Diabetes Mellitus, Type 2
Conditions
Brief summary
This study compares three doses of once daily semaglutide tablets in people with type 2 diabetes who were previously treated with other oral anti-diabetic medicines. Participants will be initiated on the lowest starting dose of 3 mg and gradually increased until they reach the final trial dose of 14 mg, 25 mg or 50 mg once daily semaglutide tablets. The final three doses will be randomized (i.e., decided by chance). Participants will be administered one tablet per day for 68 weeks. Women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period. Women who can get pregnant will be checked for pregnancy via urine tests. Once daily semaglutide tablets (3 mg, 7 mg and 14 mg) are approved for the treatment of type 2 diabetes in the US, in the EU and in some other countries, under the brand name Rybelsus®.
Interventions
DRUGOral semaglutide
Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, age above or equal to 18 years at the time of signing informed consent. * Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening. * HbA1c of 8.0-10.5% (64-91 mmol/mol) (both inclusive). * BMI equal to or above 25 kg/m\^2 * Stable daily dose(s) for 90 days prior to the day of screening of any of the following treatment regimens: * No more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a \*: * Metformin (equal to or above1500 mg or maximum tolerated or effective dose). * Sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose). * Sodium/glucose cotransporter 2 (SGLT2) inhibitors (maximum tolerated dose). * Dipeptidyl peptidase-4 (DPP-4) inhibitors (maximally indicated dose as per local label). * Subjects, on treatment with stable dose of DPP-4 inhibitors at inclusion, must be willing to discontinue DPP-4 inhibitor treatment at randomisation (with no wash-out).
Exclusion criteria
* Treatment with any medication indicated for the treatment of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed. * Renal impairment measured as estimated glomerular filtration rate (eGFR) value of below 30 mL/min/1.73 m\^2 according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by kidney disease improving global outcomes (KDIGO 2012) classification. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52) | Baseline (week 0), week 52 | Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at 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 additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HbA1c (Week 68) | Baseline (week 0), week 68 | Change from baseline (week 0) in HbA1c was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages. |
| Change From Week 12 in HbA1c (Week 52) | Week 12, Week 52 | Change in HbA1c was evaluated from week 12 to 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 additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages. |
| Change From Baseline in Fasting Plasma Glucose (FPG) (Week 52) | Baseline (week 0), week 52 | Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Change From Baseline in FPG (Week 68) | Baseline (week 0), week 68 | Change from baseline (week 0) in FPG was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Percentage of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Week 52) | At week 52 | Percentage of participants who achieved HbA1c \<7.0 % at 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Change From Baseline in Total Cholesterol (Week 52) | Baseline, Week 52 | Change from baseline (week 0) in total cholesterol was evaluated at 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Percentage of Participants Who Achieved HbA1c < 7.0 % (Week 68) | At week 68 | Percentage of participants who achieved HbA1c \<7.0 % at week 68 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Percentage of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 % (Week 52) | At week 52 | Percentage of participants who achieved HbA1c \<=6.5 % at 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Percentage of Participants Who Achieved HbA1c <= 6.5 % (Week 68) | At week 68 | Percentage of participants who achieved HbA1c \<=6.5 % at week 68 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Time to Event Analyses of Rescue Medication | Baseline (week 0), week 68 | Time to event analyses of rescue medication was evaluated from baseline (week 0) to week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Change From Baseline in Body Weight (Week 68) | Baseline (week 0), week 68 | Change from baseline (week 0) in body weight was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Percentage Change From Baseline in Body Weight (Week 52) | Baseline (week 0), week 52 | Percentage change from baseline (week 0) in body weight was evaluated at 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Percentage Change From Baseline in Body Weight (Week 68) | Baseline (week 0), week 68 | Percentage change from baseline (week 0) in body weight was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Percentage Change From Week 12 in Body Weight (Week 52) | Week 12, Week 52 | Percentage change in body weight was evaluated from week 12 to 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Change From Baseline in Body Mass Index (BMI) (Week 52) | Baseline (week 0), week 52 | Change from baseline (week 0) in body mass index (BMI) was evaluated at 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Change From Baseline in BMI (Week 68) | Baseline (week 0), week 68 | Change from baseline (week 0) in BMI was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Change From Baseline in Waist Circumference (Week 52) | Baseline (week 0), week 52 | Change from baseline (week 0) in waist circumference was evaluated at 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Change From Baseline in Waist Circumference (Week 68) | Baseline (week 0), week 68 | Change from baseline (week 0) in waist circumference was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Change From Baseline in Body Weight (Week 52) | Baseline (week 0), week 52 | Change from baseline (week 0) in body weight was evaluated at 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Change From Baseline in Total Cholesterol (Week 68) | Baseline, Week 68 | Change from baseline (week 0) in total cholesterol was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Percentage of Participants Who Achieved Weight Loss >= 5 % (Week 68) | At week 68 | Percentage of participants who achieved weight loss \>= 5 % at week 68 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 52) | At week 52 | Percentage of participants who achieved weight loss \>= 10 % at 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 68) | At week 68 | Percentage of participants who achieved weight loss \>= 10 % at week 68 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Change From Baseline in Low Density Lipoproteins (LDL) (Week 52) | Baseline, Week 52 | Change from baseline (week 0) in LDL was evaluated at 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Change From Baseline in LDL (Week 68) | Baseline, Week 68 | Change from baseline (week 0) in LDL was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Change From Baseline in High Density Lipoproteins (HDL) (Week 52) | Baseline, Week 52 | Change from baseline (week 0) in HDL was evaluated at 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Change From Baseline in HDL (Week 68) | Baseline, Week 68 | Change from baseline (week 0) in HDL was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Change From Baseline in Triglycerides (Week 52) | Baseline, Week 52 | Change from baseline (week 0) in triglycerides was evaluated at 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Change From Baseline in Triglycerides (Week 68) | Baseline, Week 68 | Change from baseline (week 0) in triglycerides was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment. |
| Number of Adverse Events | From baseline (week 0) up to week 73 | An adverse event (AE) defined as any unfavourable and unintended sign, including an abnormal laboratory finding, symptom or disease (new or exacerbated) temporally associated with the use of an investigational medicinal products (IMP). Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication. |
| Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) or Severe Hypoglycaemic Episodes (Level 3) | From baseline (week 0) up to week 68 | Hypoglycaemic episodes were classified according to the American Diabetes Association 2018/ International Hypoglycaemia Study Group 2017, where glycemic criteria for level 2 was \< 3.0 mmol/L (54 mg/dL) and level 3 had no specific glucose threshold. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication. |
| Change From Baseline in Systolic Blood Pressure (Week 52) | Baseline (week 0), week 52 | Change from baseline (week 0) in systolic blood pressure at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication. |
| Change From Baseline in Systolic Blood Pressure (Week 68) | Baseline (week 0), week 68 | Change from baseline (week 0) in systolic blood pressure at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication. |
| Change From Baseline in Diastolic Blood Pressure (Week 52) | Baseline (week 0), week 52 | Change from baseline (week 0) in diastolic blood pressure at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication. |
| Change From Baseline in Diastolic Blood Pressure (Week 68) | Baseline (week 0), week 68 | Change from baseline (week 0) in diastolic blood pressure at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication. |
| Change From Baseline in Pulse (Week 52) | Baseline (week 0), week 52 | Change from baseline (week 0) in pulse at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication. |
| Change From Baseline in Pulse (Week 68) | Baseline (week 0), week 68 | Change from baseline (week 0) in pulse at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication. |
| Percentage of Participants Who Achieved Weight Loss Greater Than or Equal to (>=) 5 % (Week 52) | At week 52 | Percentage of participants who achieved weight loss \>= 5 % at 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 additional anti-diabetic medication or discontinuation of trial treatment. |
Countries
Australia, Bulgaria, Canada, Croatia, Czechia, Estonia, Germany, Hungary, India, Poland, Puerto Rico, Slovakia, Slovenia, Taiwan, United States
Participant flow
Recruitment details
The trial was conducted in 14 countries (184 sites screened/177 randomised participants) as follows: Australia: 7/6; Bulgaria: 15/15; Canada: 13/13; Croatia: 5/5; Czech Republic: 5/5; Estonia: 6/5; Germany: 8/8; Hungary: 9/9; India: 20/20; Poland: 18/18; Slovakia: 9/9; Slovenia: 5/5; Taiwan: 2/2; United States: 62/57. In addition, Bulgaria (1 site), Canada (1 site), Croatia (1 site) and Poland (1 site) were approved by the institutional review board, but did not randomise any participant.
Pre-assignment details
Participants were randomized in 1:1:1 ratio to receive either 14 milligram (mg), 25 mg or 50 mg oral semaglutide once daily. The trial had a 68-week treatment period (8-16 weeks of dose escalation period and 52-60 weeks of maintenance period), followed by a 5-week follow-up period.
