Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Asia. The aim of this trial is to investigate Safety and efficacy of oral semaglutide versus dulaglutide both in combination with one OAD (oral antidiabetic drug) in Japanese subjects with type 2 diabetes.
Interventions
DRUGSemaglutide
Oral administration once-daily, as add-on to pre-trial oral antidiabetic drug (OAD).
DRUGDulaglutide
Subcutaneously administration (s.c., under the skin) once-weekly, as add-on to pre-trial oral antidiabetic drug (OAD).
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Japanese male or female, age above or equal to 20 years at the time of signing informed consent * Diagnosed with type 2 diabetes mellitus for at least 60 days prior to day of screening * HbA1c (glycosylated haemoglobin) between 7.0%-10.5% (53-91 mmol/mol) (both inclusive) * OAD (oral antidiabetic drug) monotherapy with stable daily dose for at least 60 days prior to the day of screening of one of SU (sulphonylurea) glinide , TZD (thiazolidinedione), α-GI (alpha-glucosidase inhibitor) or SGLT-2 (sodium-glucose cotransporter-2) inhibitor according to Japanese labelling
Exclusion criteria
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives * Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol * Family or personal history of multiple endocrine neoplasia type 2 (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 hospitalisation for unstable angina or transient ischaemic attack (TIA) within the past 180 days prior to the day of screening and randomisation * Subjects presently classified as being in New York Heart Association (NYHA) Class IV * Planned coronary, carotid or peripheral artery revascularisation known on the day of screening * Subjects with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL) * Renal impairment defined as estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) * Treatment with once-weekly glucagon-like peptide-1 receptor agonists (GLP-1 RA) or once weekly dipeptidyl peptidase-4 (DPP-4) inhibitor in a period of 90 days before the day of screening * For subjects treated with an OAD other than TZD at screening: Treatment with TZD in a period of 90 days before the day of screening * Treatment with any medication for the indication of diabetes or obesity in addition to background OAD medication (SU, glinide, TZD, α-GI or SGLT-2 inhibitor) in a period of 60 days before the day of screening with the exception of short-term insulin treatment for acute illness for a total of at least 14 days * Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation * History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in situ carcinomas) * History of diabetic ketoacidosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment-emergent Adverse Events (TEAEs) | Weeks 0-57 | Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Plasma Glucose | Week 0, week 26, week 52 | Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26 and 52. 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 Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile | Week 0, week 26, week 52 | Change from baseline (week 0) in mean 7-point SMPG profile was evaluated at weeks 26 and 52. 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 Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals | Week 0, week 26, week 52 | Change from baseline (week 0) in the average of the post-prandial increments over all meals was evaluated at weeks 26 and 52. 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) | Week 0, week 26, week 52 | Change from baseline (week 0) in body weight was evaluated at weeks 26 and 52. 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 | Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26 and 52. 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 Mass Index (BMI) | Week 0, week 26, week 52 | Change from baseline (week 0) in BMI was evaluated at weeks 26 and 52. 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 | Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52. 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 Fasting Total Cholesterol (Ratio to Baseline) | Week 0, week 26, week 52 | Change from baseline (week 0) in fasting total cholesterol (mmol/L) at weeks 26 and 52 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 Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline) | Week 0, week 26, week 52 | Change from baseline (week 0) in fasting low-density lipoprotein (LDL) (mmol/L) at weeks 26 and 52 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 Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline) | Week 0, week 26, week 52 | Change from baseline (week 0) in fasting high-density lipoprotein (HDL) (mmol/L) at weeks 26 and 52 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 Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline) | Week 0, week 26, week 52 | Change from baseline (week 0) in fasting very-low density lipoprotein (VLDL) (mmol/L) at weeks 26 and 52 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 Fasting Triglyceride (Ratio to Baseline) | Week 0, week 26, week 52 | Change from baseline (week 0) in fasting triglycerides (mmol/L) at weeks 26 and 52 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. |
| Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) | Week 26, week 52 | Participants who achieved HbA1c below 7.0% (53 millimoles per mole \[mmol/mol\]) according to American Diabetes Association (ADA) target (yes/no) at weeks 26 and 52 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 Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) | Week 26, week 52 | Participants who achieved HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) target (yes/no) at weeks 26 and 52 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 Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 26, week 52 | Participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia episodes and without weight gain (yes/no) at weeks 26 and 52 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. |
| Change in HbA1c | Week 0, week 26, week 52 | Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at weeks 26 and 52. 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 More Than or Equal to 5% (Yes/No). | Week 26, week 52 | Participants who achieved weight loss more than or equal to 5% (yes/no) at weeks 26 and 52 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 More Than or Equal to 10% (Yes/No) | Week 26, week 52 | Participants who achieved weight loss more than or equal to 10% (yes/no) at weeks 26 and 52 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 0-52 | Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. 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, 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 0-52 | Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. 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. |
| Change in Amylase (Ratio to Baseline) | Week 0, week 26, week 52 | Change from baseline (week 0) in amylase (measured as units per liter \[U/L\]) at weeks 26 and 52 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 | Change from baseline (week 0) in lipase (measured as U/L) at weeks 26 and 52 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 | Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52. 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 Blood Pressure | Week 0, week 26, week 52 | Change from baseline (week 0) in blood pressure (systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) was evaluated at weeks 26 and 52. 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 | Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. 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 and 52. 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 26, week 52 | Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2), week 26 and weeks 52 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 | Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 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. |
| Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes | Weeks 0-57 | Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-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. |
| Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | Weeks 0-57 | Participants with 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. |
| Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Week 0, week 26, week 52 | 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 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period. |
| Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | week 0, week 26, week 52 | DTR-QoL questionnaire is a 29-item patient-reported survey of patient health that measures the influence of diabetes treatment on health related-QoL on 4 domains on individual scale ranges: Burden on social activities and daily activities, Anxiety and dissatisfaction with treatment, Hypoglycemia and Satisfaction with treatment on a 7-point graded response scale. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100 (best-case response = 100; worst case response = 0). The total score, after simple addition of the item scores, is converted to 0 - 100 (best-case response = 100; worst case response = 0). Change from baseline (week 0) in the scores were evaluated at week 26, week 52. Data based on in-trial observation period is presented. W26 and W52 refer to week 26 and week 52 respectively. |
| Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) | Week 26, week 52 | Participants who achieved HbA1c reduction more than or equal to 1% (10.9 mmol/mol) and weight loss more than or equal to 3% (yes/no) at weeks 26 and 52 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. |
Countries
Japan
Participant flow
Recruitment details
The trial was conducted at 36 sites in Japan.
