Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted globally. The aim of the trial is to investigate efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes.
Interventions
DRUGsemaglutide
Oral administration once-daily
DRUGsitagliptin
Oral administration once-daily
DRUGplacebo
Oral administration once-daily
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, age at least 18 years at the time of signing informed consent For Japan only: Male or female, age at least 20 years at the time of signing informed consent * Diagnosed with T2DM (type 2 diabetes mellitus) for at least 90 days prior to day of screening * HbA1c (glycosylated haemoglobin) 7.0-10.5 % (53-91 mmol/mol) (both inclusive). * Stable daily dose of metformin (equal or above 1500 mg or maximum tolerated dose as documented in subject medical record) alone or in combination with SU (= half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) within 90 days prior to the 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 adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). For certain specific countries: Additional specific requirements apply * Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC) * History of pancreatitis (acute or chronic) * History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) * Any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack within the past 180 days prior to the day of screening * Subjects presently classified as being in New York Heart Association (NYHA) Class IV. * Planned coronary, carotid or peripheral artery revascularisation known on the day of screening. * Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) * History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c: Week 26 | Week 0, week 26 | Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c: Weeks 52 and 78 | Week 0, week 52, week 78 | Change from baseline (week 0) in HbA1c was evaluated at weeks 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in Body Weight (kg): Weeks 52 and 78 | Week 0, week 52, week 78 | Change from baseline (week 0) in body weight was evaluated at weeks 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in Body Weight (%) | Week 0, week 26, week 52, week 78 | Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in FPG | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in BMI | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in Waist Circumference | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in waist circumference was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in Total Cholesterol (Ratio to Baseline) | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in total cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in LDL Cholesterol (Ratio to Baseline) | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in low-density lipoprotein (LDL) cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in VLDL Cholesterol (Ratio to Baseline) | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in very-low-density lipoprotein (VLDL) cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in HDL Cholesterol (Ratio to Baseline) | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in Triglycerides (Ratio to Baseline) | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in Free Fatty Acids (Ratio to Baseline) | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in free fatty acids (FFA) (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Because of an issue with the handling of the blood samples for FFA, all FFA data were considered invalid for this trial; thus, no conclusion with regards to FFA levels can be made based on the data presented here. |
| Change in SMPG - Mean 7-point Profile | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in mean 7-point self-measured plasma glucose (SMPG) profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in SMPG - Mean Postprandial Increment Over All Meals | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in the average of the post-prandial increments over all meals was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26, week 52, week 78 | Participants who achieved HbA1c \<7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 26, week 52, week 78 | Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at weeks 26, 52 and 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 26, week 52, week 78 | Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 26, 52 and 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 26, week 52, week 78 | Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at weeks 26, 52 and 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26, week 52, week 78 | Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26, 52 and 78 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26, week 52, week 78 | Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26, 52 and 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Time to Additional Anti-diabetic Medication | Weeks 0-78 | Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26, week 0 to week 52 and week 0 to week 78. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 78), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Time to Rescue Medication | Weeks 0-78 | Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26, week 0 to week 52 and week 0 to week 78. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation. |
| Number of TEAEs During Exposure to Trial Product | Weeks 0-83 | Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 83 (78-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in Amylase (Ratio to Baseline) | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in Lipase (Ratio to Baseline) | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in lipase (U/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in Pulse Rate | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in pulse rate was evaluated at weeks 26, 52 and 78. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in SBP and DBP | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at weeks 26, 52 and 78. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in ECG Evaluation | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26, 52 and 78. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in Physical Examination | Week -2, week 52, week 78 | Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2), weeks 52 and 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland. |
| Change in Eye Examination Category | Week -2, week 52, week 78 | Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2), week 52 and week 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Occurrence of Anti-semaglutide Binding Antibodies (Yes/no) | Weeks 0-83 | This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (weeks 0-83) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no) | Weeks 0-83 | This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (weeks 0-83) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no) | Weeks 0-83 | This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (weeks 0-83) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no) | Weeks 0-83 | This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (weeks 0-83) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Anti-semaglutide Binding Antibody Levels | Weeks 0-83 | This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-83). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | Weeks 0-83 | Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-83 (78-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. |
| Change in Body Weight: Week 26 | Week 0, week 26 | Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation. |
| Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Weeks 0-83 | This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Semaglutide plasma concentrations for participants in the pharmacokinetic (PK) subpopulation are presented. The PK subpopulation consisted of participants from sites in Germany, Japan and the United States receiving oral semaglutide (3 mg, 7 mg or 14 mg). Results are based on the data from the on-treatment observation period and follow-up period. The on-treatment observation period was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. |
| Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Week 0, week 26, week 52, week 78 | SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26, 52 and 78. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period. |
| Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | Week 0, week 26, week 52, week 78 | The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. The items of the IWQOL-Lite-CT pertain to physical functioning (physical, physical function and pain/discomfort) and psychosocial domains and all items employ a 5-point graded response scale (never, rarely, sometimes, usually, always; or not at all true, a little true, moderately true, mostly true, completely true). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in CoEQ: Scores From the 4 Domains and the 19 Items | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in Control of Eating Questionnaire (CoEQ) was evaluated at weeks (wk) 26, 52 and 78. The CoEQ comprised 19 items to assess the intensity and type of food cravings, as well as subjective sensation of appetite and mood, with the 4 domains: 'craving control' (items 9-12, 19), 'positive mood' (items 5-8), 'craving for savoury' (items 4, 16-18) and 'craving for sweet' (items 3, 13-15). The 19 items were scored on an 11-point graded response scale ranging from 10 to 0, with items relating to each of the 4 domains being averaged to create a final score. A low score in the domains 'craving for sweet and 'craving for savoury' represents a low level of craving; whereas a high score in the domains 'craving control' and 'positive mood' represents good control and a good mood, respectively. Results are based on the data from the in-trial observation period. |
| Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | Weeks 0-83 | Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 83 (78-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. |
Countries
Argentina, Brazil, France, Germany, India, Israel, Japan, Mexico, Romania, Russia, South Africa, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Recruitment details
The trial was conducted at 200 sites in 14 countries: Argentina-5, Brazil-1, France-10, Germany-12, Israel-8, Japan-16, Mexico-5, Romania-12, Russian Federation-8, South Africa-11, Turkey-7, Ukraine-8, United Kingdom (UK)-14, United States (US)-83. In addition, 6 sites screened, but didn't randomise any subjects: France-1, Turkey-1, UK-1 and US-3.
Pre-assignment details
Data presented in participant flow is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Participants by arm
| Arm | Count |
|---|---|
| Oral Semaglutide 3 mg Participants were to take oral semaglutide 3 mg tablets once daily from week 0 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78. | 466 |
| Oral Semaglutide 7 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78. | 465 |
| Oral Semaglutide 14 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 78: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 78. In addition, participants were to take sitagliptin placebo tablets once daily from week 0 to week 78. | 465 |
| Sitagliptin 100 mg Participants were to take sitagliptin 100 mg tablets once daily from week 0 to week 78. In addition, participants were to take oral semaglutide placebo tablets once daily from week 0 to week 78. | 467 |
| Total | 1,863 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 5 | 4 | 1 | 3 |
| Overall Study | Lost to Follow-up | 9 | 7 | 7 | 5 |
| Overall Study | Unclassified | 1 | 1 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 18 | 18 | 17 | 8 |
Baseline characteristics
| Characteristic | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Sitagliptin 100 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 10 | 58 years STANDARD_DEVIATION 10 | 57 years STANDARD_DEVIATION 10 | 58 years STANDARD_DEVIATION 10 | 58 years STANDARD_DEVIATION 10 |
| Glycosylated haemoglobin (HbA1c) | 8.3 Percentage of HbA1c STANDARD_DEVIATION 1 | 8.4 Percentage of HbA1c STANDARD_DEVIATION 1 | 8.3 Percentage of HbA1c STANDARD_DEVIATION 0.9 | 8.3 Percentage of HbA1c STANDARD_DEVIATION 0.9 | 8.3 Percentage of HbA1c STANDARD_DEVIATION 0.9 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Participants | 3 Participants | 5 Participants | 6 Participants | 18 Participants |
| Race/Ethnicity, Customized Asian | 56 Participants | 69 Participants | 61 Participants | 59 Participants | 245 Participants |
| Race/Ethnicity, Customized Black or African American | 38 Participants | 38 Participants | 45 Participants | 39 Participants | 160 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 76 Participants | 77 Participants | 75 Participants | 93 Participants | 321 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not applicable | 5 Participants | 14 Participants | 17 Participants | 18 Participants | 59 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 385 Participants | 378 Participants | 377 Participants | 366 Participants | 1506 Participants |
| Race/Ethnicity, Customized Other | 13 Participants | 11 Participants | 20 Participants | 12 Participants | 56 Participants |
| Race/Ethnicity, Customized White | 344 Participants | 330 Participants | 317 Participants | 333 Participants | 1324 Participants |
| Sex: Female, Male Female | 212 Participants | 220 Participants | 218 Participants | 229 Participants | 879 Participants |
| Sex: Female, Male Male | 254 Participants | 245 Participants | 247 Participants | 238 Participants | 984 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 | 5 / 466 | 4 / 464 | 1 / 465 | 3 / 466 |
| other Total, other adverse events | 222 / 466 | 234 / 464 | 232 / 465 | 239 / 466 |
| serious Total, serious adverse events | 64 / 466 | 47 / 464 | 44 / 465 | 58 / 466 |
Outcome results
Primary
Change in HbA1c: Week 26
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Time frame: Week 0, week 26
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in HbA1c: Week 26 | In-trial | -0.6 Percentage of HbA1c | Standard Deviation 1 |
| Oral Semaglutide 3 mg | Change in HbA1c: Week 26 | On-treatment without rescue medication | -0.6 Percentage of HbA1c | Standard Deviation 1 |
| Oral Semaglutide 7 mg | Change in HbA1c: Week 26 | On-treatment without rescue medication | -1.2 Percentage of HbA1c | Standard Deviation 1.1 |
| Oral Semaglutide 7 mg | Change in HbA1c: Week 26 | In-trial | -1.1 Percentage of HbA1c | Standard Deviation 1.1 |
| Oral Semaglutide 14 mg | Change in HbA1c: Week 26 | In-trial | -1.3 Percentage of HbA1c | Standard Deviation 1 |
| Oral Semaglutide 14 mg | Change in HbA1c: Week 26 | On-treatment without rescue medication | -1.4 Percentage of HbA1c | Standard Deviation 1 |
| Sitagliptin 100 mg | Change in HbA1c: Week 26 | In-trial | -0.8 Percentage of HbA1c | Standard Deviation 0.9 |
| Sitagliptin 100 mg | Change in HbA1c: Week 26 | On-treatment without rescue medication | -0.8 Percentage of HbA1c | Standard Deviation 0.9 |
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [-0.6, -0.4]Pattern mixture model
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [-0.6, -0.4]Pattern mixture model
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [-0.4, -0.1]Pattern mixture model
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [-0.4, -0.1]Pattern mixture model
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: =0.085695% CI: [0.1, 0.3]Pattern mixture model
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: =0.00895% CI: [0, 0.3]Pattern mixture model
Comparison: The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: <0.000195% CI: [-0.7, -0.5]MMRM
Comparison: The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: <0.000195% CI: [-0.7, -0.5]MMRM
Comparison: The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: <0.000195% CI: [-0.4, -0.2]MMRM
Comparison: The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: <0.000195% CI: [-0.4, -0.2]MMRM
Comparison: The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: =0.385195% CI: [0.1, 0.4]MMRM
Comparison: The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: <0.000195% CI: [0.1, 0.4]MMRM
Secondary
Anti-semaglutide Binding Antibody Levels
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-83). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Weeks 0-83
Population: Overall number of participants analysed = participants who were found positive for anti-semaglutide antibodies.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Anti-semaglutide Binding Antibody Levels | Week 8 | 1.93 %B/T | Standard Deviation 0 |
| Oral Semaglutide 7 mg | Anti-semaglutide Binding Antibody Levels | Week 14 | 3.28 %B/T | Standard Deviation 0 |
| Oral Semaglutide 7 mg | Anti-semaglutide Binding Antibody Levels | Week 26 | 2.39 %B/T | Standard Deviation 0 |
| Oral Semaglutide 14 mg | Anti-semaglutide Binding Antibody Levels | Week 4 | 9.82 %B/T | Standard Deviation 0 |
| Oral Semaglutide 14 mg | Anti-semaglutide Binding Antibody Levels | Week 26 | 2.05 %B/T | Standard Deviation 0 |
| Oral Semaglutide 14 mg | Anti-semaglutide Binding Antibody Levels | Week 38 | 2.24 %B/T | Standard Deviation 0 |
Secondary
Change in Amylase (Ratio to Baseline)
Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 26, week 52, week 78
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Amylase (Ratio to Baseline) | Week 26 | 1.03 Ratio | Geometric Coefficient of Variation 25.6 |
| Oral Semaglutide 3 mg | Change in Amylase (Ratio to Baseline) | Week 78 | 1.02 Ratio | Geometric Coefficient of Variation 28.4 |
| Oral Semaglutide 3 mg | Change in Amylase (Ratio to Baseline) | Week 52 | 1.03 Ratio | Geometric Coefficient of Variation 25.8 |
| Oral Semaglutide 7 mg | Change in Amylase (Ratio to Baseline) | Week 26 | 1.07 Ratio | Geometric Coefficient of Variation 27.5 |
| Oral Semaglutide 7 mg | Change in Amylase (Ratio to Baseline) | Week 78 | 1.09 Ratio | Geometric Coefficient of Variation 29.2 |
| Oral Semaglutide 7 mg | Change in Amylase (Ratio to Baseline) | Week 52 | 1.09 Ratio | Geometric Coefficient of Variation 28.8 |
| Oral Semaglutide 14 mg | Change in Amylase (Ratio to Baseline) | Week 52 | 1.11 Ratio | Geometric Coefficient of Variation 29 |
| Oral Semaglutide 14 mg | Change in Amylase (Ratio to Baseline) | Week 26 | 1.14 Ratio | Geometric Coefficient of Variation 30.4 |
| Oral Semaglutide 14 mg | Change in Amylase (Ratio to Baseline) | Week 78 | 1.09 Ratio | Geometric Coefficient of Variation 25.5 |
| Sitagliptin 100 mg | Change in Amylase (Ratio to Baseline) | Week 26 | 1.08 Ratio | Geometric Coefficient of Variation 21.4 |
| Sitagliptin 100 mg | Change in Amylase (Ratio to Baseline) | Week 78 | 1.08 Ratio | Geometric Coefficient of Variation 25.9 |
| Sitagliptin 100 mg | Change in Amylase (Ratio to Baseline) | Week 52 | 1.08 Ratio | Geometric Coefficient of Variation 24.1 |
Secondary
Change in BMI
Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in BMI | Week 26 | -0.4 Kg/m^2 | Standard Deviation 1.2 |
| Oral Semaglutide 3 mg | Change in BMI | Week 78 | -0.7 Kg/m^2 | Standard Deviation 1.8 |
| Oral Semaglutide 3 mg | Change in BMI | Week 52 | -0.6 Kg/m^2 | Standard Deviation 1.5 |
| Oral Semaglutide 7 mg | Change in BMI | Week 26 | -0.8 Kg/m^2 | Standard Deviation 1.4 |
| Oral Semaglutide 7 mg | Change in BMI | Week 78 | -1.0 Kg/m^2 | Standard Deviation 1.9 |
| Oral Semaglutide 7 mg | Change in BMI | Week 52 | -0.9 Kg/m^2 | Standard Deviation 1.7 |
| Oral Semaglutide 14 mg | Change in BMI | Week 52 | -1.2 Kg/m^2 | Standard Deviation 1.7 |
| Oral Semaglutide 14 mg | Change in BMI | Week 26 | -1.1 Kg/m^2 | Standard Deviation 1.4 |
| Oral Semaglutide 14 mg | Change in BMI | Week 78 | -1.1 Kg/m^2 | Standard Deviation 1.7 |
| Sitagliptin 100 mg | Change in BMI | Week 26 | -0.2 Kg/m^2 | Standard Deviation 1.1 |
| Sitagliptin 100 mg | Change in BMI | Week 78 | -0.4 Kg/m^2 | Standard Deviation 1.5 |
