional status | Good | 59 Participants |
| Placebo | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning status | Good | 71 Participants |
| Placebo | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional status | Poor | 9 Participants |
| Placebo | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional status | Fair | 42 Participants |
| Placebo | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional status | Very good | 41 Participants |
| Placebo | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 2) Emotional status | Excellent | 15 Participants |
| Placebo | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning status | Poor | 7 Participants |
| Placebo | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning status | Very good | 23 Participants |
| Placebo | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning status | Excellent | 7 Participants |
| Placebo | PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire) | 1) Physical functioning status | Fair | 59 Participants |
Secondary
Semaglutide Plasma Concentrations for Population PK Analysis
This outcome measure is only applicable for the oral semaglutide 3 mg, 7 mg and 14 mg treatment arms. Semaglutide plasma concentrations were measured at weeks 4, 8, 14 and 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Weeks 0 - 26
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentrations for Population PK Analysis | Week 8 | 3.073 Nanomoles per litre (nmol/L) | Geometric Coefficient of Variation 132 |
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentrations for Population PK Analysis | Week 14 | 2.716 Nanomoles per litre (nmol/L) | Geometric Coefficient of Variation 145.7 |
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentrations for Population PK Analysis | Week 4 | 3.120 Nanomoles per litre (nmol/L) | Geometric Coefficient of Variation 130.2 |
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentrations for Population PK Analysis | Week 26 | 2.466 Nanomoles per litre (nmol/L) | Geometric Coefficient of Variation 158.7 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentrations for Population PK Analysis | Week 26 | 5.016 Nanomoles per litre (nmol/L) | Geometric Coefficient of Variation 195.3 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentrations for Population PK Analysis | Week 8 | 6.216 Nanomoles per litre (nmol/L) | Geometric Coefficient of Variation 158.5 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentrations for Population PK Analysis | Week 4 | 2.765 Nanomoles per litre (nmol/L) | Geometric Coefficient of Variation 118.7 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentrations for Population PK Analysis | Week 14 | 6.375 Nanomoles per litre (nmol/L) | Geometric Coefficient of Variation 177.3 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentrations for Population PK Analysis | Week 26 | 11.07 Nanomoles per litre (nmol/L) | Geometric Coefficient of Variation 252.6 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentrations for Population PK Analysis | Week 14 | 12.69 Nanomoles per litre (nmol/L) | Geometric Coefficient of Variation 235.2 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentrations for Population PK Analysis | Week 4 | 2.829 Nanomoles per litre (nmol/L) | Geometric Coefficient of Variation 127.6 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentrations for Population PK Analysis | Week 8 | 6.461 Nanomoles per litre (nmol/L) | Geometric Coefficient of Variation 164.3 |
Secondary
SNAC Plasma Concentrations
This outcome measure is only applicable for the oral semaglutide 3 mg, 7 mg and 14 mg treatment arms. Sodium N-\[8-(2-hydroxybenzoyl) amino\]caprylate (SNAC) plasma concentrations were measured after 25 and 40 minutes post-dose at weeks 4, 14 and 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Weeks 0-26
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | SNAC Plasma Concentrations | Week 26: 25 minutes post-dose | 412.4 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 533.3 |
| Oral Semaglutide 3 mg | SNAC Plasma Concentrations | Week 14: 25 minutes post-dose | 384.6 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 415.4 |
| Oral Semaglutide 3 mg | SNAC Plasma Concentrations | Week 26: 40 minutes post-dose | 299.1 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 411.1 |
| Oral Semaglutide 3 mg | SNAC Plasma Concentrations | Week 14: 40 minutes post-dose | 361.0 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 259.2 |
| Oral Semaglutide 3 mg | SNAC Plasma Concentrations | Week 4: 40 minutes post-dose | 381.7 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 227.5 |
| Oral Semaglutide 3 mg | SNAC Plasma Concentrations | Week 4: 25 minutes post-dose | 443.5 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 378.4 |
| Oral Semaglutide 7 mg | SNAC Plasma Concentrations | Week 26: 40 minutes post-dose | 401.0 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 271.6 |
| Oral Semaglutide 7 mg | SNAC Plasma Concentrations | Week 4: 25 minutes post-dose | 446.0 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 329.4 |
| Oral Semaglutide 7 mg | SNAC Plasma Concentrations | Week 4: 40 minutes post-dose | 367.3 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 238.5 |
| Oral Semaglutide 7 mg | SNAC Plasma Concentrations | Week 14: 25 minutes post-dose | 380.6 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 427 |
| Oral Semaglutide 7 mg | SNAC Plasma Concentrations | Week 14: 40 minutes post-dose | 326.4 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 350.1 |
| Oral Semaglutide 7 mg | SNAC Plasma Concentrations | Week 26: 25 minutes post-dose | 479.6 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 334.3 |
| Oral Semaglutide 14 mg | SNAC Plasma Concentrations | Week 14: 40 minutes post-dose | 262.2 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 377.4 |
| Oral Semaglutide 14 mg | SNAC Plasma Concentrations | Week 4: 40 minutes post-dose | 387.7 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 186.3 |
| Oral Semaglutide 14 mg | SNAC Plasma Concentrations | Week 26: 40 minutes post-dose | 300.9 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 372.5 |
| Oral Semaglutide 14 mg | SNAC Plasma Concentrations | Week 26: 25 minutes post-dose | 330.9 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 578.4 |
| Oral Semaglutide 14 mg | SNAC Plasma Concentrations | Week 14: 25 minutes post-dose | 338.2 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 339.5 |
| Oral Semaglutide 14 mg | SNAC Plasma Concentrations | Week 4: 25 minutes post-dose | 449.4 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 330.5 |
Secondary
Time to Additional Anti-diabetic Medication
Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the period from week 0 to week 26. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 26), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.
Time frame: Weeks 0-26
Population: Overall number of participants analyzed = FAS which comprised all randomised participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 3 mg | Time to Additional Anti-diabetic Medication | 16 Participants |
| Oral Semaglutide 7 mg | Time to Additional Anti-diabetic Medication | 8 Participants |
| Oral Semaglutide 14 mg | Time to Additional Anti-diabetic Medication | 7 Participants |
| Placebo | Time to Additional Anti-diabetic Medication | 35 Participants |
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.p-value: 0.004395% CI: [0.26, 0.78]Regression, Cox
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.p-value: 0.000295% CI: [0.18, 0.59]Regression, Cox
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.p-value: 0.000295% CI: [0.19, 0.6]Regression, Cox
Secondary
Time to Rescue Medication
Presented results are the number of participants who had taken rescue medication anytime during the period from week 0 to week 26. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication or premature trial product discontinuation.
Time frame: Weeks 0-26
Population: Overall number of participants analyzed = FAS which comprised all randomised participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 3 mg | Time to Rescue Medication | 13 Participants |
| Oral Semaglutide 7 mg | Time to Rescue Medication | 4 Participants |
| Oral Semaglutide 14 mg | Time to Rescue Medication | 2 Participants |
| Placebo | Time to Rescue Medication | 27 Participants |
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: 0.0395% CI: [0.25, 0.93]Regression, Cox
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: 0.000195% CI: [0.04, 0.36]Regression, Cox
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: 0.000195% CI: [0.01, 0.26]Regression, Cox