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 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52. | 131 |
| Oral Semaglutide 7 mg Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52. | 132 |
| Oral Semaglutide 14 mg Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52. | 130 |
| Dulaglutide 0.75 mg Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52. | 65 |
| Total | 458 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 2 | 2 |
Baseline characteristics
| Characteristic | Oral Semaglutide 3 mg | Oral Semaglutide 7 mg | Oral Semaglutide 14 mg | Dulaglutide 0.75 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 59 Years STANDARD_DEVIATION 10 | 58 Years STANDARD_DEVIATION 11 | 57 Years STANDARD_DEVIATION 10 | 61 Years STANDARD_DEVIATION 9 | 58 Years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 131 Participants | 132 Participants | 130 Participants | 65 Participants | 458 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 131 Participants | 132 Participants | 130 Participants | 65 Participants | 458 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 31 Participants | 42 Participants | 30 Participants | 14 Participants | 117 Participants |
| Sex: Female, Male Male | 100 Participants | 90 Participants | 100 Participants | 51 Participants | 341 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 131 | 0 / 132 | 0 / 130 | 0 / 65 |
| other Total, other adverse events | 65 / 131 | 79 / 132 | 84 / 130 | 36 / 65 |
| serious Total, serious adverse events | 9 / 131 | 4 / 132 | 7 / 130 | 1 / 65 |
Outcome results
Primary
Number of Treatment-emergent Adverse Events (TEAEs)
Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-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 0-57
Population: Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide 3 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 330 Events |
| Oral Semaglutide 7 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 350 Events |
| Oral Semaglutide 14 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 324 Events |
| Dulaglutide 0.75 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 178 Events |
Secondary
Change in Amylase (Ratio to Baseline)
Change from baseline (week 0) in amylase (measured as units per liter \[U/L\]) at weeks 26 and 52 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
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 52 | 1.03 Ratio of amylase | Geometric Coefficient of Variation 18.5 |
| Oral Semaglutide 3 mg | Change in Amylase (Ratio to Baseline) | Week 26 | 1.01 Ratio of amylase | Geometric Coefficient of Variation 15.1 |
| Oral Semaglutide 7 mg | Change in Amylase (Ratio to Baseline) | Week 26 | 1.07 Ratio of amylase | Geometric Coefficient of Variation 18.1 |
| Oral Semaglutide 7 mg | Change in Amylase (Ratio to Baseline) | Week 52 | 1.10 Ratio of amylase | Geometric Coefficient of Variation 23.8 |
| Oral Semaglutide 14 mg | Change in Amylase (Ratio to Baseline) | Week 26 | 1.10 Ratio of amylase | Geometric Coefficient of Variation 19.4 |
| Oral Semaglutide 14 mg | Change in Amylase (Ratio to Baseline) | Week 52 | 1.11 Ratio of amylase | Geometric Coefficient of Variation 20 |
| Dulaglutide 0.75 mg | Change in Amylase (Ratio to Baseline) | Week 52 | 1.07 Ratio of amylase | Geometric Coefficient of Variation 18.8 |
| Dulaglutide 0.75 mg | Change in Amylase (Ratio to Baseline) | Week 26 | 1.05 Ratio of amylase | Geometric Coefficient of Variation 23.4 |
Secondary
Change in Blood Pressure
Change from baseline (week 0) in blood pressure (systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) was evaluated at weeks 26 and 52. 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
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 Blood Pressure | Week 26: SBP | -3.0 Millimeters of mercury (mmHg) | Standard Deviation 13 |
| Oral Semaglutide 3 mg | Change in Blood Pressure | Week 52: SBP | -2.0 Millimeters of mercury (mmHg) | Standard Deviation 14 |
| Oral Semaglutide 3 mg | Change in Blood Pressure | Week 26: DBP | -1.0 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Oral Semaglutide 3 mg | Change in Blood Pressure | Week 52: DBP | 0.0 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Oral Semaglutide 7 mg | Change in Blood Pressure | Week 52: SBP | -2.0 Millimeters of mercury (mmHg) | Standard Deviation 13 |
| Oral Semaglutide 7 mg | Change in Blood Pressure | Week 26: DBP | -1.0 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Oral Semaglutide 7 mg | Change in Blood Pressure | Week 52: DBP | 0.0 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Oral Semaglutide 7 mg | Change in Blood Pressure | Week 26: SBP | -5.0 Millimeters of mercury (mmHg) | Standard Deviation 13 |
| Oral Semaglutide 14 mg | Change in Blood Pressure | Week 26: DBP | -2.0 Millimeters of mercury (mmHg) | Standard Deviation 10 |
| Oral Semaglutide 14 mg | Change in Blood Pressure | Week 52: SBP | -2.0 Millimeters of mercury (mmHg) | Standard Deviation 13 |
| Oral Semaglutide 14 mg | Change in Blood Pressure | Week 52: DBP | -1.0 Millimeters of mercury (mmHg) | Standard Deviation 10 |
| Oral Semaglutide 14 mg | Change in Blood Pressure | Week 26: SBP | -6.0 Millimeters of mercury (mmHg) | Standard Deviation 15 |
| Dulaglutide 0.75 mg | Change in Blood Pressure | Week 52: DBP | 0.0 Millimeters of mercury (mmHg) | Standard Deviation 9 |
| Dulaglutide 0.75 mg | Change in Blood Pressure | Week 52: SBP | -3.0 Millimeters of mercury (mmHg) | Standard Deviation 13 |
| Dulaglutide 0.75 mg | Change in Blood Pressure | Week 26: SBP | -4.0 Millimeters of mercury (mmHg) | Standard Deviation 12 |
| Dulaglutide 0.75 mg | Change in Blood Pressure | Week 26: DBP | -1.0 Millimeters of mercury (mmHg) | Standard Deviation 11 |
Secondary
Change in Body Mass Index (BMI)
Change from baseline (week 0) in BMI was evaluated at weeks 26 and 52. 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
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 Mass Index (BMI) | Week 26 | -0.1 Kilogram per square meter (kg/m^2) | Standard Deviation 0.7 |
| Oral Semaglutide 3 mg | Change in Body Mass Index (BMI) | Week 52 | -0.0 Kilogram per square meter (kg/m^2) | Standard Deviation 0.9 |
| Oral Semaglutide 7 mg | Change in Body Mass Index (BMI) | Week 52 | -0.3 Kilogram per square meter (kg/m^2) | Standard Deviation 1.3 |
| Oral Semaglutide 7 mg | Change in Body Mass Index (BMI) | Week 26 | -0.4 Kilogram per square meter (kg/m^2) | Standard Deviation 1.1 |
| Oral Semaglutide 14 mg | Change in Body Mass Index (BMI) | Week 26 | -0.8 Kilogram per square meter (kg/m^2) | Standard Deviation 1.2 |
| Oral Semaglutide 14 mg | Change in Body Mass Index (BMI) | Week 52 | -0.6 Kilogram per square meter (kg/m^2) | Standard Deviation 1.3 |
| Dulaglutide 0.75 mg | Change in Body Mass Index (BMI) | Week 26 | 0.1 Kilogram per square meter (kg/m^2) | Standard Deviation 0.8 |
| Dulaglutide 0.75 mg | Change in Body Mass Index (BMI) | Week 52 | 0.3 Kilogram per square meter (kg/m^2) | Standard Deviation 1 |
Secondary
Change in Body Weight (%)
Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26 and 52. 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
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 | -0.28 Percentage change | Standard Deviation 2.79 |
| Oral Semaglutide 3 mg | Change in Body Weight (%) | Week 52 | -0.02 Percentage change | Standard Deviation 3.28 |
| Oral Semaglutide 7 mg | Change in Body Weight (%) | Week 52 | -1.34 Percentage change | Standard Deviation 4.77 |
| Oral Semaglutide 7 mg | Change in Body Weight (%) | Week 26 | -1.49 Percentage change | Standard Deviation 4.25 |
| Oral Semaglutide 14 mg | Change in Body Weight (%) | Week 26 | -3.21 Percentage change | Standard Deviation 4.32 |
| Oral Semaglutide 14 mg | Change in Body Weight (%) | Week 52 | -2.33 Percentage change | Standard Deviation 4.67 |
| Dulaglutide 0.75 mg | Change in Body Weight (%) | Week 26 | 0.25 Percentage change | Standard Deviation 3.33 |
| Dulaglutide 0.75 mg | Change in Body Weight (%) | Week 52 | 1.25 Percentage change | Standard Deviation 4.06 |
Secondary
Change in Body Weight (kg)
Change from baseline (week 0) in body weight was evaluated at weeks 26 and 52. 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
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) | Week 52 | 0.0 kg | Standard Deviation 2.4 |
| Oral Semaglutide 3 mg | Change in Body Weight (kg) | Week 26 | -0.1 kg | Standard Deviation 2 |
| Oral Semaglutide 7 mg | Change in Body Weight (kg) | Week 52 | -0.9 kg | Standard Deviation 3.4 |
| Oral Semaglutide 7 mg | Change in Body Weight (kg) | Week 26 | -1.0 kg | Standard Deviation 3 |
| Oral Semaglutide 14 mg | Change in Body Weight (kg) | Week 26 | -2.2 kg | Standard Deviation 3.2 |
| Oral Semaglutide 14 mg | Change in Body Weight (kg) | Week 52 | -1.7 kg | Standard Deviation 3.5 |
| Dulaglutide 0.75 mg | Change in Body Weight (kg) | Week 52 | 1.0 kg | Standard Deviation 2.7 |
| Dulaglutide 0.75 mg | Change in Body Weight (kg) | Week 26 | 0.3 kg | Standard Deviation 2.1 |
Secondary
Change in ECG Evaluation
Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. 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 and 52. 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
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 | Abnormal (week 0) CS to abnormal NCS (week 52) | 0 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 NCS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to normal (week 52) | 2 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 52) | 2 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal CS (week 52) | 0 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal NCS (week 26) | 16 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal CS (week 26) | 2 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 26) | 4 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal NCS (week 52) | 13 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 52) | 103 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 52) | 3 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 26) | 103 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 26) | 2 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal CS (week 0) to normal (week 26) | 1 Participants |
| Oral Semaglutide 3 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal CS (week 52) | 3 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal CS (week 26) | 1 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal CS (week 52) | 0 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to normal (week 52) | 5 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 | Normal (week 0) to abnormal NCS (week 26) | 3 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal NCS (week 52) | 0 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal CS (week 52) | 0 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to normal (week 26) | 3 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal NCS (week 26) | 12 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 52) | 108 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal NCS (week 52) | 10 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 52) | 5 Participants |
| Oral Semaglutide 7 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal CS (week 26) | 0 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 normal (week 26) | 110 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 CS (week 0) to normal (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to normal (week 52) | 6 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 26) | 99 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 26) | 3 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to normal (week 26) | 4 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal NCS (week 26) | 18 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 52) | 6 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal CS (week 26) | 2 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal CS (week 26) | 2 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 52) | 95 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) CS to normal (week 52) | 0 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal NCS (week 52) | 18 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 abnormal NCS (week 52) | 0 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal CS (week 52) | 1 Participants |
| Dulaglutide 0.75 mg | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal NCS (week 26) | 0 Participants |