| Sitagliptin 100 mg | Change in BMI | Week 52 | -0.3 Kg/m^2 | Standard Deviation 1.3 |
Secondary
Change in Body Weight (%)
Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Body Weight (%) | Week 26 | -1.23 Percentage change | Standard Deviation 3.57 |
| Oral Semaglutide 3 mg | Change in Body Weight (%) | Week 78 | -1.87 Percentage change | Standard Deviation 4.87 |
| Oral Semaglutide 3 mg | Change in Body Weight (%) | Week 52 | -1.65 Percentage change | Standard Deviation 4.28 |
| Oral Semaglutide 7 mg | Change in Body Weight (%) | Week 26 | -2.36 Percentage change | Standard Deviation 4.09 |
| Oral Semaglutide 7 mg | Change in Body Weight (%) | Week 78 | -2.92 Percentage change | Standard Deviation 5.67 |
| Oral Semaglutide 7 mg | Change in Body Weight (%) | Week 52 | -2.63 Percentage change | Standard Deviation 5.09 |
| Oral Semaglutide 14 mg | Change in Body Weight (%) | Week 52 | -3.83 Percentage change | Standard Deviation 5.14 |
| Oral Semaglutide 14 mg | Change in Body Weight (%) | Week 26 | -3.44 Percentage change | Standard Deviation 4.21 |
| Oral Semaglutide 14 mg | Change in Body Weight (%) | Week 78 | -3.47 Percentage change | Standard Deviation 5.34 |
| Sitagliptin 100 mg | Change in Body Weight (%) | Week 26 | -0.64 Percentage change | Standard Deviation 3.38 |
| Sitagliptin 100 mg | Change in Body Weight (%) | Week 78 | -0.99 Percentage change | Standard Deviation 4.39 |
| Sitagliptin 100 mg | Change in Body Weight (%) | Week 52 | -0.76 Percentage change | Standard Deviation 3.91 |
Secondary
Change in Body Weight (kg): Weeks 52 and 78
Change from baseline (week 0) in body weight was evaluated at weeks 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Body Weight (kg): Weeks 52 and 78 | Week 52 | -1.6 Kg | Standard Deviation 4.1 |
| Oral Semaglutide 3 mg | Change in Body Weight (kg): Weeks 52 and 78 | Week 78 | -1.8 Kg | Standard Deviation 4.9 |
| Oral Semaglutide 7 mg | Change in Body Weight (kg): Weeks 52 and 78 | Week 78 | -2.8 Kg | Standard Deviation 5.4 |
| Oral Semaglutide 7 mg | Change in Body Weight (kg): Weeks 52 and 78 | Week 52 | -2.5 Kg | Standard Deviation 4.9 |
| Oral Semaglutide 14 mg | Change in Body Weight (kg): Weeks 52 and 78 | Week 52 | -3.5 Kg | Standard Deviation 4.7 |
| Oral Semaglutide 14 mg | Change in Body Weight (kg): Weeks 52 and 78 | Week 78 | -3.2 Kg | Standard Deviation 4.9 |
| Sitagliptin 100 mg | Change in Body Weight (kg): Weeks 52 and 78 | Week 52 | -0.7 Kg | Standard Deviation 3.7 |
| Sitagliptin 100 mg | Change in Body Weight (kg): Weeks 52 and 78 | Week 78 | -1.0 Kg | Standard Deviation 4.1 |
Secondary
Change in Body Weight: Week 26
Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Time frame: Week 0, week 26
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Body Weight: Week 26 | In-trial | -1.2 Kg | Standard Deviation 3.2 |
| Oral Semaglutide 3 mg | Change in Body Weight: Week 26 | on-treatment without rescue medication | -1.2 Kg | Standard Deviation 3.3 |
| Oral Semaglutide 7 mg | Change in Body Weight: Week 26 | on-treatment without rescue medication | -2.2 Kg | Standard Deviation 4 |
| Oral Semaglutide 7 mg | Change in Body Weight: Week 26 | In-trial | -2.2 Kg | Standard Deviation 3.9 |
| Oral Semaglutide 14 mg | Change in Body Weight: Week 26 | In-trial | -3.1 Kg | Standard Deviation 3.8 |
| Oral Semaglutide 14 mg | Change in Body Weight: Week 26 | on-treatment without rescue medication | -3.2 Kg | Standard Deviation 3.8 |
| Sitagliptin 100 mg | Change in Body Weight: Week 26 | In-trial | -0.6 Kg | Standard Deviation 3.2 |
| Sitagliptin 100 mg | Change in Body Weight: Week 26 | on-treatment without rescue medication | -0.6 Kg | Standard Deviation 3.2 |
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [-3, -2]Pattern mixture model
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [-2, -1.1]Pattern mixture model
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: =0.018595% CI: [-1.1, -0.1]Pattern mixture model
Comparison: The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: <0.000195% CI: [-3.1, -2.1]MMRM
Comparison: The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: <0.000195% CI: [-2, -1.1]MMRM
Comparison: The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: =0.025795% CI: [-1, -0.1]MMRM
Secondary
Change in CoEQ: Scores From the 4 Domains and the 19 Items
Change from baseline (week 0) in Control of Eating Questionnaire (CoEQ) was evaluated at weeks (wk) 26, 52 and 78. The CoEQ comprised 19 items to assess the intensity and type of food cravings, as well as subjective sensation of appetite and mood, with the 4 domains: 'craving control' (items 9-12, 19), 'positive mood' (items 5-8), 'craving for savoury' (items 4, 16-18) and 'craving for sweet' (items 3, 13-15). The 19 items were scored on an 11-point graded response scale ranging from 10 to 0, with items relating to each of the 4 domains being averaged to create a final score. A low score in the domains 'craving for sweet and 'craving for savoury' represents a low level of craving; whereas a high score in the domains 'craving control' and 'positive mood' represents good control and a good mood, respectively. Results are based on the data from the in-trial observation period.
Time frame: Week 0, week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 1) Feeling of hunger (wk 26) | -0.41 Score on a scale | Standard Deviation 2.61 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 12) Eating in response to food cravings (wk 78) | -0.02 Score on a scale | Standard Deviation 2.67 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for savoury: items 4, 16-18 (wk 52) | -0.41 Score on a scale | Standard Deviation 2.01 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 18) Cravings for savoury foods (wk 26) | -0.41 Score on a scale | Standard Deviation 2.74 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 13) Cravings for chocolate (wk 26) | -0.27 Score on a scale | Standard Deviation 2.69 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 4) Desire to eat savoury foods (wk 26) | -0.27 Score on a scale | Standard Deviation 2.48 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 13) Cravings for chocolate (wk 52) | -0.28 Score on a scale | Standard Deviation 2.58 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 17) Cravings for starchy foods (wk 78) | -0.44 Score on a scale | Standard Deviation 2.94 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 13) Cravings for chocolate (wk 78) | -0.08 Score on a scale | Standard Deviation 2.74 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 14) Cravings for other sweet foods (wk 26) | -0.33 Score on a scale | Standard Deviation 2.65 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for sweet: items 3, 13-15 (wk 78) | -0.20 Score on a scale | Standard Deviation 1.94 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 17) Cravings for starchy foods (wk 52) | -0.54 Score on a scale | Standard Deviation 2.86 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 14) Cravings for other sweet foods (wk 52) | -0.33 Score on a scale | Standard Deviation 2.79 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 17) Cravings for starchy foods (wk 26) | -0.42 Score on a scale | Standard Deviation 2.65 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 14) Cravings for other sweet foods (wk 78) | -0.20 Score on a scale | Standard Deviation 2.84 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 4) Desire to eat savoury foods (wk 52) | -0.27 Score on a scale | Standard Deviation 2.78 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 15) Cravings for fruit or fruit juice (wk 26) | -0.20 Score on a scale | Standard Deviation 3.05 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 16) Cravings for dairy foods (wk 78) | -0.30 Score on a scale | Standard Deviation 3 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 15) Cravings for fruit or fruit juice (wk 52) | -0.40 Score on a scale | Standard Deviation 2.99 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for sweet: items 3, 13-15 (wk 52) | -0.33 Score on a scale | Standard Deviation 1.97 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 15) Cravings for fruit or fruit juice (wk 78) | -0.14 Score on a scale | Standard Deviation 2.97 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for savoury: items 4, 16-18 (wk 26) | -0.33 Score on a scale | Standard Deviation 1.88 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 16) Cravings for dairy foods (wk 52) | -0.42 Score on a scale | Standard Deviation 2.96 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 16) Cravings for dairy foods (wk 26) | -0.23 Score on a scale | Standard Deviation 3.06 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 4) Desire to eat savoury foods (wk 78) | -0.39 Score on a scale | Standard Deviation 2.64 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 2) Feeling of fullness (wk 26) | -0.08 Score on a scale | Standard Deviation 2.66 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 5) Feeling of happiness (wk 26) | 0.01 Score on a scale | Standard Deviation 2.22 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Positive mood: items 5-8 (wk 78) | -0.01 Score on a scale | Standard Deviation 1.57 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 5) Feeling of happiness (wk 52) | 0.09 Score on a scale | Standard Deviation 2.25 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 1) Feeling of hunger (wk 52) | -0.28 Score on a scale | Standard Deviation 2.5 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 5) Feeling of happiness (wk 78) | -0.05 Score on a scale | Standard Deviation 2.32 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Positive mood: items 5-8 (wk 52) | 0.04 Score on a scale | Standard Deviation 1.5 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 6) Feeling of anxiousness (wk 26) | 0.02 Score on a scale | Standard Deviation 2.86 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 2) Feeling of fullness (wk 52) | -0.02 Score on a scale | Standard Deviation 2.61 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 6) Feeling of anxiousness (wk 52) | -0.05 Score on a scale | Standard Deviation 2.59 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Positive mood: items 5-8 (wk 26) | 0.04 Score on a scale | Standard Deviation 1.51 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 6) Feeling of anxiousness (wk 78) | 0.05 Score on a scale | Standard Deviation 2.69 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 7) Feeling of alertness (wk 26) | 0.11 Score on a scale | Standard Deviation 2.44 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for sweet: items 3, 13-15 (wk 26) | -0.30 Score on a scale | Standard Deviation 1.88 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving control: items 9-12, 19 (wk 78) | 0.22 Score on a scale | Standard Deviation 2.3 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 7) Feeling of alertness (wk 52) | 0.01 Score on a scale | Standard Deviation 2.52 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 2) Feeling of fullness (wk 78) | -0.03 Score on a scale | Standard Deviation 2.59 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 7) Feeling of alertness (wk 78) | 0.10 Score on a scale | Standard Deviation 2.43 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving control: items 9-12, 19 (wk 52) | 0.20 Score on a scale | Standard Deviation 2.2 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 8) Feeling of contentment (wk 26) | 0.05 Score on a scale | Standard Deviation 2.37 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 8) Feeling of contentment (wk 52) | 0.04 Score on a scale | Standard Deviation 2.35 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving control: items 9-12, 19 (wk 26) | 0.49 Score on a scale | Standard Deviation 2.13 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 8) Feeling of contentment (wk 78) | -0.04 Score on a scale | Standard Deviation 2.5 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 9) Food cravings during last 7 days (wk 26) | -0.59 Score on a scale | Standard Deviation 2.87 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 3) Desire to eat sweet foods (wk 26) | -0.41 Score on a scale | Standard Deviation 2.55 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 19) Difficulty to control eating in general(wk 78) | -0.40 Score on a scale | Standard Deviation 2.71 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 9) Food cravings during last 7 days (wk 52) | -0.40 Score on a scale | Standard Deviation 2.99 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 9) Food cravings during last 7 days (wk 78) | -0.47 Score on a scale | Standard Deviation 2.87 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 19) Difficulty to control eating in general(wk 52) | -0.32 Score on a scale | Standard Deviation 2.76 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 10) Strength of food cravings (wk 26) | -0.50 Score on a scale | Standard Deviation 2.75 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for savoury: items 4, 16-18 (wk 78) | -0.35 Score on a scale | Standard Deviation 2.06 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 10) Strength of food cravings (wk 52) | -0.23 Score on a scale | Standard Deviation 2.84 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 3) Desire to eat sweet foods (wk 52) | -0.31 Score on a scale | Standard Deviation 2.74 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 19) Difficulty to control eating in general(wk 26) | -0.47 Score on a scale | Standard Deviation 2.68 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 10) Strength of food cravings (wk 78) | -0.20 Score on a scale | Standard Deviation 2.89 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 11) Difficulty to resist food cravings (wk 26) | -0.46 Score on a scale | Standard Deviation 2.74 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 1) Feeling of hunger (wk 78) | -0.31 Score on a scale | Standard Deviation 2.56 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 18) Cravings for savoury foods (wk 78) | -0.27 Score on a scale | Standard Deviation 2.88 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 11) Difficulty to resist food cravings (wk 52) | 0.00 Score on a scale | Standard Deviation 2.79 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 11) Difficulty to resist food cravings (wk 78) | -0.04 Score on a scale | Standard Deviation 3.02 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 3) Desire to eat sweet foods (wk 78) | -0.38 Score on a scale | Standard Deviation 2.51 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 12) Eating in response to food cravings (wk 26) | -0.40 Score on a scale | Standard Deviation 2.49 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 18) Cravings for savoury foods (wk 52) | -0.41 Score on a scale | Standard Deviation 2.85 |
| Oral Semaglutide 3 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 12) Eating in response to food cravings (wk 52) | -0.04 Score on a scale | Standard Deviation 2.55 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 9) Food cravings during last 7 days (wk 78) | -0.28 Score on a scale | Standard Deviation 2.9 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 18) Cravings for savoury foods (wk 26) | -0.16 Score on a scale | Standard Deviation 2.69 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 6) Feeling of anxiousness (wk 78) | 0.12 Score on a scale | Standard Deviation 3.22 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 12) Eating in response to food cravings (wk 78) | 0.01 Score on a scale | Standard Deviation 2.76 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 1) Feeling of hunger (wk 52) | -0.23 Score on a scale | Standard Deviation 2.69 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving control: items 9-12, 19 (wk 78) | 0.29 Score on a scale | Standard Deviation 2.35 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for sweet: items 3, 13-15 (wk 52) | -0.15 Score on a scale | Standard Deviation 2.17 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 13) Cravings for chocolate (wk 26) | -0.03 Score on a scale | Standard Deviation 2.93 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 7) Feeling of alertness (wk 26) | 0.03 Score on a scale | Standard Deviation 2.61 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 17) Cravings for starchy foods (wk 78) | -0.32 Score on a scale | Standard Deviation 2.76 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 3) Desire to eat sweet foods (wk 78) | -0.42 Score on a scale | Standard Deviation 3.02 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 13) Cravings for chocolate (wk 52) | 0.03 Score on a scale | Standard Deviation 2.93 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 4) Desire to eat savoury foods (wk 26) | -0.16 Score on a scale | Standard Deviation 2.88 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for sweet: items 3, 13-15 (wk 78) | -0.16 Score on a scale | Standard Deviation 2.22 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 10) Strength of food cravings (wk 26) | -0.33 Score on a scale | Standard Deviation 2.93 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 13) Cravings for chocolate (wk 78) | 0.00 Score on a scale | Standard Deviation 2.87 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 1) Feeling of hunger (wk 78) | -0.22 Score on a scale | Standard Deviation 2.73 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 17) Cravings for starchy foods (wk 52) | -0.35 Score on a scale | Standard Deviation 2.68 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 7) Feeling of alertness (wk 52) | -0.14 Score on a scale | Standard Deviation 2.87 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 14) Cravings for other sweet foods (wk 26) | -0.31 Score on a scale | Standard Deviation 2.91 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 12) Eating in response to food cravings (wk 52) | -0.11 Score on a scale | Standard Deviation 2.85 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving control: items 9-12, 19 (wk 52) | 0.27 Score on a scale | Standard Deviation 2.26 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 19) Difficulty to control eating in general(wk 26) | -0.69 Score on a scale | Standard Deviation 2.77 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 17) Cravings for starchy foods (wk 26) | -0.24 Score on a scale | Standard Deviation 2.56 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 14) Cravings for other sweet foods (wk 52) | -0.34 Score on a scale | Standard Deviation 2.93 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for savoury: items 4, 16-18 (wk 26) | -0.19 Score on a scale | Standard Deviation 1.94 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 7) Feeling of alertness (wk 78) | -0.04 Score on a scale | Standard Deviation 2.69 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 2) Feeling of fullness (wk 78) | -0.09 Score on a scale | Standard Deviation 2.71 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 14) Cravings for other sweet foods (wk 78) | -0.14 Score on a scale | Standard Deviation 3.01 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 11) Difficulty to resist food cravings (wk 52) | -0.23 Score on a scale | Standard Deviation 3.04 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 16) Cravings for dairy foods (wk 78) | -0.20 Score on a scale | Standard Deviation 2.95 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 10) Strength of food cravings (wk 52) | -0.14 Score on a scale | Standard Deviation 2.9 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 15) Cravings for fruit or fruit juice (wk 26) | -0.03 Score on a scale | Standard Deviation 3.27 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 4) Desire to eat savoury foods (wk 52) | -0.21 Score on a scale | Standard Deviation 2.8 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 8) Feeling of contentment (wk 26) | 0.04 Score on a scale | Standard Deviation 