Diabetes Mellitus, Type 2
Conditions
Brief summary
This study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and sitagliptin (a medicine doctors can already prescribe). Participants will either get oral semaglutide or sitagliptin - which treatment is decided by chance. Participants will get 2 tablets a day to take first thing in the morning on an empty stomach. Only 1 tablet has study medicine in it. The other tablet is a dummy medicine (placebo). After taking the semaglutide tablet, participants may not eat or drink anything for at least 30 minutes. After the 30 minutes, participants must take the sitagliptin tablet. Then participants can have their first meal of the day and take any other medicines they may need, including their metformin. The study will last for about 7 months (33 weeks). Participants will have 8 clinic visits and 1 phone call with the study doctor. At all 8 of the clinic visits, participants will have blood samples taken.
Interventions
DRUGOral semaglutide
Oral semaglutide to be taken every morning in a fasting state, to be followed by sitagliptin placebo after 30 minutes. Only then participants can have their first meal of the day and their pre-study metformin tablets
DRUGSitagliptin
Sitagliptin to be taken every morning, 30 minutes after taking the oral semaglutide placebo tablet. Then participants can have their first meal of the day and their pre-study metformin tablets
DRUGPlacebo (oral semaglutide)
Placebo tablet to be taken first thing in the morning
Placebo tablet to be taken 30 minutes after oral semaglutide
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 informed consent. For Taiwan only: Male or female, age above or equal to 20 years at the time of signing informed consent * Diagnosed with type 2 diabetes mellitus 60 days or more prior to day of screening. * HbA1c between 7.0-10.5% (53-91 mmol/mol) (both inclusive). * Stable daily dose of metformin (equal to or above 1500 mg or maximum tolerated dose as documented in the subject medical record) 60 days or more prior to day of screening
Exclusion criteria
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method (adequate contraceptive measure as required by local regulation or practice). * 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 and randomisation. * 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). * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation. Fundus examination without dilation is only allowed if the digital camera used for fundus photography has this feature. * 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 to Week 26 in Glycated Haemoglobin (HbA1c) (%) | From baseline to week 26 | Change in HbA1c from baseline to week 26 in percentage (%) point of HbA1c is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period and in-trial observation period. On-treatment without rescue medication observation period: from date of first dose of trial product following randomization and 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. In-trial observation period: the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile | From baseline to week 26 | Change from baseline 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 and 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 to Week 26 in 7 Point SMPG Profile: Mean Postprandial Increment (Over All Meals) | From baseline to week 26 | Change from baseline in 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 and 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) (American Diabetes Association [ADA] Target) (Yes/no) | At week 26 | Number of participants who achieved HbA1c \<7.0% (53 mmol/mol) (ADA target) is presented in category Yes and participants who could not achieve HbA1C \<7.0 (53 mmol/mol) (ADA target) is presented in category No. 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 and 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 Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) | At week 26 | Number of participants who achieved HbA1c equal to or below 6.5 percent (48 mmol/mol) (AACE target) (yes/no) 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 and 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 Equal to or Above 1 Percent-point (10.9 mmol/Mol) (Yes/no) | At week 26 | Number of participants who achieved HbA1c reduction equal to or above 1 percent-point (10.9 mmol/mol) (yes/no) 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 and 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 to Rescue Medication | From baseline to week 31 | Time to rescue medication is presented as the number of participants who had taken rescue medication anytime from baseline to week 31. 'Rescue medication': use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. 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 and 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 to Week 26 in Body Weight (Kilogram [kg]) | From baseline to week 26 | Change in body weight from baseline to week 26 in kg 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 and 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. |
| Percentage Change From Baseline to Week 26 in Body Weight | From baseline to week 26 | Percentage change from baseline to week 26 in body weight 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 and 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 to Week 26 in Body Mass Index (BMI) | From baseline to week 26 | Change from baseline in BMI 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 and 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 to Week 26 in Waist Circumference | From baseline to week 26 | Change from baseline in waist circumference 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 and 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 to Week 26 in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline) | From baseline to week 26 | Change from baseline in total cholesterol (measured in mmol/L) 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 to Week 26 in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) | From baseline to week 26 | Change from baseline in LDL cholesterol (measured in mmol/L) 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 to Week 26 in Fasting Lipid Profile: Very-low-density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline) | From baseline to week 26 | Change from baseline in VLDL cholesterol (measured in mmol/L) 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 to Week 26 in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) | From baseline to week 26 | Change from baseline in HDL Cholesterol (measured in mmol/L) 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 to Week 26 in Fasting Lipid Profile: Triglycerides (Ratio to Baseline) | From baseline to week 26 | Change from baseline in triglycerides (measured in mmol/L) 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 to Week 26 in Fasting Lipid Profile: Free Fatty Acids (Ratio to Baseline) | From baseline to week 26 | Change from baseline in free fatty acids (measured in mmol/L) 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 to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | From baseline to 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). A positive change score indicates an improvement since baseline. 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 end date which was first date of any of following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Number of Participants Who Achieved Body Weight Loss Equal to or Above 3 Percent (Yes/no) | At week 26 | Number of participants who achieved body weight loss equal to or above 3 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above. |
| Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | From baseline to week 26 | Change from baseline in hematology parameters such as basophils, eosinophils, lymphocytes, monocytes, and neutrophils were reported. 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period. |
| Number of Participants Who Achieved Body Weight Loss Equal to or Above 5 Percent (Yes/no) | At week 26 | Number of participants who achieved body weight loss equal to or above 5 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above. |
| Number of Participants Who Achieved Body Weight Loss Equal to or Above 10 Percent (Yes/no) | At week 26 | Number of participants who achieved body weight loss equal to or above 10 percent (yes/no). The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above. |
| Number of Participants Who Achieved HbA1c Below 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 | 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 In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above. |
| Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) and Body Weight Loss Equal to or Above 3 Percent (Yes/no) | At week 26 | Number of participants who achieved HbA1c reduction equal to or above 1 percent-point (10.9 mmol/mol) and body weight loss equal to or above 3 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above. |
| Number of Treatment-emergent Adverse Events During Exposure to Trial Product | From baseline to week 31 | An adverse event (AE) was defined as 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. AEs with onset during the on-treatment period correspond to treatment-emergent AEs (TEAEs). 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period. |
| Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | From baseline to week 31 | Number of treatment-emergent severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes during exposure to trial product is presented. Severe: requiring assistance from another person for recovery. 'BG-confirmed': hypoglycaemic episode with a plasma glucose value \< 3.1 mmol/L (56 mg/dL); 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period. |
| Change From Baseline to Week 26 in Haematology Parameter: Haematocrit (Ratio to Baseline) | From baseline to week 26 | Change from baseline in Haematocrit at week 26 is reported 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period. |
| Change From Baseline to Week 26 in Haematology Parameter: Haemoglobin (Ratio to Baseline) | From baseline to week 26 | Change from baseline in Haemoglobin at week 26 is reported 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period. |
| Change From Baseline to Week 26 in Haematology Parameter: Leucocytes (Ratio to Baseline) | From baseline to week 26 | Change from baseline in Leucocytes at week 26 is reported 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period. |
| Change From Baseline to Week 26 in Haematology Parameter: Thrombocytes (Ratio to Baseline) | From baseline to week 26 | Change from baseline in thrombocytes at week 26 is reported 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period. |
| Change From Baseline to Week 26 in Biochemistry Parameter: Calcium (Total) (Ratio to Baseline) | From baseline to week 26 | Change from baseline in calcium (total) (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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period. |
| Change From Baseline to Week 26 in Biochemistry Parameter: Potassium (Ratio to Baseline) | From baseline to week 26 | Change from baseline in potassium (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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period. |
| Change From Baseline to Week 26 in Biochemistry Parameter: Sodium (Ratio to Baseline) | From baseline to week 26 | Change from baseline in sodium (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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period. |
| Change From Baseline to Week 26 in Biochemistry Parameter: Urea (Ratio to Baseline) | From baseline to week 26 | Change from baseline 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period. |
| Change From Baseline to Week 26 in Biochemistry Parameter: Albumin (Ratio to Baseline) | From baseline to week 26 | Change from baseline in Albumin (measured in grams per deciliter \[g/dL\]) 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period. |
| Change From Baseline to Week 26 in Calcitonin (Ratio to Baseline) | From baseline to week 26 | Change from baseline 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period. |
| Change From Baseline to Week 26 in Vital Signs: Pulse Rate | From baseline to week 26 | Change from baseline in pulse rate 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period. |
| Change From Baseline to Week 26 in Vital Signs: Systolic Blood Pressure | From baseline to week 26 | Change from baseline in systolic blood pressure 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period. |
| Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG) | From baseline to week 26 | Change in fasting plasma glucose (FPG) from baseline to week 26 in millimole per liter (mmol/l) 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 and 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 to Week 26 in Electrocardiogram (ECG) Category | From baseline to week 26 | Change from baseline 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period. |
| Physical Examination Category | Baseline and week 26 | The physical examination values for different body systems at baseline and week 26 are presented. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. The physical examination 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period. |
| Change From Baseline to Week 26 in Eye Examination Category | From baseline to week 26 | The eye examination category at baseline and week 26 are presented. The investigator interpreted the results and categorised them as: normal, abnormal NCS or 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period. |
| Number of Participants With Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | From baseline to week 31 | Number of participants with treatment-emergent severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes during exposure to trial product is presented. Severe: requiring assistance from another person for recovery. 'BG-confirmed': hypoglycaemic episode with a plasma glucose value \< 3.1 mmol/L (56 mg/dL); 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period. |
| Change From Baseline to Week 26 in Vital Signs: Diastolic Blood Pressure | From baseline to week 26 | Change from baseline in diastolic blood pressure 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period. |
Countries
Algeria, Brazil, China, Czechia, Hong Kong, Romania, Serbia, South Africa, Taiwan
Participant flow
Recruitment details
The trial was conducted at 90 sites in 8 countries as follows: Brazil (3 sites), China (58 sites), Czech Republic (4 sites); Hong Kong (1 site), Romania (6 sites), Serbia (7 sites), Taiwan (4 sites), and South Africa (7 sites).