| Dulaglutide 0.75 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Dulaglutide 0.75 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal NCS (week 52) | 0 Participants |
| Dulaglutide 0.75 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal CS (week 52) | 0 Participants |
| Dulaglutide 0.75 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 26) | 54 Participants |
| Dulaglutide 0.75 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to abnormal NCS (week 52) | 3 Participants |
| Dulaglutide 0.75 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to normal (week 26) | 2 Participants |
| Dulaglutide 0.75 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Dulaglutide 0.75 mg | Change in ECG Evaluation | Abnormal CS (week 0) to normal (week 26) | 0 Participants |
| Dulaglutide 0.75 mg | Change in ECG Evaluation | Abnormal (week 0) CS to normal (week 52) | 0 Participants |
| Dulaglutide 0.75 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal NCS (week 26) | 4 Participants |
| Dulaglutide 0.75 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 26) | 4 Participants |
| Dulaglutide 0.75 mg | Change in ECG Evaluation | Abnormal (week 0) CS to abnormal CS (week 52) | 0 Participants |
| Dulaglutide 0.75 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 52) | 0 Participants |
| Dulaglutide 0.75 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 52) | 2 Participants |
| Dulaglutide 0.75 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 52) | 55 Participants |
| Dulaglutide 0.75 mg | Change in ECG Evaluation | Abnormal (week 0) NCS to normal (week 52) | 3 Participants |
| Dulaglutide 0.75 mg | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal CS (week 26) | 0 Participants |
Secondary
Change in Eye Examination Category
Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 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
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 | Right eye (week -2) | Normal | 94 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal NCS | 10 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week 52) | Normal | 90 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week -2) | Normal | 96 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 | Right eye (week 52) | Normal | 93 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal CS | 31 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal NCS | 7 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal NCS | 9 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal NCS | 6 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal CS | 26 Participants |
| Oral Semaglutide 3 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal CS | 28 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal CS | 33 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week -2) | Normal | 97 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week 52) | Normal | 92 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal NCS | 8 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal CS | 29 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week -2) | Normal | 98 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal NCS | 3 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal CS | 31 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week 52) | Normal | 90 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal NCS | 8 Participants |
| Oral Semaglutide 7 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal CS | 31 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal NCS | 6 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week -2) | Normal | 90 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week -2) | Normal | 89 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week 52) | Normal | 90 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week 52) | Normal | 93 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal CS | 38 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal CS | 31 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal NCS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal CS | 39 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal CS | 31 Participants |
| Dulaglutide 0.75 mg | Change in Eye Examination Category | Left eye (week 52) | Normal | 46 Participants |
| Dulaglutide 0.75 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal CS | 14 Participants |
| Dulaglutide 0.75 mg | Change in Eye Examination Category | Right eye (week -2) | Normal | 44 Participants |
| Dulaglutide 0.75 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal NCS | 6 Participants |
| Dulaglutide 0.75 mg | Change in Eye Examination Category | Left eye (week -2) | Normal | 48 Participants |
| Dulaglutide 0.75 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal NCS | 4 Participants |
| Dulaglutide 0.75 mg | Change in Eye Examination Category | Right eye (week -2) | Abnormal CS | 15 Participants |
| Dulaglutide 0.75 mg | Change in Eye Examination Category | Right eye (week 52) | Abnormal CS | 11 Participants |
| Dulaglutide 0.75 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal CS | 13 Participants |
| Dulaglutide 0.75 mg | Change in Eye Examination Category | Right eye (week 52) | Normal | 48 Participants |
| Dulaglutide 0.75 mg | Change in Eye Examination Category | Left eye (week 52) | Abnormal NCS | 3 Participants |
| Dulaglutide 0.75 mg | Change in Eye Examination Category | Left eye (week -2) | Abnormal NCS | 4 Participants |
Secondary
Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in fasting high-density lipoprotein (HDL) (mmol/L) at weeks 26 and 52 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
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 Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline) | Week 26 | 1.02 Ratio of fasting HDL | Geometric Coefficient of Variation 13.1 |
| Oral Semaglutide 3 mg | Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline) | Week 52 | 1.03 Ratio of fasting HDL | Geometric Coefficient of Variation 11.2 |
| Oral Semaglutide 7 mg | Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline) | Week 52 | 0.99 Ratio of fasting HDL | Geometric Coefficient of Variation 14.5 |
| Oral Semaglutide 7 mg | Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline) | Week 26 | 0.99 Ratio of fasting HDL | Geometric Coefficient of Variation 12.8 |
| Oral Semaglutide 14 mg | Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline) | Week 26 | 1.00 Ratio of fasting HDL | Geometric Coefficient of Variation 12.5 |
| Oral Semaglutide 14 mg | Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline) | Week 52 | 1.01 Ratio of fasting HDL | Geometric Coefficient of Variation 13.1 |
| Dulaglutide 0.75 mg | Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline) | Week 26 | 0.99 Ratio of fasting HDL | Geometric Coefficient of Variation 11.6 |
| Dulaglutide 0.75 mg | Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline) | Week 52 | 1.00 Ratio of fasting HDL | Geometric Coefficient of Variation 11.6 |
Secondary
Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in fasting low-density lipoprotein (LDL) (mmol/L) at weeks 26 and 52 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
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 Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline) | Week 26 | 0.92 Ratio of fasting LDL | Geometric Coefficient of Variation 15.9 |
| Oral Semaglutide 3 mg | Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline) | Week 52 | 0.98 Ratio of fasting LDL | Geometric Coefficient of Variation 17.4 |
| Oral Semaglutide 7 mg | Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline) | Week 52 | 0.94 Ratio of fasting LDL | Geometric Coefficient of Variation 19 |
| Oral Semaglutide 7 mg | Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline) | Week 26 | 0.88 Ratio of fasting LDL | Geometric Coefficient of Variation 18.4 |
| Oral Semaglutide 14 mg | Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline) | Week 26 | 0.87 Ratio of fasting LDL | Geometric Coefficient of Variation 20.7 |
| Oral Semaglutide 14 mg | Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline) | Week 52 | 0.92 Ratio of fasting LDL | Geometric Coefficient of Variation 18.6 |
| Dulaglutide 0.75 mg | Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline) | Week 26 | 0.88 Ratio of fasting LDL | Geometric Coefficient of Variation 14.5 |
| Dulaglutide 0.75 mg | Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline) | Week 52 | 0.91 Ratio of fasting LDL | Geometric Coefficient of Variation 16.2 |
Secondary
Change in Fasting Plasma Glucose
Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26 and 52. 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
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 Fasting Plasma Glucose | Week 26 | -1.23 mmol/L | Standard Deviation 1.54 |
| Oral Semaglutide 3 mg | Change in Fasting Plasma Glucose | Week 52 | -0.95 mmol/L | Standard Deviation 1.72 |
| Oral Semaglutide 7 mg | Change in Fasting Plasma Glucose | Week 52 | -1.96 mmol/L | Standard Deviation 1.72 |
| Oral Semaglutide 7 mg | Change in Fasting Plasma Glucose | Week 26 | -2.25 mmol/L | Standard Deviation 1.93 |
| Oral Semaglutide 14 mg | Change in Fasting Plasma Glucose | Week 52 | -2.18 mmol/L | Standard Deviation 2.5 |
| Oral Semaglutide 14 mg | Change in Fasting Plasma Glucose | Week 26 | -2.72 mmol/L | Standard Deviation 1.86 |
| Dulaglutide 0.75 mg | Change in Fasting Plasma Glucose | Week 26 | -2.22 mmol/L | Standard Deviation 1.71 |
| Dulaglutide 0.75 mg | Change in Fasting Plasma Glucose | Week 52 | -1.80 mmol/L | Standard Deviation 1.71 |
Secondary
Change in Fasting Total Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in fasting total cholesterol (mmol/L) at weeks 26 and 52 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
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 Fasting Total Cholesterol (Ratio to Baseline) | Week 52 | 0.98 Ratio of fasting total cholesterol | Geometric Coefficient of Variation 12.7 |
| Oral Semaglutide 3 mg | Change in Fasting Total Cholesterol (Ratio to Baseline) | Week 26 | 0.96 Ratio of fasting total cholesterol | Geometric Coefficient of Variation 9.4 |
| Oral Semaglutide 7 mg | Change in Fasting Total Cholesterol (Ratio to Baseline) | Week 52 | 0.95 Ratio of fasting total cholesterol | Geometric Coefficient of Variation 13.3 |
| Oral Semaglutide 7 mg | Change in Fasting Total Cholesterol (Ratio to Baseline) | Week 26 | 0.91 Ratio of fasting total cholesterol | Geometric Coefficient of Variation 12.3 |
| Oral Semaglutide 14 mg | Change in Fasting Total Cholesterol (Ratio to Baseline) | Week 26 | 0.91 Ratio of fasting total cholesterol | Geometric Coefficient of Variation 12.3 |
| Oral Semaglutide 14 mg | Change in Fasting Total Cholesterol (Ratio to Baseline) | Week 52 | 0.94 Ratio of fasting total cholesterol | Geometric Coefficient of Variation 12.5 |
| Dulaglutide 0.75 mg | Change in Fasting Total Cholesterol (Ratio to Baseline) | Week 26 | 0.92 Ratio of fasting total cholesterol | Geometric Coefficient of Variation 8.8 |
| Dulaglutide 0.75 mg | Change in Fasting Total Cholesterol (Ratio to Baseline) | Week 52 | 0.93 Ratio of fasting total cholesterol | Geometric Coefficient of Variation 11.4 |
Secondary
Change in Fasting Triglyceride (Ratio to Baseline)
Change from baseline (week 0) in fasting triglycerides (mmol/L) at weeks 26 and 52 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
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 Fasting Triglyceride (Ratio to Baseline) | Week 52 | 0.89 Ratio of fasting triglycerides | Geometric Coefficient of Variation 33.9 |
| Oral Semaglutide 3 mg | Change in Fasting Triglyceride (Ratio to Baseline) | Week 26 | 1.03 Ratio of fasting triglycerides | Geometric Coefficient of Variation 41.1 |
| Oral Semaglutide 7 mg | Change in Fasting Triglyceride (Ratio to Baseline) | Week 26 | 0.91 Ratio of fasting triglycerides | Geometric Coefficient of Variation 34.1 |
| Oral Semaglutide 7 mg | Change in Fasting Triglyceride (Ratio to Baseline) | Week 52 | 0.87 Ratio of fasting triglycerides | Geometric Coefficient of Variation 43 |
| Oral Semaglutide 14 mg | Change in Fasting Triglyceride (Ratio to Baseline) | Week 26 | 0.96 Ratio of fasting triglycerides | Geometric Coefficient of Variation 34 |
| Oral Semaglutide 14 mg | Change in Fasting Triglyceride (Ratio to Baseline) | Week 52 | 0.87 Ratio of fasting triglycerides | Geometric Coefficient of Variation 38.3 |
