Diabetes Mellitus, Type 2
Conditions
Brief summary
The study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and placebo (a dummy medicine). Researchers will test semaglutide to see how well it works compared to placebo. The study will also test if semaglutide is safe. Participants will either get semaglutide or placebo - which treatment is decided by chance. Participants will get 1 tablet a day to take with up to half a glass of water. Participants must take the tablet first thing in the morning on an empty stomach. After taking the tablet, participants must not eat or drink anything for at least 30 minutes. After the 30 minutes, participants can have their first meal of the day and take any other medicines they may need. The study will last for about 8 months (36 weeks). Participants will have 9 clinic visits and 2 phone calls with the study doctor. At all 9 of the clinic visits, participants will have blood samples taken. At 5 of the clinic visits, participants must arrive fasting. This means they cannot eat for 8 hours before the visit. It is fine to drink water up to 2 hours before the visit. This is for some of the blood samples that will be taken at the visit. Women cannot take part if pregnant, breastfeeding or planning to become pregnant during the study period.
Interventions
DRUGOral semaglutide
Tablets to be taken once-daily for 26 weeks
DRUGPlacebo
Tablets to be taken once-daily for 26 weeks
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Eligibility
Sex/Gender
ALL
Age
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 Algeria only: Male or female, age above or equal to 19 years at the time of signing the informed consent. For Taiwan only: Male or female, age above or equal to 20 years at the time of signing the informed consent. * Diagnosed with type 2 diabetes mellitus * HbA1c between 7.0 -10.0% (53-86 mmol/mol) (both inclusive).
Exclusion criteria
* \- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an highly effective contraceptive method. * Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC). Family is defined as a first degree relative. * History or presence 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, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening. * Subjects presently classified as being in New York Heart Association (NYHA) Class IV. * Planned coronary, carotid or peripheral artery revascularisation known on the day of screening. * Renal impairment measured as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula(CKD-EPI). * Subjects with alanine aminotransferase (ALT) above 2.5 x upper limit of the normal (ULN). * Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycosylated Haemoglobin (HbA1c) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in HbA1c at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in FPG at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Change From Baseline in Fasting 7-point Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile | Baseline (Week 0), Week 26 | Change from baseline (week 0) in mean 7-point SMPG profile at week 26 is presented. 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. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Change From Baseline in Fasting 7-point Self-measured Plasma Glucose Profile: Mean Postprandial Increment (Over All Meals) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in fasting 7-point SMPG: Mean postprandial increment (over all meals) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Change From Baseline in Body Weight (Percentage [%]) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in body weight (measured in kg) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Change From Baseline in Body Mass Index (BMI) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in BMI at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Change From Baseline in Waist Circumference | Baseline (Week 0), Week 26 | Change from baseline (week 0) in waist circumference at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Change From Baseline in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in total cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in LDL cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in HDL cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Change From Baseline in Fasting Lipid Profile: Triglycerides (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in triglycerides (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Baseline (Week 0), Week 26 | SF-36 v2.0 is a 36-item, patient-reported survey of patient health. SF-36 measures the participant's overall Health Related Quality of Life on 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) and two component summary scores (physical component summary and mental component summary). Range of score for domains and component summary scores : 1-100 (Higher scores indicated a better health state). Change form baseline in each domain, physical component summary score and mental component summary score at week 26 is presented. A positive change score indicates an improvement since baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Number of Participants Who Achieved HbA1c Less Than (<) 7.0 % (53 Millimoles Per Mole [mmol/Mol]) (American Diabetes Association (ADA) Target) (Yes/no) | Week 26 | Number of participants who achieved HbA1c \< 7.0 % (53 mmol/mol) (ADA target) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Number of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) | Week 26 | Number of participants who achieved HbA1c \<= 6.5 percent (48 mmol/mol) (AACE target) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Number of Participants Who Achieved HbA1c Reduction Greater Than or Equal to (>=) 1 Percent (10.9 mmol/Mol) (Yes/no) | Week 26 | Number of participants who achieved HbA1c reduction \>= 1 percent (10.9 mmol/mol) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Number of Participants Who Achieved Body Weight Loss >= 3 Percent (Yes/no) | Week 26 | Number of participants who achieved body weight loss \>= 3 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Number of Participants Who Achieved Body Weight Loss >= 5 Percent (Yes/no) | Week 26 | Number of participants who achieved body weight loss \>= 5 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Number of Participants Who Achieved Body Weight Loss >= 10 Percent (Yes/no) | Week 26 | Number of participants who achieved body weight loss \>= 10 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Number of Participants Who Achieved HbA1c < 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or Blood Glucose [BG] Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no) | Week 26 | Number of participants who achieved HbA1c \< 7.0 percent (53 mmol/mol) without hypoglycaemia (treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes) and no body weight gain (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Number of Participants Who Achieved HbA1c Reduction >= 1% (10.9 mmol/Mol) and Body Weight Loss >= 3 Percent (Yes/no) | Week 26 | Number of participants who achieved HbA1c reduction \>= 1% (10.9 mmol/mol) and body weight loss \>= 3% (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Time From First Dose to Initiation of Rescue Medication | From baseline (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 randomization 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 randomization and before last day on trial product. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Semaglutide Plasma Concentrations | Week 26: post dose any time | Semaglutide plasma concentrations at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Change From Baseline in Haematology - Haematocrit (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in haematocrit (measured in %) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Haematology - Haemoglobin (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in haemoglobin (measured in millimoles per liter \[mmol/L\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Haematology - Leucocytes (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in leucocytes (measured in 10\^9 per liter \[10\^9/L\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Haematology - Thrombocytes (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in thrombocytes (measured in 10\^9/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Baseline (Week 0), Week 26 | Change from baseline (week 0) in basophils, eosinophils, lymphocytes, monocytes and neutrophils at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Biochemistry - Urea (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in urea (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Biochemistry - Creatinine (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in creatinine (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Biochemistry - Alanine Aminotransferase (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in alanine aminotransferase (measured in units per liter \[U/L\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Biochemistry - Aspartate Aminotransferase (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in aspartate aminotransferase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Biochemistry - Alkaline Phosphatase (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in alkaline phosphatase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Biochemistry - Total Bilirubin (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in total bilirubin (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Biochemistry - Amylase (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in amylase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Biochemistry - Lipase (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in lipase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Biochemistry - Creatine Kinase (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in creatine kinase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Calcium (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in calcium (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Potassium (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in potassium (measured in milliequivalents per liter \[mEq/L\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Sodium (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in sodium (measured in mEq/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Albumin (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in albumin (measured in g/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Calcitonin (Ratio to Baseline) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in calcitonin (measured in picograms per milliliter \[pg/mL\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Pulse Rate | Baseline (Week 0), Week 26 | Change from baseline (week 0) in pulse rate at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Systolic Blood Pressure | Baseline (Week 0), Week 26 | Change from baseline (week 0) in systolic blood pressure at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Diastolic Blood Pressure | Baseline (Week 0), Week 26 | Change from baseline (week 0) in diastolic blood pressure at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Electrocardiogram (ECG) Category | Baseline (Week 0), Week 26 | Change from baseline (week 0) in ECG category at week 26 is presented. Change from baseline results are presented as shift in findings categorized as: normal, abnormal and not clinically significant (NCS), and abnormal and clinically significant (CS). The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last dose of trial product plus 38 days or the end-date for the in-trial observation period. |
| Change From Baseline in Physical Examination Category | Baseline (Week 0), Week 26 | Change from baseline (week 0) in physical examination category at week 26 is presented. The physical examination shift in findings were categorized as normal, abnormal NCS and abnormal CS and are presented for the following body systems: cardiovascular system; central and peripheral nervous system; gastrointestinal system, including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin; and thyroid gland. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days. |
| Change From Baseline in Eye Examination Category | Baseline (Week 0), Week 26 | Change from baseline (week 0) in eye examination category at week 26 is presented. Eye examination shift in findings were categorized as normal, abnormal NCS and abnormal CS. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period. |
| Change From Baseline in Body Weight (Kilograms [kg]) | Baseline (Week 0), Week 26 | Change from baseline (week 0) in body weight at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | Up to 31 weeks | Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose (PG) value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period. |
| Number of Participants With Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | Up to 31 weeks | Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose (PG) value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period. |
| Anti-semaglutide Binding Antibody Levels | Up to 31 weeks | Anti-semaglutide binding antibody levels measured anytime during post-baseline visits (week 0 to week 31) are presented. The outcome data are presented as percentage of bound radioactivity-labelled semaglutide/total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact, and death for participants who died before any of the above. |
| Number of Participants With Anti-semaglutide Binding Antibodies | Up to 31 weeks | Number of participants who had anti-semaglutide binding antibody levels anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participants-investigator contact, and death for participants who died before any of the above. |
| Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 | Up to 31 weeks | Number of participants who had 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 - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact, and death for participants who died before any of the above. |
| Number of Treatment-emergent Adverse Events (TEAEs) | Up to 31 weeks | An adverse event (AE) is any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. TEAE was defined as an AE with onset in the on-treatment observation period. On-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period. |
Countries
Algeria, China, Hungary, Serbia, Taiwan, Ukraine
Participant flow
Recruitment details
The trial was conducted at 52 sites in 3 countries and Region China (China mainland and Taiwan) as follows: China mainland (37 sites), Taiwan (3 sites); Hungary (4 sites), Serbia (2 sites) and Ukraine (6 sites).