Pre-assignment details
This was a 26-week, multicenter, multinational trial with four arms comparing efficacy and safety of oral semaglutide 3 milligram (mg), 7 mg and 14 mg once-daily with sitagliptin 100 mg once-daily. Out of 1441 participants randomized in the study, 1438 participants were exposed to trial product.
Participants by arm
| Arm | Count |
|---|---|
| Oral Semaglutide 3 mg Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks. | 361 |
| 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 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks. | 360 |
| 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 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks. | 361 |
| Sitagliptin 100 mg Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks. | 359 |
| Total | 1,441 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 2 | 2 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 3 | 3 | 1 |
| Overall Study | Physician Decision | 1 | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 13 | 12 | 21 | 7 |
Baseline characteristics
| Characteristic | Total | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg |
|---|---|---|---|---|---|
| Age, Continuous | 53.3 Years STANDARD_DEVIATION 10.8 | 53.5 Years STANDARD_DEVIATION 11.2 | 53.4 Years STANDARD_DEVIATION 10.8 | 53.5 Years STANDARD_DEVIATION 10.5 | 52.9 Years STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 69 Participants | 17 Participants | 19 Participants | 15 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1372 Participants | 344 Participants | 341 Participants | 346 Participants | 341 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1084 Participants | 272 Participants | 270 Participants | 271 Participants | 271 Participants |
| Race/Ethnicity, Customized Black or African American | 38 Participants | 8 Participants | 14 Participants | 5 Participants | 11 Participants |
| Race/Ethnicity, Customized NA | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 55 Participants | 8 Participants | 11 Participants | 18 Participants | 18 Participants |
| Race/Ethnicity, Customized White | 264 Participants | 73 Participants | 65 Participants | 67 Participants | 59 Participants |
| Sex: Female, Male Female | 601 Participants | 152 Participants | 147 Participants | 146 Participants | 156 Participants |
| Sex: Female, Male Male | 840 Participants | 209 Participants | 213 Participants | 215 Participants | 203 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 | 2 / 361 | 2 / 358 | 1 / 361 | 0 / 358 |
| other Total, other adverse events | 109 / 361 | 117 / 358 | 144 / 361 | 65 / 358 |
| serious Total, serious adverse events | 16 / 361 | 11 / 358 | 11 / 361 | 15 / 358 |
Outcome results
Primary
Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%)
Change in HbA1c from baseline to week 26 in percentage (%) point of HbA1c is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period and in-trial observation period. On-treatment without rescue medication observation period: from date of first dose of trial product following randomization and 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. In-trial observation period: the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication.
Time frame: From baseline to week 26
Population: Full analysis set (FAS) included all randomized participants. 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 (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) | On-treatment observation period | -0.8 Percentage point of HbA1C | Standard Deviation 1 |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) | In-trial observation period | -0.8 Percentage point of HbA1C | Standard Deviation 1 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) | In-trial observation period | -1.3 Percentage point of HbA1C | Standard Deviation 1 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) | On-treatment observation period | -1.3 Percentage point of HbA1C | Standard Deviation 1 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) | On-treatment observation period | -1.6 Percentage point of HbA1C | Standard Deviation 1 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) | In-trial observation period | -1.5 Percentage point of HbA1C | Standard Deviation 1 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) | On-treatment observation period | -0.7 Percentage point of HbA1C | Standard Deviation 1 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) | In-trial observation period | -0.7 Percentage point of HbA1C | Standard Deviation 1 |
p-value: 0.007895% CI: [-0.3, -0.1]Mixed model for repeated measurements
p-value: <0.000195% CI: [-0.8, -0.6]Mixed model for repeated measurements
p-value: <0.000195% CI: [-1.1, -0.8]Mixed model for repeated measurements
Secondary
Change From Baseline to Week 26 in 7 Point SMPG Profile: Mean Postprandial Increment (Over All Meals)
Change from baseline in 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 and 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 to week 26
Population: FAS 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 to Week 26 in 7 Point SMPG Profile: Mean Postprandial Increment (Over All Meals) | -0.4 mmol/L | Standard Deviation 2 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in 7 Point SMPG Profile: Mean Postprandial Increment (Over All Meals) | -0.9 mmol/L | Standard Deviation 1.9 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in 7 Point SMPG Profile: Mean Postprandial Increment (Over All Meals) | -1.0 mmol/L | Standard Deviation 2.1 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in 7 Point SMPG Profile: Mean Postprandial Increment (Over All Meals) | -0.6 mmol/L | Standard Deviation 2.1 |
Secondary
Change From Baseline to Week 26 in Biochemistry Parameter: Albumin (Ratio to Baseline)
Change from baseline in Albumin (measured in grams per deciliter \[g/dL\]) 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Population: SAS 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 to Week 26 in Biochemistry Parameter: Albumin (Ratio to Baseline) | 0.99 Ratio of albumin | Geometric Coefficient of Variation 4.4 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Biochemistry Parameter: Albumin (Ratio to Baseline) | 0.99 Ratio of albumin | Geometric Coefficient of Variation 4.57 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Biochemistry Parameter: Albumin (Ratio to Baseline) | 0.99 Ratio of albumin | Geometric Coefficient of Variation 5.22 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Biochemistry Parameter: Albumin (Ratio to Baseline) | 0.99 Ratio of albumin | Geometric Coefficient of Variation 5.05 |
Secondary
Change From Baseline to Week 26 in Biochemistry Parameter: Calcium (Total) (Ratio to Baseline)
Change from baseline in calcium (total) (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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Population: SAS 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 to Week 26 in Biochemistry Parameter: Calcium (Total) (Ratio to Baseline) | 0.98 Ratio of calcium | Geometric Coefficient of Variation 4.4 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Biochemistry Parameter: Calcium (Total) (Ratio to Baseline) | 0.98 Ratio of calcium | Geometric Coefficient of Variation 4.74 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Biochemistry Parameter: Calcium (Total) (Ratio to Baseline) | 0.99 Ratio of calcium | Geometric Coefficient of Variation 4.8 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Biochemistry Parameter: Calcium (Total) (Ratio to Baseline) | 0.98 Ratio of calcium | Geometric Coefficient of Variation 4.4 |
Secondary
Change From Baseline to Week 26 in Biochemistry Parameter: Potassium (Ratio to Baseline)
Change from baseline in potassium (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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Population: SAS 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 to Week 26 in Biochemistry Parameter: Potassium (Ratio to Baseline) | 1.00 Ratio of potassium | Geometric Coefficient of Variation 8.51 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Biochemistry Parameter: Potassium (Ratio to Baseline) | 1.00 Ratio of potassium | Geometric Coefficient of Variation 8.34 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Biochemistry Parameter: Potassium (Ratio to Baseline) | 1.00 Ratio of potassium | Geometric Coefficient of Variation 8.96 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Biochemistry Parameter: Potassium (Ratio to Baseline) | 1.01 Ratio of potassium | Geometric Coefficient of Variation 9.28 |
Secondary
Change From Baseline to Week 26 in Biochemistry Parameter: Sodium (Ratio to Baseline)
Change from baseline in sodium (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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Population: SAS 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 to Week 26 in Biochemistry Parameter: Sodium (Ratio to Baseline) | 1.00 Ratio of sodium | Geometric Coefficient of Variation 1.58 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Biochemistry Parameter: Sodium (Ratio to Baseline) | 1.00 Ratio of sodium | Geometric Coefficient of Variation 1.4 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Biochemistry Parameter: Sodium (Ratio to Baseline) | 1.00 Ratio of sodium | Geometric Coefficient of Variation 1.49 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Biochemistry Parameter: Sodium (Ratio to Baseline) | 1.00 Ratio of sodium | Geometric Coefficient of Variation 1.59 |
Secondary
Change From Baseline to Week 26 in Biochemistry Parameter: Urea (Ratio to Baseline)
Change from baseline 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Population: SAS 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 to Week 26 in Biochemistry Parameter: Urea (Ratio to Baseline) | 1.00 Ratio of urea | Geometric Coefficient of Variation 26.29 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Biochemistry Parameter: Urea (Ratio to Baseline) | 0.99 Ratio of urea | Geometric Coefficient of Variation 25.61 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Biochemistry Parameter: Urea (Ratio to Baseline) | 0.98 Ratio of urea | Geometric Coefficient of Variation 23.78 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Biochemistry Parameter: Urea (Ratio to Baseline) | 1.03 Ratio of urea | Geometric Coefficient of Variation 22.67 |
Secondary
Change From Baseline to Week 26 in Body Mass Index (BMI)
Change from baseline in BMI 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 and 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 to week 26
Population: FAS 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 to Week 26 in Body Mass Index (BMI) | -0.5 Kilogram per square meter (kg/m^2) | Standard Deviation 1.1 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Body Mass Index (BMI) | -1.1 Kilogram per square meter (kg/m^2) | Standard Deviation 1.2 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Body Mass Index (BMI) | -1.4 Kilogram per square meter (kg/m^2) | Standard Deviation 1.3 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Body Mass Index (BMI) | -0.2 Kilogram per square meter (kg/m^2) | Standard Deviation 0.9 |
Secondary
Change From Baseline to Week 26 in Body Weight (Kilogram [kg])
Change in body weight from baseline to week 26 in kg 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 and 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 to week 26
Population: FAS 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 to Week 26 in Body Weight (Kilogram [kg]) | -1.4 Kilogram | Standard Deviation 3 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Body Weight (Kilogram [kg]) | -2.9 Kilogram | Standard Deviation 3.3 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Body Weight (Kilogram [kg]) | -3.8 Kilogram | Standard Deviation 3.7 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Body Weight (Kilogram [kg]) | -0.5 Kilogram | Standard Deviation 2.6 |