| Dulaglutide 0.75 mg | Change in Fasting Triglyceride (Ratio to Baseline) | Week 52 | 0.88 Ratio of fasting triglycerides | Geometric Coefficient of Variation 30.8 |
| Dulaglutide 0.75 mg | Change in Fasting Triglyceride (Ratio to Baseline) | Week 26 | 0.93 Ratio of fasting triglycerides | Geometric Coefficient of Variation 33.7 |
Secondary
Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline)
Change from baseline (week 0) in fasting very-low density lipoprotein (VLDL) (mmol/L) at weeks 26 and 52 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
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 Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline) | Week 26 | 1.03 Ratio of fasting VLDL | Geometric Coefficient of Variation 37.9 |
| Oral Semaglutide 3 mg | Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline) | Week 52 | 0.90 Ratio of fasting VLDL | Geometric Coefficient of Variation 33.3 |
| Oral Semaglutide 7 mg | Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline) | Week 52 | 0.87 Ratio of fasting VLDL | Geometric Coefficient of Variation 39.4 |
| Oral Semaglutide 7 mg | Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline) | Week 26 | 0.92 Ratio of fasting VLDL | Geometric Coefficient of Variation 32.3 |
| Oral Semaglutide 14 mg | Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline) | Week 26 | 0.96 Ratio of fasting VLDL | Geometric Coefficient of Variation 33.6 |
| Oral Semaglutide 14 mg | Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline) | Week 52 | 0.86 Ratio of fasting VLDL | Geometric Coefficient of Variation 36.9 |
| Dulaglutide 0.75 mg | Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline) | Week 26 | 0.93 Ratio of fasting VLDL | Geometric Coefficient of Variation 33.5 |
| Dulaglutide 0.75 mg | Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline) | Week 52 | 0.88 Ratio of fasting VLDL | Geometric Coefficient of Variation 31.6 |
Secondary
Change in HbA1c
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at weeks 26 and 52. 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
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 | -1.1 Percentage of HbA1c | Standard Deviation 0.9 |
| Oral Semaglutide 3 mg | Change in HbA1c | Week 52 | -0.8 Percentage of HbA1c | Standard Deviation 1 |
| Oral Semaglutide 7 mg | Change in HbA1c | Week 52 | -1.4 Percentage of HbA1c | Standard Deviation 1 |
| Oral Semaglutide 7 mg | Change in HbA1c | Week 26 | -1.7 Percentage of HbA1c | Standard Deviation 0.9 |
| Oral Semaglutide 14 mg | Change in HbA1c | Week 26 | -2.0 Percentage of HbA1c | Standard Deviation 1 |
| Oral Semaglutide 14 mg | Change in HbA1c | Week 52 | -1.8 Percentage of HbA1c | Standard Deviation 1 |
| Dulaglutide 0.75 mg | Change in HbA1c | Week 26 | -1.6 Percentage of HbA1c | Standard Deviation 0.9 |
| Dulaglutide 0.75 mg | Change in HbA1c | Week 52 | -1.4 Percentage of HbA1c | Standard Deviation 0.9 |
Secondary
Change in Lipase (Ratio to Baseline)
Change from baseline (week 0) in lipase (measured as U/L) at weeks 26 and 52 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
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 | 1.15 Ratio of lipase | Geometric Coefficient of Variation 37.4 |
| Oral Semaglutide 3 mg | Change in Lipase (Ratio to Baseline) | Week 52 | 1.11 Ratio of lipase | Geometric Coefficient of Variation 34.7 |
| Oral Semaglutide 7 mg | Change in Lipase (Ratio to Baseline) | Week 52 | 1.36 Ratio of lipase | Geometric Coefficient of Variation 50.3 |
| Oral Semaglutide 7 mg | Change in Lipase (Ratio to Baseline) | Week 26 | 1.27 Ratio of lipase | Geometric Coefficient of Variation 35.8 |
| Oral Semaglutide 14 mg | Change in Lipase (Ratio to Baseline) | Week 26 | 1.40 Ratio of lipase | Geometric Coefficient of Variation 42.8 |
| Oral Semaglutide 14 mg | Change in Lipase (Ratio to Baseline) | Week 52 | 1.40 Ratio of lipase | Geometric Coefficient of Variation 42 |
| Dulaglutide 0.75 mg | Change in Lipase (Ratio to Baseline) | Week 26 | 1.14 Ratio of lipase | Geometric Coefficient of Variation 48.3 |
| Dulaglutide 0.75 mg | Change in Lipase (Ratio to Baseline) | Week 52 | 1.15 Ratio of lipase | Geometric Coefficient of Variation 57.7 |
Secondary
Change in Physical Examination
Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2), week 26 and weeks 52 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 26, week 52
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 | 3) Gastrointestinal system, incl. mouth (week 26) | Abnormal CS | 6 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal CS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6. Lymph node palpation (week 52) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4.General appearance (week -2) | Normal | 131 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Normal | 131 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Normal | 128 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4.General appearance (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7. Musculoskeletal system (week -2) | Normal | 128 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal CS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4.General appearance (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal NCS | 0 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 | 2) Central and peripheral nervous system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4.General appearance (week 26) | Normal | 127 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal CS | 3 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7. Musculoskeletal system (week 26) | Normal | 123 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4.General appearance (week 26) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week 26) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4.General appearance (week 26) | Abnormal CS | 0 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 | 8) Respiratory system (week 52) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4.General appearance (week 52) | Normal | 126 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Normal | 128 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Normal | 131 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4.General appearance (week 52) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7. Musculoskeletal system (week 26) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week 52) | Normal | 123 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week 26) | Normal | 124 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 4.General appearance (week 52) | Abnormal CS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Normal | 126 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal CS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week -2) | Normal | 121 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7. Musculoskeletal system (week -2) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Normal | 122 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7. Musculoskeletal system (week 26) | Abnormal CS | 3 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week -2) | Abnormal CS | 7 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6. Lymph node palpation (week 52) | Normal | 127 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 56) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 26) | Normal | 119 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Normal | 130 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Normal | 127 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 26) | Abnormal NCS | 4 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Normal | 125 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Normal | 122 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal NCS | 3 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 26) | Abnormal CS | 5 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 56) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 52) | Normal | 117 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Normal | 126 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 52) | Abnormal NCS | 3 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Abnormal CS | 3 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7. Musculoskeletal system (week 52) | Abnormal NCS | 4 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Normal | 128 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 52) | Abnormal CS | 7 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7. Musculoskeletal system (week -2) | Abnormal CS | 2 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal CS | 5 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 56) | Normal | 127 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6. Lymph node palpation (week -2) | Normal | 131 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Normal | 124 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Normal | 128 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 | 6. Lymph node palpation (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week -2) | Normal | 125 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) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week -2) | Abnormal NCS | 3 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7. Musculoskeletal system (week 52) | Abnormal CS | 3 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6. Lymph node palpation (week 26) | Normal | 128 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 7. Musculoskeletal system (week 52) | Normal | 120 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6. Lymph node palpation (week 26) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal CS | 4 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 9) Skin (week 26) | Abnormal CS | 3 Participants |
| Oral Semaglutide 3 mg | Change in Physical Examination | 6. Lymph node palpation (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 52) | Abnormal CS | 5 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6. Lymph node palpation (week 26) | Normal | 127 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6. Lymph node palpation (week 52) | Normal | 128 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week 26) | Abnormal NCS | 0 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 | 6. Lymph node palpation (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 56) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week 26) | Normal | 127 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7. Musculoskeletal system (week -2) | Normal | 126 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7. Musculoskeletal system (week 26) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7. Musculoskeletal system (week -2) | Abnormal NCS | 3 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal CS | 5 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7. Musculoskeletal system (week -2) | Abnormal CS | 3 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7. Musculoskeletal system (week 26) | Normal | 123 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Normal | 127 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7. Musculoskeletal system (week 26) | Abnormal CS | 3 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7. Musculoskeletal system (week 52) | Normal | 125 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week -2) | Normal | 127 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7. Musculoskeletal system (week 52) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 7. Musculoskeletal system (week 52) | Abnormal CS | 3 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Normal | 132 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal NCS | 0 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 | 8) Respiratory system (week 52) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Normal | 127 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Normal | 129 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 56) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Normal | 128 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week 52) | Normal | 127 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 56) | Normal | 128 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Normal | 132 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal CS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Normal | 127 