Pre-assignment details
Total of 521 participants with type 2 diabetes mellitus treated with diet and exercise only were randomized 1:1:1:1 to receive once-daily blinded treatment for 26 weeks with oral semaglutide 3, 7 or 14 milligrams (mg), or with placebo. The trial included a 4-week run-in period, a treatment period of 26 weeks and a 5-week follow-up period.
Participants by arm
| Arm | Count |
|---|---|
| Oral Semaglutide 3 mg Participants received oral semaglutide 3 mg tablets once daily from week 0 to week 26. | 130 |
| Oral Semaglutide 7 mg Participants received 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. | 130 |
| Oral Semaglutide 14 mg Participants received 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. | 130 |
| Placebo Participants received oral semaglutide matching placebo tablets once daily from week 0 to week 26. | 131 |
| Total | 521 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Overall Study | Physician Decision | 1 | 2 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 6 | 6 |
Baseline characteristics
| Characteristic | Oral Semaglutide 3 mg | Total | Placebo | Oral Semaglutide 14 mg | Oral Semaglutide 7 mg |
|---|---|---|---|---|---|
| Age, Continuous | 54 Years STANDARD_DEVIATION 11 | 52 Years STANDARD_DEVIATION 11 | 51 Years STANDARD_DEVIATION 11 | 53 Years STANDARD_DEVIATION 10 | 52 Years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 130 Participants | 520 Participants | 131 Participants | 129 Participants | 130 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 97 Participants | 389 Participants | 98 Participants | 97 Participants | 97 Participants |
| Race/Ethnicity, Customized Race White | 33 Participants | 131 Participants | 33 Participants | 33 Participants | 32 Participants |
| Sex: Female, Male Female | 58 Participants | 189 Participants | 43 Participants | 47 Participants | 41 Participants |
| Sex: Female, Male Male | 72 Participants | 332 Participants | 88 Participants | 83 Participants | 89 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 / 130 | 0 / 130 | 0 / 129 | 0 / 131 |
| other Total, other adverse events | 30 / 130 | 47 / 130 | 40 / 129 | 16 / 131 |
| serious Total, serious adverse events | 6 / 130 | 10 / 130 | 5 / 129 | 2 / 131 |
Outcome results
Primary
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Change from baseline (week 0) in HbA1c at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Glycosylated Haemoglobin (HbA1c) | -1.1 Percentage of HbA1c | Standard Deviation 0.7 |
| Oral Semaglutide 7 mg | Change From Baseline in Glycosylated Haemoglobin (HbA1c) | -1.5 Percentage of HbA1c | Standard Deviation 0.8 |
| Oral Semaglutide 14 mg | Change From Baseline in Glycosylated Haemoglobin (HbA1c) | -1.6 Percentage of HbA1c | Standard Deviation 1 |
| Placebo | Change From Baseline in Glycosylated Haemoglobin (HbA1c) | -0.2 Percentage of HbA1c | Standard Deviation 0.9 |
p-value: <0.000195% CI: [-1.8, -1.3]MMRM
p-value: <0.000195% CI: [-1.6, -1.2]MMRM
p-value: <0.000195% CI: [-1.2, -0.8]MMRM
Secondary
Anti-semaglutide Binding Antibody Levels
Anti-semaglutide binding antibody levels measured anytime during post-baseline visits (week 0 to week 31) are presented. The outcome data are presented as percentage of bound radioactivity-labelled semaglutide/total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact, and death for participants who died before any of the above.
Time frame: Up to 31 weeks
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Oral Semaglutide 7 mg | Anti-semaglutide Binding Antibody Levels | 2.1 %B/T |
Secondary
Change From Baseline in Albumin (Ratio to Baseline)
Change from baseline (week 0) in albumin (measured in g/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Albumin (Ratio to Baseline) | 1.00 Ratio of albumin | Geometric Coefficient of Variation 4.07 |
| Oral Semaglutide 7 mg | Change From Baseline in Albumin (Ratio to Baseline) | 0.99 Ratio of albumin | Geometric Coefficient of Variation 4.73 |
| Oral Semaglutide 14 mg | Change From Baseline in Albumin (Ratio to Baseline) | 0.99 Ratio of albumin | Geometric Coefficient of Variation 4.41 |
| Placebo | Change From Baseline in Albumin (Ratio to Baseline) | 0.99 Ratio of albumin | Geometric Coefficient of Variation 3.95 |
Secondary
Change From Baseline in Biochemistry - Alanine Aminotransferase (Ratio to Baseline)
Change from baseline (week 0) in alanine aminotransferase (measured in units per liter \[U/L\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Biochemistry - Alanine Aminotransferase (Ratio to Baseline) | 0.88 Ratio of alanine aminotransferase | Geometric Coefficient of Variation 44.27 |
| Oral Semaglutide 7 mg | Change From Baseline in Biochemistry - Alanine Aminotransferase (Ratio to Baseline) | 0.89 Ratio of alanine aminotransferase | Geometric Coefficient of Variation 45.23 |
| Oral Semaglutide 14 mg | Change From Baseline in Biochemistry - Alanine Aminotransferase (Ratio to Baseline) | 0.85 Ratio of alanine aminotransferase | Geometric Coefficient of Variation 47.44 |
| Placebo | Change From Baseline in Biochemistry - Alanine Aminotransferase (Ratio to Baseline) | 0.88 Ratio of alanine aminotransferase | Geometric Coefficient of Variation 42.72 |
Secondary
Change From Baseline in Biochemistry - Alkaline Phosphatase (Ratio to Baseline)
Change from baseline (week 0) in alkaline phosphatase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Biochemistry - Alkaline Phosphatase (Ratio to Baseline) | 0.94 Ratio of alkaline phosphatase | Geometric Coefficient of Variation 15.14 |
| Oral Semaglutide 7 mg | Change From Baseline in Biochemistry - Alkaline Phosphatase (Ratio to Baseline) | 0.92 Ratio of alkaline phosphatase | Geometric Coefficient of Variation 20.54 |
| Oral Semaglutide 14 mg | Change From Baseline in Biochemistry - Alkaline Phosphatase (Ratio to Baseline) | 0.95 Ratio of alkaline phosphatase | Geometric Coefficient of Variation 17.83 |
| Placebo | Change From Baseline in Biochemistry - Alkaline Phosphatase (Ratio to Baseline) | 0.95 Ratio of alkaline phosphatase | Geometric Coefficient of Variation 13.83 |
Secondary
Change From Baseline in Biochemistry - Amylase (Ratio to Baseline)
Change from baseline (week 0) in amylase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Biochemistry - Amylase (Ratio to Baseline) | 1.09 Ratio of amylase | Geometric Coefficient of Variation 23.53 |
| Oral Semaglutide 7 mg | Change From Baseline in Biochemistry - Amylase (Ratio to Baseline) | 1.20 Ratio of amylase | Geometric Coefficient of Variation 27.17 |
| Oral Semaglutide 14 mg | Change From Baseline in Biochemistry - Amylase (Ratio to Baseline) | 1.11 Ratio of amylase | Geometric Coefficient of Variation 21.64 |
| Placebo | Change From Baseline in Biochemistry - Amylase (Ratio to Baseline) | 1.05 Ratio of amylase | Geometric Coefficient of Variation 26.52 |
Secondary
Change From Baseline in Biochemistry - Aspartate Aminotransferase (Ratio to Baseline)
Change from baseline (week 0) in aspartate aminotransferase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Biochemistry - Aspartate Aminotransferase (Ratio to Baseline) | 0.91 Ratio of aspartate aminotransferase | Geometric Coefficient of Variation 30.5 |
| Oral Semaglutide 7 mg | Change From Baseline in Biochemistry - Aspartate Aminotransferase (Ratio to Baseline) | 0.91 Ratio of aspartate aminotransferase | Geometric Coefficient of Variation 34.42 |
| Oral Semaglutide 14 mg | Change From Baseline in Biochemistry - Aspartate Aminotransferase (Ratio to Baseline) | 0.90 Ratio of aspartate aminotransferase | Geometric Coefficient of Variation 35.09 |
| Placebo | Change From Baseline in Biochemistry - Aspartate Aminotransferase (Ratio to Baseline) | 0.89 Ratio of aspartate aminotransferase | Geometric Coefficient of Variation 38.14 |
Secondary
Change From Baseline in Biochemistry - Creatine Kinase (Ratio to Baseline)
Change from baseline (week 0) in creatine kinase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Biochemistry - Creatine Kinase (Ratio to Baseline) | 1.06 Ratio of creatine kinase | Geometric Coefficient of Variation 67.51 |
| Oral Semaglutide 7 mg | Change From Baseline in Biochemistry - Creatine Kinase (Ratio to Baseline) | 0.96 Ratio of creatine kinase | Geometric Coefficient of Variation 48.18 |
| Oral Semaglutide 14 mg | Change From Baseline in Biochemistry - Creatine Kinase (Ratio to Baseline) | 1.00 Ratio of creatine kinase | Geometric Coefficient of Variation 46.25 |
| Placebo | Change From Baseline in Biochemistry - Creatine Kinase (Ratio to Baseline) | 0.93 Ratio of creatine kinase | Geometric Coefficient of Variation 58.87 |
Secondary
Change From Baseline in Biochemistry - Creatinine (Ratio to Baseline)
Change from baseline (week 0) in creatinine (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Biochemistry - Creatinine (Ratio to Baseline) | 1.03 Ratio of creatinine | Geometric Coefficient of Variation 10.39 |
| Oral Semaglutide 7 mg | Change From Baseline in Biochemistry - Creatinine (Ratio to Baseline) | 1.02 Ratio of creatinine | Geometric Coefficient of Variation 13.25 |
| Oral Semaglutide 14 mg | Change From Baseline in Biochemistry - Creatinine (Ratio to Baseline) | 1.03 Ratio of creatinine | Geometric Coefficient of Variation 11.5 |
| Placebo | Change From Baseline in Biochemistry - Creatinine (Ratio to Baseline) | 0.99 Ratio of creatinine | Geometric Coefficient of Variation 11.49 |
Secondary
Change From Baseline in Biochemistry - Lipase (Ratio to Baseline)
Change from baseline (week 0) in lipase (measured in U/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Biochemistry - Lipase (Ratio to Baseline) | 1.24 Ratio of lipase | Geometric Coefficient of Variation 43.99 |
| Oral Semaglutide 7 mg | Change From Baseline in Biochemistry - Lipase (Ratio to Baseline) | 1.60 Ratio of lipase | Geometric Coefficient of Variation 55.4 |
| Oral Semaglutide 14 mg | Change From Baseline in Biochemistry - Lipase (Ratio to Baseline) | 1.35 Ratio of lipase | Geometric Coefficient of Variation 51.48 |
| Placebo | Change From Baseline in Biochemistry - Lipase (Ratio to Baseline) | 1.05 Ratio of lipase | Geometric Coefficient of Variation 32.22 |
Secondary
Change From Baseline in Biochemistry - Total Bilirubin (Ratio to Baseline)
Change from baseline (week 0) in total bilirubin (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Biochemistry - Total Bilirubin (Ratio to Baseline) | 0.89 Ratio of total bilirubin | Geometric Coefficient of Variation 34.97 |
| Oral Semaglutide 7 mg | Change From Baseline in Biochemistry - Total Bilirubin (Ratio to Baseline) | 0.84 Ratio of total bilirubin | Geometric Coefficient of Variation 32.62 |
| Oral Semaglutide 14 mg | Change From Baseline in Biochemistry - Total Bilirubin (Ratio to Baseline) | 0.85 Ratio of total bilirubin | Geometric Coefficient of Variation 41.55 |
| Placebo | Change From Baseline in Biochemistry - Total Bilirubin (Ratio to Baseline) | 0.95 Ratio of total bilirubin | Geometric Coefficient of Variation 39.68 |
Secondary
Change From Baseline in Biochemistry - Urea (Ratio to Baseline)
Change from baseline (week 0) in urea (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Biochemistry - Urea (Ratio to Baseline) | 1.02 Ratio of urea | Geometric Coefficient of Variation 21.23 |
| Oral Semaglutide 7 mg | Change From Baseline in Biochemistry - Urea (Ratio to Baseline) | 1.00 Ratio of urea | Geometric Coefficient of Variation 24.9 |
| Oral Semaglutide 14 mg | Change From Baseline in Biochemistry - Urea (Ratio to Baseline) | 1.02 Ratio of urea | Geometric Coefficient of Variation 23.12 |
| Placebo | Change From Baseline in Biochemistry - Urea (Ratio to Baseline) | 1.07 Ratio of urea | Geometric Coefficient of Variation 23.97 |
Secondary
Change From Baseline in Body Mass Index (BMI)