Secondary
Change From Baseline to Week 26 in Calcitonin (Ratio to Baseline)
Change from baseline 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Population: SAS 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 to Week 26 in Calcitonin (Ratio to Baseline) | 1.00 Ratio of calcitonin | Geometric Coefficient of Variation 38.33 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Calcitonin (Ratio to Baseline) | 1.05 Ratio of calcitonin | Geometric Coefficient of Variation 35.56 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Calcitonin (Ratio to Baseline) | 1.02 Ratio of calcitonin | Geometric Coefficient of Variation 36.49 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Calcitonin (Ratio to Baseline) | 1.01 Ratio of calcitonin | Geometric Coefficient of Variation 31.96 |
Secondary
Change From Baseline to Week 26 in Electrocardiogram (ECG) Category
Change from baseline 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Population: SAS 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 to Week 26 in Electrocardiogram (ECG) Category | Abnormal CS (Baseline) to normal (week 26) | 8 Participants |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal NCS (Baseline) to abnormal CS (week 26) | 3 Participants |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal CS (Baseline) to abnormal CS (week 26) | 27 Participants |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal NCS (Baseline) to normal (week 26) | 26 Participants |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Normal (Baseline) to abnormal CS (week 26) | 8 Participants |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Normal (Baseline) to abnormal NCS (week 26) | 21 Participants |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal CS (Baseline) to abnormal NCS (week 26) | 5 Participants |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal NCS (Baseline) to abnormal NCS (week 26) | 56 Participants |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Normal (Baseline) to normal (week 26) | 174 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal NCS (Baseline) to abnormal NCS (week 26) | 61 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal CS (Baseline) to normal (week 26) | 13 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal NCS (Baseline) to abnormal CS (week 26) | 3 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Normal (Baseline) to abnormal NCS (week 26) | 30 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Normal (Baseline) to normal (week 26) | 163 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Normal (Baseline) to abnormal CS (week 26) | 3 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal CS (Baseline) to abnormal CS (week 26) | 25 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal CS (Baseline) to abnormal NCS (week 26) | 3 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal NCS (Baseline) to normal (week 26) | 27 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal NCS (Baseline) to abnormal NCS (week 26) | 40 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Normal (Baseline) to normal (week 26) | 165 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Normal (Baseline) to abnormal NCS (week 26) | 29 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Normal (Baseline) to abnormal CS (week 26) | 10 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal NCS (Baseline) to normal (week 26) | 26 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal NCS (Baseline) to abnormal CS (week 26) | 5 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal CS (Baseline) to normal (week 26) | 7 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal CS (Baseline) to abnormal NCS (week 26) | 4 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal CS (Baseline) to abnormal CS (week 26) | 17 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal CS (Baseline) to normal (week 26) | 6 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal NCS (Baseline) to normal (week 26) | 43 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Normal (Baseline) to abnormal CS (week 26) | 5 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal CS (Baseline) to abnormal CS (week 26) | 23 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal CS (Baseline) to abnormal NCS (week 26) | 9 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Normal (Baseline) to abnormal NCS (week 26) | 17 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal NCS (Baseline) to abnormal CS (week 26) | 2 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Abnormal NCS (Baseline) to abnormal NCS (week 26) | 64 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Electrocardiogram (ECG) Category | Normal (Baseline) to normal (week 26) | 175 Participants |
Secondary
Change From Baseline to Week 26 in Eye Examination Category
The eye examination category at baseline and week 26 are presented. The investigator interpreted the results and categorised them as: normal, abnormal NCS or 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Population: SAS included all participants exposed to at least one dose of trial product. 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 to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Normal (Week 26) | 223 Participants |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal CS (Week 26) | 53 Participants |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal NCS (Baseline) | 64 Participants |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy - Normal (Baseline) | 245 Participants |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal CS (Baseline) | 57 Participants |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal CS (Baseline) | 56 Participants |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy - Normal (Week 26) | 221 Participants |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal NCS (Baseline) | 60 Participants |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal NCS (Week 26) | 49 Participants |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy -Abnormal NCS (Week 26) | 49 Participants |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal CS (Week 26) | 55 Participants |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Normal (Baseline) | 240 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal NCS (Baseline) | 51 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Normal (Baseline) | 234 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy - Normal (Week 26) | 226 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal CS (Baseline) | 69 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Normal (Week 26) | 218 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal NCS (Baseline) | 54 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy - Normal (Baseline) | 240 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal CS (Week 26) | 53 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy -Abnormal NCS (Week 26) | 44 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal CS (Baseline) | 67 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal CS (Week 26) | 55 Participants |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal NCS (Week 26) | 49 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal NCS (Baseline) | 56 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy - Normal (Baseline) | 254 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal NCS (Baseline) | 61 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal CS (Baseline) | 46 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy - Normal (Week 26) | 217 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy -Abnormal NCS (Week 26) | 50 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal CS (Week 26) | 34 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Normal (Baseline) | 257 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal CS (Baseline) | 48 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Normal (Week 26) | 220 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal NCS (Week 26) | 45 Participants |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal CS (Week 26) | 36 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal CS (Week 26) | 56 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy -Abnormal NCS (Week 26) | 39 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy - Normal (Baseline) | 248 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Normal (Week 26) | 233 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy - Normal (Week 26) | 240 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal CS (Baseline) | 58 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal CS (Week 26) | 59 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal NCS (Week 26) | 43 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal NCS (Baseline) | 53 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Normal (Baseline) | 240 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Eye Examination Category | Left Eye Ophthalmoscopy - Abnormal NCS (Baseline) | 52 Participants |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Eye Examination Category | Right Eye Ophthalmoscopy - Abnormal CS (Baseline) | 65 Participants |
Secondary
Change From Baseline to Week 26 in Fasting Lipid Profile: Free Fatty Acids (Ratio to Baseline)
Change from baseline in free fatty acids (measured in mmol/L) 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: From baseline to week 26
Population: FAS 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 to Week 26 in Fasting Lipid Profile: Free Fatty Acids (Ratio to Baseline) | 0.95 Ratio of free fatty acids | Geometric Coefficient of Variation 56.36 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Fasting Lipid Profile: Free Fatty Acids (Ratio to Baseline) | 0.89 Ratio of free fatty acids | Geometric Coefficient of Variation 56.46 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Fasting Lipid Profile: Free Fatty Acids (Ratio to Baseline) | 0.87 Ratio of free fatty acids | Geometric Coefficient of Variation 66.18 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Fasting Lipid Profile: Free Fatty Acids (Ratio to Baseline) | 0.96 Ratio of free fatty acids | Geometric Coefficient of Variation 62.5 |
Secondary
Change From Baseline to Week 26 in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)
Change from baseline in HDL Cholesterol (measured in mmol/L) 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: From baseline to week 26
Population: FAS 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 to Week 26 in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) | 1.02 Ratio of HDL cholesterol | Geometric Coefficient of Variation 13.25 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) | 1.01 Ratio of HDL cholesterol | Geometric Coefficient of Variation 14.42 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) | 1.00 Ratio of HDL cholesterol | Geometric Coefficient of Variation 14.82 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) | 1.00 Ratio of HDL cholesterol | Geometric Coefficient of Variation 16.03 |
Secondary
Change From Baseline to Week 26 in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)
Change from baseline in LDL cholesterol (measured in mmol/L) 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: From baseline to week 26