2.38 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 1) Feeling of hunger (wk 26) | -0.37 Score on a scale | Standard Deviation 2.58 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 15) Cravings for fruit or fruit juice (wk 52) | -0.01 Score on a scale | Standard Deviation 3.34 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving control: items 9-12, 19 (wk 26) | 0.39 Score on a scale | Standard Deviation 2.18 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 16) Cravings for dairy foods (wk 52) | -0.30 Score on a scale | Standard Deviation 2.97 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for savoury: items 4, 16-18 (wk 52) | -0.27 Score on a scale | Standard Deviation 1.95 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 15) Cravings for fruit or fruit juice (wk 78) | -0.11 Score on a scale | Standard Deviation 3.51 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 8) Feeling of contentment (wk 52) | 0.08 Score on a scale | Standard Deviation 2.48 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 18) Cravings for savoury foods (wk 52) | -0.20 Score on a scale | Standard Deviation 2.82 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 12) Eating in response to food cravings (wk 26) | -0.15 Score on a scale | Standard Deviation 2.78 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 16) Cravings for dairy foods (wk 26) | -0.20 Score on a scale | Standard Deviation 2.9 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 8) Feeling of contentment (wk 78) | -0.03 Score on a scale | Standard Deviation 2.41 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 4) Desire to eat savoury foods (wk 78) | -0.39 Score on a scale | Standard Deviation 2.95 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for savoury: items 4, 16-18 (wk 78) | -0.26 Score on a scale | Standard Deviation 2.12 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Positive mood: items 5-8 (wk 78) | -0.07 Score on a scale | Standard Deviation 1.52 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 19) Difficulty to control eating in general(wk 78) | -0.59 Score on a scale | Standard Deviation 2.88 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 5) Feeling of happiness (wk 26) | 0.03 Score on a scale | Standard Deviation 2.11 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 2) Feeling of fullness (wk 26) | -0.08 Score on a scale | Standard Deviation 2.77 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 10) Strength of food cravings (wk 78) | -0.28 Score on a scale | Standard Deviation 2.99 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 9) Food cravings during last 7 days (wk 26) | -0.41 Score on a scale | Standard Deviation 2.94 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 5) Feeling of happiness (wk 52) | 0.04 Score on a scale | Standard Deviation 2.21 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 3) Desire to eat sweet foods (wk 52) | -0.31 Score on a scale | Standard Deviation 2.97 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Positive mood: items 5-8 (wk 52) | 0.03 Score on a scale | Standard Deviation 1.54 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 18) Cravings for savoury foods (wk 78) | -0.16 Score on a scale | Standard Deviation 2.87 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 5) Feeling of happiness (wk 78) | -0.08 Score on a scale | Standard Deviation 2.21 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for sweet: items 3, 13-15 (wk 26) | -0.23 Score on a scale | Standard Deviation 2.12 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 11) Difficulty to resist food cravings (wk 78) | -0.32 Score on a scale | Standard Deviation 3.2 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 9) Food cravings during last 7 days (wk 52) | -0.30 Score on a scale | Standard Deviation 2.96 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 6) Feeling of anxiousness (wk 26) | -0.18 Score on a scale | Standard Deviation 2.96 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 3) Desire to eat sweet foods (wk 26) | -0.54 Score on a scale | Standard Deviation 3.02 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Positive mood: items 5-8 (wk 26) | 0.07 Score on a scale | Standard Deviation 1.43 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 19) Difficulty to control eating in general(wk 52) | -0.59 Score on a scale | Standard Deviation 2.86 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 6) Feeling of anxiousness (wk 52) | -0.16 Score on a scale | Standard Deviation 2.97 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 2) Feeling of fullness (wk 52) | -0.07 Score on a scale | Standard Deviation 2.64 |
| Oral Semaglutide 7 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 11) Difficulty to resist food cravings (wk 26) | -0.38 Score on a scale | Standard Deviation 3.02 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 3) Desire to eat sweet foods (wk 78) | -0.45 Score on a scale | Standard Deviation 2.97 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 1) Feeling of hunger (wk 26) | -0.54 Score on a scale | Standard Deviation 2.58 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 1) Feeling of hunger (wk 52) | -0.35 Score on a scale | Standard Deviation 2.65 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 1) Feeling of hunger (wk 78) | -0.36 Score on a scale | Standard Deviation 2.52 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 2) Feeling of fullness (wk 26) | 0.15 Score on a scale | Standard Deviation 2.66 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 2) Feeling of fullness (wk 52) | 0.22 Score on a scale | Standard Deviation 2.68 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 2) Feeling of fullness (wk 78) | 0.09 Score on a scale | Standard Deviation 2.74 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 3) Desire to eat sweet foods (wk 26) | -0.47 Score on a scale | Standard Deviation 2.98 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 3) Desire to eat sweet foods (wk 52) | -0.31 Score on a scale | Standard Deviation 3.02 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 4) Desire to eat savoury foods (wk 26) | -0.30 Score on a scale | Standard Deviation 3.03 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 8) Feeling of contentment (wk 52) | 0.13 Score on a scale | Standard Deviation 2.4 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 4) Desire to eat savoury foods (wk 52) | -0.44 Score on a scale | Standard Deviation 2.94 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 4) Desire to eat savoury foods (wk 78) | -0.39 Score on a scale | Standard Deviation 2.8 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 5) Feeling of happiness (wk 26) | 0.04 Score on a scale | Standard Deviation 2.22 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 5) Feeling of happiness (wk 52) | 0.09 Score on a scale | Standard Deviation 2.15 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 5) Feeling of happiness (wk 78) | 0.04 Score on a scale | Standard Deviation 2.27 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 6) Feeling of anxiousness (wk 26) | 0.20 Score on a scale | Standard Deviation 3.22 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 6) Feeling of anxiousness (wk 52) | -0.06 Score on a scale | Standard Deviation 3.02 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 6) Feeling of anxiousness (wk 78) | -0.12 Score on a scale | Standard Deviation 2.88 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 7) Feeling of alertness (wk 26) | -0.06 Score on a scale | Standard Deviation 2.49 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 7) Feeling of alertness (wk 52) | -0.05 Score on a scale | Standard Deviation 2.5 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 7) Feeling of alertness (wk 78) | 0.04 Score on a scale | Standard Deviation 2.48 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 8) Feeling of contentment (wk 26) | 0.18 Score on a scale | Standard Deviation 2.37 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 8) Feeling of contentment (wk 78) | 0.17 Score on a scale | Standard Deviation 2.38 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 9) Food cravings during last 7 days (wk 26) | -0.37 Score on a scale | Standard Deviation 2.69 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 9) Food cravings during last 7 days (wk 52) | -0.25 Score on a scale | Standard Deviation 2.86 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 9) Food cravings during last 7 days (wk 78) | -0.38 Score on a scale | Standard Deviation 2.91 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 10) Strength of food cravings (wk 26) | -0.25 Score on a scale | Standard Deviation 2.79 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 10) Strength of food cravings (wk 52) | -0.21 Score on a scale | Standard Deviation 2.74 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 10) Strength of food cravings (wk 78) | -0.32 Score on a scale | Standard Deviation 2.85 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 11) Difficulty to resist food cravings (wk 26) | -0.46 Score on a scale | Standard Deviation 3.04 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 11) Difficulty to resist food cravings (wk 52) | -0.42 Score on a scale | Standard Deviation 3.16 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 11) Difficulty to resist food cravings (wk 78) | -0.24 Score on a scale | Standard Deviation 3.14 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 12) Eating in response to food cravings (wk 26) | -0.17 Score on a scale | Standard Deviation 2.78 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 12) Eating in response to food cravings (wk 52) | -0.25 Score on a scale | Standard Deviation 2.73 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 12) Eating in response to food cravings (wk 78) | -0.17 Score on a scale | Standard Deviation 2.96 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 13) Cravings for chocolate (wk 26) | -0.14 Score on a scale | Standard Deviation 2.94 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 13) Cravings for chocolate (wk 52) | 0.06 Score on a scale | Standard Deviation 2.87 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 13) Cravings for chocolate (wk 78) | 0.06 Score on a scale | Standard Deviation 3.01 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 14) Cravings for other sweet foods (wk 26) | -0.36 Score on a scale | Standard Deviation 2.82 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 14) Cravings for other sweet foods (wk 52) | -0.31 Score on a scale | Standard Deviation 2.96 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 14) Cravings for other sweet foods (wk 78) | -0.40 Score on a scale | Standard Deviation 2.93 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 15) Cravings for fruit or fruit juice (wk 26) | -0.09 Score on a scale | Standard Deviation 3.04 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 15) Cravings for fruit or fruit juice (wk 52) | -0.22 Score on a scale | Standard Deviation 3.07 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 15) Cravings for fruit or fruit juice (wk 78) | -0.02 Score on a scale | Standard Deviation 3.12 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 16) Cravings for dairy foods (wk 26) | -0.37 Score on a scale | Standard Deviation 3.02 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 16) Cravings for dairy foods (wk 52) | -0.41 Score on a scale | Standard Deviation 2.86 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 16) Cravings for dairy foods (wk 78) | -0.45 Score on a scale | Standard Deviation 2.86 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 17) Cravings for starchy foods (wk 26) | -0.49 Score on a scale | Standard Deviation 2.75 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 17) Cravings for starchy foods (wk 52) | -0.62 Score on a scale | Standard Deviation 2.8 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 17) Cravings for starchy foods (wk 78) | -0.61 Score on a scale | Standard Deviation 2.86 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 18) Cravings for savoury foods (wk 26) | -0.49 Score on a scale | Standard Deviation 2.85 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 18) Cravings for savoury foods (wk 52) | -0.56 Score on a scale | Standard Deviation 2.72 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 18) Cravings for savoury foods (wk 78) | -0.48 Score on a scale | Standard Deviation 2.95 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 19) Difficulty to control eating in general(wk 26) | -0.49 Score on a scale | Standard Deviation 2.69 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 19) Difficulty to control eating in general(wk 52) | -0.56 Score on a scale | Standard Deviation 2.75 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 19) Difficulty to control eating in general(wk 78) | -0.54 Score on a scale | Standard Deviation 2.71 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving control: items 9-12, 19 (wk 26) | 0.35 Score on a scale | Standard Deviation 2.16 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving control: items 9-12, 19 (wk 52) | 0.34 Score on a scale | Standard Deviation 2.21 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving control: items 9-12, 19 (wk 78) | 0.33 Score on a scale | Standard Deviation 2.29 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Positive mood: items 5-8 (wk 26) | -0.01 Score on a scale | Standard Deviation 1.61 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Positive mood: items 5-8 (wk 52) | 0.05 Score on a scale | Standard Deviation 1.6 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Positive mood: items 5-8 (wk 78) | 0.09 Score on a scale | Standard Deviation 1.55 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for savoury: items 4, 16-18 (wk 26) | -0.41 Score on a scale | Standard Deviation 2.07 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for savoury: items 4, 16-18 (wk 52) | -0.51 Score on a scale | Standard Deviation 2.11 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for savoury: items 4, 16-18 (wk 78) | -0.48 Score on a scale | Standard Deviation 2.08 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for sweet: items 3, 13-15 (wk 26) | -0.26 Score on a scale | Standard Deviation 2.1 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for sweet: items 3, 13-15 (wk 52) | -0.19 Score on a scale | Standard Deviation 2.19 |
| Oral Semaglutide 14 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for sweet: items 3, 13-15 (wk 78) | -0.20 Score on a scale | Standard Deviation 2.2 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 18) Cravings for savoury foods (wk 26) | -0.40 Score on a scale | Standard Deviation 2.7 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 12) Eating in response to food cravings (wk 26) | -0.27 Score on a scale | Standard Deviation 2.64 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 11) Difficulty to resist food cravings (wk 78) | -0.22 Score on a scale | Standard Deviation 2.96 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 11) Difficulty to resist food cravings (wk 52) | -0.26 Score on a scale | Standard Deviation 3.04 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for sweet: items 3, 13-15 (wk 78) | -0.24 Score on a scale | Standard Deviation 2.06 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 18) Cravings for savoury foods (wk 52) | -0.37 Score on a scale | Standard Deviation 2.73 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 11) Difficulty to resist food cravings (wk 26) | -0.17 Score on a scale | Standard Deviation 2.84 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 10) Strength of food cravings (wk 78) | -0.38 Score on a scale | Standard Deviation 2.79 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for savoury: items 4, 16-18 (wk 52) | -0.24 Score on a scale | Standard Deviation 1.88 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 18) Cravings for savoury foods (wk 78) | -0.34 Score on a scale | Standard Deviation 2.6 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 10) Strength of food cravings (wk 52) | -0.30 Score on a scale | Standard Deviation 2.77 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 10) Strength of food cravings (wk 26) | -0.35 Score on a scale | Standard Deviation 2.77 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 3) Desire to eat sweet foods (wk 26) | -0.33 Score on a scale | Standard Deviation 2.92 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 19) Difficulty to control eating in general(wk 26) | -0.51 Score on a scale | Standard Deviation 2.7 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 9) Food cravings during last 7 days (wk 78) | -0.33 Score on a scale | Standard Deviation 3.05 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 9) Food cravings during last 7 days (wk 52) | -0.21 Score on a scale | Standard Deviation 3.09 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 2) Feeling of fullness (wk 78) | 0.26 Score on a scale | Standard Deviation 2.59 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 19) Difficulty to control eating in general(wk 52) | -0.51 Score on a scale | Standard Deviation 2.73 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 9) Food cravings during last 7 days (wk 26) | -0.46 Score on a scale | Standard Deviation 2.85 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 8) Feeling of contentment (wk 78) | 0.17 Score on a scale | Standard Deviation 2.39 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for sweet: items 3, 13-15 (wk 52) | -0.15 Score on a scale | Standard Deviation 2.06 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 19) Difficulty to control eating in general(wk 78) | -0.51 Score on a scale | Standard Deviation 2.81 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 8) Feeling of contentment (wk 52) | 0.20 Score on a scale | Standard Deviation 2.29 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 8) Feeling of contentment (wk 26) | 0.18 Score on a scale | Standard Deviation 2.14 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for savoury: items 4, 16-18 (wk 78) | -0.33 Score on a scale | Standard Deviation 1.93 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving control: items 9-12, 19 (wk 26) | 0.35 Score on a scale | Standard Deviation 2.1 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 7) Feeling of alertness (wk 78) | -0.01 Score on a scale | Standard Deviation 2.64 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 7) Feeling of alertness (wk 52) | -0.05 Score on a scale | Standard Deviation 2.56 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 2) Feeling of fullness (wk 52) | 0.27 Score on a scale | Standard Deviation 2.67 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving control: items 9-12, 19 (wk 52) | 0.29 Score on a scale | Standard Deviation 2.18 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 7) Feeling of alertness (wk 26) | 0.05 Score on a scale | Standard Deviation 2.51 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 6) Feeling of anxiousness (wk 78) | -0.01 Score on a scale | Standard Deviation 3.21 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 2) Feeling of fullness (wk 26) | 0.15 Score on a scale | Standard Deviation 2.45 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving control: items 9-12, 19 (wk 78) | 0.34 Score on a scale | Standard Deviation 2.19 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 6) Feeling of anxiousness (wk 52) | 0.17 Score on a scale | Standard Deviation 3.14 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 6) Feeling of anxiousness (wk 26) | -0.21 Score on a scale | Standard Deviation 2.96 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 1) Feeling of hunger (wk 26) | -0.18 Score on a scale | Standard Deviation 2.49 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Positive