Change from baseline (week 0) in BMI at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Body Mass Index (BMI) | -0.4 kilograms per square meter (kg/m^2) | Standard Deviation 1.2 |
| Oral Semaglutide 7 mg | Change From Baseline in Body Mass Index (BMI) | -0.8 kilograms per square meter (kg/m^2) | Standard Deviation 1.2 |
| Oral Semaglutide 14 mg | Change From Baseline in Body Mass Index (BMI) | -1.1 kilograms per square meter (kg/m^2) | Standard Deviation 1.3 |
| Placebo | Change From Baseline in Body Mass Index (BMI) | -0.4 kilograms per square meter (kg/m^2) | Standard Deviation 0.9 |
Secondary
Change From Baseline in Body Weight (Kilograms [kg])
Change from baseline (week 0) in body weight at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Body Weight (Kilograms [kg]) | -1.1 Kg | Standard Deviation 3.3 |
| Oral Semaglutide 7 mg | Change From Baseline in Body Weight (Kilograms [kg]) | -2.2 Kg | Standard Deviation 3.4 |
| Oral Semaglutide 14 mg | Change From Baseline in Body Weight (Kilograms [kg]) | -3.1 Kg | Standard Deviation 3.7 |
| Placebo | Change From Baseline in Body Weight (Kilograms [kg]) | -1.1 Kg | Standard Deviation 2.7 |
Secondary
Change From Baseline in Body Weight (Percentage [%])
Change from baseline (week 0) in body weight (measured in kg) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Body Weight (Percentage [%]) | -1 Percentage change | Standard Deviation 4 |
| Oral Semaglutide 7 mg | Change From Baseline in Body Weight (Percentage [%]) | -3 Percentage change | Standard Deviation 4 |
| Oral Semaglutide 14 mg | Change From Baseline in Body Weight (Percentage [%]) | -4 Percentage change | Standard Deviation 5 |
| Placebo | Change From Baseline in Body Weight (Percentage [%]) | -1 Percentage change | Standard Deviation 3 |
Secondary
Change From Baseline in Calcitonin (Ratio to Baseline)
Change from baseline (week 0) in calcitonin (measured in picograms per milliliter \[pg/mL\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Calcitonin (Ratio to Baseline) | 1.01 Ratio of calcitonin | Geometric Coefficient of Variation 23.53 |
| Oral Semaglutide 7 mg | Change From Baseline in Calcitonin (Ratio to Baseline) | 1.09 Ratio of calcitonin | Geometric Coefficient of Variation 39.69 |
| Oral Semaglutide 14 mg | Change From Baseline in Calcitonin (Ratio to Baseline) | 1.15 Ratio of calcitonin | Geometric Coefficient of Variation 42.68 |
| Placebo | Change From Baseline in Calcitonin (Ratio to Baseline) | 0.98 Ratio of calcitonin | Geometric Coefficient of Variation 46.93 |
Secondary
Change From Baseline in Calcium (Ratio to Baseline)
Change from baseline (week 0) in calcium (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Calcium (Ratio to Baseline) | 0.98 Ratio of calcium | Geometric Coefficient of Variation 6.66 |
| Oral Semaglutide 7 mg | Change From Baseline in Calcium (Ratio to Baseline) | 0.97 Ratio of calcium | Geometric Coefficient of Variation 4.87 |
| Oral Semaglutide 14 mg | Change From Baseline in Calcium (Ratio to Baseline) | 0.98 Ratio of calcium | Geometric Coefficient of Variation 4.52 |
| Placebo | Change From Baseline in Calcium (Ratio to Baseline) | 0.97 Ratio of calcium | Geometric Coefficient of Variation 3.79 |
Secondary
Change From Baseline in Diastolic Blood Pressure
Change from baseline (week 0) in diastolic blood pressure at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Diastolic Blood Pressure | 0 mmHg | Standard Deviation 9 |
| Oral Semaglutide 7 mg | Change From Baseline in Diastolic Blood Pressure | -1 mmHg | Standard Deviation 8 |
| Oral Semaglutide 14 mg | Change From Baseline in Diastolic Blood Pressure | -2 mmHg | Standard Deviation 9 |
| Placebo | Change From Baseline in Diastolic Blood Pressure | -2 mmHg | Standard Deviation 9 |
Secondary
Change From Baseline in Electrocardiogram (ECG) Category
Change from baseline (week 0) in ECG category at week 26 is presented. Change from baseline results are presented as shift in findings categorized as: normal, abnormal and not clinically significant (NCS), and abnormal and clinically significant (CS). The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last dose of trial product plus 38 days or the end-date for the in-trial observation period.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure and Number Analyzed = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal CS (week 0) to normal (week 26) | 6 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal NCS (week 0) to abnormal CS (week 26) | 2 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal CS (week 0) to abnormal CS (week 26) | 11 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal NCS (week 0) to normal (week 26) | 9 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Electrocardiogram (ECG) Category | Normal (week 0) to abnormal CS (week 26) | 1 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Electrocardiogram (ECG) Category | Normal (week 0) to abnormal NCS (week 26) | 12 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal CS (week 0) to abnormal NCS (week 26) | 1 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal NCS (week 0) to abnormal NCS (week 26) | 26 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Electrocardiogram (ECG) Category | Normal (week 0) to normal (week 26) | 53 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal NCS (week 0) to abnormal NCS (week 26) | 23 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal CS (week 0) to normal (week 26) | 4 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Electrocardiogram (ECG) Category | Normal (week 0) to abnormal NCS (week 26) | 11 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Electrocardiogram (ECG) Category | Normal (week 0) to normal (week 26) | 61 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Electrocardiogram (ECG) Category | Normal (week 0) to abnormal CS (week 26) | 3 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal CS (week 0) to abnormal CS (week 26) | 9 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal CS (week 0) to abnormal NCS (week 26) | 1 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal NCS (week 0) to normal (week 26) | 11 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal NCS (week 0) to abnormal NCS (week 26) | 23 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Electrocardiogram (ECG) Category | Normal (week 0) to normal (week 26) | 59 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Electrocardiogram (ECG) Category | Normal (week 0) to abnormal NCS (week 26) | 9 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Electrocardiogram (ECG) Category | Normal (week 0) to abnormal CS (week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal NCS (week 0) to normal (week 26) | 19 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal NCS (week 0) to abnormal CS (week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal CS (week 0) to normal (week 26) | 2 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal CS (week 0) to abnormal NCS (week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal CS (week 0) to abnormal CS (week 26) | 4 Participants |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal CS (week 0) to normal (week 26) | 5 Participants |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal NCS (week 0) to normal (week 26) | 12 Participants |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Category | Normal (week 0) to abnormal CS (week 26) | 3 Participants |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal CS (week 0) to abnormal CS (week 26) | 4 Participants |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal CS (week 0) to abnormal NCS (week 26) | 1 Participants |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Category | Normal (week 0) to abnormal NCS (week 26) | 5 Participants |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Category | Abnormal NCS (week 0) to abnormal NCS (week 26) | 33 Participants |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Category | Normal (week 0) to normal (week 26) | 58 Participants |
Secondary
Change From Baseline in Eye Examination Category
Change from baseline (week 0) in eye examination category at week 26 is presented. Eye examination shift in findings were categorized as normal, abnormal NCS and abnormal CS. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure and Number Analyzed = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Normal (week 0) to abnormal NCS (week 26) | 6 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Normal (week 0) to normal (week 26) | 73 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal CS (week 26) | 4 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to normal (week 26) | 10 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Normal (week 0) to normal (week 26) | 76 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to normal (week 26) | 8 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal CS (week 0) to normal (week 26) | 2 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal NCS (week 26) | 14 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal CS (week 26) | 7 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal CS (week 0) to normal (week 26) | 2 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Normal (week 0) to abnormal NCS (week 26) | 6 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Normal (week 0) to abnormal CS (week 26) | 2 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal CS (week 26) | 8 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal NCS (week 26) | 15 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Normal (week 0) to abnormal CS (week 26) | 3 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal CS (week 26) | 4 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal CS (week 26) | 9 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Normal (week 0) to normal (week 26) | 76 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal NCS (week 26) | 1 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal NCS (week 26) | 18 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Normal (week 0) to abnormal NCS (week 26) | 6 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Normal (week 0) to abnormal CS (week 26) | 4 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to normal (week 26) | 3 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to normal (week 26) | 2 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal NCS (week 26) | 19 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Normal (week 0) to abnormal NCS (week 26) | 5 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal CS (week 26) | 2 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Normal (week 0) to normal (week 26) | 77 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal CS (week 0) to normal (week 26) | 3 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal CS (week 0) to normal (week 26) | 4 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal NCS (week 26) | 1 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal CS (week 26) | 1 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Normal (week 0) to abnormal CS (week 26) | 4 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal CS (week 26) | 7 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal CS (week 0) to normal (week 26) | 5 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Normal (week 0) to normal (week 26) | 83 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Normal (week 0) to abnormal NCS (week 26) | 5 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Normal (week 0) to abnormal CS (week 26) | 2 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to normal (week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal NCS (week 26) | 15 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal CS (week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal CS (week 0) to normal (week 26) | 4 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Normal (week 0) to abnormal NCS (week 26) | 4 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal CS (week 26) | 8 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Normal (week 0) to normal (week 26) | 82 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Normal (week 0) to abnormal CS (week 26) | 3 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to normal (week 26) | 3 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal NCS (week 26) | 15 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal CS (week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal NCS (week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal CS (week 26) | 5 Participants |