Population: FAS 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 to Week 26 in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) | 1.02 Ratio of LDL cholesterol | Geometric Coefficient of Variation 25.63 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) | 0.98 Ratio of LDL cholesterol | Geometric Coefficient of Variation 28.7 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) | 0.98 Ratio of LDL cholesterol | Geometric Coefficient of Variation 28.95 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) | 1.01 Ratio of LDL cholesterol | Geometric Coefficient of Variation 30.12 |
Secondary
Change From Baseline to Week 26 in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline)
Change from baseline in total cholesterol (measured in mmol/L) 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: From baseline to week 26
Population: FAS 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 to Week 26 in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline) | 1.00 Ratio of total cholesterol | Geometric Coefficient of Variation 15.78 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline) | 0.96 Ratio of total cholesterol | Geometric Coefficient of Variation 17.34 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline) | 0.96 Ratio of total cholesterol | Geometric Coefficient of Variation 17.86 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline) | 0.99 Ratio of total cholesterol | Geometric Coefficient of Variation 19.69 |
Secondary
Change From Baseline to Week 26 in Fasting Lipid Profile: Triglycerides (Ratio to Baseline)
Change from baseline in triglycerides (measured in mmol/L) 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: From baseline to week 26
Population: FAS 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 to Week 26 in Fasting Lipid Profile: Triglycerides (Ratio to Baseline) | 0.96 Ratio of triglycerides | Geometric Coefficient of Variation 43.41 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Fasting Lipid Profile: Triglycerides (Ratio to Baseline) | 0.86 Ratio of triglycerides | Geometric Coefficient of Variation 46.28 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Fasting Lipid Profile: Triglycerides (Ratio to Baseline) | 0.86 Ratio of triglycerides | Geometric Coefficient of Variation 46.4 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Fasting Lipid Profile: Triglycerides (Ratio to Baseline) | 0.91 Ratio of triglycerides | Geometric Coefficient of Variation 44.29 |
Secondary
Change From Baseline to Week 26 in Fasting Lipid Profile: Very-low-density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)
Change from baseline in VLDL cholesterol (measured in mmol/L) 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: From baseline to week 26
Population: FAS 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 to Week 26 in Fasting Lipid Profile: Very-low-density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline) | 1.05 Ratio of VLDL cholesterol | Standard Deviation 0.45 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Fasting Lipid Profile: Very-low-density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline) | 0.94 Ratio of VLDL cholesterol | Standard Deviation 0.37 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Fasting Lipid Profile: Very-low-density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline) | 0.94 Ratio of VLDL cholesterol | Standard Deviation 0.41 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Fasting Lipid Profile: Very-low-density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline) | 0.98 Ratio of VLDL cholesterol | Standard Deviation 0.43 |
Secondary
Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG)
Change in fasting plasma glucose (FPG) from baseline to week 26 in millimole per liter (mmol/l) 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 and 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 to week 26
Population: FAS 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 to Week 26 in Fasting Plasma Glucose (FPG) | -1.03 mmol/l | Standard Deviation 2.11 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG) | -1.79 mmol/l | Standard Deviation 2.2 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG) | -2.00 mmol/l | Standard Deviation 2.42 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG) | -0.52 mmol/l | Standard Deviation 2.36 |
Secondary
Change From Baseline to Week 26 in Haematology Parameter: Haematocrit (Ratio to Baseline)
Change from baseline in Haematocrit at week 26 is reported 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Population: SAS 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 to Week 26 in Haematology Parameter: Haematocrit (Ratio to Baseline) | 1.01 Ratio of haematocrit | Geometric Coefficient of Variation 6.76 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Haematology Parameter: Haematocrit (Ratio to Baseline) | 1.00 Ratio of haematocrit | Geometric Coefficient of Variation 6.64 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Haematology Parameter: Haematocrit (Ratio to Baseline) | 1.00 Ratio of haematocrit | Geometric Coefficient of Variation 6.21 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Haematology Parameter: Haematocrit (Ratio to Baseline) | 1.00 Ratio of haematocrit | Geometric Coefficient of Variation 6.35 |
Secondary
Change From Baseline to Week 26 in Haematology Parameter: Haemoglobin (Ratio to Baseline)
Change from baseline in Haemoglobin at week 26 is reported 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Population: SAS 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 to Week 26 in Haematology Parameter: Haemoglobin (Ratio to Baseline) | 1.00 Ratio of haemoglobin | Geometric Coefficient of Variation 5.71 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Haematology Parameter: Haemoglobin (Ratio to Baseline) | 1.00 Ratio of haemoglobin | Geometric Coefficient of Variation 6.04 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Haematology Parameter: Haemoglobin (Ratio to Baseline) | 1.00 Ratio of haemoglobin | Geometric Coefficient of Variation 5.47 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Haematology Parameter: Haemoglobin (Ratio to Baseline) | 1.00 Ratio of haemoglobin | Geometric Coefficient of Variation 6.11 |
Secondary
Change From Baseline to Week 26 in Haematology Parameter: Leucocytes (Ratio to Baseline)
Change from baseline in Leucocytes at week 26 is reported 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Population: SAS 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 to Week 26 in Haematology Parameter: Leucocytes (Ratio to Baseline) | 1.01 Ratio of leucocytes | Geometric Coefficient of Variation 19.28 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Haematology Parameter: Leucocytes (Ratio to Baseline) | 1.02 Ratio of leucocytes | Geometric Coefficient of Variation 19.54 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Haematology Parameter: Leucocytes (Ratio to Baseline) | 1.01 Ratio of leucocytes | Geometric Coefficient of Variation 21.24 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Haematology Parameter: Leucocytes (Ratio to Baseline) | 1.04 Ratio of leucocytes | Geometric Coefficient of Variation 17.87 |
Secondary
Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils
Change from baseline in hematology parameters such as basophils, eosinophils, lymphocytes, monocytes, and neutrophils were reported. 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Population: SAS 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 to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | Monocytes | 0.01 10^9 cells per liter | Standard Deviation 0.15 |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | Eosinophils | 0.00 10^9 cells per liter | Standard Deviation 0.11 |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | Neutrophils | 0.03 10^9 cells per liter | Standard Deviation 1.08 |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | Lymphocytes | -0.03 10^9 cells per liter | Standard Deviation 0.46 |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | Basophils | 0.01 10^9 cells per liter | Standard Deviation 0.05 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | Lymphocytes | 0.01 10^9 cells per liter | Standard Deviation 0.4 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | Monocytes | 0.01 10^9 cells per liter | Standard Deviation 0.13 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | Neutrophils | 0.13 10^9 cells per liter | Standard Deviation 1.15 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | Eosinophils | 0.00 10^9 cells per liter | Standard Deviation 0.09 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | Basophils | 0.01 10^9 cells per liter | Standard Deviation 0.05 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | Lymphocytes | 0.00 10^9 cells per liter | Standard Deviation 0.52 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | Basophils | 0.00 10^9 cells per liter | Standard Deviation 0.04 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | Eosinophils | -0.01 10^9 cells per liter | Standard Deviation 0.25 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | Monocytes | 0.01 10^9 cells per liter | Standard Deviation 0.14 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | Neutrophils | 0.10 10^9 cells per liter | Standard Deviation 1.22 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | Monocytes | 0.02 10^9 cells per liter | Standard Deviation 0.12 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | Eosinophils | -0.00 10^9 cells per liter | Standard Deviation 0.11 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | Basophils | 0.00 10^9 cells per liter | Standard Deviation 0.05 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | Lymphocytes | 0.00 10^9 cells per liter | Standard Deviation 0.39 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | Neutrophils | 0.31 10^9 cells per liter | Standard Deviation 1.17 |
Secondary
Change From Baseline to Week 26 in Haematology Parameter: Thrombocytes (Ratio to Baseline)
Change from baseline in thrombocytes at week 26 is reported 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Population: SAS 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 to Week 26 in Haematology Parameter: Thrombocytes (Ratio to Baseline) | 0.99 Ratio of thrombocytes | Geometric Coefficient of Variation 14.53 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Haematology Parameter: Thrombocytes (Ratio to Baseline) | 0.99 Ratio of thrombocytes | Geometric Coefficient of Variation 16.65 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Haematology Parameter: Thrombocytes (Ratio to Baseline) | 0.99 Ratio of thrombocytes | Geometric Coefficient of Variation 16.65 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Haematology Parameter: Thrombocytes (Ratio to Baseline) | 0.97 Ratio of thrombocytes | Geometric Coefficient of Variation 15.65 |
Secondary
Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile
Change from baseline 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 and 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 to week 26
Population: FAS 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 to Week 26 in Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile | -1.5 mmol/L | Standard Deviation 2.2 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile | -2.3 mmol/L | Standard Deviation 2.2 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile | -2.6 mmol/L | Standard Deviation 2.2 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile | -1.2 mmol/L | Standard Deviation 2.4 |
Secondary
Change From Baseline to Week 26 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). A positive change score indicates an improvement since baseline. 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 end date which was first date of any of following: the last dose of trial product plus 3 days or initiation of rescue medication.
