Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral Semaglutide versus Liraglutide and versus Placebo in Subjects with Type 2 Diabetes Mellitus.
Interventions
DRUGsemaglutide
Oral semaglutide once-daily.
DRUGliraglutide
Subcutaneous (s.c.) injection once-daily.
DRUGplacebo
Placebo once-daily.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Male or female, age above or equal to 18 years at the time of signing informed consent. For Japan only: Male or female, age at least 20 years at the time of signing informed consent * Diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of screening. * HbA1c (glycosylated haemoglobin) of 7.0-9.5 % (53-80.3 mmol/mol) (both inclusive) * Stable daily dose of metformin (above or equal to 1500 mg or maximum tolerated dose as documented in the subject medical record) alone or in combination with a stable daily dose of a SGLT-2 (sodium-glucose co-transporter-2) inhibitor for at least 90 days prior to day of screening (fixed-dose combinations are allowed)
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 measure as required by local regulation or practice).For certain specific countries: Additional specific requirements apply * 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 and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) * Any of the following: myocardial infarction (MI), stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening * Subjects presently classified as being in New York Heart Association (NYHA) Class IV * Planned coronary, carotid or peripheral artery revascularisation known on the day of screening * Subjects with ALT (alanine aminotransferase) above 2.5 × upper normal limit (UNL) * Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of below or equal to 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 carcinoma in situ) * History of diabetic ketoacidosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c (Week 26) | Week 0, week 26 | Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c (Week 52) | Week 0, week 52 | Change from baseline (week 0) in HbA1c was evaluated at 52 weeks. 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 52) | Week 0, week 52 | Change from baseline (week 0) in body weight was evaluated at 52 weeks. 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 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 Body Mass Index | Week 0, week 26, week 52 | Change from baseline (week 0) in body mass index (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 Total Cholesterol - Ratio to Baseline | Week 0, week 26, week 52 | Change from baseline (week 0) in 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 Low-density Lipoprotein (LDL) Cholesterol - Ratio to Baseline | Week 0, week 26, week 52 | Change from baseline (week 0) in low-density lipoprotein (LDL) 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 Very Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline | Week 0, week 26, week 52 | Change from baseline (week 0) in VLDL 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 High-density Lipoprotein (HDL) Cholesterol - Ratio to Baseline | Week 0, week 26, week 52 | Change from baseline (week 0) in HDL 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 Triglycerides - Ratio to Baseline | Week 0, week 26, week 52 | Change from baseline (week 0) in 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. |
| Change in Free Fatty Acids - Ratio to Baseline | Week 0, week 26, week 52 | Change from baseline (week 0) in free fatty acids (FFA) (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 SMPG - Mean 7-point Profile | Week 0, week 26, week 52 | Change from baseline (week 0) to week 26 and week 52 in mean 7-point self-measured plasma glucose (SMPG) profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Change in SMPG - Mean Postprandial Increment Over All Meals | Week 0, week 26, week 52 | 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. |
| Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26, week 52 | Participants who achieved HbA1c \<7.0% (American Diabetes Association (ADA) target) (yes/no), 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 HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 26, week 52 | Participants who achieved HbA1c less than or equal to 6.5% (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 Weight Loss ≥5% (Yes/no) | Week 26, week 52 | Participants who achieved weight loss more than or equal to 5% of their baseline body weight (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 ≥ 10% (Yes/no) | Week 26, week 52 | Participants who achieved weight loss more than or equal to 10% of their baseline body weight (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 <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26, week 52 | Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26 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 Body Weight (Week 26) | Week 0, week 26 | Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation. |
| 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 (week 52), 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. |
| Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product | 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. |
| Change in Amylase - Ratio to Baseline | Week 0, week 26, week 52 | Change from baseline (week 0) in amylase (units/litre (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 (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 SBP and DBP | Week 0, week 26, week 52 | Change from baseline (week 0) in 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 week 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 week 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 52 | Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2) 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. |
| Occurrence of Anti-semaglutide Binding Antibodies (Yes/no) | Weeks 0-57 | This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no) | Weeks 0-57 | This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no) | Week 0-57 | This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no) | Weeks 0-57 | This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Anti-semaglutide Binding Antibody Levels | Weeks 0-57 | This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-57). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Number of Treatment-emergent Severe or 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 | Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 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. |
| Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Week 0, week 26, week 52 | Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26 (wk 26) and week 52 (wk 52). The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of hyperglycaemia and hypoglycaemia, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score has a minimum of 0 and a maximum of 36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. |
| Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26, week 52 | Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26 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
Croatia, Czechia, Germany, Hungary, Japan, Latvia, Poland, Puerto Rico, Slovakia, South Africa, Ukraine, United Arab Emirates, United States
Participant flow
Recruitment details
The trial was conducted at 101 sites in 12 countries as follows:Croatia (5), Czech Republic (3), Germany (8), Hungary (9), Japan (9), Latvia (4), Poland (9), Slovakia (5), South Africa (5), Ukraine (3), United Arab Emirates (2), United States (39).
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 14 mg Participants were to take once-daily oral semaglutide tablets for 52 weeks. Participants started oral semaglutide at 3 mg and were dose-escalated in 4-week increments until the final maintenance dose of 14 mg once-daily was reached (i.e. 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 take liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \[SGLT-2\] inhibitor) throughout the entire trial. | 285 |
| Liraglutide 1.8 mg Participants were to take once-daily liraglutide subcutaneous injection (under the skin) for 52 weeks. Participants started liraglutide at 0.6 mg and were dose-escalated in one-week increments until the final maintenance dose of 1.8 mg once-daily was reached (i.e. 0.6 mg from week 0 to week 1, 1.2 mg from week 1 to week 2 and 1.8 mg from week 2 to week 52). In addition, participants were to take oral semaglutide placebo tablets once-daily from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \[SGLT-2\] inhibitor) throughout the entire trial. | 284 |
| Placebo Participants were to take both oral semaglutide placebo tablets and liraglutide placebo once-daily as a subcutaneous injection (under the skin) from week 0 to week 52. Participants were to continue their anti-diabetic background medication (metformin alone or in combination with a sodium-glucose co-transporter-2 \[SGLT-2\] inhibitor) throughout the entire trial. | 142 |
| Total | 711 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Died | 3 | 4 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 4 |
| Overall Study | Withdrawal by Subject | 5 | 5 | 3 |
Baseline characteristics
| Characteristic | Oral Semaglutide 14 mg | Liraglutide 1.8 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 56 Years STANDARD_DEVIATION 10 | 56 Years STANDARD_DEVIATION 10 | 57 Years STANDARD_DEVIATION 10 | 56 Years STANDARD_DEVIATION 10 |
| Baseline HbA1c | 8.0 Percentage of HbA1c STANDARD_DEVIATION 0.7 | 8.0 Percentage of HbA1c STANDARD_DEVIATION 0.7 | 7.9 Percentage of HbA1c STANDARD_DEVIATION 0.7 | 8.0 Percentage of HbA1c STANDARD_DEVIATION 0.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants | 18 Participants | 5 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 268 Participants | 266 Participants | 137 Participants | 671 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 39 Participants | 36 Participants | 19 Participants | 94 Participants |
| Race/Ethnicity, Customized Black or African American | 12 Participants | 9 Participants | 8 Participants | 29 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Applicable | 23 Participants | 17 Participants | 12 Participants | 52 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 8 Participants | 3 Participants | 14 Participants |
| Race/Ethnicity, Customized White | 208 Participants | 212 Participants | 99 Participants | 519 Participants |
| Sex: Female, Male Female | 138 Participants | 135 Participants | 68 Participants | 341 Participants |
| Sex: Female, Male Male | 147 Participants | 149 Participants | 74 Participants | 370 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 285 | 4 / 284 | 1 / 142 |
| other Total, other adverse events | 148 / 285 | 120 / 284 | 47 / 142 |
| serious Total, serious adverse events | 31 / 285 | 22 / 284 | 15 / 142 |
Outcome results
Primary
Change in HbA1c (Week 26)
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Time frame: Week 0, week 26
Population: Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 14 mg | Change in HbA1c (Week 26) | In-trial | -1.2 Percentage of HbA1c | Standard Deviation 0.9 |
| Oral Semaglutide 14 mg | Change in HbA1c (Week 26) | On-treatment without rescue medication | -1.4 Percentage of HbA1c | Standard Deviation 0.9 |
| Liraglutide 1.8 mg | Change in HbA1c (Week 26) | In-trial | -1.1 Percentage of HbA1c | Standard Deviation 0.9 |
| Liraglutide 1.8 mg | Change in HbA1c (Week 26) | On-treatment without rescue medication | -1.2 Percentage of HbA1c | Standard Deviation 0.9 |
| Placebo | Change in HbA1c (Week 26) | In-trial | -0.1 Percentage of HbA1c | Standard Deviation 0.7 |
| Placebo | Change in HbA1c (Week 26) | On-treatment without rescue medication | -0.1 Percentage of HbA1c | Standard Deviation 0.7 |
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [-0.3, 0]Pattern mixture model
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: 0.064595% CI: [-0.3, 0]Pattern mixture model
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [-1.2, -0.9]Pattern mixture model
Comparison: The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: <0.000195% CI: [-0.3, -0.1]MMRM
Comparison: The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: 0.005695% CI: [-0.3, -0.1]MMRM
Comparison: The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: 0.000195% CI: [-1.4, -1]MMRM
Secondary
Anti-semaglutide Binding Antibody Levels
This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-57). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Weeks 0-57
Population: Overall number of participants analysed = participants who were found positive for anti-semaglutide antibodies.