| Placebo | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Normal (week 0) to abnormal NCS (week 26) | 5 Participants |
| Placebo | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal NCS (week 26) | 19 Participants |
| Placebo | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal CS (week 26) | 9 Participants |
| Placebo | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Normal (week 0) to normal (week 26) | 75 Participants |
| Placebo | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal CS (week 0) to normal (week 26) | 7 Participants |
| Placebo | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal NCS (week 26) | 18 Participants |
| Placebo | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal CS (week 0) to normal (week 26) | 8 Participants |
| Placebo | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to normal (week 26) | 2 Participants |
| Placebo | Change From Baseline in Eye Examination Category | Left Eye Ophthalmoscopy - Normal (week 0) to abnormal CS (week 26) | 5 Participants |
| Placebo | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal CS (week 26) | 9 Participants |
| Placebo | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Normal (week 0) to abnormal CS (week 26) | 3 Participants |
| Placebo | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to normal (week 26) | 3 Participants |
| Placebo | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Normal (week 0) to abnormal NCS (week 26) | 5 Participants |
| Placebo | Change From Baseline in Eye Examination Category | Right Eye Ophthalmoscopy - Normal (week 0) to normal (week 26) | 74 Participants |
Secondary
Change From Baseline in Fasting 7-point Self-measured Plasma Glucose Profile: Mean Postprandial Increment (Over All Meals)
Change from baseline (week 0) in fasting 7-point SMPG: Mean postprandial increment (over all meals) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Fasting 7-point Self-measured Plasma Glucose Profile: Mean Postprandial Increment (Over All Meals) | -14.5 mg/dL | Standard Deviation 34.2 |
| Oral Semaglutide 7 mg | Change From Baseline in Fasting 7-point Self-measured Plasma Glucose Profile: Mean Postprandial Increment (Over All Meals) | -20.0 mg/dL | Standard Deviation 39.9 |
| Oral Semaglutide 14 mg | Change From Baseline in Fasting 7-point Self-measured Plasma Glucose Profile: Mean Postprandial Increment (Over All Meals) | -27.9 mg/dL | Standard Deviation 40.6 |
| Placebo | Change From Baseline in Fasting 7-point Self-measured Plasma Glucose Profile: Mean Postprandial Increment (Over All Meals) | -6.7 mg/dL | Standard Deviation 35.6 |
Secondary
Change From Baseline in Fasting 7-point Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile
Change from baseline (week 0) in mean 7-point SMPG profile at week 26 is presented. 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. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Fasting 7-point Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile | -29.4 mg/dL | Standard Deviation 29.3 |
| Oral Semaglutide 7 mg | Change From Baseline in Fasting 7-point Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile | -43.0 mg/dL | Standard Deviation 36.1 |
| Oral Semaglutide 14 mg | Change From Baseline in Fasting 7-point Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile | -44.5 mg/dL | Standard Deviation 36.9 |
| Placebo | Change From Baseline in Fasting 7-point Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile | -10.3 mg/dL | Standard Deviation 37.5 |
Secondary
Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in HDL cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) | 1.03 Ratio of HDL cholesterol | Geometric Coefficient of Variation 15.78 |
| Oral Semaglutide 7 mg | Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) | 1.02 Ratio of HDL cholesterol | Geometric Coefficient of Variation 15.41 |
| Oral Semaglutide 14 mg | Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) | 1.02 Ratio of HDL cholesterol | Geometric Coefficient of Variation 17.72 |
| Placebo | Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) | 1.04 Ratio of HDL cholesterol | Geometric Coefficient of Variation 14.61 |
Secondary
Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in LDL cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) | 1.00 Ratio of LDL cholesterol | Geometric Coefficient of Variation 29.65 |
| Oral Semaglutide 7 mg | Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) | 1.00 Ratio of LDL cholesterol | Geometric Coefficient of Variation 28.35 |
| Oral Semaglutide 14 mg | Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) | 0.94 Ratio of LDL cholesterol | Geometric Coefficient of Variation 31.12 |
| Placebo | Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) | 1.00 Ratio of LDL cholesterol | Geometric Coefficient of Variation 25.32 |
Secondary
Change From Baseline in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in total cholesterol (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline) | 0.99 Ratio of total cholesterol | Geometric Coefficient of Variation 14.75 |
| Oral Semaglutide 7 mg | Change From Baseline in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline) | 0.98 Ratio of total cholesterol | Geometric Coefficient of Variation 16.62 |
| Oral Semaglutide 14 mg | Change From Baseline in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline) | 0.94 Ratio of total cholesterol | Geometric Coefficient of Variation 19.92 |
| Placebo | Change From Baseline in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline) | 1.00 Ratio of total cholesterol | Geometric Coefficient of Variation 14.45 |
Secondary
Change From Baseline in Fasting Lipid Profile: Triglycerides (Ratio to Baseline)
Change from baseline (week 0) in triglycerides (measured in mg/dL) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Fasting Lipid Profile: Triglycerides (Ratio to Baseline) | 0.96 Ratio of triglycerides | Geometric Coefficient of Variation 45.32 |
| Oral Semaglutide 7 mg | Change From Baseline in Fasting Lipid Profile: Triglycerides (Ratio to Baseline) | 0.90 Ratio of triglycerides | Geometric Coefficient of Variation 45.56 |
| Oral Semaglutide 14 mg | Change From Baseline in Fasting Lipid Profile: Triglycerides (Ratio to Baseline) | 0.87 Ratio of triglycerides | Geometric Coefficient of Variation 51.82 |
| Placebo | Change From Baseline in Fasting Lipid Profile: Triglycerides (Ratio to Baseline) | 0.93 Ratio of triglycerides | Geometric Coefficient of Variation 49.08 |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline (week 0) in FPG at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Fasting Plasma Glucose (FPG) | -19.07 milligrams per deciliter (mg/dL) | Standard Deviation 32.44 |
| Oral Semaglutide 7 mg | Change From Baseline in Fasting Plasma Glucose (FPG) | -32.28 milligrams per deciliter (mg/dL) | Standard Deviation 27.95 |
| Oral Semaglutide 14 mg | Change From Baseline in Fasting Plasma Glucose (FPG) | -32.50 milligrams per deciliter (mg/dL) | Standard Deviation 24.91 |
| Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) | 0.00 milligrams per deciliter (mg/dL) | Standard Deviation 27.49 |
Secondary
Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils
Change from baseline (week 0) in basophils, eosinophils, lymphocytes, monocytes and neutrophils at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Monocytes | 0.01 10^9 cells per liters (10^9 cells/L) | Standard Deviation 0.12 |
| Oral Semaglutide 3 mg | Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Eosinophils | 0.01 10^9 cells per liters (10^9 cells/L) | Standard Deviation 0.1 |
| Oral Semaglutide 3 mg | Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Neutrophils | 0.18 10^9 cells per liters (10^9 cells/L) | Standard Deviation 0.98 |
| Oral Semaglutide 3 mg | Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Lymphocytes | 0.05 10^9 cells per liters (10^9 cells/L) | Standard Deviation 0.43 |
| Oral Semaglutide 3 mg | Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Basophils | 0.00 10^9 cells per liters (10^9 cells/L) | Standard Deviation 0.06 |
| Oral Semaglutide 7 mg | Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Lymphocytes | -0.03 10^9 cells per liters (10^9 cells/L) | Standard Deviation 0.49 |
| Oral Semaglutide 7 mg | Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Monocytes | -0.00 10^9 cells per liters (10^9 cells/L) | Standard Deviation 0.16 |
| Oral Semaglutide 7 mg | Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Neutrophils | 0.06 10^9 cells per liters (10^9 cells/L) | Standard Deviation 1.44 |
| Oral Semaglutide 7 mg | Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Eosinophils | 0.02 10^9 cells per liters (10^9 cells/L) | Standard Deviation 0.1 |
| Oral Semaglutide 7 mg | Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Basophils | -0.01 10^9 cells per liters (10^9 cells/L) | Standard Deviation 0.06 |
| Oral Semaglutide 14 mg | Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Lymphocytes | -0.09 10^9 cells per liters (10^9 cells/L) | Standard Deviation 0.49 |
| Oral Semaglutide 14 mg | Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Basophils | -0.01 10^9 cells per liters (10^9 cells/L) | Standard Deviation 0.06 |
| Oral Semaglutide 14 mg | Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Eosinophils | 0.02 10^9 cells per liters (10^9 cells/L) | Standard Deviation 0.12 |
| Oral Semaglutide 14 mg | Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Monocytes | 0.01 10^9 cells per liters (10^9 cells/L) | Standard Deviation 0.16 |
| Oral Semaglutide 14 mg | Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Neutrophils | 0.28 10^9 cells per liters (10^9 cells/L) | Standard Deviation 1.19 |
| Placebo | Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Monocytes | 0.01 10^9 cells per liters (10^9 cells/L) | Standard Deviation 0.15 |
| Placebo | Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Eosinophils | 0.01 10^9 cells per liters (10^9 cells/L) | Standard Deviation 0.08 |
| Placebo | Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Basophils | -0.01 10^9 cells per liters (10^9 cells/L) | Standard Deviation 0.07 |
| Placebo | Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Lymphocytes | 0.02 10^9 cells per liters (10^9 cells/L) | Standard Deviation 0.46 |
| Placebo | Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils | Neutrophils | 0.21 10^9 cells per liters (10^9 cells/L) | Standard Deviation 1.14 |
Secondary
Change From Baseline in Haematology - Haematocrit (Ratio to Baseline)
Change from baseline (week 0) in haematocrit (measured in %) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Haematology - Haematocrit (Ratio to Baseline) | 1.00 Ratio of haematocrit | Geometric Coefficient of Variation 7.14 |
| Oral Semaglutide 7 mg | Change From Baseline in Haematology - Haematocrit (Ratio to Baseline) | 1.00 Ratio of haematocrit | Geometric Coefficient of Variation 8.1 |
| Oral Semaglutide 14 mg | Change From Baseline in Haematology - Haematocrit (Ratio to Baseline) | 1.00 Ratio of haematocrit | Geometric Coefficient of Variation 6.15 |