mood: items 5-8 (wk 26) | 0.15 Score on a scale | Standard Deviation 1.47 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 5) Feeling of happiness (wk 78) | 0.02 Score on a scale | Standard Deviation 2.47 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 5) Feeling of happiness (wk 52) | 0.14 Score on a scale | Standard Deviation 2.16 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for sweet: items 3, 13-15 (wk 26) | -0.22 Score on a scale | Standard Deviation 2.01 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Positive mood: items 5-8 (wk 52) | 0.03 Score on a scale | Standard Deviation 1.57 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 5) Feeling of happiness (wk 26) | 0.13 Score on a scale | Standard Deviation 2.21 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 4) Desire to eat savoury foods (wk 78) | -0.42 Score on a scale | Standard Deviation 2.81 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 1) Feeling of hunger (wk 78) | -0.22 Score on a scale | Standard Deviation 2.55 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Positive mood: items 5-8 (wk 78) | 0.05 Score on a scale | Standard Deviation 1.74 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 16) Cravings for dairy foods (wk 26) | -0.27 Score on a scale | Standard Deviation 2.83 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 15) Cravings for fruit or fruit juice (wk 78) | -0.33 Score on a scale | Standard Deviation 2.88 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 15) Cravings for fruit or fruit juice (wk 52) | -0.08 Score on a scale | Standard Deviation 3.02 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 4) Desire to eat savoury foods (wk 52) | -0.33 Score on a scale | Standard Deviation 2.7 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 16) Cravings for dairy foods (wk 52) | 0.04 Score on a scale | Standard Deviation 2.89 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 15) Cravings for fruit or fruit juice (wk 26) | -0.07 Score on a scale | Standard Deviation 3.09 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 14) Cravings for other sweet foods (wk 78) | -0.22 Score on a scale | Standard Deviation 2.87 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 4) Desire to eat savoury foods (wk 26) | -0.35 Score on a scale | Standard Deviation 2.74 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 14) Cravings for other sweet foods (wk 52) | -0.09 Score on a scale | Standard Deviation 2.9 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 16) Cravings for dairy foods (wk 78) | -0.20 Score on a scale | Standard Deviation 2.81 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 1) Feeling of hunger (wk 52) | -0.25 Score on a scale | Standard Deviation 2.39 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 17) Cravings for starchy foods (wk 26) | -0.42 Score on a scale | Standard Deviation 2.86 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 14) Cravings for other sweet foods (wk 26) | -0.33 Score on a scale | Standard Deviation 2.82 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 13) Cravings for chocolate (wk 78) | 0.06 Score on a scale | Standard Deviation 3.04 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | Craving for savoury: items 4, 16-18 (wk 26) | -0.36 Score on a scale | Standard Deviation 1.89 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 17) Cravings for starchy foods (wk 52) | -0.28 Score on a scale | Standard Deviation 2.68 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 13) Cravings for chocolate (wk 52) | 0.03 Score on a scale | Standard Deviation 2.85 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 13) Cravings for chocolate (wk 26) | -0.15 Score on a scale | Standard Deviation 2.78 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 3) Desire to eat sweet foods (wk 78) | -0.49 Score on a scale | Standard Deviation 2.84 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 17) Cravings for starchy foods (wk 78) | -0.36 Score on a scale | Standard Deviation 2.72 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 12) Eating in response to food cravings (wk 78) | -0.25 Score on a scale | Standard Deviation 2.73 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 12) Eating in response to food cravings (wk 52) | -0.17 Score on a scale | Standard Deviation 2.75 |
| Sitagliptin 100 mg | Change in CoEQ: Scores From the 4 Domains and the 19 Items | 3) Desire to eat sweet foods (wk 52) | -0.45 Score on a scale | Standard Deviation 2.75 |
Secondary
Change in ECG Evaluation
Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26, 52 and 78. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 26, week 52, week 78
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 26) | 211 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal NCS (week 26) | 3 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal CS (week 52) | 4 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 26) | 4 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal CS (week 52) | 4 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal CS (week 26) | 4 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal NCS (week 26) | 132 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal NCS (week 78) | 4 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal CS (week 78) | 5 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 52) | 196 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 78) | 196 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal NCS (week 52) | 3 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal CS (week 26) | 4 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 52) | 47 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 78) | 3 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) CS to normal (week 52) | 1 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal NCS (week 78) | 131 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 52) | 1 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) CS to normal (week 78) | 0 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to normal (week 26) | 41 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) CS to normal (week 26) | 1 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to normal (week 52) | 40 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 78) | 41 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal CS (week 78) | 4 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to normal (week 78) | 39 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal NCS (week 52) | 131 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 26) | 38 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal NCS (week 52) | 123 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 78) | 2 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal CS (week 52) | 1 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) CS to normal (week 52) | 1 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 78) | 43 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal NCS (week 52) | 3 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal NCS (week 26) | 128 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal CS (week 52) | 1 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 26) | 42 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 78) | 201 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) CS to normal (week 78) | 3 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal CS (week 26) | 1 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 26) | 214 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) CS to normal (week 26) | 1 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal NCS (week 26) | 2 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal CS (week 78) | 1 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal CS (week 26) | 2 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 26) | 5 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 52) | 218 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal CS (week 78) | 1 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal NCS (week 78) | 125 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 52) | 37 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal NCS (week 78) | 2 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 52) | 0 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to normal (week 78) | 45 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to normal (week 52) | 49 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to normal (week 26) | 44 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal CS (week 78) | 3 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 26) | 230 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 26) | 24 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to normal (week 26) | 42 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal NCS (week 26) | 133 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal CS (week 26) | 1 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) CS to normal (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal NCS (week 26) | 3 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal CS (week 26) | 6 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 52) | 219 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 52) | 33 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 52) | 1 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to normal (week 52) | 56 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal NCS (week 52) | 118 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal CS (week 52) | 0 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) CS to normal (week 52) | 2 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal NCS (week 52) | 0 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal CS (week 52) | 7 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 78) | 219 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 78) | 31 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 78) | 1 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to normal (week 78) | 51 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal NCS (week 78) | 114 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) CS to normal (week 78) | 1 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal NCS (week 78) | 3 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal CS (week 78) | 5 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal NCS (week 52) | 128 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal CS (week 78) | 4 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 78) | 1 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to normal (week 52) | 48 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 52) | 4 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal NCS (week 78) | 2 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to normal (week 78) | 47 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 52) | 40 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 52) | 204 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 26) | 41 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal NCS (week 78) | 133 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal CS (week 26) | 4 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal NCS (week 26) | 2 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Abnormal (week 0) CS to normal (week 26) | 3 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal CS (week 78) | 2 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal CS (week 26) | 3 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal NCS (week 26) | 143 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 26) | 204 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Abnormal (week 0) CS to normal (week 78) | 3 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal CS (week 52) | 6 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to normal (week 26) | 40 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 78) | 208 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal NCS (week 52) | 2 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Abnormal (week 0) CS to normal (week 52) | 1 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 26) | 4 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 78) | 40 Participants |
| Sitagliptin 100 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal CS (week 52) | 2 Participants |
Secondary
Change in Eye Examination Category
Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2), week 52 and week 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week -2, week 52, week 78
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal NCS | 130 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week -2) | Normal | 309 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week 78) | Abnormal CS | 21 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal CS | 25 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week -2) | Normal | 302 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week 78) | Abnormal NCS | 135 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week 78) | Normal | 261 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week 78) | Normal | 258 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal CS | 24 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal CS | 27 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week 78) | Abnormal CS | 23 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal NCS | 122 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week 52) | Normal | 247 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week 52) | Normal | 249 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week 78) | Abnormal NCS | 136 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal CS | 24 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal NCS | 126 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal NCS | 119 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal NCS | 113 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week -2) | Normal | 299 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal NCS | 138 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal CS | 18 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week 52) | Normal | 253 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week 78) | Abnormal CS | 14 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal CS | 22 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week 78) | Normal | 255 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week 78) | Abnormal NCS | 141 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week 78) | Abnormal CS | 19 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week -2) | Normal | 298 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal NCS | 139 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal CS | 17 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week 52) | Normal | 256 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal NCS | 112 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal CS | 20 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week 78) | Normal | 255 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week 78) | Abnormal NCS | 146 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal NCS | 101 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal NCS | 103 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal CS | 23 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal NCS | 126 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week -2) | Normal | 305 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal CS | 17 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week -2) | Normal | 308 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week 78) | Abnormal NCS | 128 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal NCS | 129 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week 78) | Normal | 273 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week 52) | Normal | 271 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal CS | 20 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week 78) | Abnormal CS | 17 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week 78) | Abnormal NCS | 130 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week 52) | Normal | 270 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal CS | 23 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week 78) | Normal | 275 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week 78) | Abnormal CS | 17 Participants |
| Sitagliptin 100 mg | Change in Eye Examination Category | Right eye (week 78) | Abnormal NCS | 122 Participants |
| Sitagliptin 100 mg | Change in Eye Examination Category | Right eye (week 78) | Normal | 279 Participants |
| Sitagliptin 100 mg | Change in Eye Examination Category | Right eye (week -2) | Normal | 297 Participants |
| Sitagliptin 100 mg | Change in Eye Examination Category | Left eye (week 52) | Normal | 252 Participants |
| Sitagliptin 100 mg | Change in Eye Examination Category | Left eye (week -2) | Normal | 297 Participants |
| Sitagliptin 100 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal NCS | 138 Participants |
| Sitagliptin 100 mg | Change in Eye Examination Category | Right eye (week 78) | Abnormal CS | 30 Participants |
| Sitagliptin 100 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal CS | 28 Participants |
| Sitagliptin 100 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal CS | 29 Participants |
| Sitagliptin 100 mg | Change in Eye Examination Category | Right eye (week 52) | Normal | 255 Participants |
| Sitagliptin 100 mg | Change in Eye Examination Category | Left eye (week 78) | Abnormal CS | 31 Participants |
| Sitagliptin 100 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal NCS | 123 Participants |
| Sitagliptin 100 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal NCS | 137 Participants |
| Sitagliptin 100 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal CS | 27 Participants |
| Sitagliptin 100 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal CS | 27 Participants |
| Sitagliptin 100 mg | Change in Eye Examination Category | Left eye (week 78) | Normal | 287 Participants |
| Sitagliptin 100 mg | Change in Eye Examination Category | Left eye (week 78) | Abnormal NCS | 113 Participants |
| Sitagliptin 100 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal NCS | 126 Participants |
Secondary
Change in FPG
Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in FPG | Week 26 | -0.83 mmol/L | Standard Deviation 2.69 |
| Oral Semaglutide 3 mg | Change in FPG | Week 78 | -1.07 mmol/L | Standard Deviation 3.21 |
| Oral Semaglutide 3 mg | Change in FPG | Week 52 | -0.98 mmol/L | Standard Deviation 2.78 |
| Oral Semaglutide 7 mg | Change in FPG | Week 26 | -1.17 mmol/L | Standard Deviation 2.54 |
| Oral Semaglutide 7 mg | Change in FPG | Week 78 | -1.11 mmol/L | Standard Deviation 2.92 |
| Oral Semaglutide 7 mg | Change in FPG | Week 52 | -1.28 mmol/L | Standard Deviation 2.62 |
| Oral Semaglutide 14 mg | Change in FPG | Week 52 | -1.75 mmol/L | Standard Deviation 2.57 |
| Oral Semaglutide 14 mg | Change in FPG | Week 26 | -1.67 mmol/L | Standard Deviation 2.6 |
| Oral Semaglutide 14 mg | Change in FPG | Week 78 | -1.65 mmol/L | Standard Deviation 2.71 |
| Sitagliptin 100 mg | Change in FPG | Week 26 | -0.90 mmol/L | Standard Deviation 2.32 |
| Sitagliptin 100 mg | Change in FPG | Week 78 | -0.91 mmol/L | Standard Deviation 2.59 |
| Sitagliptin 100 mg | Change in FPG | Week 52 | -1.03 mmol/L | Standard Deviation 2.6 |
Secondary
Change in Free Fatty Acids (Ratio to Baseline)
Change from baseline (week 0) in free fatty acids (FFA) (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Because of an issue with the handling of the blood samples for FFA, all FFA data were considered invalid for this trial; thus, no conclusion with regards to FFA levels can be made based on the data presented here.
