A Research Study Comparing a New Medicine Oral Semaglutide to Placebo in People With Type 2 Diabetes

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.

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 (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 (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 (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 (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 (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 (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 (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 (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 (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.

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 < 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 <= 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 >= 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) 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) 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) 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 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% (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.

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 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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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.

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.

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.

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 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 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 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.