| Placebo | Change From Baseline in Haematology - Haematocrit (Ratio to Baseline) | 1.00 Ratio of haematocrit | Geometric Coefficient of Variation 14.42 |
Secondary
Change From Baseline in Haematology - Haemoglobin (Ratio to Baseline)
Change from baseline (week 0) in haemoglobin (measured in millimoles per liter \[mmol/L\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Haematology - Haemoglobin (Ratio to Baseline) | 1.01 Ratio of haemoglobin | Geometric Coefficient of Variation 6 |
| Oral Semaglutide 7 mg | Change From Baseline in Haematology - Haemoglobin (Ratio to Baseline) | 1.00 Ratio of haemoglobin | Geometric Coefficient of Variation 6.82 |
| Oral Semaglutide 14 mg | Change From Baseline in Haematology - Haemoglobin (Ratio to Baseline) | 1.00 Ratio of haemoglobin | Geometric Coefficient of Variation 6.17 |
| Placebo | Change From Baseline in Haematology - Haemoglobin (Ratio to Baseline) | 1.00 Ratio of haemoglobin | Geometric Coefficient of Variation 7.5 |
Secondary
Change From Baseline in Haematology - Leucocytes (Ratio to Baseline)
Change from baseline (week 0) in leucocytes (measured in 10\^9 per liter \[10\^9/L\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Haematology - Leucocytes (Ratio to Baseline) | 1.03 Ratio of leucocytes | Geometric Coefficient of Variation 18.79 |
| Oral Semaglutide 7 mg | Change From Baseline in Haematology - Leucocytes (Ratio to Baseline) | 1.01 Ratio of leucocytes | Geometric Coefficient of Variation 22.23 |
| Oral Semaglutide 14 mg | Change From Baseline in Haematology - Leucocytes (Ratio to Baseline) | 1.04 Ratio of leucocytes | Geometric Coefficient of Variation 22.6 |
| Placebo | Change From Baseline in Haematology - Leucocytes (Ratio to Baseline) | 1.03 Ratio of leucocytes | Geometric Coefficient of Variation 20.8 |
Secondary
Change From Baseline in Haematology - Thrombocytes (Ratio to Baseline)
Change from baseline (week 0) in thrombocytes (measured in 10\^9/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Haematology - Thrombocytes (Ratio to Baseline) | 1.03 Ratio of thrombocytes | Geometric Coefficient of Variation 23.24 |
| Oral Semaglutide 7 mg | Change From Baseline in Haematology - Thrombocytes (Ratio to Baseline) | 1.01 Ratio of thrombocytes | Geometric Coefficient of Variation 17.69 |
| Oral Semaglutide 14 mg | Change From Baseline in Haematology - Thrombocytes (Ratio to Baseline) | 1.04 Ratio of thrombocytes | Geometric Coefficient of Variation 17.55 |
| Placebo | Change From Baseline in Haematology - Thrombocytes (Ratio to Baseline) | 1.02 Ratio of thrombocytes | Geometric Coefficient of Variation 19.98 |
Secondary
Change From Baseline in Physical Examination Category
Change from baseline (week 0) in physical examination category at week 26 is presented. The physical examination shift in findings were categorized as normal, abnormal NCS and abnormal CS and are presented for the following body systems: cardiovascular system; central and peripheral nervous system; gastrointestinal system, including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin; and thyroid gland. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure and Number Analyzed = number of participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Skin - Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Normal (week 0) to normal (week 26) | 120 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Skin - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to normal (week 26) | 121 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | General Appearance - Abnormal CS (week 0) to abnormal CS (week 26) | 1 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Thyroid Gland - Abnormal NCS (week 0) to abnormal NCS (week 26) | 2 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | General Appearance - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | General Appearance - Normal (week 0) to normal (week 26) | 115 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Skin - Abnormal NCS (week 0) to abnormal NCS (week 26) | 11 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | General Appearance - Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | General Appearance - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | General Appearance - Normal (week 0) to abnormal NCS (week 26) | 1 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Skin - Abnormal NCS (week 0) to normal (week 26) | 2 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Cardiovascular system - Abnormal NCS (week 0) to normal (week 26) | 3 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Cardiovascular system - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | General Appearance - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Cardiovascular system - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Cardiovascular system - Normal (week 0) to normal (week 26) | 113 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Thyroid Gland - Abnormal NCS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Skin - Normal (week 0) to abnormal CS (week 26) | 1 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Skin - Normal (week 0) to abnormal NCS (week 26) | 1 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Abnormal NCS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Skin - Normal (week 0) to normal (week 26) | 99 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Respiratory System - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Abnormal NCS (week 0) to abnormal NCS (week 26) | 2 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Respiratory System - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | General Appearance - Abnormal NCS (week 0) to normal (week 26) | 4 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Respiratory System - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Cardiovascular system - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Cardiovascular system - Abnormal NCS (week 0) to abnormal NCS (week 26) | 5 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Thyroid Gland - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Normal (week 0) to normal (week 26) | 117 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Thyroid Gland - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Respiratory System - Normal (week 0) to normal (week 26) | 121 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Normal (week 0) to abnormal NCS (week 26) | 1 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Thyroid Gland - Normal (week 0) to normal (week 26) | 119 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Abnormal NCS (week 0) to abnormal NCS (week 26) | 1 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Abnormal NCS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Skin - Abnormal CS (week 0) to abnormal CS (week 26) | 7 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Normal (week 0) to abnormal NCS (week 26) | 1 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to normal (week 26) | 2 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Skin - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Normal (week 0) to normal (week 26) | 119 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Normal (week 0) to normal (week 26) | 119 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Abnormal NCS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to abnormal NCS (week 26) | 1 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Thyroid Gland - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Abnormal NCS (week 0) to normal (week 26) | 1 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | General Appearance - Abnormal NCS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | General Appearance - Abnormal NCS (week 0) to abnormal NCS (week 26) | 2 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Cardiovascular system - Abnormal NCS (week 0) to abnormal NCS (week 26) | 2 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Cardiovascular system - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Normal (week 0) to normal (week 26) | 121 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Abnormal CS (week 0) to abnormal CS (week 26) | 1 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Normal (week 0) to normal (week 26) | 117 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | General Appearance - Abnormal NCS (week 0) to normal (week 26) | 2 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to abnormal NCS (week 26) | 3 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal CS (week 0) to abnormal CS (week 26) | 2 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | General Appearance - Normal (week 0) to normal (week 26) | 118 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | General Appearance - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | General Appearance - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Cardiovascular system - Normal (week 0) to normal (week 26) | 118 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Cardiovascular system - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Cardiovascular system - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Cardiovascular system - Abnormal NCS (week 0) to normal (week 26) | 2 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | General Appearance - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to normal (week 26) | 118 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (week 0) to abnormal NCS (week 26) | 1 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to abnormal CS (week 26) | 3 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Normal (week 0) to normal (week 26) | 121 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Abnormal NCS (week 0) to normal (week 26) | 1 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Abnormal NCS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Normal (week 0) to normal (week 26) | 119 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Abnormal NCS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Abnormal NCS (week 0) to abnormal NCS (week 26) | 1 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Abnormal CS (week 0) to normal (week 26) | 1 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Abnormal CS (week 0) to abnormal CS (week 26) | 1 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Respiratory System - Normal (week 0) to normal (week 26) | 122 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Respiratory System - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Respiratory System - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Respiratory System - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Skin - Normal (week 0) to normal (week 26) | 106 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Skin - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Skin - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Skin - Abnormal NCS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Skin - Abnormal NCS (week 0) to abnormal NCS (week 26) | 7 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Skin - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Skin - Abnormal CS (week 0) to normal (week 26) | 2 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Skin - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Skin - Abnormal CS (week 0) to abnormal CS (week 26) | 7 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Thyroid Gland - Normal (week 0) to normal (week 26) | 120 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Thyroid Gland - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Thyroid Gland - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Thyroid Gland - Abnormal NCS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Thyroid Gland - Abnormal NCS (week 0) to abnormal NCS (week 26) | 2 Participants |