Time frame: Week 0, week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Free Fatty Acids (Ratio to Baseline) | Week 78 | 0.92 Ratio of FFA | Geometric Coefficient of Variation 54.2 |
| Oral Semaglutide 3 mg | Change in Free Fatty Acids (Ratio to Baseline) | Week 52 | 1.03 Ratio of FFA | Geometric Coefficient of Variation 46.7 |
| Oral Semaglutide 3 mg | Change in Free Fatty Acids (Ratio to Baseline) | Week 26 | 0.96 Ratio of FFA | Geometric Coefficient of Variation 48.7 |
| Oral Semaglutide 7 mg | Change in Free Fatty Acids (Ratio to Baseline) | Week 78 | 0.87 Ratio of FFA | Geometric Coefficient of Variation 56.5 |
| Oral Semaglutide 7 mg | Change in Free Fatty Acids (Ratio to Baseline) | Week 26 | 0.91 Ratio of FFA | Geometric Coefficient of Variation 50.4 |
| Oral Semaglutide 7 mg | Change in Free Fatty Acids (Ratio to Baseline) | Week 52 | 1.00 Ratio of FFA | Geometric Coefficient of Variation 47.9 |
| Oral Semaglutide 14 mg | Change in Free Fatty Acids (Ratio to Baseline) | Week 26 | 0.88 Ratio of FFA | Geometric Coefficient of Variation 55.8 |
| Oral Semaglutide 14 mg | Change in Free Fatty Acids (Ratio to Baseline) | Week 78 | 0.88 Ratio of FFA | Geometric Coefficient of Variation 56.3 |
| Oral Semaglutide 14 mg | Change in Free Fatty Acids (Ratio to Baseline) | Week 52 | 0.96 Ratio of FFA | Geometric Coefficient of Variation 56 |
| Sitagliptin 100 mg | Change in Free Fatty Acids (Ratio to Baseline) | Week 52 | 0.98 Ratio of FFA | Geometric Coefficient of Variation 47.5 |
| Sitagliptin 100 mg | Change in Free Fatty Acids (Ratio to Baseline) | Week 78 | 0.87 Ratio of FFA | Geometric Coefficient of Variation 57.8 |
| Sitagliptin 100 mg | Change in Free Fatty Acids (Ratio to Baseline) | Week 26 | 0.90 Ratio of FFA | Geometric Coefficient of Variation 49.8 |
Secondary
Change in HbA1c: Weeks 52 and 78
Change from baseline (week 0) in HbA1c was evaluated at weeks 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in HbA1c: Weeks 52 and 78 | Week 52 | -0.6 Percentage of HbA1c | Standard Deviation 1.1 |
| Oral Semaglutide 3 mg | Change in HbA1c: Weeks 52 and 78 | Week 78 | -0.6 Percentage of HbA1c | Standard Deviation 1.1 |
| Oral Semaglutide 7 mg | Change in HbA1c: Weeks 52 and 78 | Week 52 | -1.0 Percentage of HbA1c | Standard Deviation 1.2 |
| Oral Semaglutide 7 mg | Change in HbA1c: Weeks 52 and 78 | Week 78 | -0.9 Percentage of HbA1c | Standard Deviation 1.3 |
| Oral Semaglutide 14 mg | Change in HbA1c: Weeks 52 and 78 | Week 78 | -1.1 Percentage of HbA1c | Standard Deviation 1.1 |
| Oral Semaglutide 14 mg | Change in HbA1c: Weeks 52 and 78 | Week 52 | -1.2 Percentage of HbA1c | Standard Deviation 1.1 |
| Sitagliptin 100 mg | Change in HbA1c: Weeks 52 and 78 | Week 78 | -0.7 Percentage of HbA1c | Standard Deviation 1.1 |
| Sitagliptin 100 mg | Change in HbA1c: Weeks 52 and 78 | Week 52 | -0.7 Percentage of HbA1c | Standard Deviation 1.1 |
Secondary
Change in HDL Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in HDL Cholesterol (Ratio to Baseline) | Week 26 | 0.97 Ratio of HDL cholesterol | Geometric Coefficient of Variation 13.6 |
| Oral Semaglutide 3 mg | Change in HDL Cholesterol (Ratio to Baseline) | Week 78 | 0.97 Ratio of HDL cholesterol | Geometric Coefficient of Variation 15.3 |
| Oral Semaglutide 3 mg | Change in HDL Cholesterol (Ratio to Baseline) | Week 52 | 0.99 Ratio of HDL cholesterol | Geometric Coefficient of Variation 13.9 |
| Oral Semaglutide 7 mg | Change in HDL Cholesterol (Ratio to Baseline) | Week 26 | 0.99 Ratio of HDL cholesterol | Geometric Coefficient of Variation 14.8 |
| Oral Semaglutide 7 mg | Change in HDL Cholesterol (Ratio to Baseline) | Week 78 | 0.99 Ratio of HDL cholesterol | Geometric Coefficient of Variation 15.6 |
| Oral Semaglutide 7 mg | Change in HDL Cholesterol (Ratio to Baseline) | Week 52 | 1.01 Ratio of HDL cholesterol | Geometric Coefficient of Variation 14.3 |
| Oral Semaglutide 14 mg | Change in HDL Cholesterol (Ratio to Baseline) | Week 52 | 1.01 Ratio of HDL cholesterol | Geometric Coefficient of Variation 15.2 |
| Oral Semaglutide 14 mg | Change in HDL Cholesterol (Ratio to Baseline) | Week 26 | 0.98 Ratio of HDL cholesterol | Geometric Coefficient of Variation 14.9 |
| Oral Semaglutide 14 mg | Change in HDL Cholesterol (Ratio to Baseline) | Week 78 | 1.00 Ratio of HDL cholesterol | Geometric Coefficient of Variation 15.5 |
| Sitagliptin 100 mg | Change in HDL Cholesterol (Ratio to Baseline) | Week 26 | 0.99 Ratio of HDL cholesterol | Geometric Coefficient of Variation 12.6 |
| Sitagliptin 100 mg | Change in HDL Cholesterol (Ratio to Baseline) | Week 78 | 0.99 Ratio of HDL cholesterol | Geometric Coefficient of Variation 14.2 |
| Sitagliptin 100 mg | Change in HDL Cholesterol (Ratio to Baseline) | Week 52 | 0.99 Ratio of HDL cholesterol | Geometric Coefficient of Variation 15.9 |
Secondary
Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains
The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. The items of the IWQOL-Lite-CT pertain to physical functioning (physical, physical function and pain/discomfort) and psychosocial domains and all items employ a 5-point graded response scale (never, rarely, sometimes, usually, always; or not at all true, a little true, moderately true, mostly true, completely true). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 1) Physical (week 26) | 3.25 Score on a scale | Standard Deviation 14.81 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 4) Psychosocial (week 78) | 3.83 Score on a scale | Standard Deviation 14.89 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 3) Pain/discomfort (week 78) | 3.06 Score on a scale | Standard Deviation 20.39 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 1) Physical (week 78) | 2.71 Score on a scale | Standard Deviation 16.16 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 4) Psychosocial (week 26) | 2.69 Score on a scale | Standard Deviation 13.32 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 4) Psychosocial (week 52) | 3.12 Score on a scale | Standard Deviation 14.55 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 2) Physical function (week 26) | 3.52 Score on a scale | Standard Deviation 16.48 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 1) Physical (week 52) | 1.84 Score on a scale | Standard Deviation 15.8 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | IWQOL-Lite-CT Total (week 52) | 2.67 Score on a scale | Standard Deviation 13.01 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 2) Physical function (week 52) | 2.28 Score on a scale | Standard Deviation 17 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 2) Physical function (week 78) | 2.55 Score on a scale | Standard Deviation 17.86 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | IWQOL-Lite-CT Total (week 26) | 2.88 Score on a scale | Standard Deviation 12.11 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 3) Pain/discomfort (week 26) | 2.51 Score on a scale | Standard Deviation 20.28 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | IWQOL-Lite-CT Total (week 78) | 3.45 Score on a scale | Standard Deviation 13.32 |
| Oral Semaglutide 3 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 3) Pain/discomfort (week 52) | 0.76 Score on a scale | Standard Deviation 22.31 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 3) Pain/discomfort (week 52) | 2.52 Score on a scale | Standard Deviation 22.04 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 4) Psychosocial (week 78) | 5.36 Score on a scale | Standard Deviation 15.62 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 2) Physical function (week 52) | 3.24 Score on a scale | Standard Deviation 18.17 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 3) Pain/discomfort (week 78) | 2.35 Score on a scale | Standard Deviation 22.66 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 1) Physical (week 52) | 3.03 Score on a scale | Standard Deviation 16.32 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 4) Psychosocial (week 52) | 5.19 Score on a scale | Standard Deviation 15.04 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | IWQOL-Lite-CT Total (week 26) | 3.62 Score on a scale | Standard Deviation 13.37 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 4) Psychosocial (week 26) | 4.30 Score on a scale | Standard Deviation 15.05 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 1) Physical (week 78) | 3.55 Score on a scale | Standard Deviation 16.47 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 3) Pain/discomfort (week 26) | 1.37 Score on a scale | Standard Deviation 21.34 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | IWQOL-Lite-CT Total (week 78) | 4.73 Score on a scale | Standard Deviation 14.07 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | IWQOL-Lite-CT Total (week 52) | 4.43 Score on a scale | Standard Deviation 13.59 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 2) Physical function (week 78) | 4.04 Score on a scale | Standard Deviation 17.99 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 2) Physical function (week 26) | 2.78 Score on a scale | Standard Deviation 16.13 |
| Oral Semaglutide 7 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 1) Physical (week 26) | 2.38 Score on a scale | Standard Deviation 14.87 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 3) Pain/discomfort (week 52) | 3.15 Score on a scale | Standard Deviation 23.29 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 1) Physical (week 26) | 2.87 Score on a scale | Standard Deviation 17.32 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 1) Physical (week 52) | 3.18 Score on a scale | Standard Deviation 18.4 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 1) Physical (week 78) | 3.86 Score on a scale | Standard Deviation 17.37 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 2) Physical function (week 26) | 3.20 Score on a scale | Standard Deviation 18.48 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 2) Physical function (week 52) | 3.19 Score on a scale | Standard Deviation 19.76 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 2) Physical function (week 78) | 3.76 Score on a scale | Standard Deviation 18.78 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 3) Pain/discomfort (week 26) | 2.03 Score on a scale | Standard Deviation 22.1 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 3) Pain/discomfort (week 78) | 4.07 Score on a scale | Standard Deviation 22.28 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 4) Psychosocial (week 26) | 2.98 Score on a scale | Standard Deviation 14.86 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 4) Psychosocial (week 52) | 3.97 Score on a scale | Standard Deviation 16.46 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 4) Psychosocial (week 78) | 3.73 Score on a scale | Standard Deviation 16.22 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | IWQOL-Lite-CT Total (week 26) | 2.95 Score on a scale | Standard Deviation 13.87 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | IWQOL-Lite-CT Total (week 52) | 3.64 Score on a scale | Standard Deviation 15.22 |
| Oral Semaglutide 14 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | IWQOL-Lite-CT Total (week 78) | 3.77 Score on a scale | Standard Deviation 14.97 |
| Sitagliptin 100 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 3) Pain/discomfort (week 26) | 2.66 Score on a scale | Standard Deviation 21.27 |
| Sitagliptin 100 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 1) Physical (week 52) | 1.49 Score on a scale | Standard Deviation 16.11 |
| Sitagliptin 100 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 4) Psychosocial (week 78) | 3.29 Score on a scale | Standard Deviation 14.53 |
| Sitagliptin 100 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 2) Physical function (week 78) | 2.54 Score on a scale | Standard Deviation 18.96 |
| Sitagliptin 100 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 2) Physical function (week 52) | 1.22 Score on a scale | Standard Deviation 18.21 |
| Sitagliptin 100 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 1) Physical (week 26) | 1.97 Score on a scale | Standard Deviation 15.07 |
| Sitagliptin 100 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | IWQOL-Lite-CT Total (week 26) | 2.05 Score on a scale | Standard Deviation 12.05 |
| Sitagliptin 100 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 2) Physical function (week 26) | 1.70 Score on a scale | Standard Deviation 16.54 |
| Sitagliptin 100 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 1) Physical (week 78) | 2.86 Score on a scale | Standard Deviation 17.55 |
| Sitagliptin 100 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | IWQOL-Lite-CT Total (week 78) | 3.16 Score on a scale | Standard Deviation 13.76 |
| Sitagliptin 100 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 4) Psychosocial (week 26) | 2.10 Score on a scale | Standard Deviation 13.21 |
| Sitagliptin 100 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 3) Pain/discomfort (week 78) | 3.63 Score on a scale | Standard Deviation 22.38 |
| Sitagliptin 100 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | IWQOL-Lite-CT Total (week 52) | 2.17 Score on a scale | Standard Deviation 12.86 |
| Sitagliptin 100 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 4) Psychosocial (week 52) | 2.53 Score on a scale | Standard Deviation 14.09 |
| Sitagliptin 100 mg | Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains | 3) Pain/discomfort (week 52) | 2.12 Score on a scale | Standard Deviation 21.73 |
Secondary
Change in LDL Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in low-density lipoprotein (LDL) cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in LDL Cholesterol (Ratio to Baseline) | Week 26 | 1.02 Ratio of LDL cholesterol | Geometric Coefficient of Variation 28.2 |
| Oral Semaglutide 3 mg | Change in LDL Cholesterol (Ratio to Baseline) | Week 78 | 1.03 Ratio of LDL cholesterol | Geometric Coefficient of Variation 30.8 |
| Oral Semaglutide 3 mg | Change in LDL Cholesterol (Ratio to Baseline) | Week 52 | 1.02 Ratio of LDL cholesterol | Geometric Coefficient of Variation 28.1 |
| Oral Semaglutide 7 mg | Change in LDL Cholesterol (Ratio to Baseline) | Week 26 | 0.98 Ratio of LDL cholesterol | Geometric Coefficient of Variation 28 |
| Oral Semaglutide 7 mg | Change in LDL Cholesterol (Ratio to Baseline) | Week 78 | 1.00 Ratio of LDL cholesterol | Geometric Coefficient of Variation 30.2 |
| Oral Semaglutide 7 mg | Change in LDL Cholesterol (Ratio to Baseline) | Week 52 | 0.99 Ratio of LDL cholesterol | Geometric Coefficient of Variation 29.7 |
| Oral Semaglutide 14 mg | Change in LDL Cholesterol (Ratio to Baseline) | Week 52 | 0.99 Ratio of LDL cholesterol | Geometric Coefficient of Variation 27.4 |
| Oral Semaglutide 14 mg | Change in LDL Cholesterol (Ratio to Baseline) | Week 26 | 0.98 Ratio of LDL cholesterol | Geometric Coefficient of Variation 28.6 |
| Oral Semaglutide 14 mg | Change in LDL Cholesterol (Ratio to Baseline) | Week 78 | 1.00 Ratio of LDL cholesterol | Geometric Coefficient of Variation 30.2 |
| Sitagliptin 100 mg | Change in LDL Cholesterol (Ratio to Baseline) | Week 26 | 1.02 Ratio of LDL cholesterol | Geometric Coefficient of Variation 26.4 |
| Sitagliptin 100 mg | Change in LDL Cholesterol (Ratio to Baseline) | Week 78 | 1.03 Ratio of LDL cholesterol | Geometric Coefficient of Variation 32.6 |
| Sitagliptin 100 mg | Change in LDL Cholesterol (Ratio to Baseline) | Week 52 | 1.03 Ratio of LDL cholesterol | Geometric Coefficient of Variation 27.7 |
Secondary
Change in Lipase (Ratio to Baseline)
Change from baseline (week 0) in lipase (U/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 26, week 52, week 78
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Lipase (Ratio to Baseline) | Week 26 | 1.07 Ratio | Geometric Coefficient of Variation 52.6 |
| Oral Semaglutide 3 mg | Change in Lipase (Ratio to Baseline) | Week 78 | 1.04 Ratio | Geometric Coefficient of Variation 56.2 |
| Oral Semaglutide 3 mg | Change in Lipase (Ratio to Baseline) | Week 52 | 1.06 Ratio | Geometric Coefficient of Variation 51.5 |
| Oral Semaglutide 7 mg | Change in Lipase (Ratio to Baseline) | Week 26 | 1.13 Ratio | Geometric Coefficient of Variation 60.1 |
| Oral Semaglutide 7 mg | Change in Lipase (Ratio to Baseline) | Week 78 | 1.14 Ratio | Geometric Coefficient of Variation 61.9 |
| Oral Semaglutide 7 mg | Change in Lipase (Ratio to Baseline) | Week 52 | 1.15 Ratio | Geometric Coefficient of Variation 59.4 |
| Oral Semaglutide 14 mg | Change in Lipase (Ratio to Baseline) | Week 52 | 1.25 Ratio | Geometric Coefficient of Variation 56.6 |
| Oral Semaglutide 14 mg | Change in Lipase (Ratio to Baseline) | Week 26 | 1.26 Ratio | Geometric Coefficient of Variation 64.9 |
| Oral Semaglutide 14 mg | Change in Lipase (Ratio to Baseline) | Week 78 | 1.18 Ratio | Geometric Coefficient of Variation 54.3 |
| Sitagliptin 100 mg | Change in Lipase (Ratio to Baseline) | Week 26 | 1.14 Ratio | Geometric Coefficient of Variation 50.3 |
| Sitagliptin 100 mg | Change in Lipase (Ratio to Baseline) | Week 78 | 1.10 Ratio | Geometric Coefficient of Variation 50.7 |
| Sitagliptin 100 mg | Change in Lipase (Ratio to Baseline) | Week 52 | 1.15 Ratio | Geometric Coefficient of Variation 54.2 |
Secondary
Change in Physical Examination
Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2), weeks 52 and 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.