Time frame: From baseline to week 26
Population: FAS included all randomized participants. 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 (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | General Health | 1.47 Score on a scale | Standard Deviation 7.54 |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Vitality | 0.44 Score on a scale | Standard Deviation 6.68 |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Social Function | 0.49 Score on a scale | Standard Deviation 6.14 |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Role Emotional | 0.06 Score on a scale | Standard Deviation 8.8 |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Mental Health | 0.51 Score on a scale | Standard Deviation 7.01 |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Physical Component | 0.15 Score on a scale | Standard Deviation 5.32 |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Mental Component | 0.50 Score on a scale | Standard Deviation 6.71 |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Physical Function | 0.20 Score on a scale | Standard Deviation 5.63 |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Role Physical | -0.47 Score on a scale | Standard Deviation 6.72 |
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Bodily Pain | -0.06 Score on a scale | Standard Deviation 8.44 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Social Function | -0.36 Score on a scale | Standard Deviation 6.45 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Role Physical | -0.41 Score on a scale | Standard Deviation 6.82 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Role Emotional | -0.66 Score on a scale | Standard Deviation 8.37 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Mental Health | 0.33 Score on a scale | Standard Deviation 6.71 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Physical Component | 0.29 Score on a scale | Standard Deviation 4.74 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Mental Component | -0.07 Score on a scale | Standard Deviation 6.5 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Bodily Pain | -0.37 Score on a scale | Standard Deviation 8.08 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Physical Function | 0.48 Score on a scale | Standard Deviation 3.95 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | General Health | 1.04 Score on a scale | Standard Deviation 7.09 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Vitality | 0.84 Score on a scale | Standard Deviation 6.64 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Physical Function | 0.93 Score on a scale | Standard Deviation 4.51 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Mental Component | 0.44 Score on a scale | Standard Deviation 6.75 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Bodily Pain | 0.51 Score on a scale | Standard Deviation 8.03 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | General Health | 1.95 Score on a scale | Standard Deviation 7.44 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Role Emotional | 0.23 Score on a scale | Standard Deviation 8.26 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Physical Component | 0.98 Score on a scale | Standard Deviation 5 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Role Physical | 0.28 Score on a scale | Standard Deviation 6.11 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Vitality | 1.21 Score on a scale | Standard Deviation 7.66 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Mental Health | 0.70 Score on a scale | Standard Deviation 7.34 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Social Function | 0.17 Score on a scale | Standard Deviation 5.92 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Mental Health | -0.7 Score on a scale | Standard Deviation 7.13 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Physical Function | 0.31 Score on a scale | Standard Deviation 5.25 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Physical Component | 0.69 Score on a scale | Standard Deviation 5.62 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Bodily Pain | 0.22 Score on a scale | Standard Deviation 8.44 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Mental Component | -0.39 Score on a scale | Standard Deviation 6.64 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Vitality | 0.33 Score on a scale | Standard Deviation 7.28 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Social Function | 0.10 Score on a scale | Standard Deviation 6.36 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Role Emotional | 0.03 Score on a scale | Standard Deviation 8.4 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | General Health | 0.95 Score on a scale | Standard Deviation 7.19 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey | Role Physical | 0.24 Score on a scale | Standard Deviation 7.27 |
Secondary
Change From Baseline to Week 26 in Vital Signs: Diastolic Blood Pressure
Change from baseline in diastolic blood pressure 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Population: SAS included all participants exposed to at least one dose of trial product.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Vital Signs: Diastolic Blood Pressure | 83 Millimeter of mercury (mmHg) | Standard Deviation 10 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Vital Signs: Diastolic Blood Pressure | 84 Millimeter of mercury (mmHg) | Standard Deviation 9 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Vital Signs: Diastolic Blood Pressure | 83 Millimeter of mercury (mmHg) | Standard Deviation 10 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Vital Signs: Diastolic Blood Pressure | 83 Millimeter of mercury (mmHg) | Standard Deviation 9 |
Secondary
Change From Baseline to Week 26 in Vital Signs: Pulse Rate
Change from baseline in pulse rate 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Population: SAS included all participants exposed to at least one dose of trial product.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Vital Signs: Pulse Rate | 78 Beats per minute (beats/min) | Standard Deviation 10 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Vital Signs: Pulse Rate | 78 Beats per minute (beats/min) | Standard Deviation 11 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Vital Signs: Pulse Rate | 78 Beats per minute (beats/min) | Standard Deviation 10 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Vital Signs: Pulse Rate | 78 Beats per minute (beats/min) | Standard Deviation 10 |
Secondary
Change From Baseline to Week 26 in Vital Signs: Systolic Blood Pressure
Change from baseline in systolic blood pressure 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 26
Population: SAS included all participants exposed to at least one dose of trial product.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change From Baseline to Week 26 in Vital Signs: Systolic Blood Pressure | 131 Millimeter of mercury (mmHg) | Standard Deviation 16 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Vital Signs: Systolic Blood Pressure | 132 Millimeter of mercury (mmHg) | Standard Deviation 15 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Vital Signs: Systolic Blood Pressure | 130 Millimeter of mercury (mmHg) | Standard Deviation 14 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Vital Signs: Systolic Blood Pressure | 130 Millimeter of mercury (mmHg) | Standard Deviation 14 |
Secondary
Change From Baseline to Week 26 in Waist Circumference
Change from baseline in waist circumference 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 and 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 to week 26
Population: FAS 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 to Week 26 in Waist Circumference | -1.6 Centimeter | Standard Deviation 4 |
| Oral Semaglutide 7 mg | Change From Baseline to Week 26 in Waist Circumference | -2.7 Centimeter | Standard Deviation 4.4 |
| Oral Semaglutide 14 mg | Change From Baseline to Week 26 in Waist Circumference | -3.7 Centimeter | Standard Deviation 4.1 |
| Sitagliptin 100 mg | Change From Baseline to Week 26 in Waist Circumference | -0.8 Centimeter | Standard Deviation 3.4 |
Secondary
Number of Participants Who Achieved Body Weight Loss Equal to or Above 10 Percent (Yes/no)
Number of participants who achieved body weight loss equal to or above 10 percent (yes/no). The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.