Secondary
Change in Amylase - Ratio to Baseline
Change from baseline (week 0) in amylase (units/litre (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 14 mg | Change in Amylase - Ratio to Baseline | Week 26 | 1.13 Ratio of amylase | Geometric Coefficient of Variation 24.9 |
| Oral Semaglutide 14 mg | Change in Amylase - Ratio to Baseline | Week 52 | 1.14 Ratio of amylase | Geometric Coefficient of Variation 27.4 |
| Liraglutide 1.8 mg | Change in Amylase - Ratio to Baseline | Week 26 | 1.11 Ratio of amylase | Geometric Coefficient of Variation 26.1 |
| Liraglutide 1.8 mg | Change in Amylase - Ratio to Baseline | Week 52 | 1.10 Ratio of amylase | Geometric Coefficient of Variation 26.1 |
| Placebo | Change in Amylase - Ratio to Baseline | Week 26 | 0.99 Ratio of amylase | Geometric Coefficient of Variation 23.1 |
| Placebo | Change in Amylase - Ratio to Baseline | Week 52 | 0.98 Ratio of amylase | Geometric Coefficient of Variation 21.9 |
Secondary
Change in Body Mass Index
Change from baseline (week 0) in body mass index (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 14 mg | Change in Body Mass Index | Week 26 | -1.6 kg/m^2 | Standard Deviation 1.6 |
| Oral Semaglutide 14 mg | Change in Body Mass Index | Week 52 | -1.6 kg/m^2 | Standard Deviation 2 |
| Liraglutide 1.8 mg | Change in Body Mass Index | Week 26 | -1.1 kg/m^2 | Standard Deviation 1.3 |
| Liraglutide 1.8 mg | Change in Body Mass Index | Week 52 | -1.1 kg/m^2 | Standard Deviation 1.5 |
| Placebo | Change in Body Mass Index | Week 26 | -0.2 kg/m^2 | Standard Deviation 1.1 |
| Placebo | Change in Body Mass Index | Week 52 | -0.4 kg/m^2 | Standard Deviation 1.4 |
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 14 mg | Change in Body Weight (%) | Week 52 | -4.94 Percentage change | Standard Deviation 6.37 |
| Oral Semaglutide 14 mg | Change in Body Weight (%) | Week 26 | -4.89 Percentage change | Standard Deviation 4.95 |
| Liraglutide 1.8 mg | Change in Body Weight (%) | Week 26 | -3.33 Percentage change | Standard Deviation 3.78 |
| Liraglutide 1.8 mg | Change in Body Weight (%) | Week 52 | -3.25 Percentage change | Standard Deviation 4.33 |
| Placebo | Change in Body Weight (%) | Week 26 | -0.60 Percentage change | Standard Deviation 3.34 |
| Placebo | Change in Body Weight (%) | Week 52 | -0.99 Percentage change | Standard Deviation 4.12 |
Secondary
Change in Body Weight (Week 26)
Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Time frame: Week 0, week 26
Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Semaglutide 14 mg | Change in Body Weight (Week 26) | In-trial | -4.4 Kg | Standard Deviation 4.4 |
| Oral Semaglutide 14 mg | Change in Body Weight (Week 26) | On-treatment without rescue medication | -4.7 Kg | Standard Deviation 4.3 |
| Liraglutide 1.8 mg | Change in Body Weight (Week 26) | In-trial | -3.2 Kg | Standard Deviation 3.7 |
| Liraglutide 1.8 mg | Change in Body Weight (Week 26) | On-treatment without rescue medication | -3.3 Kg | Standard Deviation 3.7 |
| Placebo | Change in Body Weight (Week 26) | In-trial | -0.6 Kg | Standard Deviation 3.1 |
| Placebo | Change in Body Weight (Week 26) | On-treatment without rescue medication | -0.7 Kg | Standard Deviation 3.1 |
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: 0.000395% CI: [-1.9, -0.6]Pattern mixture model
Comparison: The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.p-value: <0.000195% CI: [-4.7, -3]Pattern mixture model
Comparison: The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: <0.000195% CI: [-2.2, -0.9]MMRM
Comparison: The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.p-value: <0.000195% CI: [-4.8, -3.2]MMRM
Secondary
Change in Body Weight (Week 52)
Change from baseline (week 0) in body weight was evaluated at 52 weeks. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change in Body Weight (Week 52) | -4.4 Kg | Standard Deviation 5.5 |
| Liraglutide 1.8 mg | Change in Body Weight (Week 52) | -3.1 Kg | Standard Deviation 4.4 |
| Placebo | Change in Body Weight (Week 52) | -1.0 Kg | Standard Deviation 3.8 |
Secondary
Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed)
Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26 (wk 26) and week 52 (wk 52). The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of hyperglycaemia and hypoglycaemia, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score has a minimum of 0 and a maximum of 36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction.