Time frame: Week -2, week 52, week 78
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week 78) | Normal | 395 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week 78) | Abnormal NCS | 37 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Abnormal NCS | 25 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week 78) | Abnormal CS | 3 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week 78) | Abnormal NCS | 24 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week 52) | Normal | 381 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week 52) | Normal | 372 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week 78) | Normal | 421 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week 78) | Abnormal CS | 5 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Normal | 466 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Abnormal CS | 3 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week 78) | Abnormal NCS | 33 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Normal | 410 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Normal | 425 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week 78) | Abnormal CS | 8 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week 78) | Abnormal NCS | 11 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal NCS | 44 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week 78) | Abnormal CS | 8 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 78) | Normal | 400 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week 78) | Normal | 388 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal CS | 12 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week 52) | Abnormal CS | 8 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week -2) | Normal | 394 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 78) | Abnormal CS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Normal | 376 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 78) | Abnormal NCS | 22 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week 78) | Abnormal NCS | 3 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Abnormal CS | 6 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Abnormal NCS | 44 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal NCS | 11 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Normal | 451 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Normal | 441 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Abnormal CS | 7 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Normal | 418 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week 78) | Abnormal CS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Abnormal NCS | 37 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 78) | Normal | 377 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal CS | 6 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal NCS | 6 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 78) | Abnormal NCS | 43 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Normal | 431 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Normal | 383 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 78) | Abnormal CS | 4 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal NCS | 25 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal NCS | 13 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Normal | 419 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal CS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal NCS | 30 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal CS | 6 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal NCS | 45 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week 78) | Normal | 411 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week 78) | Normal | 361 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week 78) | Normal | 379 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal CS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal CS | 5 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week 78) | Normal | 419 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal NCS | 39 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Normal | 386 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal CS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week 52) | Abnormal NCS | 37 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal NCS | 39 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal NCS | 6 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Normal | 398 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Normal | 421 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal CS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal CS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal NCS | 52 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal NCS | 66 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 78) | Normal | 398 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal NCS | 24 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week 78) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 78) | Abnormal NCS | 26 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Normal | 398 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Normal | 413 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week 78) | Abnormal CS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 78) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Normal | 458 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal CS | 5 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6) Lymph node palpation (week 78) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week -2) | Normal | 407 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week -2) | Abnormal CS | 16 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week 78) | Abnormal NCS | 55 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal CS | 3 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4) General appearance (week -2) | Abnormal NCS | 43 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal CS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week -2) | Abnormal NCS | 45 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week -2) | Abnormal CS | 14 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week 52) | Normal | 384 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal NCS | 10 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week 52) | Abnormal NCS | 37 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal CS | 8 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week 52) | Abnormal CS | 12 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal NCS | 4 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week 78) | Normal | 373 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Normal | 432 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week 78) | Abnormal NCS | 40 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week 78) | Abnormal CS | 10 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Normal | 440 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal NCS | 24 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week 78) | Normal | 411 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Normal | 411 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Normal | 462 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Abnormal NCS | 21 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Normal | 427 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 78) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 78) | Normal | 405 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week 78) | Abnormal NCS | 12 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 78) | Abnormal NCS | 17 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal CS | 6 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week 78) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal NCS | 56 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal CS | 4 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Normal | 425 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week 78) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal NCS | 38 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal NCS | 9 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week 78) | Normal | 370 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Normal | 396 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Normal | 451 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal NCS | 36 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week 78) | Abnormal CS | 3 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week 78) | Normal | 386 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week 78) | Abnormal NCS | 45 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week 78) | Abnormal NCS | 33 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week 78) | Abnormal NCS | 31 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week 78) | Abnormal CS | 4 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week 78) | Abnormal NCS | 4 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Normal | 415 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week 78) | Normal | 389 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal NCS | 42 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week 78) | Abnormal CS | 8 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal CS | 6 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week 52) | Normal | 383 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Abnormal CS | 5 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Normal | 382 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Abnormal NCS | 45 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Abnormal NCS | 28 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Abnormal CS | 6 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Normal | 452 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 78) | Normal | 376 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Normal | 400 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 78) | Abnormal NCS | 43 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week 78) | Normal | 418 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 78) | Abnormal CS | 4 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal CS | 5 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Normal | 421 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal NCS | 11 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal NCS | 39 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week -2) | Normal | 400 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal NCS | 24 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal CS | 4 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Normal | 402 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Normal | 435 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal NCS | 28 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal CS | 3 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week 78) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 78) | Normal | 387 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal CS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 78) | Abnormal NCS | 31 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week 78) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 78) | Abnormal CS | 5 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Normal | 423 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4) General appearance (week -2) | Normal | 405 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal NCS | 44 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6) Lymph node palpation (week 78) | Normal | 423 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week -2) | Abnormal NCS | 38 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal CS | 10 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week 52) | Normal | 383 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal NCS | 44 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal CS | 8 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week 78) | Normal | 382 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week 78) | Abnormal NCS | 38 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week 78) | Abnormal CS | 8 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Normal | 451 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal NCS | 11 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal CS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Normal | 425 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal NCS | 7 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal CS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week 78) | Normal | 418 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week 78) | Abnormal NCS | 8 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week 78) | Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Normal | 432 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal NCS | 30 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal CS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Normal | 404 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal NCS | 28 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal CS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week 78) | Normal | 402 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week 78) | Abnormal NCS | 24 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week 78) | Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Normal | 407 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal NCS | 49 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal CS | 8 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Normal | 388 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Abnormal NCS | 38 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Abnormal CS | 9 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 78) | Normal | 384 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 78) | Abnormal NCS | 37 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 78) | Abnormal CS | 7 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Normal | 420 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal NCS | 45 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Normal | 397 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal NCS | 36 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 78) | Normal | 393 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 78) | Abnormal NCS | 35 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 78) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week -2) | Normal | 412 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal NCS | 61 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week -2) | Abnormal CS | 15 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week 52) | Normal | 390 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week 52) | Abnormal NCS | 33 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week 52) | Abnormal CS | 12 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week 78) | Normal | 388 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week 78) | Abnormal NCS | 28 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (week 78) | Abnormal CS | 12 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Normal | 435 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal NCS | 27 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal CS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Normal | 404 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Abnormal NCS | 27 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Abnormal CS | 4 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 78) | Normal | 399 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 78) | Abnormal NCS | 28 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 78) | Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Normal | 463 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Normal | 434 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week 78) | Normal | 425 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week 78) | Abnormal NCS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (week 78) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Normal | 440 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal NCS | 23 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Normal | 408 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Abnormal NCS | 24 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Abnormal CS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week 78) | Normal | 402 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week 78) | Abnormal NCS | 24 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (week 78) | Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Normal | 462 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Normal | 431 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal NCS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week 78) | Normal | 427 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week 78) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week 78) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week -2) | Normal | 394 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 4) General appearance (week -2) | Abnormal NCS | 46 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 4) General appearance (week -2) | Normal | 405 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Normal | 427 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 6) Lymph node palpation (week 78) | Normal | 441 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 78) | Abnormal CS | 2 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 78) | Abnormal NCS | 31 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal CS | 0 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 6) Lymph node palpation (week 78) | Abnormal NCS | 0 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 78) | Normal | 408 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal CS | 2 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 9) Skin (week 52) | Normal | 375 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 6) Lymph node palpation (week 78) | Abnormal CS | 0 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal NCS | 40 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Normal | 394 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal CS | 1 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Normal | 430 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal CS | 0 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal NCS | 45 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal NCS | 12 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal NCS | 32 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Normal | 421 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 78) | Abnormal CS | 5 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Normal | 454 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 7) Musculoskeletal system (week -2) | Abnormal CS | 4 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 78) | Abnormal NCS | 37 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 78) | Normal | 399 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal NCS | 58 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Normal | 403 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Abnormal CS | 8 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Abnormal NCS | 42 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 8) Respiratory system (week 78) | Normal | 434 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Abnormal NCS | 26 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 52) | Normal | 385 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal CS | 14 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 9) Skin (week 78) | Abnormal CS | 7 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 7) Musculoskeletal system (week 52) | Abnormal CS | 6 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal NCS | 43 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Normal | 409 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 9) Skin (week 78) | Abnormal NCS | 41 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 7) Musculoskeletal system (week 78) | Normal | 413 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 1) Cardiovascular system (week 78) | Abnormal CS | 1 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 1) Cardiovascular system (week 78) | Abnormal NCS | 41 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 9) Skin (week -2) | Normal | 402 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 7) Musculoskeletal system (week 78) | Abnormal NCS | 23 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 1) Cardiovascular system (week 78) | Normal | 399 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal CS | 0 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 8) Respiratory system (week 78) | Abnormal NCS | 6 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 7) Musculoskeletal system (week 78) | Abnormal CS | 5 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal NCS | 37 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Normal | 399 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 9) Skin (week 78) | Normal | 393 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Normal | 456 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal CS | 1 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal NCS | 41 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal CS | 10 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal NCS | 10 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Normal | 424 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 10) Thyroid gland (week 78) | Abnormal CS | 1 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal CS | 6 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal CS | 0 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 10) Thyroid gland (week 78) | Abnormal NCS | 7 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 78) | Abnormal NCS | 25 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 78) | Normal | 415 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Abnormal CS | 0 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 10) Thyroid gland (week 78) | Normal | 433 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 78) | Abnormal CS | 1 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Abnormal NCS | 26 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week 52) | Normal | 410 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 8) Respiratory system (week 78) | Abnormal CS | 1 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Normal | 464 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal CS | 1 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Abnormal NCS | 21 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Normal | 429 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal NCS | 2 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (week -2) | Normal | 444 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 4) General appearance (week 78) | Abnormal CS | 10 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal CS | 1 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 6) Lymph node palpation (week -2) | Abnormal CS | 0 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 4) General appearance (week 78) | Abnormal NCS | 37 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 4) General appearance (week 78) | Normal | 394 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal NCS | 8 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Normal | 436 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 4) General appearance (week 52) | Abnormal CS | 12 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 4) General appearance (week 52) | Abnormal NCS | 39 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal NCS | 51 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Abnormal NCS | 0 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 4) General appearance (week 52) | Normal | 385 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 4) General appearance (week -2) | Abnormal CS | 15 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal NCS | 6 Participants |
| Sitagliptin 100 mg | Change in Physical Examination | 6) Lymph node palpation (week 52) | Abnormal CS | 0 Participants |
Secondary
Change in Pulse Rate
Change from baseline (week 0) in pulse rate was evaluated at weeks 26, 52 and 78. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 26, week 52, week 78
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Pulse Rate | Week 26 | 1 Beats/minute | Standard Deviation 9 |
| Oral Semaglutide 3 mg | Change in Pulse Rate | Week 78 | 1 Beats/minute | Standard Deviation 10 |
| Oral Semaglutide 3 mg | Change in Pulse Rate | Week 52 | 0 Beats/minute | Standard Deviation 10 |
| Oral Semaglutide 7 mg | Change in Pulse Rate | Week 26 | 2 Beats/minute | Standard Deviation 9 |
| Oral Semaglutide 7 mg | Change in Pulse Rate | Week 78 | 1 Beats/minute | Standard Deviation 10 |
| Oral Semaglutide 7 mg | Change in Pulse Rate | Week 52 | 2 Beats/minute | Standard Deviation 9 |
| Oral Semaglutide 14 mg | Change in Pulse Rate | Week 52 | 2 Beats/minute | Standard Deviation 10 |
| Oral Semaglutide 14 mg | Change in Pulse Rate | Week 26 | 3 Beats/minute | Standard Deviation 10 |
| Oral Semaglutide 14 mg | Change in Pulse Rate | Week 78 | 2 Beats/minute | Standard Deviation 10 |
| Sitagliptin 100 mg | Change in Pulse Rate | Week 26 | 0 Beats/minute | Standard Deviation 10 |
| Sitagliptin 100 mg | Change in Pulse Rate | Week 78 | 0 Beats/minute | Standard Deviation 10 |
| Sitagliptin 100 mg | Change in Pulse Rate | Week 52 | -0 Beats/minute | Standard Deviation 10 |
Secondary
Change in SBP and DBP
Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at weeks 26, 52 and 78. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 26, week 52, week 78
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in SBP and DBP | SBP: Week 26 | -2 mmHg | Standard Deviation 14 |
| Oral Semaglutide 3 mg | Change in SBP and DBP | SBP: Week 52 | -2 mmHg | Standard Deviation 15 |
| Oral Semaglutide 3 mg | Change in SBP and DBP | SBP: Week 78 | -2 mmHg | Standard Deviation 15 |
| Oral Semaglutide 3 mg | Change in SBP and DBP | DBP: Week 26 | -1 mmHg | Standard Deviation 9 |
| Oral Semaglutide 3 mg | Change in SBP and DBP | DBP: Week 52 | -2 mmHg | Standard Deviation 9 |
| Oral Semaglutide 3 mg | Change in SBP and DBP | DBP: Week 78 | -1 mmHg | Standard Deviation 10 |
| Oral Semaglutide 7 mg | Change in SBP and DBP | DBP: Week 78 | -1 mmHg | Standard Deviation 10 |
| Oral Semaglutide 7 mg | Change in SBP and DBP | DBP: Week 26 | -0 mmHg | Standard Deviation 9 |
| Oral Semaglutide 7 mg | Change in SBP and DBP | SBP: Week 26 | -2 mmHg | Standard Deviation 15 |
| Oral Semaglutide 7 mg | Change in SBP and DBP | SBP: Week 78 | -3 mmHg | Standard Deviation 15 |
| Oral Semaglutide 7 mg | Change in SBP and DBP | SBP: Week 52 | -4 mmHg | Standard Deviation 14 |
| Oral Semaglutide 7 mg | Change in SBP and DBP | DBP: Week 52 | -1 mmHg | Standard Deviation 9 |
| Oral Semaglutide 14 mg | Change in SBP and DBP | SBP: Week 52 | -3 mmHg | Standard Deviation 15 |
| Oral Semaglutide 14 mg | Change in SBP and DBP | SBP: Week 78 | -3 mmHg | Standard Deviation 14 |
| Oral Semaglutide 14 mg | Change in SBP and DBP | DBP: Week 26 | -1 mmHg | Standard Deviation 9 |
| Oral Semaglutide 14 mg | Change in SBP and DBP | DBP: Week 78 | -1 mmHg | Standard Deviation 10 |
| Oral Semaglutide 14 mg | Change in SBP and DBP | DBP: Week 52 | -1 mmHg | Standard Deviation 9 |
| Oral Semaglutide 14 mg | Change in SBP and DBP | SBP: Week 26 | -3 mmHg | Standard Deviation 14 |
| Sitagliptin 100 mg | Change in SBP and DBP | DBP: Week 52 | -1 mmHg | Standard Deviation 9 |
| Sitagliptin 100 mg | Change in SBP and DBP | DBP: Week 78 | -1 mmHg | Standard Deviation 10 |
| Sitagliptin 100 mg | Change in SBP and DBP | SBP: Week 52 | -1 mmHg | Standard Deviation 14 |
| Sitagliptin 100 mg | Change in SBP and DBP | DBP: Week 26 | -0 mmHg | Standard Deviation 9 |
| Sitagliptin 100 mg | Change in SBP and DBP | SBP: Week 26 | -2 mmHg | Standard Deviation 15 |
| Sitagliptin 100 mg | Change in SBP and DBP | SBP: Week 78 | 0 mmHg | Standard Deviation 15 |
Secondary
Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26, 52 and 78. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.