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4.General appearance (week -2) | Normal | 132 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4.General appearance (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4.General appearance (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4.General appearance (week 26) | Normal | 128 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4.General appearance (week 26) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4.General appearance (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Normal | 131 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4.General appearance (week 52) | Normal | 128 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4.General appearance (week 52) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 4.General appearance (week 52) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Normal | 128 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week -2) | Normal | 127 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week -2) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Normal | 123 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week -2) | Abnormal CS | 3 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Normal | 129 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 26) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 26) | Abnormal CS | 5 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Normal | 124 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal CS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Normal | 128 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 52) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal NCS | 3 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6. Lymph node palpation (week 26) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6. Lymph node palpation (week -2) | Normal | 131 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Abnormal CS | 3 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 | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6. Lymph node palpation (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Normal | 130 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 26) | Normal | 122 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 9) Skin (week 26) | Abnormal CS | 1 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 6. Lymph node palpation (week 26) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 7 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 52) | Normal | 123 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4.General appearance (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week 52) | Normal | 125 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Normal | 128 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Normal | 126 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 56) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Normal | 129 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4.General appearance (week -2) | Normal | 130 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week 26) | Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Normal | 125 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Normal | 128 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4.General appearance (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4.General appearance (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4.General appearance (week 26) | Normal | 127 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4.General appearance (week 26) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4.General appearance (week 52) | Normal | 127 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4.General appearance (week 52) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4.General appearance (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week -2) | Normal | 124 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week -2) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week -2) | Abnormal CS | 4 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 26) | Normal | 125 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 26) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 26) | Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 52) | Normal | 122 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 52) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 52) | Abnormal CS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6. Lymph node palpation (week -2) | Normal | 129 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6. Lymph node palpation (week -2) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6. Lymph node palpation (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6. Lymph node palpation (week 26) | Normal | 128 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6. Lymph node palpation (week 26) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6. Lymph node palpation (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6. Lymph node palpation (week 52) | Normal | 127 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6. Lymph node palpation (week 52) | Abnormal NCS | 0 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 | 7. Musculoskeletal system (week -2) | Normal | 127 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7. Musculoskeletal system (week -2) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7. Musculoskeletal system (week -2) | Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7. Musculoskeletal system (week 26) | Normal | 124 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7. Musculoskeletal system (week 26) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7. Musculoskeletal system (week 26) | Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7. Musculoskeletal system (week 52) | Normal | 123 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7. Musculoskeletal system (week 52) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7. Musculoskeletal system (week 52) | Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Normal | 130 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Normal | 128 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Normal | 127 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week -2) | Normal | 128 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week 26) | Normal | 126 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (week 26) | Abnormal NCS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Normal | 129 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Normal | 127 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Normal | 130 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Normal | 128 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 56) | Normal | 126 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 56) | Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Normal | 125 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Normal | 126 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 7. Musculoskeletal system (week -2) | Normal | 64 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 6. Lymph node palpation (week 52) | Abnormal CS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal NCS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 9) Skin (week 26) | Normal | 62 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 6. Lymph node palpation (week 52) | Abnormal NCS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 6. Lymph node palpation (week 52) | Normal | 63 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Normal | 59 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 9) Skin (week 26) | Abnormal NCS | 1 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 6. Lymph node palpation (week 26) | Abnormal NCS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 6. Lymph node palpation (week 26) | Normal | 64 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 6. Lymph node palpation (week -2) | Abnormal CS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal CS | 2 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Normal | 64 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 6. Lymph node palpation (week -2) | Abnormal NCS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal CS | 5 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal NCS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 6. Lymph node palpation (week -2) | Normal | 65 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 52) | Abnormal CS | 6 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 10) Thyroid gland (week -2) | Abnormal CS | 1 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 52) | Abnormal NCS | 4 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 52) | Normal | 53 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Abnormal NCS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 26) | Abnormal CS | 5 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 26) | Abnormal NCS | 3 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Abnormal CS | 1 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week 26) | Normal | 56 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week -2) | Abnormal CS | 6 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Abnormal NCS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Normal | 62 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week -2) | Abnormal NCS | 4 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 5.Head, ears, eyes, nose, throat, neck (week -2) | Normal | 55 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Normal | 60 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal CS | 1 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 4.General appearance (week 52) | Abnormal CS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 4.General appearance (week 52) | Abnormal NCS | 1 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 9) Skin (week 52) | Normal | 61 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal CS | 4 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 4.General appearance (week 52) | Normal | 62 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 4.General appearance (week 26) | Abnormal CS | 1 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Normal | 60 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Normal | 64 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 4.General appearance (week 26) | Abnormal NCS | 1 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 4.General appearance (week 26) | Normal | 62 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Abnormal CS | 2 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Normal | 62 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal NCS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 4.General appearance (week -2) | Abnormal CS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 4.General appearance (week -2) | Abnormal NCS | 1 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal NCS | 1 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week -2) | Abnormal CS | 1 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 4.General appearance (week -2) | Normal | 64 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 52) | Abnormal CS | 4 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 10) Thyroid gland (week 52) | Abnormal NCS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Abnormal NCS | 1 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 1) Cardiovascular system (week 52) | Normal | 58 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 26) | Abnormal NCS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Normal | 60 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Abnormal CS | 4 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Abnormal NCS | 1 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 10) Thyroid gland (week 26) | Normal | 63 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 56) | Normal | 62 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 1) Cardiovascular system (week 26) | Normal | 59 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 1) Cardiovascular system (week -2) | Abnormal CS | 4 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 56) | Abnormal NCS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal NCS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 7. Musculoskeletal system (week 26) | Normal | 61 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Abnormal