Time frame: At week 26
Population: FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 10 Percent (Yes/no) | Yes | 5 Participants |
| Oral Semaglutide 3 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 10 Percent (Yes/no) | No | 338 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 10 Percent (Yes/no) | No | 318 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 10 Percent (Yes/no) | Yes | 24 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 10 Percent (Yes/no) | Yes | 42 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 10 Percent (Yes/no) | No | 291 Participants |
| Sitagliptin 100 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 10 Percent (Yes/no) | Yes | 2 Participants |
| Sitagliptin 100 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 10 Percent (Yes/no) | No | 349 Participants |
Secondary
Number of Participants Who Achieved Body Weight Loss Equal to or Above 3 Percent (Yes/no)
Number of participants who achieved body weight loss equal to or above 3 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.
Time frame: At week 26
Population: FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 3 Percent (Yes/no) | Yes | 109 Participants |
| Oral Semaglutide 3 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 3 Percent (Yes/no) | No | 234 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 3 Percent (Yes/no) | No | 164 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 3 Percent (Yes/no) | Yes | 175 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 3 Percent (Yes/no) | Yes | 199 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 3 Percent (Yes/no) | No | 133 Participants |
| Sitagliptin 100 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 3 Percent (Yes/no) | Yes | 68 Participants |
| Sitagliptin 100 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 3 Percent (Yes/no) | No | 282 Participants |
Secondary
Number of Participants Who Achieved Body Weight Loss Equal to or Above 5 Percent (Yes/no)
Number of participants who achieved body weight loss equal to or above 5 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.
Time frame: At week 26
Population: FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 5 Percent (Yes/no) | Yes | 55 Participants |
| Oral Semaglutide 3 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 5 Percent (Yes/no) | No | 288 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 5 Percent (Yes/no) | No | 235 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 5 Percent (Yes/no) | Yes | 107 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 5 Percent (Yes/no) | Yes | 149 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 5 Percent (Yes/no) | No | 184 Participants |
| Sitagliptin 100 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 5 Percent (Yes/no) | Yes | 28 Participants |
| Sitagliptin 100 mg | Number of Participants Who Achieved Body Weight Loss Equal to or Above 5 Percent (Yes/no) | No | 323 Participants |
Secondary
Number of Participants Who Achieved HbA1c <7.0 % (53 mmol/Mol) (American Diabetes Association [ADA] Target) (Yes/no)
Number of participants who achieved HbA1c \<7.0% (53 mmol/mol) (ADA target) is presented in category Yes and participants who could not achieve HbA1C \<7.0 (53 mmol/mol) (ADA target) is presented in category No. 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 and 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: At week 26
Population: FAS included all randomised participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Number of Participants Who Achieved HbA1c <7.0 % (53 mmol/Mol) (American Diabetes Association [ADA] Target) (Yes/no) | Yes | 139 Participants |
| Oral Semaglutide 3 mg | Number of Participants Who Achieved HbA1c <7.0 % (53 mmol/Mol) (American Diabetes Association [ADA] Target) (Yes/no) | No | 182 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved HbA1c <7.0 % (53 mmol/Mol) (American Diabetes Association [ADA] Target) (Yes/no) | No | 102 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved HbA1c <7.0 % (53 mmol/Mol) (American Diabetes Association [ADA] Target) (Yes/no) | Yes | 213 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved HbA1c <7.0 % (53 mmol/Mol) (American Diabetes Association [ADA] Target) (Yes/no) | Yes | 226 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved HbA1c <7.0 % (53 mmol/Mol) (American Diabetes Association [ADA] Target) (Yes/no) | No | 72 Participants |
| Sitagliptin 100 mg | Number of Participants Who Achieved HbA1c <7.0 % (53 mmol/Mol) (American Diabetes Association [ADA] Target) (Yes/no) | Yes | 122 Participants |
| Sitagliptin 100 mg | Number of Participants Who Achieved HbA1c <7.0 % (53 mmol/Mol) (American Diabetes Association [ADA] Target) (Yes/no) | No | 212 Participants |
Secondary
Number of Participants Who Achieved HbA1c Below 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or 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 In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.
Time frame: At week 26
Population: FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Number of Participants Who Achieved HbA1c Below 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no) | Yes | 114 Participants |
| Oral Semaglutide 3 mg | Number of Participants Who Achieved HbA1c Below 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no) | No | 230 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved HbA1c Below 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no) | No | 144 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved HbA1c Below 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no) | Yes | 195 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved HbA1c Below 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no) | Yes | 222 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved HbA1c Below 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no) | No | 110 Participants |
| Sitagliptin 100 mg | Number of Participants Who Achieved HbA1c Below 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no) | Yes | 79 Participants |
| Sitagliptin 100 mg | Number of Participants Who Achieved HbA1c Below 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no) | No | 271 Participants |
Secondary
Number of Participants Who Achieved HbA1c Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no)
Number of participants who achieved HbA1c equal to or below 6.5 percent (48 mmol/mol) (AACE target) (yes/no) 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 and 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: At week 26
Population: FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Number of Participants Who Achieved HbA1c Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) | Yes | 81 Participants |
| Oral Semaglutide 3 mg | Number of Participants Who Achieved HbA1c Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) | No | 240 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved HbA1c Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) | No | 154 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved HbA1c Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) | Yes | 161 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved HbA1c Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) | Yes | 188 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved HbA1c Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) | No | 110 Participants |
| Sitagliptin 100 mg | Number of Participants Who Achieved HbA1c Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) | Yes | 54 Participants |
| Sitagliptin 100 mg | Number of Participants Who Achieved HbA1c Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) | No | 280 Participants |
Secondary
Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) and Body Weight Loss Equal to or Above 3 Percent (Yes/no)
Number of participants who achieved HbA1c reduction equal to or above 1 percent-point (10.9 mmol/mol) and body weight loss equal to or above 3 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.
Time frame: At week 26
Population: FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) and Body Weight Loss Equal to or Above 3 Percent (Yes/no) | Yes | 64 Participants |
| Oral Semaglutide 3 mg | Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) and Body Weight Loss Equal to or Above 3 Percent (Yes/no) | No | 280 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) and Body Weight Loss Equal to or Above 3 Percent (Yes/no) | No | 211 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) and Body Weight Loss Equal to or Above 3 Percent (Yes/no) | Yes | 128 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) and Body Weight Loss Equal to or Above 3 Percent (Yes/no) | Yes | 159 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) and Body Weight Loss Equal to or Above 3 Percent (Yes/no) | No | 173 Participants |
| Sitagliptin 100 mg | Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) and Body Weight Loss Equal to or Above 3 Percent (Yes/no) | Yes | 33 Participants |
| Sitagliptin 100 mg | Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) and Body Weight Loss Equal to or Above 3 Percent (Yes/no) | No | 317 Participants |
Secondary
Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) (Yes/no)
Number of participants who achieved HbA1c reduction equal to or above 1 percent-point (10.9 mmol/mol) (yes/no) 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 and 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: At week 26
Population: FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) (Yes/no) | Yes | 141 Participants |
| Oral Semaglutide 3 mg | Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) (Yes/no) | No | 180 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) (Yes/no) | No | 111 Participants |
| Oral Semaglutide 7 mg | Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) (Yes/no) | Yes | 203 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) (Yes/no) | Yes | 226 Participants |
| Oral Semaglutide 14 mg | Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) (Yes/no) | No | 72 Participants |
| Sitagliptin 100 mg | Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) (Yes/no) | Yes | 129 Participants |
| Sitagliptin 100 mg | Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) (Yes/no) | No | 205 Participants |
Secondary
Number of Participants With Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product
Number of participants with treatment-emergent severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes during exposure to trial product is presented. Severe: requiring assistance from another person for recovery. 'BG-confirmed': hypoglycaemic episode with a plasma glucose value \< 3.1 mmol/L (56 mg/dL); 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 31
Population: SAS 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 Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | 2 Participants |
| Oral Semaglutide 7 mg | Number of Participants With Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | 2 Participants |
| Oral Semaglutide 14 mg | Number of Participants With Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | 2 Participants |
| Sitagliptin 100 mg | Number of Participants With Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | 1 Participants |
Secondary
Number of Treatment-emergent Adverse Events During Exposure to Trial Product
An adverse event (AE) was defined as 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. AEs with onset during the on-treatment period correspond to treatment-emergent AEs (TEAEs). 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 31
Population: Safety analysis set (SAS) 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 During Exposure to Trial Product | 635 Events |
| Oral Semaglutide 7 mg | Number of Treatment-emergent Adverse Events During Exposure to Trial Product | 741 Events |
| Oral Semaglutide 14 mg | Number of Treatment-emergent Adverse Events During Exposure to Trial Product | 793 Events |
| Sitagliptin 100 mg | Number of Treatment-emergent Adverse Events During Exposure to Trial Product | 643 Events |
Secondary
Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product
Number of treatment-emergent severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes during exposure to trial product is presented. Severe: requiring assistance from another person for recovery. 'BG-confirmed': hypoglycaemic episode with a plasma glucose value \< 3.1 mmol/L (56 mg/dL); 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, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: From baseline to week 31
Population: SAS included all 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 Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | 2 Episodes |
| Oral Semaglutide 7 mg | Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | 2 Episodes |
| Oral Semaglutide 14 mg | Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | 2 Episodes |
| Sitagliptin 100 mg | Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product | 1 Episodes |
Secondary
Percentage Change From Baseline to Week 26 in Body Weight
Percentage change from baseline to week 26 in body weight 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 and 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 to week 26
Population: FAS 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 | Percentage Change From Baseline to Week 26 in Body Weight | -2 Percentage change | Standard Deviation 4 |
| Oral Semaglutide 7 mg | Percentage Change From Baseline to Week 26 in Body Weight | -4 Percentage change | Standard Deviation 4 |
| Oral Semaglutide 14 mg | Percentage Change From Baseline to Week 26 in Body Weight | -5 Percentage change | Standard Deviation 5 |
| Sitagliptin 100 mg | Percentage Change From Baseline to Week 26 in Body Weight | -1 Percentage change | Standard Deviation 3 |
Secondary
Physical Examination Category
The physical examination values for different body systems at baseline and week 26 are presented. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. The physical examination 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 first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.