Time frame: Week 0, week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (week 52) | -0.25 Score on a scale | Standard Deviation 8.35 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (week 26) | 0.11 Score on a scale | Standard Deviation 7.93 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily pain (week 78) | 0.48 Score on a scale | Standard Deviation 9.24 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary (week 52) | 0.23 Score on a scale | Standard Deviation 8.41 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (week 78) | 1.05 Score on a scale | Standard Deviation 8.06 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (week 52) | 0.45 Score on a scale | Standard Deviation 7.5 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General health (week 26) | 1.17 Score on a scale | Standard Deviation 6.5 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary (week 52) | 0.31 Score on a scale | Standard Deviation 6.5 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (week 26) | 0.59 Score on a scale | Standard Deviation 7.28 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General health (week 78) | 1.02 Score on a scale | Standard Deviation 7.23 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General health (week 52) | 1.06 Score on a scale | Standard Deviation 7.07 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary (week 26) | 0.56 Score on a scale | Standard Deviation 6.42 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role-Physical (week 26) | 0.42 Score on a scale | Standard Deviation 7.85 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (week 52) | 0.29 Score on a scale | Standard Deviation 7.14 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (week 78) | 0.19 Score on a scale | Standard Deviation 9.08 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (week 26) | 0.37 Score on a scale | Standard Deviation 7.25 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role-Physical (week 52) | -0.05 Score on a scale | Standard Deviation 8.4 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary (week 78) | 0.27 Score on a scale | Standard Deviation 9.18 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (week 52) | 0.45 Score on a scale | Standard Deviation 8.02 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (week 26) | 0.33 Score on a scale | Standard Deviation 8.32 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role-Physical (week 78) | 0.28 Score on a scale | Standard Deviation 8.14 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary (week 26) | 0.48 Score on a scale | Standard Deviation 8.62 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (week 78) | 0.32 Score on a scale | Standard Deviation 10.98 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (week 52) | 0.15 Score on a scale | Standard Deviation 10.99 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily pain (week 26) | 0.56 Score on a scale | Standard Deviation 9.2 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary (week 78) | 0.46 Score on a scale | Standard Deviation 6.74 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (week 26) | 0.84 Score on a scale | Standard Deviation 10.47 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (week 78) | -0.38 Score on a scale | Standard Deviation 8.29 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily pain (week 52) | 0.16 Score on a scale | Standard Deviation 9.44 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (week 78) | 0.06 Score on a scale | Standard Deviation 8.09 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (week 52) | 0.42 Score on a scale | Standard Deviation 9.11 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (week 26) | 1.12 Score on a scale | Standard Deviation 6.52 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (week 52) | 0.64 Score on a scale | Standard Deviation 7.34 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (week 78) | 0.94 Score on a scale | Standard Deviation 6.91 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role-Physical (week 26) | 0.76 Score on a scale | Standard Deviation 7.15 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role-Physical (week 52) | -0.06 Score on a scale | Standard Deviation 9.42 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role-Physical (week 78) | -0.01 Score on a scale | Standard Deviation 8.4 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily pain (week 26) | -0.11 Score on a scale | Standard Deviation 8.6 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily pain (week 52) | -0.65 Score on a scale | Standard Deviation 9.92 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily pain (week 78) | 0.32 Score on a scale | Standard Deviation 8.85 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General health (week 26) | 1.67 Score on a scale | Standard Deviation 6.98 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General health (week 52) | 1.20 Score on a scale | Standard Deviation 7.08 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General health (week 78) | 1.21 Score on a scale | Standard Deviation 7.6 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (week 26) | 1.11 Score on a scale | Standard Deviation 7.3 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (week 52) | 0.79 Score on a scale | Standard Deviation 8.33 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (week 78) | 0.85 Score on a scale | Standard Deviation 7.92 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (week 26) | 0.15 Score on a scale | Standard Deviation 8.03 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (week 52) | -0.37 Score on a scale | Standard Deviation 9.39 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (week 78) | 0.19 Score on a scale | Standard Deviation 8.77 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (week 26) | 0.67 Score on a scale | Standard Deviation 9.18 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (week 52) | -0.45 Score on a scale | Standard Deviation 11.89 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (week 78) | 0.23 Score on a scale | Standard Deviation 10.95 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (week 26) | 0.24 Score on a scale | Standard Deviation 8.17 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (week 78) | 0.29 Score on a scale | Standard Deviation 9.33 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary (week 26) | 0.98 Score on a scale | Standard Deviation 5.72 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary (week 52) | 0.36 Score on a scale | Standard Deviation 6.82 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary (week 78) | 0.71 Score on a scale | Standard Deviation 6.24 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary (week 26) | 0.34 Score on a scale | Standard Deviation 8.26 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary (week 52) | -0.00 Score on a scale | Standard Deviation 9.43 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary (week 78) | 0.23 Score on a scale | Standard Deviation 9.5 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (week 52) | 0.05 Score on a scale | Standard Deviation 7.99 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily pain (week 52) | -0.64 Score on a scale | Standard Deviation 9.4 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role-Physical (week 26) | -0.13 Score on a scale | Standard Deviation 7.59 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary (week 78) | -0.07 Score on a scale | Standard Deviation 9.31 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (week 78) | 0.28 Score on a scale | Standard Deviation 8.87 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary (week 26) | 0.08 Score on a scale | Standard Deviation 8.18 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (week 52) | -0.86 Score on a scale | Standard Deviation 10.65 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary (week 52) | -0.37 Score on a scale | Standard Deviation 8.64 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary (week 26) | 0.63 Score on a scale | Standard Deviation 6 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (week 52) | 0.36 Score on a scale | Standard Deviation 7.3 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (week 78) | 0.54 Score on a scale | Standard Deviation 7.98 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role-Physical (week 78) | -0.33 Score on a scale | Standard Deviation 7.57 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General health (week 52) | 1.03 Score on a scale | Standard Deviation 6.88 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (week 78) | -0.27 Score on a scale | Standard Deviation 8.66 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (week 78) | -0.30 Score on a scale | Standard Deviation 11 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary (week 52) | 0.09 Score on a scale | Standard Deviation 6.47 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General health (week 78) | 1.21 Score on a scale | Standard Deviation 7.62 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (week 26) | 0.31 Score on a scale | Standard Deviation 7.33 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General health (week 26) | 1.19 Score on a scale | Standard Deviation 7 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily pain (week 26) | 0.22 Score on a scale | Standard Deviation 9.02 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (week 26) | 0.88 Score on a scale | Standard Deviation 7.42 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (week 52) | -0.83 Score on a scale | Standard Deviation 8.83 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (week 26) | 0.24 Score on a scale | Standard Deviation 8.14 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (week 26) | -0.37 Score on a scale | Standard Deviation 9.77 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (week 52) | 0.58 Score on a scale | Standard Deviation 8.15 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role-Physical (week 52) | -0.82 Score on a scale | Standard Deviation 8.49 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily pain (week 78) | 0.74 Score on a scale | Standard Deviation 9.4 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (week 26) | 0.63 Score on a scale | Standard Deviation 7.13 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (week 78) | 0.71 Score on a scale | Standard Deviation 8.42 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary (week 78) | 0.67 Score on a scale | Standard Deviation 6.29 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (week 78) | 1.07 Score on a scale | Standard Deviation 8.27 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (week 26) | 0.09 Score on a scale | Standard Deviation 8.38 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary (week 78) | 0.70 Score on a scale | Standard Deviation 6.38 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (week 52) | -0.68 Score on a scale | Standard Deviation 9.23 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily pain (week 26) | 0.44 Score on a scale | Standard Deviation 9.18 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (week 78) | 0.57 Score on a scale | Standard Deviation 8.93 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary (week 78) | 0.30 Score on a scale | Standard Deviation 9.46 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (week 26) | 0.15 Score on a scale | Standard Deviation 9.97 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role-Physical (week 78) | 0.44 Score on a scale | Standard Deviation 7.96 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (week 52) | -0.63 Score on a scale | Standard Deviation 10.33 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary (week 26) | 0.41 Score on a scale | Standard Deviation 8.16 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (week 78) | -0.24 Score on a scale | Standard Deviation 10.58 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role-Physical (week 52) | -0.69 Score on a scale | Standard Deviation 8.08 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (week 26) | 0.46 Score on a scale | Standard Deviation 6.73 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (week 26) | 0.61 Score on a scale | Standard Deviation 8.03 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role-Physical (week 26) | 0.38 Score on a scale | Standard Deviation 8 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (week 52) | 0.23 Score on a scale | Standard Deviation 8.2 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (week 78) | 0.30 Score on a scale | Standard Deviation 9.33 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (week 78) | 0.09 Score on a scale | Standard Deviation 7.6 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary (week 26) | 0.69 Score on a scale | Standard Deviation 6.24 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary (week 52) | -0.31 Score on a scale | Standard Deviation 8.71 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General health (week 52) | 0.95 Score on a scale | Standard Deviation 7.38 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General health (week 26) | 1.42 Score on a scale | Standard Deviation 7.02 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4) General health (week 78) | 1.32 Score on a scale | Standard Deviation 7.99 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary (week 52) | 0.31 Score on a scale | Standard Deviation 6.54 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (week 26) | 1.03 Score on a scale | Standard Deviation 7.42 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily pain (week 78) | 0.54 Score on a scale | Standard Deviation 9.44 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (week 52) | 0.06 Score on a scale | Standard Deviation 7.3 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (week 52) | 0.19 Score on a scale | Standard Deviation 7.73 |
| Sitagliptin 100 mg | Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily pain (week 52) | 0.67 Score on a scale | Standard Deviation 8.93 |
Secondary
Change in SMPG - Mean 7-point Profile
Change from baseline (week 0) in mean 7-point self-measured plasma glucose (SMPG) profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in SMPG - Mean 7-point Profile | Week 26 | -1.1 mmol/L | Standard Deviation 2.3 |
| Oral Semaglutide 3 mg | Change in SMPG - Mean 7-point Profile | Week 78 | -1.3 mmol/L | Standard Deviation 2.7 |
| Oral Semaglutide 3 mg | Change in SMPG - Mean 7-point Profile | Week 52 | -1.3 mmol/L | Standard Deviation 2.4 |
| Oral Semaglutide 7 mg | Change in SMPG - Mean 7-point Profile | Week 26 | -1.5 mmol/L | Standard Deviation 2.3 |
| Oral Semaglutide 7 mg | Change in SMPG - Mean 7-point Profile | Week 78 | -1.5 mmol/L | Standard Deviation 2.7 |
| Oral Semaglutide 7 mg | Change in SMPG - Mean 7-point Profile | Week 52 | -1.5 mmol/L | Standard Deviation 2.5 |
| Oral Semaglutide 14 mg | Change in SMPG - Mean 7-point Profile | Week 52 | -1.8 mmol/L | Standard Deviation 2.4 |
| Oral Semaglutide 14 mg | Change in SMPG - Mean 7-point Profile | Week 26 | -1.7 mmol/L | Standard Deviation 2.4 |
| Oral Semaglutide 14 mg | Change in SMPG - Mean 7-point Profile | Week 78 | -1.7 mmol/L | Standard Deviation 2.2 |
| Sitagliptin 100 mg | Change in SMPG - Mean 7-point Profile | Week 26 | -1.2 mmol/L | Standard Deviation 2.3 |
| Sitagliptin 100 mg | Change in SMPG - Mean 7-point Profile | Week 78 | -1.3 mmol/L | Standard Deviation 2.5 |
| Sitagliptin 100 mg | Change in SMPG - Mean 7-point Profile | Week 52 | -1.4 mmol/L | Standard Deviation 2.4 |
Secondary
Change in SMPG - Mean Postprandial Increment Over All Meals
Change from baseline (week 0) in the average of the post-prandial increments over all meals was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in SMPG - Mean Postprandial Increment Over All Meals | Week 26 | -0.4 mmol/L | Standard Deviation 2.1 |
| Oral Semaglutide 3 mg | Change in SMPG - Mean Postprandial Increment Over All Meals | Week 78 | -0.4 mmol/L | Standard Deviation 2.1 |
| Oral Semaglutide 3 mg | Change in SMPG - Mean Postprandial Increment Over All Meals | Week 52 | -0.4 mmol/L | Standard Deviation 2 |
| Oral Semaglutide 7 mg | Change in SMPG - Mean Postprandial Increment Over All Meals | Week 26 | -0.4 mmol/L | Standard Deviation 2.1 |
| Oral Semaglutide 7 mg | Change in SMPG - Mean Postprandial Increment Over All Meals | Week 78 | -0.4 mmol/L | Standard Deviation 2.1 |
| Oral Semaglutide 7 mg | Change in SMPG - Mean Postprandial Increment Over All Meals | Week 52 | -0.4 mmol/L | Standard Deviation 2.1 |
| Oral Semaglutide 14 mg | Change in SMPG - Mean Postprandial Increment Over All Meals | Week 52 | -0.7 mmol/L | Standard Deviation 2 |
| Oral Semaglutide 14 mg | Change in SMPG - Mean Postprandial Increment Over All Meals | Week 26 | -0.6 mmol/L | Standard Deviation 2.1 |
| Oral Semaglutide 14 mg | Change in SMPG - Mean Postprandial Increment Over All Meals | Week 78 | -0.6 mmol/L | Standard Deviation 2 |
| Sitagliptin 100 mg | Change in SMPG - Mean Postprandial Increment Over All Meals | Week 26 | -0.6 mmol/L | Standard Deviation 2.1 |
| Sitagliptin 100 mg | Change in SMPG - Mean Postprandial Increment Over All Meals | Week 78 | -0.6 mmol/L | Standard Deviation 2.2 |
| Sitagliptin 100 mg | Change in SMPG - Mean Postprandial Increment Over All Meals | Week 52 | -0.4 mmol/L | Standard Deviation 2.1 |
Secondary
Change in Total Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in total cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Total Cholesterol (Ratio to Baseline) | Week 26 | 1.00 Ratio of total cholesterol | Geometric Coefficient of Variation 16.8 |
| Oral Semaglutide 3 mg | Change in Total Cholesterol (Ratio to Baseline) | Week 78 | 1.00 Ratio of total cholesterol | Geometric Coefficient of Variation 18.3 |
| Oral Semaglutide 3 mg | Change in Total Cholesterol (Ratio to Baseline) | Week 52 | 1.00 Ratio of total cholesterol | Geometric Coefficient of Variation 17.5 |
| Oral Semaglutide 7 mg | Change in Total Cholesterol (Ratio to Baseline) | Week 26 | 0.98 Ratio of total cholesterol | Geometric Coefficient of Variation 17.5 |
| Oral Semaglutide 7 mg | Change in Total Cholesterol (Ratio to Baseline) | Week 78 | 0.99 Ratio of total cholesterol | Geometric Coefficient of Variation 19.3 |
| Oral Semaglutide 7 mg | Change in Total Cholesterol (Ratio to Baseline) | Week 52 | 0.99 Ratio of total cholesterol | Geometric Coefficient of Variation 18.5 |
| Oral Semaglutide 14 mg | Change in Total Cholesterol (Ratio to Baseline) | Week 52 | 0.98 Ratio of total cholesterol | Geometric Coefficient of Variation 17 |
| Oral Semaglutide 14 mg | Change in Total Cholesterol (Ratio to Baseline) | Week 26 | 0.97 Ratio of total cholesterol | Geometric Coefficient of Variation 17.1 |
| Oral Semaglutide 14 mg | Change in Total Cholesterol (Ratio to Baseline) | Week 78 | 0.99 Ratio of total cholesterol | Geometric Coefficient of Variation 18.7 |
| Sitagliptin 100 mg | Change in Total Cholesterol (Ratio to Baseline) | Week 26 | 1.00 Ratio of total cholesterol | Geometric Coefficient of Variation 16.4 |
| Sitagliptin 100 mg | Change in Total Cholesterol (Ratio to Baseline) | Week 78 | 1.00 Ratio of total cholesterol | Geometric Coefficient of Variation 19.4 |
| Sitagliptin 100 mg | Change in Total Cholesterol (Ratio to Baseline) | Week 52 | 1.01 Ratio of total cholesterol | Geometric Coefficient of Variation 16.9 |
Secondary
Change in Triglycerides (Ratio to Baseline)
Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Triglycerides (Ratio to Baseline) | Week 78 | 0.95 Ratio of triglycerides | Geometric Coefficient of Variation 43.9 |
| Oral Semaglutide 3 mg | Change in Triglycerides (Ratio to Baseline) | Week 52 | 1.00 Ratio of triglycerides | Geometric Coefficient of Variation 35.7 |
| Oral Semaglutide 3 mg | Change in Triglycerides (Ratio to Baseline) | Week 26 | 0.99 Ratio of triglycerides | Geometric Coefficient of Variation 38.1 |
| Oral Semaglutide 7 mg | Change in Triglycerides (Ratio to Baseline) | Week 78 | 0.94 Ratio of triglycerides | Geometric Coefficient of Variation 43.7 |
| Oral Semaglutide 7 mg | Change in Triglycerides (Ratio to Baseline) | Week 52 | 0.97 Ratio of triglycerides | Geometric Coefficient of Variation 41.3 |
| Oral Semaglutide 7 mg | Change in Triglycerides (Ratio to Baseline) | Week 26 | 0.96 Ratio of triglycerides | Geometric Coefficient of Variation 39.2 |
| Oral Semaglutide 14 mg | Change in Triglycerides (Ratio to Baseline) | Week 26 | 0.92 Ratio of triglycerides | Geometric Coefficient of Variation 39.8 |
| Oral Semaglutide 14 mg | Change in Triglycerides (Ratio to Baseline) | Week 52 | 0.93 Ratio of triglycerides | Geometric Coefficient of Variation 42.3 |
| Oral Semaglutide 14 mg | Change in Triglycerides (Ratio to Baseline) | Week 78 | 0.92 Ratio of triglycerides | Geometric Coefficient of Variation 43.1 |
| Sitagliptin 100 mg | Change in Triglycerides (Ratio to Baseline) | Week 78 | 0.93 Ratio of triglycerides | Geometric Coefficient of Variation 41.6 |
| Sitagliptin 100 mg | Change in Triglycerides (Ratio to Baseline) | Week 52 | 0.98 Ratio of triglycerides | Geometric Coefficient of Variation 37.8 |
| Sitagliptin 100 mg | Change in Triglycerides (Ratio to Baseline) | Week 26 | 0.97 Ratio of triglycerides | Geometric Coefficient of Variation 36.2 |
Secondary
Change in VLDL Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in very-low-density lipoprotein (VLDL) cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in VLDL Cholesterol (Ratio to Baseline) | Week 26 | 0.99 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 36.4 |
| Oral Semaglutide 3 mg | Change in VLDL Cholesterol (Ratio to Baseline) | Week 78 | 0.95 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 41.7 |
| Oral Semaglutide 3 mg | Change in VLDL Cholesterol (Ratio to Baseline) | Week 52 | 1.00 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 35 |
| Oral Semaglutide 7 mg | Change in VLDL Cholesterol (Ratio to Baseline) | Week 26 | 0.96 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 36.1 |
| Oral Semaglutide 7 mg | Change in VLDL Cholesterol (Ratio to Baseline) | Week 78 | 0.94 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 41.5 |
| Oral Semaglutide 7 mg | Change in VLDL Cholesterol (Ratio to Baseline) | Week 52 | 0.98 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 39.1 |
| Oral Semaglutide 14 mg | Change in VLDL Cholesterol (Ratio to Baseline) | Week 52 | 0.93 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 39.6 |
| Oral Semaglutide 14 mg | Change in VLDL Cholesterol (Ratio to Baseline) | Week 26 | 0.91 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 36.3 |
| Oral Semaglutide 14 mg | Change in VLDL Cholesterol (Ratio to Baseline) | Week 78 | 0.91 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 40.4 |
| Sitagliptin 100 mg | Change in VLDL Cholesterol (Ratio to Baseline) | Week 26 | 0.97 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 34.1 |
| Sitagliptin 100 mg | Change in VLDL Cholesterol (Ratio to Baseline) | Week 78 | 0.94 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 39.6 |
| Sitagliptin 100 mg | Change in VLDL Cholesterol (Ratio to Baseline) | Week 52 | 0.98 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 34.4 |
Secondary