NCS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 9) Skin (week 52) | Abnormal NCS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Abnormal CS | 2 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 8) Respiratory system (week 26) | Normal | 62 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 2) Central and peripheral nervous system (week 56) | Abnormal CS | 1 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Normal | 62 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal CS | 1 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Abnormal NCS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 8) Respiratory system (week -2) | Normal | 64 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 7. Musculoskeletal system (week 52) | Abnormal CS | 1 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 6. Lymph node palpation (week 26) | Abnormal CS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 8) Respiratory system (week 52) | Abnormal CS | 1 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 7. Musculoskeletal system (week 52) | Abnormal NCS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 7. Musculoskeletal system (week 52) | Normal | 62 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 9) Skin (week 26) | Abnormal CS | 1 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 9) Skin (week -2) | Normal | 63 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 7. Musculoskeletal system (week 26) | Abnormal CS | 3 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 7. Musculoskeletal system (week 26) | Abnormal NCS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week 26) | Abnormal CS | 4 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal NCS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 7. Musculoskeletal system (week -2) | Abnormal CS | 1 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 7. Musculoskeletal system (week -2) | Abnormal NCS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (week -2) | Abnormal NCS | 0 Participants |
| Dulaglutide 0.75 mg | Change in Physical Examination | 9) Skin (week -2) | Abnormal CS | 2 Participants |
Secondary
Change in Pulse Rate
Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52. 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
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 | 3 Beats per minute (beats/min) | Standard Deviation 9 |
| Oral Semaglutide 3 mg | Change in Pulse Rate | Week 52 | 3 Beats per minute (beats/min) | Standard Deviation 10 |
| Oral Semaglutide 7 mg | Change in Pulse Rate | Week 52 | 3 Beats per minute (beats/min) | Standard Deviation 9 |
| Oral Semaglutide 7 mg | Change in Pulse Rate | Week 26 | 4 Beats per minute (beats/min) | Standard Deviation 10 |
| Oral Semaglutide 14 mg | Change in Pulse Rate | Week 26 | 4 Beats per minute (beats/min) | Standard Deviation 9 |
| Oral Semaglutide 14 mg | Change in Pulse Rate | Week 52 | 3 Beats per minute (beats/min) | Standard Deviation 9 |
| Dulaglutide 0.75 mg | Change in Pulse Rate | Week 26 | 4 Beats per minute (beats/min) | Standard Deviation 9 |
| Dulaglutide 0.75 mg | Change in Pulse Rate | Week 52 | 2 Beats per minute (beats/min) | Standard Deviation 10 |
Secondary
Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile
Change from baseline (week 0) in mean 7-point SMPG profile was evaluated at weeks 26 and 52. 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
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 Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile | Week 26 | -1.8 mmol/L | Standard Deviation 2.2 |
| Oral Semaglutide 3 mg | Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile | Week 52 | -1.7 mmol/L | Standard Deviation 2.1 |
| Oral Semaglutide 7 mg | Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile | Week 52 | -2.5 mmol/L | Standard Deviation 2.4 |
| Oral Semaglutide 7 mg | Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile | Week 26 | -2.7 mmol/L | Standard Deviation 2.1 |
| Oral Semaglutide 14 mg | Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile | Week 26 | -3.5 mmol/L | Standard Deviation 2.3 |
| Oral Semaglutide 14 mg | Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile | Week 52 | -3.3 mmol/L | Standard Deviation 2.6 |
| Dulaglutide 0.75 mg | Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile | Week 26 | -2.9 mmol/L | Standard Deviation 2.4 |
| Dulaglutide 0.75 mg | Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile | Week 52 | -2.6 mmol/L | Standard Deviation 2.6 |
Secondary
Change in Self-measured Plasma Glucose (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 and 52. 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
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 Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals | Week 26 | -0.9 mmol/L | Standard Deviation 2.5 |
| Oral Semaglutide 3 mg | Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals | Week 52 | -0.6 mmol/L | Standard Deviation 2.6 |
| Oral Semaglutide 7 mg | Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals | Week 52 | -0.8 mmol/L | Standard Deviation 2 |
| Oral Semaglutide 7 mg | Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals | Week 26 | -1.3 mmol/L | Standard Deviation 2 |
| Oral Semaglutide 14 mg | Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals | Week 26 | -1.2 mmol/L | Standard Deviation 2.4 |
| Oral Semaglutide 14 mg | Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals | Week 52 | -0.9 mmol/L | Standard Deviation 2.6 |
| Dulaglutide 0.75 mg | Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals | Week 26 | -0.7 mmol/L | Standard Deviation 2.3 |
| Dulaglutide 0.75 mg | Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals | Week 52 | -0.7 mmol/L | Standard Deviation 2.3 |
Secondary
Change in SF-36v2 (Acute Version) Health Survey Scores: 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 and 52. 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
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: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (week 52) | -0.37 Score on a scale | Standard Deviation 3.34 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (week 26) | -0.77 Score on a scale | Standard Deviation 5.87 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4)General Health (week 52) | -0.34 Score on a scale | Standard Deviation 5.27 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (week 26) | -0.18 Score on a scale | Standard Deviation 3.34 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role Physical (week 26) | -0.58 Score on a scale | Standard Deviation 5.12 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4)General Health (week 26) | 0.42 Score on a scale | Standard Deviation 4.59 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary (week 52) | -0.88 Score on a scale | Standard Deviation 4.73 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role Physical (week 52) | -0.92 Score on a scale | Standard Deviation 5.66 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (week 52) | -1.02 Score on a scale | Standard Deviation 7.7 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily Pain (week 52) | -2.72 Score on a scale | Standard Deviation 9.74 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily Pain (week 26) | -0.88 Score on a scale | Standard Deviation 8.39 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (week 26) | -1.03 Score on a scale | Standard Deviation 6.54 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (week 26) | -0.54 Score on a scale | Standard Deviation 7.87 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary (week 26) | -1.13 Score on a scale | Standard Deviation 6.54 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (week 52) | -0.90 Score on a scale | Standard Deviation 7.29 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (week 26) | -1.62 Score on a scale | Standard Deviation 7.49 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (week 52) | -1.98 Score on a scale | Standard Deviation 8.1 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary (week 52) | -1.52 Score on a scale | Standard Deviation 7.26 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary (week 26) | -0.17 Score on a scale | Standard Deviation 4.19 |
| Oral Semaglutide 3 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (week 52) | -1.64 Score on a scale | Standard Deviation 7.63 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (week 26) | -0.79 Score on a scale | Standard Deviation 7.08 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (week 52) | -0.35 Score on a scale | Standard Deviation 6.68 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary (week 26) | 0.14 Score on a scale | Standard Deviation 4.27 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary (week 52) | 0.19 Score on a scale | Standard Deviation 4.91 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary (week 26) | -0.07 Score on a scale | Standard Deviation 5.85 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role Physical (week 26) | 0.59 Score on a scale | Standard Deviation 5.49 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary (week 52) | -0.19 Score on a scale | Standard Deviation 6.31 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (week 26) | 0.08 Score on a scale | Standard Deviation 4.04 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (week 52) | 0.70 Score on a scale | Standard Deviation 4.08 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: 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 5.95 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (week 52) | -0.42 Score on a scale | Standard Deviation 6.8 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: 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 6.13 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily Pain (week 26) | 0.05 Score on a scale | Standard Deviation 8.26 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily Pain (week 52) | -0.27 Score on a scale | Standard Deviation 8.88 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4)General Health (week 26) | 0.09 Score on a scale | Standard Deviation 5.26 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (week 52) | 0.59 Score on a scale | Standard Deviation 6.89 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4)General Health (week 52) | 0.01 Score on a scale | Standard Deviation 5.27 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (week 52) | -0.11 Score on a scale | Standard Deviation 7.03 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (week 26) | 0.16 Score on a scale | Standard Deviation 6.66 |
| Oral Semaglutide 7 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (week 26) | 0.42 Score on a scale | Standard Deviation 6.96 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (week 52) | -1.05 Score on a scale | Standard Deviation 8.16 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (week 52) | -0.02 Score on a scale | Standard Deviation 4.27 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (week 26) | -1.16 Score on a scale | Standard Deviation 6.6 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4)General Health (week 52) | 0.59 Score on a scale | Standard Deviation 6.13 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (week 26) | -0.06 Score on a scale | Standard Deviation 4.16 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary (week 26) | -0.71 Score on a scale | Standard Deviation 5.91 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (week 26) | -0.83 Score on a scale | Standard Deviation 6.84 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary (week 52) | -0.03 Score on a scale | Standard Deviation 5.34 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (week 52) | 0.27 Score on a scale | Standard Deviation 7.58 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (week 52) | 0.09 Score on a scale | Standard Deviation 6.83 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary (week 26) | -0.23 Score on a scale | Standard Deviation 5.24 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: 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 6.08 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (week 26) | -0.41 Score on a scale | Standard Deviation 7.32 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily Pain (week 26) | -0.99 Score on a scale | Standard Deviation 9.32 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role Physical (week 52) | -0.92 Score on a scale | Standard Deviation 7.26 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: 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 6.15 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily Pain (week 52) | 0.01 Score on a scale | Standard Deviation 9.48 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role Physical (week 26) | -1.01 Score on a scale | Standard Deviation 6 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (week 52) | -0.12 Score on a scale | Standard Deviation 5.92 |