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 14 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably low blood sugars: wk 26 | -0.18 Scores on a scale | Standard Deviation 1.81 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with treatment: wk 52 | 0.67 Scores on a scale | Standard Deviation 1.67 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably high blood sugars: wk 26 | -1.94 Scores on a scale | Standard Deviation 2.03 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably high blood sugars: wk 52 | -1.97 Scores on a scale | Standard Deviation 2.13 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with treatment: wk 26 | 0.72 Scores on a scale | Standard Deviation 1.49 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably low blood sugars: wk 52 | -0.17 Scores on a scale | Standard Deviation 1.85 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Convenience of treatment: wk 26 | 0.55 Scores on a scale | Standard Deviation 1.38 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Convenience of treatment: wk 52 | 0.50 Scores on a scale | Standard Deviation 1.47 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Flexibility of treatment: wk 26 | 0.45 Scores on a scale | Standard Deviation 1.53 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Flexibility of treatment: wk 52 | 0.38 Scores on a scale | Standard Deviation 1.52 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with understanding of diabetes: wk 26 | 0.66 Scores on a scale | Standard Deviation 1.31 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with understanding of diabetes: wk 52 | 0.65 Scores on a scale | Standard Deviation 1.29 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Recommending treatment to others: wk 26 | 0.57 Scores on a scale | Standard Deviation 1.47 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Recommending treatment to others: wk 52 | 0.60 Scores on a scale | Standard Deviation 1.55 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction to continue present treatment: wk 26 | 0.64 Scores on a scale | Standard Deviation 1.68 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction to continue present treatment: wk 52 | 0.60 Scores on a scale | Standard Deviation 1.81 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Total treatment satisfaction: wk 26 | 3.59 Scores on a scale | Standard Deviation 6.12 |
| Oral Semaglutide 14 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Total treatment satisfaction: wk 52 | 3.41 Scores on a scale | Standard Deviation 6.81 |
| Liraglutide 1.8 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Total treatment satisfaction: wk 52 | 3.11 Scores on a scale | Standard Deviation 6.93 |
| Liraglutide 1.8 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with treatment: wk 26 | 0.73 Scores on a scale | Standard Deviation 1.54 |
| Liraglutide 1.8 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Flexibility of treatment: wk 52 | 0.40 Scores on a scale | Standard Deviation 1.62 |
| Liraglutide 1.8 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Recommending treatment to others: wk 26 | 0.63 Scores on a scale | Standard Deviation 1.59 |
| Liraglutide 1.8 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with treatment: wk 52 | 0.70 Scores on a scale | Standard Deviation 1.46 |
| Liraglutide 1.8 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction to continue present treatment: wk 26 | 0.74 Scores on a scale | Standard Deviation 1.76 |
| Liraglutide 1.8 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction to continue present treatment: wk 52 | 0.56 Scores on a scale | Standard Deviation 1.74 |
| Liraglutide 1.8 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably high blood sugars: wk 26 | -1.72 Scores on a scale | Standard Deviation 2.1 |
| Liraglutide 1.8 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with understanding of diabetes: wk 26 | 0.52 Scores on a scale | Standard Deviation 1.37 |
| Liraglutide 1.8 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Total treatment satisfaction: wk 26 | 3.44 Scores on a scale | Standard Deviation 6.51 |
| Liraglutide 1.8 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably high blood sugars: wk 52 | -1.71 Scores on a scale | Standard Deviation 2.11 |
| Liraglutide 1.8 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Flexibility of treatment: wk 26 | 0.43 Scores on a scale | Standard Deviation 1.48 |
| Liraglutide 1.8 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Recommending treatment to others: wk 52 | 0.48 Scores on a scale | Standard Deviation 1.61 |
| Liraglutide 1.8 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably low blood sugars: wk 26 | 0.03 Scores on a scale | Standard Deviation 1.9 |
| Liraglutide 1.8 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Convenience of treatment: wk 52 | 0.42 Scores on a scale | Standard Deviation 1.44 |
| Liraglutide 1.8 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with understanding of diabetes: wk 52 | 0.54 Scores on a scale | Standard Deviation 1.41 |
| Liraglutide 1.8 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably low blood sugars: wk 52 | -0.06 Scores on a scale | Standard Deviation 1.75 |
| Liraglutide 1.8 mg | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Convenience of treatment: wk 26 | 0.39 Scores on a scale | Standard Deviation 1.48 |
| Placebo | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably low blood sugars: wk 52 | -0.14 Scores on a scale | Standard Deviation 1.45 |
| Placebo | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Convenience of treatment: wk 26 | 0.17 Scores on a scale | Standard Deviation 1.81 |
| Placebo | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Convenience of treatment: wk 52 | 0.21 Scores on a scale | Standard Deviation 1.75 |
| Placebo | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction to continue present treatment: wk 26 | 0.22 Scores on a scale | Standard Deviation 1.8 |
| Placebo | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Flexibility of treatment: wk 26 | 0.09 Scores on a scale | Standard Deviation 1.34 |
| Placebo | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Total treatment satisfaction: wk 52 | 1.23 Scores on a scale | Standard Deviation 6.96 |
| Placebo | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Flexibility of treatment: wk 52 | 0.14 Scores on a scale | Standard Deviation 1.51 |
| Placebo | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with understanding of diabetes: wk 26 | 0.38 Scores on a scale | Standard Deviation 1.18 |
| Placebo | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction to continue present treatment: wk 52 | 0.11 Scores on a scale | Standard Deviation 1.77 |
| Placebo | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with understanding of diabetes: wk 52 | 0.27 Scores on a scale | Standard Deviation 1.38 |
| Placebo | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with treatment: wk 26 | 0.28 Scores on a scale | Standard Deviation 1.69 |
| Placebo | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Satisfaction with treatment: wk 52 | 0.48 Scores on a scale | Standard Deviation 1.45 |
| Placebo | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Recommending treatment to others: wk 26 | 0.10 Scores on a scale | Standard Deviation 1.34 |
| Placebo | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably high blood sugars: wk 26 | -0.87 Scores on a scale | Standard Deviation 2.11 |
| Placebo | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably high blood sugars: wk 52 | -1.04 Scores on a scale | Standard Deviation 2.1 |
| Placebo | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Feeling of unacceptably low blood sugars: wk 26 | -0.07 Scores on a scale | Standard Deviation 1.57 |
| Placebo | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Recommending treatment to others: wk 52 | 0.02 Scores on a scale | Standard Deviation 1.7 |
| Placebo | Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed) | Total treatment satisfaction: wk 26 | 1.24 Scores on a scale | Standard Deviation 6.71 |
Secondary
Change in ECG Evaluation
Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and week 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 week 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 14 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to Abnormal NCS (week 52) | 73 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 CS (week 0) to Normal (week 52) | 0 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 abnormal NCS (week 26) | 2 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to Normal (week 52) | 19 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal NCS (week 26) | 81 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal CS (week 26) | 3 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal CS (week 0) to Abnormal NCS (week 52) | 1 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 26) | 130 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to Normal (week 52) | 113 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to Abnormal CS (week 52) | 0 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to normal (week 26) | 15 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Normal (week 0) to Abnormal NCS (week 52) | 31 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Oral Semaglutide 14 mg | Change in ECG Evaluation | Abnormal CS (week 0) to Abnormal CS (week 52) | 3 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 | Normal (week 0) to abnormal NCS (week 26) | 19 Participants |
| Liraglutide 1.8 mg | Change in ECG Evaluation | Normal (week 0) to Abnormal CS (week 52) | 1 Participants |
| Liraglutide 1.8 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to Normal (week 52) | 26 Participants |
| Liraglutide 1.8 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to Abnormal NCS (week 52) | 73 Participants |
| Liraglutide 1.8 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to Abnormal CS (week 52) | 0 Participants |
| Liraglutide 1.8 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal NCS (week 26) | 75 Participants |