| Oral Semaglutide 7 mg | Change From Baseline in Physical Examination Category | Thyroid Gland - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to abnormal CS (week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Normal (week 0) to normal (week 26) | 115 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Skin - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to abnormal NCS (week 26) | 2 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Abnormal NCS (week 0) to normal (week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | General Appearance - Abnormal NCS (week 0) to normal (week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Abnormal NCS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Skin - Abnormal CS (week 0) to abnormal CS (week 26) | 2 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Normal (week 0) to normal (week 26) | 115 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Thyroid Gland - Normal (week 0) to normal (week 26) | 113 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Abnormal NCS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Abnormal NCS (week 0) to abnormal NCS (week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Musculoskeletal System - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Thyroid Gland - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Thyroid Gland - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Normal (week 0) to normal (week 26) | 114 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Cardiovascular system - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Respiratory System - Normal (week 0) to normal (week 26) | 116 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Respiratory System - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Thyroid Gland - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Respiratory System - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Respiratory System - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Skin - Normal (week 0) to normal (week 26) | 98 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Skin - Normal (week 0) to abnormal NCS (week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Thyroid Gland - Abnormal NCS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Skin - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Skin - Abnormal NCS (week 0) to normal (week 26) | 3 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Cardiovascular system - Normal (week 0) to normal (week 26) | 115 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | General Appearance - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Cardiovascular system - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Cardiovascular system - Abnormal NCS (week 0) to abnormal NCS (week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Cardiovascular system - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | General Appearance - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Skin - Abnormal NCS (week 0) to abnormal NCS (week 26) | 11 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | General Appearance - Abnormal NCS (week 0) to abnormal NCS (week 26) | 4 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | General Appearance - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | General Appearance - Normal (week 0) to normal (week 26) | 110 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | General Appearance - Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | General Appearance - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | General Appearance - Abnormal CS (week 0) to abnormal CS (week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Cardiovascular system - Abnormal NCS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to normal (week 26) | 115 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Skin - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Normal (week 0) to normal (week 26) | 116 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Thyroid Gland - Abnormal NCS (week 0) to abnormal NCS (week 26) | 3 Participants |
| Oral Semaglutide 14 mg | Change From Baseline in Physical Examination Category | Skin - Abnormal CS (week 0) to normal (week 26) | 1 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Respiratory System - Normal (week 0) to normal (week 26) | 121 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Thyroid Gland - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Skin - Abnormal NCS (week 0) to abnormal NCS (week 26) | 9 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Respiratory System - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Abnormal NCS (week 0) to abnormal NCS (week 26) | 1 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | General Appearance - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Respiratory System - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | General Appearance - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Thyroid Gland - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Respiratory System - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Abnormal NCS (week 0) to normal (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Cardiovascular system - Abnormal NCS (week 0) to abnormal NCS (week 26) | 4 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (week 0) to abnormal NCS (week 26) | 1 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Skin - Abnormal CS (week 0) to normal (week 26) | 1 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Skin - Normal (week 0) to normal (week 26) | 105 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Cardiovascular system - Abnormal CS (week 0) to abnormal CS (week 26) | 1 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to abnormal CS (week 26) | 1 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Thyroid Gland - Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Thyroid Gland - Abnormal NCS (week 0) to abnormal NCS (week 26) | 1 Participants |
| Placebo | Change From Baseline in Physical Examination Category | General Appearance - Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Normal (week 0) to normal (week 26) | 119 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to abnormal NCS (week 26) | 5 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Skin - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal CS (week 0) to abnormal CS (week 26) | 1 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Skin - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | General Appearance - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | General Appearance - Abnormal NCS (week 0) to normal (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Cardiovascular system - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Skin - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Abnormal NCS (week 0) to normal (week 26) | 2 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Cardiovascular system - Abnormal NCS (week 0) to normal (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Thyroid Gland - Abnormal NCS (week 0) to normal (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Abnormal NCS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to normal (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Skin - Abnormal NCS (week 0) to normal (week 26) | 3 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Lymph Node Palpation - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to abnormal CS (week 26) | 1 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Skin - Abnormal CS (week 0) to abnormal CS (week 26) | 3 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Cardiovascular system - Normal (week 0) to normal (week 26) | 115 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Musculoskeletal System - Normal (week 0) to normal (week 26) | 119 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Cardiovascular system - Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | General Appearance - Abnormal CS (week 0) to abnormal CS (week 26) | 1 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Musculoskeletal System - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Skin - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Thyroid Gland - Abnormal CS (week 0) to abnormal CS (week 26) | 1 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Central and Peripheral Nervous System - Normal (week 0) to normal (week 26) | 120 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Musculoskeletal System - Normal (week 0) to abnormal CS (week 26) | 1 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Cardiovascular system - Normal (week 0) to abnormal NCS (week 26) | 1 Participants |
| Placebo | Change From Baseline in Physical Examination Category | General Appearance - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (week 0) to normal (week 26) | 1 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Thyroid Gland - Normal (week 0) to normal (week 26) | 119 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to normal (week 26) | 117 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Normal (week 0) to normal (week 26) | 115 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Cardiovascular system - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Cardiovascular system - Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Musculoskeletal System - Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Thyroid Gland - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Musculoskeletal System - Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Thyroid Gland - Normal (week 0) to abnormal NCS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Musculoskeletal System - Abnormal CS (week 0) to abnormal CS (week 26) | 1 Participants |
| Placebo | Change From Baseline in Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change From Baseline in Physical Examination Category | General Appearance - Abnormal NCS (week 0) to abnormal NCS (week 26) | 1 Participants |
| Placebo | Change From Baseline in Physical Examination Category | General Appearance - Normal (week 0) to normal (week 26) | 119 Participants |
Secondary
Change From Baseline in Potassium (Ratio to Baseline)
Change from baseline (week 0) in potassium (measured in milliequivalents per liter \[mEq/L\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Potassium (Ratio to Baseline) | 1.02 Ratio of potassium | Geometric Coefficient of Variation 9.73 |
| Oral Semaglutide 7 mg | Change From Baseline in Potassium (Ratio to Baseline) | 1.01 Ratio of potassium | Geometric Coefficient of Variation 8.96 |
| Oral Semaglutide 14 mg | Change From Baseline in Potassium (Ratio to Baseline) | 1.00 Ratio of potassium | Geometric Coefficient of Variation 9.94 |
| Placebo | Change From Baseline in Potassium (Ratio to Baseline) | 1.01 Ratio of potassium | Geometric Coefficient of Variation 9.98 |
Secondary
Change From Baseline in Pulse Rate
Change from baseline (week 0) in pulse rate at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Pulse Rate | 2 Beats per minute (beats/min) | Standard Deviation 9 |
| Oral Semaglutide 7 mg | Change From Baseline in Pulse Rate | 4 Beats per minute (beats/min) | Standard Deviation 9 |
| Oral Semaglutide 14 mg | Change From Baseline in Pulse Rate | 5 Beats per minute (beats/min) | Standard Deviation 9 |
| Placebo | Change From Baseline in Pulse Rate | 1 Beats per minute (beats/min) | Standard Deviation 9 |
Secondary
Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey
SF-36 v2.0 is a 36-item, patient-reported survey of patient health. SF-36 measures the participant's overall Health Related Quality of Life on 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) and two component summary scores (physical component summary and mental component summary). Range of score for domains and component summary scores : 1-100 (Higher scores indicated a better health state). Change form baseline in each domain, physical component summary score and mental component summary score at week 26 is presented. A positive change score indicates an improvement since baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Physical functioning | 0.25 Units on a score | Standard Deviation 4.83 |