| Oral Semaglutide 14 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4)General Health (week 26) | 0.71 Score on a scale | Standard Deviation 5.94 |
| Dulaglutide 0.75 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary (week 52) | -0.74 Score on a scale | Standard Deviation 8.57 |
| Dulaglutide 0.75 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 3) Bodily Pain (week 52) | 0.24 Score on a scale | Standard Deviation 5.77 |
| Dulaglutide 0.75 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (week 52) | -0.86 Score on a scale | Standard Deviation 7.63 |
| Dulaglutide 0.75 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 6) Social functioning (week 52) | -0.08 Score on a scale | Standard Deviation 6.73 |
| Dulaglutide 0.75 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (week 52) | -1.21 Score on a scale | Standard Deviation 7.31 |
| Dulaglutide 0.75 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (week 26) | 0.27 Score on a scale | Standard Deviation 7.34 |
| Dulaglutide 0.75 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary (week 52) | -0.24 Score on a scale | Standard Deviation 4.52 |
| Dulaglutide 0.75 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (week 26) | -0.24 Score on a scale | Standard Deviation 3.71 |
| Dulaglutide 0.75 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 1) Physical functioning (week 52) | -0.61 Score on a scale | Standard Deviation 5.01 |
| Dulaglutide 0.75 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role Physical (week 26) | -0.48 Score on a scale | Standard Deviation 5.22 |
| Dulaglutide 0.75 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 2) Role Physical (week 52) | -0.28 Score on a scale | Standard Deviation 5.31 |
| Dulaglutide 0.75 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: 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 7.25 |
| Dulaglutide 0.75 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4)General Health (week 26) | -1.03 Score on a scale | Standard Deviation 5.28 |
| Dulaglutide 0.75 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 4)General Health (week 52) | -0.97 Score on a scale | Standard Deviation 6.63 |
| Dulaglutide 0.75 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 5) Vitality (week 26) | -1.40 Score on a scale | Standard Deviation 7.94 |
| Dulaglutide 0.75 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: 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 4.98 |
| Dulaglutide 0.75 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 7) Role emotional (week 26) | -1.01 Score on a scale | Standard Deviation 6.28 |
| Dulaglutide 0.75 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | 8) Mental health (week 52) | -0.31 Score on a scale | Standard Deviation 10.24 |
| Dulaglutide 0.75 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Physical component summary (week 26) | -0.57 Score on a scale | Standard Deviation 4.8 |
| Dulaglutide 0.75 mg | Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) | Mental component summary (week 26) | -0.42 Score on a scale | Standard Deviation 6.04 |
Secondary
Change in Waist Circumference
Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52. 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
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 | 0.0 Centimeters (cm) | Standard Deviation 3.1 |
| Oral Semaglutide 3 mg | Change in Waist Circumference | Week 52 | -0.1 Centimeters (cm) | Standard Deviation 3.6 |
| Oral Semaglutide 7 mg | Change in Waist Circumference | Week 52 | -0.8 Centimeters (cm) | Standard Deviation 3.9 |
| Oral Semaglutide 7 mg | Change in Waist Circumference | Week 26 | -0.6 Centimeters (cm) | Standard Deviation 3.4 |
| Oral Semaglutide 14 mg | Change in Waist Circumference | Week 26 | -1.2 Centimeters (cm) | Standard Deviation 4.3 |
| Oral Semaglutide 14 mg | Change in Waist Circumference | Week 52 | -1.7 Centimeters (cm) | Standard Deviation 4.2 |
| Dulaglutide 0.75 mg | Change in Waist Circumference | Week 26 | 0.3 Centimeters (cm) | Standard Deviation 2.9 |
| Dulaglutide 0.75 mg | Change in Waist Circumference | Week 52 | 0.7 Centimeters (cm) | Standard Deviation 3.6 |
Secondary
Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains
DTR-QoL questionnaire is a 29-item patient-reported survey of patient health that measures the influence of diabetes treatment on health related-QoL on 4 domains on individual scale ranges: Burden on social activities and daily activities, Anxiety and dissatisfaction with treatment, Hypoglycemia and Satisfaction with treatment on a 7-point graded response scale. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100 (best-case response = 100; worst case response = 0). The total score, after simple addition of the item scores, is converted to 0 - 100 (best-case response = 100; worst case response = 0). Change from baseline (week 0) in the scores were evaluated at week 26, week 52. Data based on in-trial observation period is presented. W26 and W52 refer to week 26 and week 52 respectively.
Time frame: week 0, week 26, week 52
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 | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 1.Burden on social and daily activities (W26) | 6.44 Score on a scale | Standard Deviation 17.59 |
| Oral Semaglutide 3 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 3.Hypoglycemia (W52) | 4.20 Score on a scale | Standard Deviation 19.61 |
| Oral Semaglutide 3 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 4.Satisfaction with treatment(W52) | 2.46 Score on a scale | Standard Deviation 19.66 |
| Oral Semaglutide 3 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 4.Satisfaction with treatment(W26) | 9.67 Score on a scale | Standard Deviation 19.08 |
| Oral Semaglutide 3 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | Total score(W52) | 3.31 Score on a scale | Standard Deviation 13.47 |
| Oral Semaglutide 3 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 2.Anxiety and dissatisfaction with treatment(W52) | 0.98 Score on a scale | Standard Deviation 18.6 |
| Oral Semaglutide 3 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 1.Burden on social and daily activities (W52) | 4.73 Score on a scale | Standard Deviation 18.69 |
| Oral Semaglutide 3 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 2.Anxiety and dissatisfaction with treatment(W26) | 6.54 Score on a scale | Standard Deviation 18.08 |
| Oral Semaglutide 3 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | Total score(W26) | 6.74 Score on a scale | Standard Deviation 13.01 |
| Oral Semaglutide 3 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 3.Hypoglycemia (W26) | 5.18 Score on a scale | Standard Deviation 20.62 |
| Oral Semaglutide 7 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 2.Anxiety and dissatisfaction with treatment(W26) | 10.94 Score on a scale | Standard Deviation 17.83 |
| Oral Semaglutide 7 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 4.Satisfaction with treatment(W52) | 7.88 Score on a scale | Standard Deviation 23.92 |
| Oral Semaglutide 7 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | Total score(W26) | 7.88 Score on a scale | Standard Deviation 14.4 |
| Oral Semaglutide 7 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 3.Hypoglycemia (W52) | 1.94 Score on a scale | Standard Deviation 19.36 |
| Oral Semaglutide 7 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | Total score(W52) | 7.15 Score on a scale | Standard Deviation 15.69 |
| Oral Semaglutide 7 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 2.Anxiety and dissatisfaction with treatment(W52) | 9.93 Score on a scale | Standard Deviation 19.61 |
| Oral Semaglutide 7 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 4.Satisfaction with treatment(W26) | 10.81 Score on a scale | Standard Deviation 24.53 |
| Oral Semaglutide 7 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 1.Burden on social and daily activities (W52) | 6.81 Score on a scale | Standard Deviation 18.85 |
| Oral Semaglutide 7 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 3.Hypoglycemia (W26) | 1.95 Score on a scale | Standard Deviation 18.14 |
| Oral Semaglutide 7 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 1.Burden on social and daily activities (W26) | 6.93 Score on a scale | Standard Deviation 18.09 |
| Oral Semaglutide 14 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 3.Hypoglycemia (W26) | 2.67 Score on a scale | Standard Deviation 21.14 |
| Oral Semaglutide 14 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 1.Burden on social and daily activities (W52) | 5.44 Score on a scale | Standard Deviation 16.57 |
| Oral Semaglutide 14 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 2.Anxiety and dissatisfaction with treatment(W26) | 12.24 Score on a scale | Standard Deviation 17.41 |
| Oral Semaglutide 14 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 2.Anxiety and dissatisfaction with treatment(W52) | 11.37 Score on a scale | Standard Deviation 18.68 |
| Oral Semaglutide 14 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | Total score(W52) | 8.25 Score on a scale | Standard Deviation 12.81 |
| Oral Semaglutide 14 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 1.Burden on social and daily activities (W26) | 4.88 Score on a scale | Standard Deviation 16.46 |
| Oral Semaglutide 14 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 3.Hypoglycemia (W52) | 3.87 Score on a scale | Standard Deviation 20.7 |
| Oral Semaglutide 14 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 4.Satisfaction with treatment(W26) | 14.29 Score on a scale | Standard Deviation 28.11 |
| Oral Semaglutide 14 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 4.Satisfaction with treatment(W52) | 15.49 Score on a scale | Standard Deviation 27.01 |
| Oral Semaglutide 14 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | Total score(W26) | 7.90 Score on a scale | Standard Deviation 12.72 |
| Dulaglutide 0.75 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 3.Hypoglycemia (W26) | 3.26 Score on a scale | Standard Deviation 19.82 |
| Dulaglutide 0.75 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 1.Burden on social and daily activities (W52) | 3.99 Score on a scale | Standard Deviation 19.25 |
| Dulaglutide 0.75 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 4.Satisfaction with treatment(W52) | 6.35 Score on a scale | Standard Deviation 26.22 |
| Dulaglutide 0.75 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 2.Anxiety and dissatisfaction with treatment(W52) | 3.14 Score on a scale | Standard Deviation 19.79 |
| Dulaglutide 0.75 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 1.Burden on social and daily activities (W26) | 5.29 Score on a scale | Standard Deviation 19.65 |
| Dulaglutide 0.75 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | Total score(W52) | 3.44 Score on a scale | Standard Deviation 14.89 |
| Dulaglutide 0.75 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | Total score(W26) | 7.18 Score on a scale | Standard Deviation 15.56 |
| Dulaglutide 0.75 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 2.Anxiety and dissatisfaction with treatment(W26) | 9.24 Score on a scale | Standard Deviation 20.87 |
| Dulaglutide 0.75 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 4.Satisfaction with treatment(W26) | 13.15 Score on a scale | Standard Deviation 24.69 |
| Dulaglutide 0.75 mg | Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains | 3.Hypoglycemia (W52) | -0.66 Score on a scale | Standard Deviation 23.1 |
Secondary
Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes
Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-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 0-57
Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide 3 mg | Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes | 4 Episodes |