| Liraglutide 1.8 mg | Change in ECG Evaluation | Abnormal CS (week 0) to Normal (week 52) | 3 Participants |
| Liraglutide 1.8 mg | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 26) | 20 Participants |
| Liraglutide 1.8 mg | Change in ECG Evaluation | Abnormal CS (week 0) to Abnormal NCS (week 52) | 1 Participants |
| Liraglutide 1.8 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Liraglutide 1.8 mg | Change in ECG Evaluation | Normal (week 0) to normal (week 26) | 123 Participants |
| Liraglutide 1.8 mg | Change in ECG Evaluation | Abnormal CS (week 0) to normal (week 26) | 2 Participants |
| Liraglutide 1.8 mg | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal NCS (week 26) | 2 Participants |
| Liraglutide 1.8 mg | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Liraglutide 1.8 mg | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal CS (week 26) | 7 Participants |
| Liraglutide 1.8 mg | Change in ECG Evaluation | Normal (week 0) to Normal (week 52) | 123 Participants |
| Liraglutide 1.8 mg | Change in ECG Evaluation | Normal (week 0) to Abnormal NCS (week 52) | 14 Participants |
| Liraglutide 1.8 mg | Change in ECG Evaluation | Abnormal CS (week 0) to Abnormal CS (week 52) | 5 Participants |
| Liraglutide 1.8 mg | Change in ECG Evaluation | Abnormal NCS (week 0) to normal (week 26) | 27 Participants |
| Placebo | Change in ECG Evaluation | Normal (week 0) to Abnormal NCS (week 52) | 5 Participants |
| Placebo | Change in ECG Evaluation | Normal (week 0) to normal (week 26) | 67 Participants |
| Placebo | Change in ECG Evaluation | Normal (week 0) to abnormal NCS (week 26) | 6 Participants |
| Placebo | Change in ECG Evaluation | Normal (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change in ECG Evaluation | Abnormal NCS (week 0) to normal (week 26) | 19 Participants |
| Placebo | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal NCS (week 26) | 33 Participants |
| Placebo | Change in ECG Evaluation | Abnormal NCS (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change in ECG Evaluation | Abnormal CS (week 0) to normal (week 26) | 2 Participants |
| Placebo | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal NCS (week 26) | 1 Participants |
| Placebo | Change in ECG Evaluation | Abnormal CS (week 0) to abnormal CS (week 26) | 0 Participants |
| Placebo | Change in ECG Evaluation | Normal (week 0) to Normal (week 52) | 64 Participants |
| Placebo | Change in ECG Evaluation | Normal (week 0) to Abnormal CS (week 52) | 1 Participants |
| Placebo | Change in ECG Evaluation | Abnormal NCS (week 0) to Normal (week 52) | 14 Participants |
| Placebo | Change in ECG Evaluation | Abnormal NCS (week 0) to Abnormal NCS (week 52) | 37 Participants |
| Placebo | Change in ECG Evaluation | Abnormal NCS (week 0) to Abnormal CS (week 52) | 0 Participants |
| Placebo | Change in ECG Evaluation | Abnormal CS (week 0) to Normal (week 52) | 2 Participants |
| Placebo | Change in ECG Evaluation | Abnormal CS (week 0) to Abnormal NCS (week 52) | 1 Participants |
| Placebo | Change in ECG Evaluation | Abnormal CS (week 0) to Abnormal CS (week 52) | 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye - Abnormal NCS to abnormal NCS | 63 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye - Normal to Abnormal NCS | 10 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye - Normal to Abnormal CS | 4 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye - Abnormal NCS to normal | 15 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye - Normal to Normal | 130 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye - Abnormal NCS to abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye - Abnormal CS to normal | 1 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye - Abnormal CS to abnormal NCS | 5 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Left eye - Abnormal CS to abnormal CS | 7 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye - Normal to Normal | 127 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye - Normal to Abnormal NCS | 10 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye - Normal to Abnormal CS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye - Abnormal NCS to Normal | 16 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye - Abnormal NCS to Abnormal NCS | 64 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye - Abnormal NCS to Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye - Abnormal CS to Normal | 2 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye - Abnormal CS to Abnormal NCS | 5 Participants |
| Oral Semaglutide 14 mg | Change in Eye Examination Category | Right eye - Abnormal CS to Abnormal CS | 7 Participants |
| Liraglutide 1.8 mg | Change in Eye Examination Category | Right eye - Abnormal CS to Abnormal CS | 11 Participants |
| Liraglutide 1.8 mg | Change in Eye Examination Category | Left eye - Normal to Normal | 144 Participants |
| Liraglutide 1.8 mg | Change in Eye Examination Category | Right eye - Normal to Normal | 150 Participants |
| Liraglutide 1.8 mg | Change in Eye Examination Category | Right eye - Abnormal NCS to Normal | 12 Participants |
| Liraglutide 1.8 mg | Change in Eye Examination Category | Left eye - Normal to Abnormal NCS | 15 Participants |
| Liraglutide 1.8 mg | Change in Eye Examination Category | Right eye - Abnormal NCS to Abnormal CS | 1 Participants |
| Liraglutide 1.8 mg | Change in Eye Examination Category | Right eye - Abnormal CS to Normal | 3 Participants |
| Liraglutide 1.8 mg | Change in Eye Examination Category | Left eye - Normal to Abnormal CS | 4 Participants |
| Liraglutide 1.8 mg | Change in Eye Examination Category | Right eye - Normal to Abnormal NCS | 13 Participants |
| Liraglutide 1.8 mg | Change in Eye Examination Category | Right eye - Abnormal CS to Abnormal NCS | 2 Participants |
| Liraglutide 1.8 mg | Change in Eye Examination Category | Left eye - Abnormal NCS to normal | 13 Participants |
| Liraglutide 1.8 mg | Change in Eye Examination Category | Left eye - Abnormal CS to abnormal CS | 12 Participants |
| Liraglutide 1.8 mg | Change in Eye Examination Category | Right eye - Abnormal NCS to Abnormal NCS | 42 Participants |
| Liraglutide 1.8 mg | Change in Eye Examination Category | Left eye - Abnormal NCS to abnormal NCS | 43 Participants |
| Liraglutide 1.8 mg | Change in Eye Examination Category | Left eye - Abnormal CS to abnormal NCS | 3 Participants |
| Liraglutide 1.8 mg | Change in Eye Examination Category | Right eye - Normal to Abnormal CS | 4 Participants |
| Liraglutide 1.8 mg | Change in Eye Examination Category | Left eye - Abnormal NCS to abnormal CS | 1 Participants |
| Liraglutide 1.8 mg | Change in Eye Examination Category | Left eye - Abnormal CS to normal | 3 Participants |
| Placebo | Change in Eye Examination Category | Left eye - Abnormal NCS to abnormal CS | 1 Participants |
| Placebo | Change in Eye Examination Category | Left eye - Abnormal CS to normal | 0 Participants |
| Placebo | Change in Eye Examination Category | Left eye - Abnormal CS to abnormal NCS | 2 Participants |
| Placebo | Change in Eye Examination Category | Right eye - Abnormal NCS to Abnormal CS | 1 Participants |
| Placebo | Change in Eye Examination Category | Left eye - Abnormal CS to abnormal CS | 8 Participants |
| Placebo | Change in Eye Examination Category | Right eye - Abnormal CS to Abnormal CS | 6 Participants |
| Placebo | Change in Eye Examination Category | Right eye - Normal to Normal | 57 Participants |
| Placebo | Change in Eye Examination Category | Right eye - Normal to Abnormal NCS | 7 Participants |
| Placebo | Change in Eye Examination Category | Right eye - Abnormal CS to Normal | 1 Participants |
| Placebo | Change in Eye Examination Category | Right eye - Normal to Abnormal CS | 2 Participants |
| Placebo | Change in Eye Examination Category | Left eye - Normal to Normal | 57 Participants |
| Placebo | Change in Eye Examination Category | Left eye - Normal to Abnormal NCS | 5 Participants |
| Placebo | Change in Eye Examination Category | Right eye - Abnormal NCS to Normal | 6 Participants |
| Placebo | Change in Eye Examination Category | Left eye - Normal to Abnormal CS | 2 Participants |
| Placebo | Change in Eye Examination Category | Left eye - Abnormal NCS to normal | 5 Participants |
| Placebo | Change in Eye Examination Category | Left eye - Abnormal NCS to abnormal NCS | 38 Participants |
| Placebo | Change in Eye Examination Category | Right eye - Abnormal NCS to Abnormal NCS | 37 Participants |
| Placebo | Change in Eye Examination Category | Right eye - Abnormal CS to Abnormal NCS | 1 Participants |
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 14 mg | Change in Fasting Plasma Glucose | Week 26 | -2.04 mmol/L | Standard Deviation 2.28 |
| Oral Semaglutide 14 mg | Change in Fasting Plasma Glucose | Week 52 | -1.91 mmol/L | Standard Deviation 2.41 |
| Liraglutide 1.8 mg | Change in Fasting Plasma Glucose | Week 26 | -1.91 mmol/L | Standard Deviation 2.05 |
| Liraglutide 1.8 mg | Change in Fasting Plasma Glucose | Week 52 | -1.54 mmol/L | Standard Deviation 2.41 |
| Placebo | Change in Fasting Plasma Glucose | Week 26 | -0.33 mmol/L | Standard Deviation 2.03 |
| Placebo | Change in Fasting Plasma Glucose | Week 52 | -0.66 mmol/L | Standard Deviation 1.99 |
Secondary
Change in Free Fatty Acids - Ratio to Baseline
Change from baseline (week 0) in free fatty acids (FFA) (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 14 mg | Change in Free Fatty Acids - Ratio to Baseline | Week 26 | 0.94 Ratio of FFA | Geometric Coefficient of Variation 48 |
| Oral Semaglutide 14 mg | Change in Free Fatty Acids - Ratio to Baseline | Week 52 | 0.83 Ratio of FFA | Geometric Coefficient of Variation 49.3 |
| Liraglutide 1.8 mg | Change in Free Fatty Acids - Ratio to Baseline | Week 52 | 0.87 Ratio of FFA | Geometric Coefficient of Variation 51.2 |
| Liraglutide 1.8 mg | Change in Free Fatty Acids - Ratio to Baseline | Week 26 | 0.95 Ratio of FFA | Geometric Coefficient of Variation 50.7 |
| Placebo | Change in Free Fatty Acids - Ratio to Baseline | Week 26 | 1.06 Ratio of FFA | Geometric Coefficient of Variation 49.1 |