| Oral Semaglutide 3 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Role physical | 0.34 Units on a score | Standard Deviation 5.7 |
| Oral Semaglutide 3 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Bodily pain | 0.11 Units on a score | Standard Deviation 8.72 |
| Oral Semaglutide 3 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | General health | 2.01 Units on a score | Standard Deviation 7.14 |
| Oral Semaglutide 3 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Vitality | 1.23 Units on a score | Standard Deviation 7.62 |
| Oral Semaglutide 3 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Social functioning | 0.22 Units on a score | Standard Deviation 6.26 |
| Oral Semaglutide 3 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Role emotional | 0.46 Units on a score | Standard Deviation 6.94 |
| Oral Semaglutide 3 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Mental health | 0.22 Units on a score | Standard Deviation 7.59 |
| Oral Semaglutide 3 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Physical component score | 0.66 Units on a score | Standard Deviation 5.21 |
| Oral Semaglutide 3 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Mental component score | 0.51 Units on a score | Standard Deviation 6.86 |
| Oral Semaglutide 7 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Bodily pain | -0.86 Units on a score | Standard Deviation 8.19 |
| Oral Semaglutide 7 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Physical component score | 0.88 Units on a score | Standard Deviation 4.98 |
| Oral Semaglutide 7 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | General health | 2.51 Units on a score | Standard Deviation 7.52 |
| Oral Semaglutide 7 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Vitality | -0.23 Units on a score | Standard Deviation 6.96 |
| Oral Semaglutide 7 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Social functioning | 0.25 Units on a score | Standard Deviation 7.22 |
| Oral Semaglutide 7 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Role emotional | 0.58 Units on a score | Standard Deviation 8.34 |
| Oral Semaglutide 7 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Mental component score | -0.15 Units on a score | Standard Deviation 7.65 |
| Oral Semaglutide 7 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Mental health | -0.38 Units on a score | Standard Deviation 7.96 |
| Oral Semaglutide 7 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Physical functioning | 0.97 Units on a score | Standard Deviation 5.16 |
| Oral Semaglutide 7 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Role physical | 0.43 Units on a score | Standard Deviation 5.83 |
| Oral Semaglutide 14 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Mental health | -0.30 Units on a score | Standard Deviation 7.78 |
| Oral Semaglutide 14 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Role emotional | 0.33 Units on a score | Standard Deviation 7.03 |
| Oral Semaglutide 14 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Mental component score | -0.10 Units on a score | Standard Deviation 6.44 |
| Oral Semaglutide 14 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Physical functioning | 0.34 Units on a score | Standard Deviation 4.24 |
| Oral Semaglutide 14 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | General health | 1.32 Units on a score | Standard Deviation 8.61 |
| Oral Semaglutide 14 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Social functioning | -0.60 Units on a score | Standard Deviation 6.18 |
| Oral Semaglutide 14 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Physical component score | 0.39 Units on a score | Standard Deviation 4.6 |
| Oral Semaglutide 14 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Role physical | -0.00 Units on a score | Standard Deviation 5.02 |
| Oral Semaglutide 14 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Vitality | 0.54 Units on a score | Standard Deviation 8.02 |
| Oral Semaglutide 14 mg | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Bodily pain | -0.34 Units on a score | Standard Deviation 6.56 |
| Placebo | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Vitality | 0.49 Units on a score | Standard Deviation 6.35 |
| Placebo | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Mental health | 0.05 Units on a score | Standard Deviation 6.99 |
| Placebo | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Social functioning | 0.98 Units on a score | Standard Deviation 7.04 |
| Placebo | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Mental component score | 0.08 Units on a score | Standard Deviation 6.88 |
| Placebo | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Role emotional | -0.04 Units on a score | Standard Deviation 9.03 |
| Placebo | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Role physical | 0.33 Units on a score | Standard Deviation 7.5 |
| Placebo | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Bodily pain | 0.49 Units on a score | Standard Deviation 8.4 |
| Placebo | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | General health | 1.17 Units on a score | Standard Deviation 5.91 |
| Placebo | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Physical functioning | 0.87 Units on a score | Standard Deviation 4.98 |
| Placebo | Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Physical component score | 0.94 Units on a score | Standard Deviation 4.71 |
Secondary
Change From Baseline in Sodium (Ratio to Baseline)
Change from baseline (week 0) in sodium (measured in mEq/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Sodium (Ratio to Baseline) | 1.00 Ratio of sodium | Geometric Coefficient of Variation 1.49 |
| Oral Semaglutide 7 mg | Change From Baseline in Sodium (Ratio to Baseline) | 1.00 Ratio of sodium | Geometric Coefficient of Variation 1.46 |
| Oral Semaglutide 14 mg | Change From Baseline in Sodium (Ratio to Baseline) | 1.00 Ratio of sodium | Geometric Coefficient of Variation 1.42 |
| Placebo | Change From Baseline in Sodium (Ratio to Baseline) | 1.00 Ratio of sodium | Geometric Coefficient of Variation 1.32 |
Secondary
Change From Baseline in Systolic Blood Pressure
Change from baseline (week 0) in systolic blood pressure at week 26 is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the last date on trial product plus 3 days.
Time frame: Baseline (Week 0), Week 26
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Systolic Blood Pressure | 1 millimeters of mercury (mmHg) | Standard Deviation 13 |
| Oral Semaglutide 7 mg | Change From Baseline in Systolic Blood Pressure | -2 millimeters of mercury (mmHg) | Standard Deviation 12 |
| Oral Semaglutide 14 mg | Change From Baseline in Systolic Blood Pressure | -4 millimeters of mercury (mmHg) | Standard Deviation 13 |
| Placebo | Change From Baseline in Systolic Blood Pressure | -2 millimeters of mercury (mmHg) | Standard Deviation 13 |
Secondary
Change From Baseline in Waist Circumference
Change from baseline (week 0) in waist circumference at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Baseline (Week 0), Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline in Waist Circumference | -2.1 centimetres (cm) | Standard Deviation 4.5 |
| Oral Semaglutide 7 mg | Change From Baseline in Waist Circumference | -2.2 centimetres (cm) | Standard Deviation 4.8 |
| Oral Semaglutide 14 mg | Change From Baseline in Waist Circumference | -2.8 centimetres (cm) | Standard Deviation 4.4 |
| Placebo | Change From Baseline in Waist Circumference | -1.4 centimetres (cm) | Standard Deviation 3.3 |
Secondary
Number of Participants Who Achieved Body Weight Loss >= 10 Percent (Yes/no)
Number of participants who achieved body weight loss \>= 10 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Number of Participants Who Achieved Body Weight Loss >= 10 Percent (Yes/no) | Yes | 5 Participants |
| Oral Semaglutide 3 mg | Number of Participants Who Achieved Body Weight Loss >= 10 Percent (Yes/no) | No | 110 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved Body Weight Loss >= 10 Percent (Yes/no) | No | 112 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved Body Weight Loss >= 10 Percent (Yes/no) | Yes | 7 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved Body Weight Loss >= 10 Percent (Yes/no) | Yes | 12 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved Body Weight Loss >= 10 Percent (Yes/no) | No | 104 Participants |
| Placebo | Number of Participants Who Achieved Body Weight Loss >= 10 Percent (Yes/no) | Yes | 0 Participants |
| Placebo | Number of Participants Who Achieved Body Weight Loss >= 10 Percent (Yes/no) | No | 106 Participants |
Secondary
Number of Participants Who Achieved Body Weight Loss >= 3 Percent (Yes/no)
Number of participants who achieved body weight loss \>= 3 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Number of Participants Who Achieved Body Weight Loss >= 3 Percent (Yes/no) | Yes | 33 Participants |
| Oral Semaglutide 3 mg | Number of Participants Who Achieved Body Weight Loss >= 3 Percent (Yes/no) | No | 81 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved Body Weight Loss >= 3 Percent (Yes/no) | No | 68 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved Body Weight Loss >= 3 Percent (Yes/no) | Yes | 49 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved Body Weight Loss >= 3 Percent (Yes/no) | Yes | 62 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved Body Weight Loss >= 3 Percent (Yes/no) | No | 54 Participants |
| Placebo | Number of Participants Who Achieved Body Weight Loss >= 3 Percent (Yes/no) | Yes | 28 Participants |
| Placebo | Number of Participants Who Achieved Body Weight Loss >= 3 Percent (Yes/no) | No | 78 Participants |
Secondary
Number of Participants Who Achieved Body Weight Loss >= 5 Percent (Yes/no)
Number of participants who achieved body weight loss \>= 5 percent (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Number of Participants Who Achieved Body Weight Loss >= 5 Percent (Yes/no) | Yes | 17 Participants |
| Oral Semaglutide 3 mg | Number of Participants Who Achieved Body Weight Loss >= 5 Percent (Yes/no) | No | 98 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved Body Weight Loss >= 5 Percent (Yes/no) | No | 90 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved Body Weight Loss >= 5 Percent (Yes/no) | Yes | 29 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved Body Weight Loss >= 5 Percent (Yes/no) | Yes | 43 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved Body Weight Loss >= 5 Percent (Yes/no) | No | 73 Participants |
| Placebo | Number of Participants Who Achieved Body Weight Loss >= 5 Percent (Yes/no) | Yes | 11 Participants |
| Placebo | Number of Participants Who Achieved Body Weight Loss >= 5 Percent (Yes/no) | No | 95 Participants |
Secondary
Number of Participants Who Achieved HbA1c < 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or Blood Glucose [BG] Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no)
Number of participants who achieved HbA1c \< 7.0 percent (53 mmol/mol) without hypoglycaemia (treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes) and no body weight gain (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Number of Participants Who Achieved HbA1c < 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or Blood Glucose [BG] Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no) | Yes | 54 Participants |