| Oral Semaglutide 7 mg | Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes | 4 Episodes |
| Oral Semaglutide 14 mg | Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes | 4 Episodes |
| Dulaglutide 0.75 mg | Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes | 0 Episodes |
Secondary
Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)
Participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia episodes and without weight gain (yes/no) at weeks 26 and 52 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
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 Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 26 | Yes | 39 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 26 | No | 89 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 52 | Yes | 23 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 52 | No | 103 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 26 | Yes | 63 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 26 | No | 65 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 52 | Yes | 53 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 52 | No | 76 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 26 | No | 44 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 52 | Yes | 71 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 26 | Yes | 84 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 52 | No | 56 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 52 | No | 47 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 52 | Yes | 16 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 26 | No | 39 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No) | Week 26 | Yes | 25 Participants |
Secondary
Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No)
Participants who achieved HbA1c below 7.0% (53 millimoles per mole \[mmol/mol\]) according to American Diabetes Association (ADA) target (yes/no) at weeks 26 and 52 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
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 Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) | Week 52 | No | 83 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) | Week 26 | No | 69 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) | Week 26 | Yes | 59 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) | Week 52 | Yes | 43 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) | Week 26 | No | 32 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) | Week 52 | No | 52 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) | Week 26 | Yes | 96 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) | Week 52 | Yes | 77 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) | Week 26 | Yes | 105 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) | Week 52 | No | 37 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) | Week 52 | Yes | 90 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) | Week 26 | No | 23 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) | Week 26 | No | 19 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) | Week 52 | No | 31 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) | Week 26 | Yes | 45 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No) | Week 52 | Yes | 32 Participants |
Secondary
Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No)
Participants who achieved HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) target (yes/no) at weeks 26 and 52 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
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 Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) | Week 52 | Yes | 22 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) | Week 52 | No | 104 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) | Week 26 | No | 88 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) | Week 26 | Yes | 40 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) | Week 52 | Yes | 50 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) | Week 26 | Yes | 67 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) | Week 52 | No | 79 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) | Week 26 | No | 61 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) | Week 26 | Yes | 88 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) | Week 52 | Yes | 69 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) | Week 26 | No | 40 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) | Week 52 | No | 58 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) | Week 26 | No | 33 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) | Week 26 | Yes | 31 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) | Week 52 | No | 40 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No) | Week 52 | Yes | 23 Participants |
Secondary
Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No)
Participants who achieved HbA1c reduction more than or equal to 1% (10.9 mmol/mol) and weight loss more than or equal to 3% (yes/no) at weeks 26 and 52 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
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 More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) | Week 26 | Yes | 15 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) | Week 52 | No | 115 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) | Week 52 | Yes | 11 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) | Week 26 | No | 113 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) | Week 52 | No | 97 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) | Week 26 | Yes | 34 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) | Week 26 | No | 94 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) | Week 52 | Yes | 32 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) | Week 52 | No | 85 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) | Week 26 | No | 66 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) | Week 26 | Yes | 62 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) | Week 52 | Yes | 42 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) | Week 26 | Yes | 8 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) | Week 26 | No | 56 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) | Week 52 | Yes | 7 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No) | Week 52 | No | 56 Participants |
Secondary
Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No)
Participants who achieved weight loss more than or equal to 10% (yes/no) at weeks 26 and 52 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
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 More Than or Equal to 10% (Yes/No) | Week 26 | Yes | 0 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No) | Week 26 | No | 128 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No) | Week 52 | Yes | 0 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No) | Week 52 | No | 127 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No) | Week 26 | No | 122 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No) | Week 52 | Yes | 9 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No) | Week 52 | No | 120 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No) | Week 26 | Yes | 6 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No) | Week 52 | Yes | 7 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No) | Week 26 | No | 120 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No) | Week 52 | No | 120 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No) | Week 26 | Yes | 8 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No) | Week 52 | No | 63 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No) | Week 26 | No | 63 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No) | Week 26 | Yes | 1 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No) | Week 52 | Yes | 0 Participants |
Secondary
Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No).
Participants who achieved weight loss more than or equal to 5% (yes/no) at weeks 26 and 52 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
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 More Than or Equal to 5% (Yes/No). | Week 26 | Yes | 6 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No). | Week 52 | No | 120 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No). | Week 26 | No | 122 Participants |
| Oral Semaglutide 3 mg | Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No). | Week 52 | Yes | 7 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No). | Week 26 | Yes | 23 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No). | Week 52 | Yes | 21 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No). | Week 52 | No | 108 Participants |
| Oral Semaglutide 7 mg | Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No). | Week 26 | No | 105 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No). | Week 52 | Yes | 28 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No). | Week 52 | No | 99 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No). | Week 26 | Yes | 39 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No). | Week 26 | No | 89 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No). | Week 52 | No | 59 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No). | Week 52 | Yes | 4 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No). | Week 26 | No | 60 Participants |
| Dulaglutide 0.75 mg | Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No). | Week 26 | Yes | 4 Participants |
Secondary
Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes
Participants with 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 0-57
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 | 3 Participants |
| Oral Semaglutide 7 mg | Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 3 Participants |
| Oral Semaglutide 14 mg | Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 4 Participants |
| Dulaglutide 0.75 mg | Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 0 Participants |
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 and week 0 to week 52. 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, 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 0-52
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 | 1 Participants |
| Oral Semaglutide 3 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 52 | 24 Participants |
| Oral Semaglutide 7 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 52 | 13 Participants |
| Oral Semaglutide 7 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 26 | 3 Participants |
| Oral Semaglutide 14 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 26 | 6 Participants |
| Oral Semaglutide 14 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 52 | 8 Participants |
| Dulaglutide 0.75 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 26 | 1 Participants |
| Dulaglutide 0.75 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 52 | 8 Participants |
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata 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: 0.296395% CI: [0.7, 3.2]Regression, Cox
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata 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: 0.599795% CI: [0.35, 1.83]Regression, Cox
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata 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: 0.187195% CI: [0.23, 1.33]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 and week 0 to week 52. 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 0-52
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 | 0 Participants |
| Oral Semaglutide 3 mg | Time to Rescue Medication | Week 0 to week 52 | 22 Participants |
| Oral Semaglutide 7 mg | Time to Rescue Medication | Week 0 to week 52 | 8 Participants |
| Oral Semaglutide 7 mg | Time to Rescue Medication | Week 0 to week 26 | 0 Participants |
| Oral Semaglutide 14 mg | Time to Rescue Medication | Week 0 to week 26 | 1 Participants |
| Oral Semaglutide 14 mg | Time to Rescue Medication | Week 0 to week 52 | 2 Participants |
| Dulaglutide 0.75 mg | Time to Rescue Medication | Week 0 to week 26 | 1 Participants |
| Dulaglutide 0.75 mg | Time to Rescue Medication | Week 0 to week 52 | 6 Participants |
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: 0.167295% CI: [0.76, 4.72]Regression, Cox
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: 0.339195% CI: [0.21, 1.72]Regression, Cox
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: 0.01195% CI: [0.02, 0.62]Regression, Cox