| Placebo | Change in Free Fatty Acids - Ratio to Baseline | Week 52 | 0.89 Ratio of FFA | Geometric Coefficient of Variation 46.8 |
Secondary
Change in HbA1c (Week 52)
Change from baseline (week 0) in HbA1c was evaluated at 52 weeks. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 52
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change in HbA1c (Week 52) | -1.2 Percentage of HbA1c | Standard Deviation 1 |
| Liraglutide 1.8 mg | Change in HbA1c (Week 52) | -0.9 Percentage of HbA1c | Standard Deviation 1 |
| Placebo | Change in HbA1c (Week 52) | -0.1 Percentage of HbA1c | Standard Deviation 0.9 |
Secondary
Change in High-density Lipoprotein (HDL) Cholesterol - Ratio to Baseline
Change from baseline (week 0) in HDL 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 14 mg | Change in High-density Lipoprotein (HDL) Cholesterol - Ratio to Baseline | Week 26 | 1.02 Ratio of HDL-cholesterol | Geometric Coefficient of Variation 13.8 |
| Oral Semaglutide 14 mg | Change in High-density Lipoprotein (HDL) Cholesterol - Ratio to Baseline | Week 52 | 1.03 Ratio of HDL-cholesterol | Geometric Coefficient of Variation 13.8 |
| Liraglutide 1.8 mg | Change in High-density Lipoprotein (HDL) Cholesterol - Ratio to Baseline | Week 26 | 1.02 Ratio of HDL-cholesterol | Geometric Coefficient of Variation 15.2 |
| Liraglutide 1.8 mg | Change in High-density Lipoprotein (HDL) Cholesterol - Ratio to Baseline | Week 52 | 1.01 Ratio of HDL-cholesterol | Geometric Coefficient of Variation 14.7 |
| Placebo | Change in High-density Lipoprotein (HDL) Cholesterol - Ratio to Baseline | Week 26 | 1.02 Ratio of HDL-cholesterol | Geometric Coefficient of Variation 12.2 |
| Placebo | Change in High-density Lipoprotein (HDL) Cholesterol - Ratio to Baseline | Week 52 | 1.00 Ratio of HDL-cholesterol | Geometric Coefficient of Variation 12.7 |
Secondary
Change in Lipase - Ratio to Baseline
Change from baseline (week 0) in lipase (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 14 mg | Change in Lipase - Ratio to Baseline | Week 26 | 1.33 Ratio of lipase | Geometric Coefficient of Variation 53.3 |
| Oral Semaglutide 14 mg | Change in Lipase - Ratio to Baseline | Week 52 | 1.28 Ratio of lipase | Geometric Coefficient of Variation 59.3 |
| Liraglutide 1.8 mg | Change in Lipase - Ratio to Baseline | Week 26 | 1.40 Ratio of lipase | Geometric Coefficient of Variation 58.8 |
| Liraglutide 1.8 mg | Change in Lipase - Ratio to Baseline | Week 52 | 1.32 Ratio of lipase | Geometric Coefficient of Variation 51.5 |
| Placebo | Change in Lipase - Ratio to Baseline | Week 26 | 0.99 Ratio of lipase | Geometric Coefficient of Variation 45.7 |
| Placebo | Change in Lipase - Ratio to Baseline | Week 52 | 0.96 Ratio of lipase | Geometric Coefficient of Variation 44.2 |
Secondary
Change in Low-density Lipoprotein (LDL) Cholesterol - Ratio to Baseline
Change from baseline (week 0) in low-density lipoprotein (LDL) 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 14 mg | Change in Low-density Lipoprotein (LDL) Cholesterol - Ratio to Baseline | Week 26 | 0.95 Ratio of LDL cholesterol | Geometric Coefficient of Variation 29.9 |
| Oral Semaglutide 14 mg | Change in Low-density Lipoprotein (LDL) Cholesterol - Ratio to Baseline | Week 52 | 0.99 Ratio of LDL cholesterol | Geometric Coefficient of Variation 31.6 |
| Liraglutide 1.8 mg | Change in Low-density Lipoprotein (LDL) Cholesterol - Ratio to Baseline | Week 26 | 0.97 Ratio of LDL cholesterol | Geometric Coefficient of Variation 43.6 |
| Liraglutide 1.8 mg | Change in Low-density Lipoprotein (LDL) Cholesterol - Ratio to Baseline | Week 52 | 1.00 Ratio of LDL cholesterol | Geometric Coefficient of Variation 38.5 |
| Placebo | Change in Low-density Lipoprotein (LDL) Cholesterol - Ratio to Baseline | Week 26 | 0.99 Ratio of LDL cholesterol | Geometric Coefficient of Variation 30.8 |
| Placebo | Change in Low-density Lipoprotein (LDL) Cholesterol - Ratio to Baseline | Week 52 | 1.06 Ratio of LDL cholesterol | Geometric Coefficient of Variation 33.1 |
Secondary
Change in Physical Examination
Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2) 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 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 14 mg | Change in Physical Examination | 4) General appearance (Week -2) | Abnormal CS | 15 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (Week -2) | Abnormal NCS | 16 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (Week 52) | Abnormal NCS | 11 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (Week 52) | Normal | 208 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (Week 52) | Normal | 267 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (Week 52) | Normal | 262 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (Week 52) | Abnormal NCS | 59 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (Week -2) | Abnormal NCS | 23 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (Week -2) | Abnormal CS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (Week 52) | Abnormal CS | 8 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (Week -2) | Abnormal CS | 11 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (Week -2) | Abnormal NCS | 14 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (Week -2) | Normal | 275 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (Week 52) | Normal | 255 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (Week -2) | Normal | 268 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (Week -2) | Abnormal NCS | 9 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (Week 52) | Abnormal NCS | 30 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 | 5) Head, ears, eyes, nose, throat, neck (Week -2) | Abnormal CS | 1 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (Week 52) | Normal | 247 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 | 5) Head, ears, eyes, nose, throat, neck (Week 52) | Normal | 267 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (Week -2) | Normal | 260 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (Week 52) | Normal | 275 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (Week 52) | Abnormal NCS | 8 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (Week 52) | Normal | 243 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 | 5) Head, ears, eyes, nose, throat, neck (Week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (Week 52) | Abnormal NCS | 20 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (Week -2) | Abnormal NCS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 6) Lymph node palpation (Week -2) | Normal | 285 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (Week -2) | Abnormal CS | 4 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (Week -2) | Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (Week 52) | Abnormal CS | 8 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 1) Cardiovascular system (Week 52) | Abnormal NCS | 19 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (Week -2) | Abnormal NCS | 40 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (Week -2) | Normal | 275 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (Week 52) | Abnormal NCS | 5 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (Week -2) | Normal | 243 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (Week -2) | Abnormal NCS | 10 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (Week -2) | Abnormal NCS | 5 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 | 3) Gastrointestinal system, incl. mouth (Week -2) | 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 | 8) Respiratory system (Week 52) | Abnormal NCS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (Week 52) | Normal | 266 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 | 8) Respiratory system (Week 52) | Normal | 273 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (Week 52) | Abnormal NCS | 9 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (Week -2) | Normal | 276 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 | 3) Gastrointestinal system, incl. mouth (Week 52) | Abnormal CS | 0 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 2) Central and peripheral nervous system (Week -2) | Normal | 258 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (Week -2) | Abnormal NCS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (Week -2) | Normal | 203 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 10) Thyroid gland (Week 52) | Abnormal CS | 3 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 8) Respiratory system (Week -2) | Normal | 282 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 4) General appearance (Week -2) | Abnormal NCS | 67 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 9) Skin (Week 52) | Abnormal CS | 2 Participants |