| Oral Semaglutide 3 mg | Number of Participants Who Achieved HbA1c < 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or Blood Glucose [BG] Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no) | No | 60 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved HbA1c < 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or Blood Glucose [BG] Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no) | No | 37 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved HbA1c < 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or Blood Glucose [BG] Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no) | Yes | 80 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved HbA1c < 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or Blood Glucose [BG] Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no) | Yes | 84 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved HbA1c < 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or Blood Glucose [BG] Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no) | No | 32 Participants |
| Placebo | Number of Participants Who Achieved HbA1c < 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or Blood Glucose [BG] Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no) | Yes | 19 Participants |
| Placebo | Number of Participants Who Achieved HbA1c < 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or Blood Glucose [BG] Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no) | No | 87 Participants |
Secondary
Number of Participants Who Achieved HbA1c Less Than (<) 7.0 % (53 Millimoles Per Mole [mmol/Mol]) (American Diabetes Association (ADA) Target) (Yes/no)
Number of participants who achieved HbA1c \< 7.0 % (53 mmol/mol) (ADA target) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Number of Participants Who Achieved HbA1c Less Than (<) 7.0 % (53 Millimoles Per Mole [mmol/Mol]) (American Diabetes Association (ADA) Target) (Yes/no) | Yes | 75 Participants |
| Oral Semaglutide 3 mg | Number of Participants Who Achieved HbA1c Less Than (<) 7.0 % (53 Millimoles Per Mole [mmol/Mol]) (American Diabetes Association (ADA) Target) (Yes/no) | No | 39 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved HbA1c Less Than (<) 7.0 % (53 Millimoles Per Mole [mmol/Mol]) (American Diabetes Association (ADA) Target) (Yes/no) | No | 17 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved HbA1c Less Than (<) 7.0 % (53 Millimoles Per Mole [mmol/Mol]) (American Diabetes Association (ADA) Target) (Yes/no) | Yes | 100 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved HbA1c Less Than (<) 7.0 % (53 Millimoles Per Mole [mmol/Mol]) (American Diabetes Association (ADA) Target) (Yes/no) | Yes | 92 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved HbA1c Less Than (<) 7.0 % (53 Millimoles Per Mole [mmol/Mol]) (American Diabetes Association (ADA) Target) (Yes/no) | No | 24 Participants |
| Placebo | Number of Participants Who Achieved HbA1c Less Than (<) 7.0 % (53 Millimoles Per Mole [mmol/Mol]) (American Diabetes Association (ADA) Target) (Yes/no) | Yes | 27 Participants |
| Placebo | Number of Participants Who Achieved HbA1c Less Than (<) 7.0 % (53 Millimoles Per Mole [mmol/Mol]) (American Diabetes Association (ADA) Target) (Yes/no) | No | 79 Participants |
Secondary
Number of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no)
Number of participants who achieved HbA1c \<= 6.5 percent (48 mmol/mol) (AACE target) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Number of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) | Yes | 53 Participants |
| Oral Semaglutide 3 mg | Number of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) | No | 61 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) | No | 41 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) | Yes | 76 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) | Yes | 76 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) | No | 40 Participants |
| Placebo | Number of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) | Yes | 12 Participants |
| Placebo | Number of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) | No | 94 Participants |
Secondary
Number of Participants Who Achieved HbA1c Reduction >= 1% (10.9 mmol/Mol) and Body Weight Loss >= 3 Percent (Yes/no)
Number of participants who achieved HbA1c reduction \>= 1% (10.9 mmol/mol) and body weight loss \>= 3% (yes/no) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Number of Participants Who Achieved HbA1c Reduction >= 1% (10.9 mmol/Mol) and Body Weight Loss >= 3 Percent (Yes/no) | Yes | 26 Participants |
| Oral Semaglutide 3 mg | Number of Participants Who Achieved HbA1c Reduction >= 1% (10.9 mmol/Mol) and Body Weight Loss >= 3 Percent (Yes/no) | No | 88 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved HbA1c Reduction >= 1% (10.9 mmol/Mol) and Body Weight Loss >= 3 Percent (Yes/no) | No | 74 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved HbA1c Reduction >= 1% (10.9 mmol/Mol) and Body Weight Loss >= 3 Percent (Yes/no) | Yes | 43 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved HbA1c Reduction >= 1% (10.9 mmol/Mol) and Body Weight Loss >= 3 Percent (Yes/no) | Yes | 53 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved HbA1c Reduction >= 1% (10.9 mmol/Mol) and Body Weight Loss >= 3 Percent (Yes/no) | No | 63 Participants |
| Placebo | Number of Participants Who Achieved HbA1c Reduction >= 1% (10.9 mmol/Mol) and Body Weight Loss >= 3 Percent (Yes/no) | Yes | 10 Participants |
| Placebo | Number of Participants Who Achieved HbA1c Reduction >= 1% (10.9 mmol/Mol) and Body Weight Loss >= 3 Percent (Yes/no) | No | 96 Participants |
Secondary
Number of Participants Who Achieved HbA1c Reduction Greater Than or Equal to (>=) 1 Percent (10.9 mmol/Mol) (Yes/no)
Number of participants who achieved HbA1c reduction \>= 1 percent (10.9 mmol/mol) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Number of Participants Who Achieved HbA1c Reduction Greater Than or Equal to (>=) 1 Percent (10.9 mmol/Mol) (Yes/no) | Yes | 67 Participants |
| Oral Semaglutide 3 mg | Number of Participants Who Achieved HbA1c Reduction Greater Than or Equal to (>=) 1 Percent (10.9 mmol/Mol) (Yes/no) | No | 47 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved HbA1c Reduction Greater Than or Equal to (>=) 1 Percent (10.9 mmol/Mol) (Yes/no) | No | 28 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved HbA1c Reduction Greater Than or Equal to (>=) 1 Percent (10.9 mmol/Mol) (Yes/no) | Yes | 89 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved HbA1c Reduction Greater Than or Equal to (>=) 1 Percent (10.9 mmol/Mol) (Yes/no) | Yes | 87 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved HbA1c Reduction Greater Than or Equal to (>=) 1 Percent (10.9 mmol/Mol) (Yes/no) | No | 29 Participants |
| Placebo | Number of Participants Who Achieved HbA1c Reduction Greater Than or Equal to (>=) 1 Percent (10.9 mmol/Mol) (Yes/no) | Yes | 19 Participants |
| Placebo | Number of Participants Who Achieved HbA1c Reduction Greater Than or Equal to (>=) 1 Percent (10.9 mmol/Mol) (Yes/no) | No | 87 Participants |
Secondary
Number of Participants With Anti-semaglutide Binding Antibodies
Number of participants who had anti-semaglutide binding antibody levels anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participants-investigator contact, and death for participants who died before any of the above.
Time frame: Up to 31 weeks
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 3 mg | Number of Participants With Anti-semaglutide Binding Antibodies | 0 Participants |
| Oral Semaglutide 7 mg | Number of Participants With Anti-semaglutide Binding Antibodies | 1 Participants |
| Oral Semaglutide 14 mg | Number of Participants With Anti-semaglutide Binding Antibodies | 0 Participants |
Secondary
Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1
Number of participants who had 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 - the in-trial observation period started at randomization and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact, and death for participants who died before any of the above.
Time frame: Up to 31 weeks
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 3 mg | Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 | 0 Participants |
| Oral Semaglutide 7 mg | Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 | 0 Participants |
| Oral Semaglutide 14 mg | Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 | 0 Participants |
Secondary
Number of Participants With Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose (PG) value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period.
Time frame: Up to 31 weeks
Population: Safety analysis set included all participants exposed to at least one dose of trial product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 3 mg | Number of Participants With Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | 0 Participants |
| Oral Semaglutide 7 mg | Number of Participants With Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | 0 Participants |
| Oral Semaglutide 14 mg | Number of Participants With Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | 0 Participants |
| Placebo | Number of Participants With Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | 0 Participants |
Secondary
Number of Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. TEAE was defined as an AE with onset in the on-treatment observation period. On-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period.
Time frame: Up to 31 weeks
Population: Safety analysis set included all participants exposed to at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide 3 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 251 Events |
| Oral Semaglutide 7 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 292 Events |
| Oral Semaglutide 14 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 231 Events |
| Placebo | Number of Treatment-emergent Adverse Events (TEAEs) | 212 Events |
Secondary
Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose (PG) value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, follow-up prematurely discontinuation visit, last date on trial product plus 38 days or the end-date for the in-trial observation period.
Time frame: Up to 31 weeks
Population: Safety analysis set included all participants exposed to at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide 3 mg | Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | 0 Episodes |
| Oral Semaglutide 7 mg | Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | 0 Episodes |
| Oral Semaglutide 14 mg | Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | 0 Episodes |
| Placebo | Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | 0 Episodes |
Secondary
Semaglutide Plasma Concentrations
Semaglutide plasma concentrations at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: Week 26: post dose any time
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentrations | 4.36 nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 103.74 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentrations | 11.22 nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 106.34 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentrations | 17.71 nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 232.82 |
Secondary
Time From First Dose to Initiation of Rescue Medication
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 randomization 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 randomization and before last day on trial product. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: From baseline (Week 0) to Week 26
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oral Semaglutide 3 mg | Time From First Dose to Initiation of Rescue Medication | NA Days |
| Oral Semaglutide 7 mg | Time From First Dose to Initiation of Rescue Medication | NA Days |
| Placebo | Time From First Dose to Initiation of Rescue Medication | NA Days |