Time frame: Baseline and week 26
Population: SAS included all participants exposed to at least one dose of trial product. Number Analyzed: number of participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Physical Examination Category | Thyroid Gland - Abnormal CS (Baseline) | 1 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (Week 26) | 2 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (Baseline) | 4 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Cardiovascular system - Abnormal NCS (Week 26) | 5 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Lymph Node Palpation - Abnormal CS (Baseline) | 0 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Skin - Abnormal NCS (Week 26) | 60 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Musculoskeletal System - Abnormal NCS (Week 26) | 6 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Cardiovascular system - Abnormal CS (Week 26) | 3 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Respiratory System - Abnormal CS (Baseline) | 3 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Lymph Node Palpation - Abnormal NCS (Baseline) | 0 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Normal (Week 26) | 322 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Central and Peripheral Nervous System - Normal (Baseline) | 355 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | General Appearance - Abnormal CS (Week 26) | 6 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Skin - Normal (Baseline) | 282 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Musculoskeletal System - Normal (Week 26) | 314 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Central and Peripheral Nervous System - Abnormal NCS (Baseline) | 2 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Thyroid Gland - Abnormal NCS (Week 26) | 3 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Respiratory System - Abnormal NCS (Week 26) | 2 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (Week 26) | 3 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Central and Peripheral Nervous System - Abnormal CS (Baseline) | 4 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | General Appearance - Normal (Week 26) | 300 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Skin - Abnormal CS (Week 26) | 7 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Musculoskeletal System - Abnormal CS (Baseline) | 4 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Central and Peripheral Nervous System - Normal (Week 26) | 322 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Skin - Abnormal CS (Baseline) | 8 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Respiratory System -Abnormal NCS (Baseline) | 3 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Thyroid Gland - Abnormal CS (Week 26) | 2 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Central and Peripheral Nervous System - Abnormal NCS (Week 26) | 2 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Thyroid Gland - Normal (Week 26) | 322 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | General Appearance - Abnormal NCS (Baseline) | 25 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Musculoskeletal System - Abnormal NCS (Baseline) | 13 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Central and Peripheral Nervous System - Abnormal CS (Week 26) | 2 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Normal (Baseline) | 348 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Thyroid Gland - Normal (Baseline) | 356 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Cardiovascular system - Normal (Baseline) | 354 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Normal (Baseline) | 350 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | General Appearance - Abnormal CS (Baseline) | 7 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Musculoskeletal System - Normal (Baseline) | 344 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Lymph Node Palpation - Normal (Week 26) | 325 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Respiratory System - Normal (Baseline) | 355 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal NCS (Baseline) | 10 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Cardiovascular system - abnormal NCS (Baseline) | 5 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Skin - Abnormal NCS (Baseline) | 71 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Lymph Node Palpation - Abnormal CS (Week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal CS (Baseline) | 1 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Lymph Node Palpation - Normal (Baseline) | 361 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Respiratory System - Normal (Week 26) | 324 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Respiratory System - Abnormal CS (Week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Normal (Week 26) | 314 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (Baseline) | 9 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Thyroid Gland - Abnormal NCS (Baseline) | 4 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal NCS (Week 26) | 12 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Cardiovascular system - Abnormal CS (Baseline) | 2 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | General Appearance - Abnormal NCS (Week 26) | 21 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Lymph Node Palpation - Abnormal NCS (Week 26) | 1 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal CS (Week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Skin - Normal (Week 26) | 260 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Musculoskeletal System - Abnormal CS (Week 26) | 6 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | Cardiovascular system -Normal (Week 26) | 319 Participants |
| Oral Semaglutide 3 mg | Physical Examination Category | General Appearance - Normal (Baseline) | 329 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Cardiovascular system -Normal (Week 26) | 322 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Respiratory System - Abnormal CS (Baseline) | 0 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | General Appearance - Abnormal NCS (Baseline) | 27 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Lymph Node Palpation - Abnormal CS (Baseline) | 0 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | General Appearance - Abnormal CS (Baseline) | 6 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Thyroid Gland - Abnormal CS (Baseline) | 3 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | General Appearance - Normal (Week 26) | 295 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Skin - Normal (Week 26) | 263 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Lymph Node Palpation - Abnormal NCS (Baseline) | 5 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | General Appearance - Abnormal NCS (Week 26) | 27 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (Week 26) | 1 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | General Appearance - Abnormal CS (Week 26) | 4 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Lymph Node Palpation - Normal (Baseline) | 353 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Normal (Baseline) | 349 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Thyroid Gland - Normal (Week 26) | 319 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (Baseline) | 8 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Respiratory System - Abnormal CS (Week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (Baseline) | 0 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Respiratory System -Abnormal NCS (Baseline) | 3 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (Week 26) | 5 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Normal (Week 26) | 319 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Thyroid Gland - Abnormal NCS (Week 26) | 4 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Thyroid Gland - Abnormal CS (Week 26) | 3 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Skin - Abnormal CS (Baseline) | 11 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Respiratory System - Normal (Baseline) | 355 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Cardiovascular system - Normal (Baseline) | 353 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Skin - Normal (Baseline) | 282 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Cardiovascular system - abnormal NCS (Baseline) | 4 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Musculoskeletal System - Abnormal CS (Week 26) | 3 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Cardiovascular system - Abnormal CS (Baseline) | 1 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | General Appearance - Normal (Baseline) | 325 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Respiratory System - Abnormal NCS (Week 26) | 1 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Musculoskeletal System - Abnormal NCS (Week 26) | 4 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Cardiovascular system - Abnormal NCS (Week 26) | 2 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Cardiovascular system - Abnormal CS (Week 26) | 2 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Skin - Abnormal NCS (Week 26) | 52 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Musculoskeletal System - Normal (Week 26) | 319 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Central and Peripheral Nervous System - Normal (Baseline) | 351 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Central and Peripheral Nervous System - Abnormal NCS (Baseline) | 5 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Musculoskeletal System - Abnormal CS (Baseline) | 5 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Central and Peripheral Nervous System - Abnormal CS (Baseline) | 2 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Central and Peripheral Nervous System - Normal (Week 26) | 321 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Skin - Abnormal CS (Week 26) | 11 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Musculoskeletal System - Abnormal NCS (Baseline) | 8 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Central and Peripheral Nervous System - Abnormal NCS (Week 26) | 3 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Respiratory System - Normal (Week 26) | 325 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Central and Peripheral Nervous System - Abnormal CS (Week 26) | 2 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Musculoskeletal System - Normal (Baseline) | 345 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Normal (Baseline) | 343 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Thyroid Gland - Normal (Baseline) | 351 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Lymph Node Palpation - Abnormal CS (Week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal NCS (Baseline) | 14 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal CS (Baseline) | 1 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Lymph Node Palpation - Abnormal NCS (Week 26) | 3 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Normal (Week 26) | 315 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal NCS (Week 26) | 10 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Thyroid Gland - Abnormal NCS (Baseline) | 4 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal CS (Week 26) | 1 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Skin - Abnormal NCS (Baseline) | 65 Participants |