| Oral Semaglutide 14 mg | Change in Physical Examination | 7) Musculoskeletal system (Week 52) | Abnormal CS | 2 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 9) Skin (Week 52) | Abnormal NCS | 30 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 1) Cardiovascular system (Week -2) | Normal | 249 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 1) Cardiovascular system (Week -2) | Abnormal NCS | 26 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 1) Cardiovascular system (Week -2) | Abnormal CS | 9 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 1) Cardiovascular system (Week 52) | Normal | 236 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 1) Cardiovascular system (Week 52) | Abnormal NCS | 24 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 1) Cardiovascular system (Week 52) | Abnormal CS | 9 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 2) Central and peripheral nervous system (Week -2) | Normal | 254 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 2) Central and peripheral nervous system (Week -2) | Abnormal NCS | 16 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 2) Central and peripheral nervous system (Week -2) | Abnormal CS | 14 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 2) Central and peripheral nervous system (Week 52) | Normal | 239 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 2) Central and peripheral nervous system (Week 52) | Abnormal NCS | 20 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 2) Central and peripheral nervous system (Week 52) | Abnormal CS | 10 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (Week -2) | Normal | 271 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (Week -2) | Abnormal NCS | 13 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (Week -2) | Abnormal CS | 0 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (Week 52) | Normal | 260 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (Week 52) | Abnormal NCS | 9 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (Week 52) | Abnormal CS | 0 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 4) General appearance (Week -2) | Normal | 212 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 4) General appearance (Week -2) | Abnormal NCS | 54 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 4) General appearance (Week -2) | Abnormal CS | 18 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 4) General appearance (Week 52) | Normal | 204 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 4) General appearance (Week 52) | Abnormal NCS | 55 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 4) General appearance (Week 52) | Abnormal CS | 10 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (Week -2) | Normal | 269 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (Week -2) | Abnormal NCS | 13 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (Week -2) | Abnormal CS | 2 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (Week 52) | Normal | 258 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (Week 52) | Abnormal NCS | 10 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (Week 52) | Abnormal CS | 0 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 6) Lymph node palpation (Week -2) | Normal | 283 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 6) Lymph node palpation (Week -2) | Abnormal NCS | 1 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 6) Lymph node palpation (Week -2) | Abnormal CS | 0 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 6) Lymph node palpation (Week 52) | Normal | 268 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 6) Lymph node palpation (Week 52) | Abnormal NCS | 1 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 6) Lymph node palpation (Week 52) | Abnormal CS | 0 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 7) Musculoskeletal system (Week -2) | Normal | 264 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 7) Musculoskeletal system (Week -2) | Abnormal NCS | 17 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 7) Musculoskeletal system (Week -2) | Abnormal CS | 3 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 7) Musculoskeletal system (Week 52) | Normal | 257 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 7) Musculoskeletal system (Week 52) | Abnormal NCS | 10 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 7) Musculoskeletal system (Week 52) | Abnormal CS | 1 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 8) Respiratory system (Week -2) | Normal | 278 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 8) Respiratory system (Week -2) | Abnormal NCS | 5 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 8) Respiratory system (Week -2) | Abnormal CS | 1 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 8) Respiratory system (Week 52) | Normal | 262 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 8) Respiratory system (Week 52) | Abnormal NCS | 6 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 8) Respiratory system (Week 52) | Abnormal CS | 1 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 9) Skin (Week -2) | Normal | 243 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 9) Skin (Week -2) | Abnormal NCS | 36 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 9) Skin (Week -2) | Abnormal CS | 5 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 9) Skin (Week 52) | Normal | 235 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 9) Skin (Week 52) | Abnormal CS | 4 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 10) Thyroid gland (Week -2) | Normal | 277 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 10) Thyroid gland (Week -2) | Abnormal NCS | 5 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 10) Thyroid gland (Week -2) | Abnormal CS | 2 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 10) Thyroid gland (Week 52) | Normal | 262 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 10) Thyroid gland (Week 52) | Abnormal NCS | 6 Participants |
| Liraglutide 1.8 mg | Change in Physical Examination | 10) Thyroid gland (Week 52) | Abnormal CS | 1 Participants |
| Placebo | Change in Physical Examination | 4) General appearance (Week -2) | Abnormal CS | 11 Participants |
| Placebo | Change in Physical Examination | 9) Skin (Week 52) | Abnormal CS | 2 Participants |
| Placebo | Change in Physical Examination | 7) Musculoskeletal system (Week 52) | Abnormal NCS | 7 Participants |
| Placebo | Change in Physical Examination | 4) General appearance (Week -2) | Abnormal NCS | 22 Participants |
| Placebo | Change in Physical Examination | 1) Cardiovascular system (Week 52) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 7) Musculoskeletal system (Week 52) | Abnormal CS | 1 Participants |
| Placebo | Change in Physical Examination | 4) General appearance (Week -2) | Normal | 109 Participants |
| Placebo | Change in Physical Examination | 1) Cardiovascular system (Week -2) | Abnormal NCS | 12 Participants |
| Placebo | Change in Physical Examination | 8) Respiratory system (Week -2) | Normal | 140 Participants |
| Placebo | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (Week 52) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 10) Thyroid gland (Week -2) | Normal | 132 Participants |
| Placebo | Change in Physical Examination | 8) Respiratory system (Week -2) | Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (Week 52) | Abnormal NCS | 10 Participants |
| Placebo | Change in Physical Examination | 1) Cardiovascular system (Week 52) | Abnormal NCS | 15 Participants |
| Placebo | Change in Physical Examination | 8) Respiratory system (Week -2) | Abnormal CS | 2 Participants |
| Placebo | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (Week 52) | Normal | 123 Participants |
| Placebo | Change in Physical Examination | 10) Thyroid gland (Week 52) | Abnormal CS | 2 Participants |
| Placebo | Change in Physical Examination | 8) Respiratory system (Week 52) | Normal | 131 Participants |
| Placebo | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (Week -2) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 10) Thyroid gland (Week -2) | Abnormal NCS | 8 Participants |
| Placebo | Change in Physical Examination | 8) Respiratory system (Week 52) | Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (Week -2) | Abnormal NCS | 9 Participants |
| Placebo | Change in Physical Examination | 1) Cardiovascular system (Week 52) | Normal | 118 Participants |
| Placebo | Change in Physical Examination | 8) Respiratory system (Week 52) | Abnormal CS | 2 Participants |
| Placebo | Change in Physical Examination | 3) Gastrointestinal system, incl. mouth (Week -2) | Normal | 133 Participants |
| Placebo | Change in Physical Examination | 10) Thyroid gland (Week 52) | Abnormal NCS | 4 Participants |
| Placebo | Change in Physical Examination | 9) Skin (Week -2) | Normal | 122 Participants |
| Placebo | Change in Physical Examination | 2) Central and peripheral nervous system (Week 52) | Abnormal CS | 7 Participants |
| Placebo | Change in Physical Examination | 10) Thyroid gland (Week -2) | Abnormal CS | 2 Participants |
| Placebo | Change in Physical Examination | 9) Skin (Week -2) | Abnormal NCS | 17 Participants |
| Placebo | Change in Physical Examination | 2) Central and peripheral nervous system (Week 52) | Abnormal NCS | 11 Participants |
| Placebo | Change in Physical Examination | 1) Cardiovascular system (Week -2) | Abnormal CS | 2 Participants |
| Placebo | Change in Physical Examination | 6) Lymph node palpation (Week -2) | Normal | 142 Participants |
| Placebo | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (Week 52) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 9) Skin (Week -2) | Abnormal CS | 3 Participants |
| Placebo | Change in Physical Examination | 6) Lymph node palpation (Week -2) | Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (Week 52) | Abnormal NCS | 3 Participants |
| Placebo | Change in Physical Examination | 2) Central and peripheral nervous system (Week 52) | Normal | 115 Participants |
| Placebo | Change in Physical Examination | 6) Lymph node palpation (Week -2) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (Week 52) | Normal | 129 Participants |
| Placebo | Change in Physical Examination | 1) Cardiovascular system (Week -2) | Normal | 128 Participants |
| Placebo | Change in Physical Examination | 6) Lymph node palpation (Week 52) | Normal | 133 Participants |
| Placebo | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (Week -2) | Abnormal CS | 1 Participants |
| Placebo | Change in Physical Examination | 9) Skin (Week 52) | Normal | 114 Participants |
| Placebo | Change in Physical Examination | 6) Lymph node palpation (Week 52) | Abnormal NCS | 0 Participants |
| Placebo | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (Week -2) | Abnormal NCS | 3 Participants |
| Placebo | Change in Physical Examination | 2) Central and peripheral nervous system (Week -2) | Abnormal CS | 6 Participants |
| Placebo | Change in Physical Examination | 6) Lymph node palpation (Week 52) | Abnormal CS | 0 Participants |
| Placebo | Change in Physical Examination | 5) Head, ears, eyes, nose, throat, neck (Week -2) | Normal | 138 Participants |
| Placebo | Change in Physical Examination | 2) Central and peripheral nervous system (Week -2) | Abnormal NCS | 13 Participants |
| Placebo | Change in Physical Examination | 7) Musculoskeletal system (Week -2) | Normal | 131 Participants |
| Placebo | Change in Physical Examination | 4) General appearance (Week 52) | Abnormal CS | 8 Participants |