Change in Waist Circumference
Change from baseline (week 0) in waist circumference was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Change in Waist Circumference | Week 26 | -0.7 cm | Standard Deviation 5 |
| Oral Semaglutide 3 mg | Change in Waist Circumference | Week 78 | -1.2 cm | Standard Deviation 6 |
| Oral Semaglutide 3 mg | Change in Waist Circumference | Week 52 | -1.3 cm | Standard Deviation 5.7 |
| Oral Semaglutide 7 mg | Change in Waist Circumference | Week 26 | -1.8 cm | Standard Deviation 5.2 |
| Oral Semaglutide 7 mg | Change in Waist Circumference | Week 78 | -2.4 cm | Standard Deviation 7.2 |
| Oral Semaglutide 7 mg | Change in Waist Circumference | Week 52 | -2.3 cm | Standard Deviation 6.8 |
| Oral Semaglutide 14 mg | Change in Waist Circumference | Week 52 | -2.6 cm | Standard Deviation 6.2 |
| Oral Semaglutide 14 mg | Change in Waist Circumference | Week 26 | -2.3 cm | Standard Deviation 5.2 |
| Oral Semaglutide 14 mg | Change in Waist Circumference | Week 78 | -2.4 cm | Standard Deviation 6.1 |
| Sitagliptin 100 mg | Change in Waist Circumference | Week 26 | -0.6 cm | Standard Deviation 4.4 |
| Sitagliptin 100 mg | Change in Waist Circumference | Week 78 | -0.7 cm | Standard Deviation 5.6 |
| Sitagliptin 100 mg | Change in Waist Circumference | Week 52 | -0.5 cm | Standard Deviation 5.1 |
Secondary
Number of TEAEs During Exposure to Trial Product
Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 83 (78-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Weeks 0-83
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide 3 mg | Number of TEAEs During Exposure to Trial Product | 1774 Events |
| Oral Semaglutide 7 mg | Number of TEAEs During Exposure to Trial Product | 1686 Events |
| Oral Semaglutide 14 mg | Number of TEAEs During Exposure to Trial Product | 1824 Events |
| Sitagliptin 100 mg | Number of TEAEs During Exposure to Trial Product | 1852 Events |
Secondary
Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes
Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-83 (78-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time frame: Weeks 0-83
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide 3 mg | Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 56 Episodes |
| Oral Semaglutide 7 mg | Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 42 Episodes |
| Oral Semaglutide 14 mg | Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 60 Episodes |
| Sitagliptin 100 mg | Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 76 Episodes |
Secondary
Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (weeks 0-83) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Weeks 0-83
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 3 mg | Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no) | 0 Participants |
| Oral Semaglutide 7 mg | Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no) | 1 Participants |
| Oral Semaglutide 14 mg | Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no) | 1 Participants |
Secondary
Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (weeks 0-83) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Weeks 0-83
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 3 mg | Occurrence of Anti-semaglutide Binding Antibodies (Yes/no) | 1 Participants |
| Oral Semaglutide 7 mg | Occurrence of Anti-semaglutide Binding Antibodies (Yes/no) | 2 Participants |
| Oral Semaglutide 14 mg | Occurrence of Anti-semaglutide Binding Antibodies (Yes/no) | 3 Participants |
Secondary
Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (weeks 0-83) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Weeks 0-83
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 3 mg | Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no) | 0 Participants |
| Oral Semaglutide 7 mg | Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no) | 0 Participants |
| Oral Semaglutide 14 mg | Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no) | 0 Participants |
Secondary
Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (weeks 0-83) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Weeks 0-83
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 3 mg | Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no) | 0 Participants |
| Oral Semaglutide 7 mg | Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no) | 0 Participants |
| Oral Semaglutide 14 mg | Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no) | 0 Participants |
Secondary
Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)
Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at weeks 26, 52 and 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 26 | Yes | 55 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 26 | No | 380 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 52 | Yes | 55 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 52 | No | 372 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 78 | Yes | 49 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 78 | No | 372 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 78 | No | 324 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 52 | No | 332 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 26 | Yes | 116 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 52 | Yes | 99 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 26 | No | 322 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 78 | Yes | 100 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 26 | No | 275 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 52 | Yes | 146 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 52 | No | 288 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 78 | No | 296 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 78 | Yes | 129 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 26 | Yes | 161 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 78 | Yes | 60 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 78 | No | 379 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 26 | No | 385 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 52 | No | 377 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 26 | Yes | 61 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 52 | Yes | 59 Participants |
Secondary
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)
Participants who achieved HbA1c \<7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | Yes | 116 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | No | 319 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | Yes | 113 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | No | 314 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 78 | Yes | 113 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 78 | No | 308 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 78 | No | 259 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | No | 263 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | Yes | 192 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | Yes | 168 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | No | 246 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 78 | Yes | 165 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | No | 190 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | Yes | 238 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | No | 196 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 78 | No | 234 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 78 | Yes | 191 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | Yes | 246 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 78 | Yes | 129 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 78 | No | 310 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | No | 302 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | No | 298 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | Yes | 144 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | Yes | 138 Participants |
Secondary
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)
Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26, 52 and 78 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | Yes | 87 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | No | 348 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | Yes | 87 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | No | 340 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 78 | Yes | 85 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 78 | No | 336 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 78 | No | 288 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | No | 297 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | Yes | 155 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | Yes | 134 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | No | 283 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 78 | Yes | 136 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | No | 228 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | Yes | 195 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | No | 239 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 78 | No | 274 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 78 | Yes | 151 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | Yes | 208 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 78 | Yes | 84 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 78 | No | 355 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | No | 356 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | No | 349 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | Yes | 90 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | Yes | 87 Participants |
Secondary
Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)
Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26, 52 and 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | No | 354 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | Yes | 55 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | Yes | 73 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | No | 380 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 78 | Yes | 76 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 78 | No | 345 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 78 | Yes | 113 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 78 | No | 311 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | No | 321 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | Yes | 106 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | Yes | 117 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | No | 325 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | No | 270 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 78 | Yes | 149 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | No | 270 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | Yes | 166 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | Yes | 164 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 78 | No | 276 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 78 | No | 379 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | No | 403 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | Yes | 51 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | No | 385 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 78 | Yes | 60 Participants |
| Sitagliptin 100 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | Yes | 43 Participants |
Secondary
Participants Who Achieve Weight Loss ≥10% (Yes/no)
Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at weeks 26, 52 and 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 26 | Yes | 5 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 26 | No | 433 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 52 | Yes | 13 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 52 | No | 415 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 78 | Yes | 12 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 78 | No | 413 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 78 | No | 382 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 52 | No | 402 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 26 | Yes | 23 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 52 | Yes | 31 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 26 | No | 417 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 78 | Yes | 43 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 26 | No | 410 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 52 | Yes | 48 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 52 | No | 387 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 78 | No | 382 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 78 | Yes | 46 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 26 | Yes | 29 Participants |
| Sitagliptin 100 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 78 | Yes | 17 Participants |
| Sitagliptin 100 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 78 | No | 426 Participants |
| Sitagliptin 100 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 26 | No | 439 Participants |
| Sitagliptin 100 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 52 | No | 426 Participants |
| Sitagliptin 100 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 26 | Yes | 8 Participants |
| Sitagliptin 100 mg | Participants Who Achieve Weight Loss ≥10% (Yes/no) | Week 52 | Yes | 11 Participants |
Secondary
Participants Who Achieve Weight Loss ≥5% (Yes/no)
Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 26, 52 and 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 26, week 52, week 78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 52 | No | 362 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 52 | Yes | 66 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 78 | No | 342 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 78 | Yes | 83 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 26 | No | 385 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 26 | Yes | 53 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 26 | Yes | 81 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 26 | No | 359 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 52 | Yes | 118 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 52 | No | 315 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 78 | Yes | 115 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 78 | No | 310 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 26 | No | 308 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 52 | No | 288 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 78 | No | 289 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 78 | Yes | 139 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 26 | Yes | 131 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 52 | Yes | 147 Participants |
| Sitagliptin 100 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 52 | Yes | 50 Participants |
| Sitagliptin 100 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 78 | No | 384 Participants |
| Sitagliptin 100 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 78 | Yes | 59 Participants |
| Sitagliptin 100 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 52 | No | 387 Participants |
| Sitagliptin 100 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 26 | Yes | 45 Participants |
| Sitagliptin 100 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 26 | No | 402 Participants |
Secondary
Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes
Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 83 (78-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time frame: Weeks 0-83
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 3 mg | Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 23 Participants |
| Oral Semaglutide 7 mg | Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 24 Participants |
| Oral Semaglutide 14 mg | Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 36 Participants |
| Sitagliptin 100 mg | Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 39 Participants |
Secondary
Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses
This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Semaglutide plasma concentrations for participants in the pharmacokinetic (PK) subpopulation are presented. The PK subpopulation consisted of participants from sites in Germany, Japan and the United States receiving oral semaglutide (3 mg, 7 mg or 14 mg). Results are based on the data from the on-treatment observation period and follow-up period. The on-treatment observation period was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Weeks 0-83
Population: Overall number of participants analysed = number of participants in the PK subpopulation. Number Analyzed = number of participants with available data in the PK subpopulation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 14 | 1.4 nmol/L | Geometric Coefficient of Variation 111.8 |
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 83 | 0.4 nmol/L | Geometric Coefficient of Variation 10.3 |
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 38 | 1.4 nmol/L | Geometric Coefficient of Variation 107.8 |
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 26 | 1.3 nmol/L | Geometric Coefficient of Variation 104.5 |
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 0 | 0.4 nmol/L | Geometric Coefficient of Variation 0 |
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 78 | 1.3 nmol/L | Geometric Coefficient of Variation 115.3 |
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 8 | 1.5 nmol/L | Geometric Coefficient of Variation 103.9 |
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 4 | 1.5 nmol/L | Geometric Coefficient of Variation 109.3 |
| Oral Semaglutide 3 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 52 | 1.4 nmol/L | Geometric Coefficient of Variation 105.8 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 26 | 3.7 nmol/L | Geometric Coefficient of Variation 122.5 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 0 | 0.4 nmol/L | Geometric Coefficient of Variation 0 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 4 | 1.5 nmol/L | Geometric Coefficient of Variation 102.1 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 8 | 4.1 nmol/L | Geometric Coefficient of Variation 129.4 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 14 | 4.0 nmol/L | Geometric Coefficient of Variation 146.8 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 38 | 3.5 nmol/L | Geometric Coefficient of Variation 106.4 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 52 | 3.5 nmol/L | Geometric Coefficient of Variation 119 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 78 | 3.5 nmol/L | Geometric Coefficient of Variation 127.2 |
| Oral Semaglutide 7 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 83 | 0.4 nmol/L | Geometric Coefficient of Variation 16.5 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 8 | 4.2 nmol/L | Geometric Coefficient of Variation 128 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 0 | 0.4 nmol/L | Geometric Coefficient of Variation 0 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 52 | 8.2 nmol/L | Geometric Coefficient of Variation 167 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 4 | 1.6 nmol/L | Geometric Coefficient of Variation 109.1 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 83 | 0.4 nmol/L | Geometric Coefficient of Variation 42.6 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 26 | 8.6 nmol/L | Geometric Coefficient of Variation 162.2 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 14 | 9.4 nmol/L | Geometric Coefficient of Variation 156.6 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 78 | 8.9 nmol/L | Geometric Coefficient of Variation 152.7 |
| Oral Semaglutide 14 mg | Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses | Week 38 | 8.6 nmol/L | Geometric Coefficient of Variation 163 |
Secondary
Time to Additional Anti-diabetic Medication
Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26, week 0 to week 52 and week 0 to week 78. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 78), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Weeks 0-78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 26 | 33 Participants |
| Oral Semaglutide 3 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 78 | 179 Participants |
| Oral Semaglutide 3 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 52 | 137 Participants |
| Oral Semaglutide 7 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 26 | 20 Participants |
| Oral Semaglutide 7 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 78 | 119 Participants |
| Oral Semaglutide 7 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 52 | 86 Participants |
| Oral Semaglutide 14 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 52 | 51 Participants |
| Oral Semaglutide 14 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 26 | 15 Participants |
| Oral Semaglutide 14 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 78 | 75 Participants |
| Sitagliptin 100 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 26 | 20 Participants |
| Sitagliptin 100 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 78 | 148 Participants |
| Sitagliptin 100 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 52 | 111 Participants |
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.p-value: =0.006395% CI: [1.09, 1.65]Regression, Cox
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.p-value: =0.022195% CI: [0.61, 0.96]Regression, Cox
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.p-value: <0.000195% CI: [0.41, 0.68]Regression, Cox
Secondary
Time to Rescue Medication
Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26, week 0 to week 52 and week 0 to week 78. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Time frame: Weeks 0-78
Population: Overall number of participants analyzed = FAS which comprised all randomised participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 3 mg | Time to Rescue Medication | Week 0 to week 26 | 25 Participants |
| Oral Semaglutide 3 mg | Time to Rescue Medication | Week 0 to week 78 | 160 Participants |
| Oral Semaglutide 3 mg | Time to Rescue Medication | Week 0 to week 52 | 121 Participants |
| Oral Semaglutide 7 mg | Time to Rescue Medication | Week 0 to week 26 | 11 Participants |
| Oral Semaglutide 7 mg | Time to Rescue Medication | Week 0 to week 78 | 103 Participants |
| Oral Semaglutide 7 mg | Time to Rescue Medication | Week 0 to week 52 | 73 Participants |
| Oral Semaglutide 14 mg | Time to Rescue Medication | Week 0 to week 52 | 31 Participants |
| Oral Semaglutide 14 mg | Time to Rescue Medication | Week 0 to week 26 | 5 Participants |
| Oral Semaglutide 14 mg | Time to Rescue Medication | Week 0 to week 78 | 47 Participants |
| Sitagliptin 100 mg | Time to Rescue Medication | Week 0 to week 26 | 13 Participants |
| Sitagliptin 100 mg | Time to Rescue Medication | Week 0 to week 78 | 129 Participants |
| Sitagliptin 100 mg | Time to Rescue Medication | Week 0 to week 52 | 94 Participants |
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: =0.01695% CI: [1.05, 1.68]Regression, Cox
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: =0.002295% CI: [0.51, 0.86]Regression, Cox
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: <0.000195% CI: [0.22, 0.43]Regression, Cox