| Oral Semaglutide 7 mg | Physical Examination Category | Lymph Node Palpation - Normal (Week 26) | 323 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (Baseline) | 5 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Skin - Normal (Baseline) | 296 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Skin - Abnormal NCS (Baseline) | 54 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Skin - Abnormal CS (Baseline) | 11 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Skin - Normal (Week 26) | 256 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Skin - Abnormal NCS (Week 26) | 42 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Thyroid Gland - Normal (Baseline) | 358 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Thyroid Gland - Abnormal NCS (Baseline) | 1 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Thyroid Gland - Abnormal CS (Baseline) | 2 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Thyroid Gland - Normal (Week 26) | 304 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Thyroid Gland - Abnormal NCS (Week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Thyroid Gland - Abnormal CS (Week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Cardiovascular system - Normal (Baseline) | 355 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Cardiovascular system - abnormal NCS (Baseline) | 6 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Cardiovascular system - Abnormal CS (Baseline) | 0 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Cardiovascular system -Normal (Week 26) | 301 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Cardiovascular system - Abnormal NCS (Week 26) | 3 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Cardiovascular system - Abnormal CS (Week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Central and Peripheral Nervous System - Normal (Baseline) | 358 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Central and Peripheral Nervous System - Abnormal NCS (Baseline) | 3 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Central and Peripheral Nervous System - Abnormal CS (Baseline) | 0 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Central and Peripheral Nervous System - Normal (Week 26) | 302 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Central and Peripheral Nervous System - Abnormal NCS (Week 26) | 2 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Central and Peripheral Nervous System - Abnormal CS (Week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Normal (Baseline) | 353 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal NCS (Baseline) | 7 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal CS (Baseline) | 1 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Normal (Week 26) | 300 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal NCS (Week 26) | 4 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal CS (Week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | General Appearance - Normal (Baseline) | 328 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | General Appearance - Abnormal NCS (Baseline) | 21 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | General Appearance - Abnormal CS (Baseline) | 12 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | General Appearance - Normal (Week 26) | 280 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | General Appearance - Abnormal NCS (Week 26) | 19 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | General Appearance - Abnormal CS (Week 26) | 6 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Normal (Baseline) | 351 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Skin - Abnormal CS (Week 26) | 7 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (Baseline) | 4 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Normal (Week 26) | 297 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (Week 26) | 4 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (Week 26) | 2 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Lymph Node Palpation - Normal (Baseline) | 357 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Lymph Node Palpation - Abnormal NCS (Baseline) | 3 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Lymph Node Palpation - Abnormal CS (Baseline) | 1 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Lymph Node Palpation - Normal (Week 26) | 304 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Lymph Node Palpation - Abnormal NCS (Week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Lymph Node Palpation - Abnormal CS (Week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Musculoskeletal System - Normal (Baseline) | 351 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Musculoskeletal System - Abnormal NCS (Baseline) | 7 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Musculoskeletal System - Abnormal CS (Baseline) | 3 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Musculoskeletal System - Normal (Week 26) | 301 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Musculoskeletal System - Abnormal NCS (Week 26) | 2 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Musculoskeletal System - Abnormal CS (Week 26) | 2 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Respiratory System - Normal (Baseline) | 359 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Respiratory System -Abnormal NCS (Baseline) | 1 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Respiratory System - Abnormal CS (Baseline) | 1 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Respiratory System - Normal (Week 26) | 305 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Respiratory System - Abnormal NCS (Week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Physical Examination Category | Respiratory System - Abnormal CS (Week 26) | 0 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal CS (Week 26) | 2 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Skin - Abnormal NCS (Baseline) | 65 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Lymph Node Palpation - Normal (Week 26) | 341 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal NCS (Week 26) | 10 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal CS (Baseline) | 1 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Respiratory System - Abnormal CS (Baseline) | 0 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Lymph Node Palpation - Abnormal NCS (Week 26) | 0 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Abnormal NCS (Baseline) | 11 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Normal (Baseline) | 346 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Thyroid Gland - Normal (Baseline) | 350 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Lymph Node Palpation - Abnormal CS (Week 26) | 0 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Gastrointestinal System incl. Mouth - Normal (Week 26) | 329 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Central and Peripheral Nervous System - Abnormal CS (Week 26) | 0 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Skin - Abnormal CS (Week 26) | 14 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Musculoskeletal System - Normal (Baseline) | 352 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Central and Peripheral Nervous System - Abnormal NCS (Week 26) | 2 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Central and Peripheral Nervous System - Normal (Week 26) | 339 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Skin - Normal (Baseline) | 277 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Musculoskeletal System - Abnormal NCS (Baseline) | 4 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Central and Peripheral Nervous System - Abnormal CS (Baseline) | 0 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Central and Peripheral Nervous System - Abnormal NCS (Baseline) | 1 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Respiratory System - Normal (Week 26) | 341 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Musculoskeletal System - Abnormal CS (Baseline) | 2 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Central and Peripheral Nervous System - Normal (Baseline) | 357 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Cardiovascular system - Abnormal CS (Week 26) | 0 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Skin - Abnormal NCS (Week 26) | 60 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Musculoskeletal System - Normal (Week 26) | 335 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Cardiovascular system - Abnormal NCS (Week 26) | 2 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Cardiovascular system -Normal (Week 26) | 339 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Skin - Normal (Week 26) | 267 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Musculoskeletal System - Abnormal NCS (Week 26) | 3 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Cardiovascular system - Abnormal CS (Baseline) | 0 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Cardiovascular system - abnormal NCS (Baseline) | 2 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Respiratory System - Abnormal CS (Week 26) | 0 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Musculoskeletal System - Abnormal CS (Week 26) | 3 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Cardiovascular system - Normal (Baseline) | 356 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Thyroid Gland - Abnormal CS (Week 26) | 2 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Respiratory System - Abnormal NCS (Week 26) | 0 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Respiratory System - Normal (Baseline) | 357 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Thyroid Gland - Abnormal NCS (Week 26) | 2 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Normal (Week 26) | 330 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (Baseline) | 5 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Thyroid Gland - Normal (Week 26) | 337 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (Week 26) | 4 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (Baseline) | 6 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Skin - Abnormal CS (Baseline) | 16 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (Week 26) | 5 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Head, Ears, Eyes, Nose, Throat, Neck - Normal (Baseline) | 344 Participants |
| Sitagliptin 100 mg | Physical Examination Category | General Appearance - Abnormal CS (Week 26) | 7 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Respiratory System -Abnormal NCS (Baseline) | 1 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Lymph Node Palpation - Normal (Baseline) | 357 Participants |
| Sitagliptin 100 mg | Physical Examination Category | General Appearance - Abnormal NCS (Week 26) | 21 Participants |
| Sitagliptin 100 mg | Physical Examination Category | General Appearance - Normal (Week 26) | 313 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Thyroid Gland - Abnormal CS (Baseline) | 4 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Lymph Node Palpation - Abnormal NCS (Baseline) | 1 Participants |
| Sitagliptin 100 mg | Physical Examination Category | General Appearance - Abnormal CS (Baseline) | 8 Participants |
| Sitagliptin 100 mg | Physical Examination Category | General Appearance - Abnormal NCS (Baseline) | 22 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Thyroid Gland - Abnormal NCS (Baseline) | 4 Participants |
| Sitagliptin 100 mg | Physical Examination Category | Lymph Node Palpation - Abnormal CS (Baseline) | 0 Participants |
| Sitagliptin 100 mg | Physical Examination Category | General Appearance - Normal (Baseline) | 328 Participants |
Secondary
Time to Rescue Medication
Time to rescue medication is presented as the number of participants who had taken rescue medication anytime from baseline to week 31. 'Rescue medication': use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. 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 and 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 to week 31
Population: FAS included all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 3 mg | Time to Rescue Medication | 5 Participants |
| Oral Semaglutide 7 mg | Time to Rescue Medication | 6 Participants |
| Oral Semaglutide 14 mg | Time to Rescue Medication | 6 Participants |
| Sitagliptin 100 mg | Time to Rescue Medication | 7 Participants |