| Placebo | Change in Physical Examination | 9) Skin (Week 52) | Abnormal NCS | 17 Participants |
| Placebo | Change in Physical Examination | 7) Musculoskeletal system (Week -2) | Abnormal NCS | 10 Participants |
| Placebo | Change in Physical Examination | 4) General appearance (Week 52) | Abnormal NCS | 20 Participants |
| Placebo | Change in Physical Examination | 2) Central and peripheral nervous system (Week -2) | Normal | 123 Participants |
| Placebo | Change in Physical Examination | 7) Musculoskeletal system (Week -2) | Abnormal CS | 1 Participants |
| Placebo | Change in Physical Examination | 4) General appearance (Week 52) | Normal | 105 Participants |
| Placebo | Change in Physical Examination | 10) Thyroid gland (Week 52) | Normal | 127 Participants |
| Placebo | Change in Physical Examination | 7) Musculoskeletal system (Week 52) | Normal | 124 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 14 mg | Change in Pulse Rate | Week 26 | 2 Beats/min | Standard Deviation 9 |
| Oral Semaglutide 14 mg | Change in Pulse Rate | Week 52 | 2 Beats/min | Standard Deviation 9 |
| Liraglutide 1.8 mg | Change in Pulse Rate | Week 26 | 3 Beats/min | Standard Deviation 11 |
| Liraglutide 1.8 mg | Change in Pulse Rate | Week 52 | 3 Beats/min | Standard Deviation 9 |
| Placebo | Change in Pulse Rate | Week 26 | 0 Beats/min | Standard Deviation 9 |
| Placebo | Change in Pulse Rate | Week 52 | 0 Beats/min | Standard Deviation 9 |
Secondary
Change in SBP and DBP
Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at weeks 26 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 14 mg | Change in SBP and DBP | DBP: 26 weeks | -1 mmHg | Standard Deviation 9 |
| Oral Semaglutide 14 mg | Change in SBP and DBP | SBP: 26 weeks | -4 mmHg | Standard Deviation 13 |
| Oral Semaglutide 14 mg | Change in SBP and DBP | DBP: 52 weeks | -1 mmHg | Standard Deviation 8 |
| Oral Semaglutide 14 mg | Change in SBP and DBP | SBP: 52 weeks | -3 mmHg | Standard Deviation 14 |
| Liraglutide 1.8 mg | Change in SBP and DBP | DBP: 26 weeks | -0 mmHg | Standard Deviation 9 |
| Liraglutide 1.8 mg | Change in SBP and DBP | SBP: 52 weeks | -3 mmHg | Standard Deviation 13 |
| Liraglutide 1.8 mg | Change in SBP and DBP | SBP: 26 weeks | -4 mmHg | Standard Deviation 13 |
| Liraglutide 1.8 mg | Change in SBP and DBP | DBP: 52 weeks | -1 mmHg | Standard Deviation 9 |
| Placebo | Change in SBP and DBP | DBP: 52 weeks | 0 mmHg | Standard Deviation 9 |
| Placebo | Change in SBP and DBP | SBP: 26 weeks | -2 mmHg | Standard Deviation 13 |
| Placebo | Change in SBP and DBP | SBP: 52 weeks | -0 mmHg | Standard Deviation 13 |
| Placebo | Change in SBP and DBP | DBP: 26 weeks | -1 mmHg | Standard Deviation 9 |
Secondary
Change in SMPG - Mean 7-point Profile
Change from baseline (week 0) to week 26 and week 52 in mean 7-point self-measured plasma glucose (SMPG) profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Week 0, week 26, week 52
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 14 mg | Change in SMPG - Mean 7-point Profile | Week 52 | -2.2 mmol/L | Standard Deviation 2.3 |
| Oral Semaglutide 14 mg | Change in SMPG - Mean 7-point Profile | Week 26 | -2.2 mmol/L | Standard Deviation 2.3 |
| Liraglutide 1.8 mg | Change in SMPG - Mean 7-point Profile | Week 26 | -2.0 mmol/L | Standard Deviation 2 |
| Liraglutide 1.8 mg | Change in SMPG - Mean 7-point Profile | Week 52 | -1.8 mmol/L | Standard Deviation 2.2 |
| Placebo | Change in SMPG - Mean 7-point Profile | Week 26 | -0.7 mmol/L | Standard Deviation 1.8 |
| Placebo | Change in SMPG - Mean 7-point Profile | Week 52 | -0.9 mmol/L | Standard Deviation 1.7 |
Secondary
Change in SMPG - Mean Postprandial Increment Over All Meals
Change from baseline (week 0) in the average of the post-prandial increments over all meals was evaluated at weeks 26 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 14 mg | Change in SMPG - Mean Postprandial Increment Over All Meals | Week 26 | -0.7 mmol/L | Standard Deviation 1.9 |
| Oral Semaglutide 14 mg | Change in SMPG - Mean Postprandial Increment Over All Meals | Week 52 | -0.5 mmol/L | Standard Deviation 1.9 |
| Liraglutide 1.8 mg | Change in SMPG - Mean Postprandial Increment Over All Meals | Week 26 | -0.4 mmol/L | Standard Deviation 2 |
| Liraglutide 1.8 mg | Change in SMPG - Mean Postprandial Increment Over All Meals | Week 52 | -0.5 mmol/L | Standard Deviation 2.1 |
| Placebo | Change in SMPG - Mean Postprandial Increment Over All Meals | Week 52 | -0.4 mmol/L | Standard Deviation 1.9 |
| Placebo | Change in SMPG - Mean Postprandial Increment Over All Meals | Week 26 | -0.2 mmol/L | Standard Deviation 1.9 |
Secondary
Change in Total Cholesterol - Ratio to Baseline
Change from baseline (week 0) in 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 14 mg | Change in Total Cholesterol - Ratio to Baseline | Week 26 | 0.96 Ratio of total cholesterol | Geometric Coefficient of Variation 20.3 |
| Oral Semaglutide 14 mg | Change in Total Cholesterol - Ratio to Baseline | Week 52 | 0.98 Ratio of total cholesterol | Geometric Coefficient of Variation 20.5 |
| Liraglutide 1.8 mg | Change in Total Cholesterol - Ratio to Baseline | Week 52 | 0.98 Ratio of total cholesterol | Geometric Coefficient of Variation 19.6 |
| Liraglutide 1.8 mg | Change in Total Cholesterol - Ratio to Baseline | Week 26 | 0.97 Ratio of total cholesterol | Geometric Coefficient of Variation 21.6 |
| Placebo | Change in Total Cholesterol - Ratio to Baseline | Week 26 | 0.99 Ratio of total cholesterol | Geometric Coefficient of Variation 17 |
| Placebo | Change in Total Cholesterol - Ratio to Baseline | Week 52 | 1.02 Ratio of total cholesterol | Geometric Coefficient of Variation 18.3 |
Secondary
Change in Triglycerides - Ratio to Baseline
Change from baseline (week 0) in 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 14 mg | Change in Triglycerides - Ratio to Baseline | Week 26 | 0.89 Ratio of triglycerides | Geometric Coefficient of Variation 48.4 |
| Oral Semaglutide 14 mg | Change in Triglycerides - Ratio to Baseline | Week 52 | 0.87 Ratio of triglycerides | Geometric Coefficient of Variation 47 |
| Liraglutide 1.8 mg | Change in Triglycerides - Ratio to Baseline | Week 26 | 0.91 Ratio of triglycerides | Geometric Coefficient of Variation 38.3 |
| Liraglutide 1.8 mg | Change in Triglycerides - Ratio to Baseline | Week 52 | 0.89 Ratio of triglycerides | Geometric Coefficient of Variation 41.1 |
| Placebo | Change in Triglycerides - Ratio to Baseline | Week 26 | 1.01 Ratio of triglycerides | Geometric Coefficient of Variation 34.7 |
| Placebo | Change in Triglycerides - Ratio to Baseline | Week 52 | 0.97 Ratio of triglycerides | Geometric Coefficient of Variation 43.4 |
Secondary
Change in Very Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline
Change from baseline (week 0) in VLDL 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 14 mg | Change in Very Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline | Week 26 | 0.90 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 43.5 |
| Oral Semaglutide 14 mg | Change in Very Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline | Week 52 | 0.87 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 41.9 |
| Liraglutide 1.8 mg | Change in Very Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline | Week 26 | 0.91 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 37.1 |
| Liraglutide 1.8 mg | Change in Very Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline | Week 52 | 0.90 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 37.5 |
| Placebo | Change in Very Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline | Week 26 | 1.02 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 29.4 |
| Placebo | Change in Very Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline | Week 52 | 0.98 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 39.8 |
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 14 mg | Change in Waist Circumference | Week 26 | -4.2 cm | Standard Deviation 5.4 |
| Oral Semaglutide 14 mg | Change in Waist Circumference | Week 52 | -4.4 cm | Standard Deviation 6.1 |
| Liraglutide 1.8 mg | Change in Waist Circumference | Week 26 | -3.0 cm | Standard Deviation 4.5 |
| Liraglutide 1.8 mg | Change in Waist Circumference | Week 52 | -2.7 cm | Standard Deviation 5.1 |
| Placebo | Change in Waist Circumference | Week 26 | -1.2 cm | Standard Deviation 3.9 |
| Placebo | Change in Waist Circumference | Week 52 | -1.7 cm | Standard Deviation 4.7 |
Secondary
Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product
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 14 mg | Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product | 973 Events |
| Liraglutide 1.8 mg | Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product | 927 Events |
| Placebo | Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product | 300 Events |
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 14 mg | Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes | 2 Episodes |
| Liraglutide 1.8 mg | Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes | 9 Episodes |
| Placebo | Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes | 3 Episodes |
Secondary
Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)
This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (weeks 0-57) 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 0-57
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 14 mg | Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no) | 0 Participants |
Secondary
Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)
This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Weeks 0-57
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 14 mg | Occurrence of Anti-semaglutide Binding Antibodies (Yes/no) | 0 Participants |
Secondary
Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)
This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Weeks 0-57
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 14 mg | Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no) | 0 Participants |
Secondary
Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)
This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.
Time frame: Weeks 0-57
Population: Overall number of participants analyzed = number of participants with available data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 14 mg | Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no) | 0 Participants |
Secondary
Participants Who Achieve HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no)
Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at weeks 26 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 14 mg | Participants Who Achieve HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 26 | Yes | 133 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 26 | No | 145 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 52 | Yes | 119 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 52 | No | 156 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 52 | No | 181 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 26 | Yes | 116 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 52 | Yes | 88 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 26 | No | 156 Participants |
| Placebo | Participants Who Achieve HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 52 | No | 128 Participants |
| Placebo | Participants Who Achieve HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 26 | No | 127 Participants |
| Placebo | Participants Who Achieve HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 52 | Yes | 5 Participants |
| Placebo | Participants Who Achieve HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no) | Week 26 | Yes | 7 Participants |
Secondary
Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)
Participants who achieved HbA1c \<7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at weeks 26 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 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 14 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | Yes | 188 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | No | 90 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | Yes | 167 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | No | 108 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | No | 121 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | Yes | 168 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | Yes | 148 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | No | 104 Participants |
| Placebo | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | No | 113 Participants |
| Placebo | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | No | 115 Participants |
| Placebo | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 52 | Yes | 20 Participants |
| Placebo | Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no) | Week 26 | Yes | 19 Participants |
Secondary
Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)
Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26 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 14 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | Yes | 169 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | No | 109 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | Yes | 155 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | No | 120 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | No | 139 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | Yes | 145 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | Yes | 130 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | No | 126 Participants |
| Placebo | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | No | 118 Participants |
| Placebo | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | No | 119 Participants |
| Placebo | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 52 | Yes | 15 Participants |
| Placebo | Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no) | Week 26 | Yes | 15 Participants |
Secondary
Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)
Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26 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 14 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | Yes | 130 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | No | 148 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | Yes | 120 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | No | 155 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | No | 192 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | Yes | 93 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | Yes | 77 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | No | 178 Participants |
| Placebo | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | No | 124 Participants |
| Placebo | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | No | 129 Participants |
| Placebo | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 52 | Yes | 9 Participants |
| Placebo | Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no) | Week 26 | Yes | 5 Participants |
Secondary
Participants Who Achieve Weight Loss ≥ 10% (Yes/no)
Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at weeks 26 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 14 mg | Participants Who Achieve Weight Loss ≥ 10% (Yes/no) | Week 26 | Yes | 39 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss ≥ 10% (Yes/no) | Week 26 | No | 239 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss ≥ 10% (Yes/no) | Week 52 | Yes | 45 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss ≥ 10% (Yes/no) | Week 52 | No | 230 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve Weight Loss ≥ 10% (Yes/no) | Week 52 | No | 249 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve Weight Loss ≥ 10% (Yes/no) | Week 26 | Yes | 16 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve Weight Loss ≥ 10% (Yes/no) | Week 52 | Yes | 20 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve Weight Loss ≥ 10% (Yes/no) | Week 26 | No | 255 Participants |
| Placebo | Participants Who Achieve Weight Loss ≥ 10% (Yes/no) | Week 52 | No | 129 Participants |
| Placebo | Participants Who Achieve Weight Loss ≥ 10% (Yes/no) | Week 26 | No | 134 Participants |
| Placebo | Participants Who Achieve Weight Loss ≥ 10% (Yes/no) | Week 52 | Yes | 4 Participants |
| Placebo | Participants Who Achieve Weight Loss ≥ 10% (Yes/no) | Week 26 | Yes | 0 Participants |
Secondary
Participants Who Achieve Weight Loss ≥5% (Yes/no)
Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 26 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 14 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 26 | Yes | 121 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 26 | No | 157 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 52 | Yes | 123 Participants |
| Oral Semaglutide 14 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 52 | No | 152 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 52 | No | 203 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 26 | Yes | 75 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 52 | Yes | 66 Participants |
| Liraglutide 1.8 mg | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 26 | No | 196 Participants |
| Placebo | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 52 | No | 117 Participants |
| Placebo | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 26 | No | 124 Participants |
| Placebo | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 52 | Yes | 16 Participants |
| Placebo | Participants Who Achieve Weight Loss ≥5% (Yes/no) | Week 26 | Yes | 10 Participants |
Secondary
Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes
Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Semaglutide 14 mg | Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 2 Participants |
| Liraglutide 1.8 mg | Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 7 Participants |
| Placebo | Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes | 3 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 (week 52), 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 14 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 26 | 20 Participants |
| Oral Semaglutide 14 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 52 | 39 Participants |
| Liraglutide 1.8 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 26 | 16 Participants |
| Liraglutide 1.8 mg | Time to Additional Anti-diabetic Medication | Week 0 to week 52 | 29 Participants |
| Placebo | Time to Additional Anti-diabetic Medication | Week 0 to week 26 | 12 Participants |
| Placebo | Time to Additional Anti-diabetic Medication | Week 0 to week 52 | 46 Participants |
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.p-value: 0.491595% CI: [0.75, 1.8]Regression, Cox
Comparison: Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.p-value: <0.000195% CI: [0.21, 0.48]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 14 mg | Time to Rescue Medication | Week 0 - week 26 | 10 Participants |
| Oral Semaglutide 14 mg | Time to Rescue Medication | Week 0 - week 52 | 20 Participants |
| Liraglutide 1.8 mg | Time to Rescue Medication | Week 0 - week 26 | 9 Participants |
| Liraglutide 1.8 mg | Time to Rescue Medication | Week 0 - week 52 | 18 Participants |
| Placebo | Time to Rescue Medication | Week 0 - week 26 | 11 Participants |
| Placebo | Time to Rescue Medication | Week 0 - week 52 | 43 Participants |
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: 0.625295% CI: [0.62, 2.22]Regression, Cox
Comparison: Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.p-value: <0.000195% CI: [0.09, 0.26]Regression, Cox