Participants by arm
| Arm | Count |
|---|---|
| Oral Semaglutide 14 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68. | 536 |
| Oral Semaglutide 25 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68. | 535 |
| Oral Semaglutide 50 mg Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68. | 535 |
| Total | 1,606 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 6 | 2 |
| Overall Study | Lost to Follow-up | 9 | 19 | 14 |
| Overall Study | Physician Decision | 2 | 2 | 2 |
| Overall Study | Site closure | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 17 | 16 | 12 |
Baseline characteristics
| Characteristic | Oral Semaglutide 14 mg | Oral Semaglutide 25 mg | Oral Semaglutide 50 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 58.4 Years STANDARD_DEVIATION 10.4 | 58.8 Years STANDARD_DEVIATION 10.7 | 57.6 Years STANDARD_DEVIATION 11.2 | 58.2 Years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants | 37 Participants | 36 Participants | 111 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 498 Participants | 498 Participants | 499 Participants | 1495 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 85 Participants | 73 Participants | 111 Participants | 269 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 22 Participants | 18 Participants | 59 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 6 Participants | 8 Participants | 21 Participants |
| Race (NIH/OMB) White | 424 Participants | 432 Participants | 398 Participants | 1254 Participants |
| Sex: Female, Male Female | 211 Participants | 231 Participants | 228 Participants | 670 Participants |
| Sex: Female, Male Male | 325 Participants | 304 Participants | 307 Participants | 936 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 534 | 6 / 534 | 2 / 534 |
| other Total, other adverse events | 277 / 534 | 294 / 534 | 314 / 534 |
| serious Total, serious adverse events | 53 / 534 | 57 / 534 | 44 / 534 |
Outcome results
Primary
Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52)
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at 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 additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.
Time frame: Baseline (week 0), week 52
Population: Full Analysis Set (FAS) which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52) | -1.5 Percentage point of HbA1c | Standard Deviation 1.3 |
| Oral Semaglutide 25 mg | Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52) | -1.9 Percentage point of HbA1c | Standard Deviation 1.3 |
| Oral Semaglutide 50 mg | Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52) | -2.1 Percentage point of HbA1c | Standard Deviation 1.4 |
Comparison: Treatment policy estimandp-value: 0.000695% CI: [-0.42, -0.12]ANCOVA
Comparison: Treatment policy estimandp-value: <0.000195% CI: [-0.68, -0.38]ANCOVA
Secondary
Change From Baseline in BMI (Week 68)
Change from baseline (week 0) in BMI was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: Baseline (week 0), week 68
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in BMI (Week 68) | -1.6 kg/m^2 | Standard Deviation 1.9 |
| Oral Semaglutide 25 mg | Change From Baseline in BMI (Week 68) | -2.5 kg/m^2 | Standard Deviation 2.7 |
| Oral Semaglutide 50 mg | Change From Baseline in BMI (Week 68) | -2.9 kg/m^2 | Standard Deviation 2.8 |
Secondary
Change From Baseline in Body Mass Index (BMI) (Week 52)
Change from baseline (week 0) in body mass index (BMI) was evaluated at 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: Baseline (week 0), week 52
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in Body Mass Index (BMI) (Week 52) | -1.6 kilogram per square metre (kg/m^2) | Standard Deviation 1.8 |
| Oral Semaglutide 25 mg | Change From Baseline in Body Mass Index (BMI) (Week 52) | -2.5 kilogram per square metre (kg/m^2) | Standard Deviation 2.5 |
| Oral Semaglutide 50 mg | Change From Baseline in Body Mass Index (BMI) (Week 52) | -2.9 kilogram per square metre (kg/m^2) | Standard Deviation 2.6 |
Secondary
Change From Baseline in Body Weight (Week 52)
Change from baseline (week 0) in body weight was evaluated at 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: Baseline (week 0), week 52
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in Body Weight (Week 52) | -4.4 Kilogram (Kg) | Standard Deviation 5.2 |
| Oral Semaglutide 25 mg | Change From Baseline in Body Weight (Week 52) | -7.1 Kilogram (Kg) | Standard Deviation 6.8 |
| Oral Semaglutide 50 mg | Change From Baseline in Body Weight (Week 52) | -8.3 Kilogram (Kg) | Standard Deviation 7.5 |
Secondary
Change From Baseline in Body Weight (Week 68)
Change from baseline (week 0) in body weight was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: Baseline (week 0), week 68
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in Body Weight (Week 68) | -4.5 Kg | Standard Deviation 5.5 |
| Oral Semaglutide 25 mg | Change From Baseline in Body Weight (Week 68) | -7.1 Kg | Standard Deviation 7.4 |
| Oral Semaglutide 50 mg | Change From Baseline in Body Weight (Week 68) | -8.2 Kg | Standard Deviation 8.1 |
Secondary
Change From Baseline in Diastolic Blood Pressure (Week 52)
Change from baseline (week 0) in diastolic blood pressure at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Time frame: Baseline (week 0), week 52
Population: SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in Diastolic Blood Pressure (Week 52) | -2 mmHg | Standard Deviation 8 |
| Oral Semaglutide 25 mg | Change From Baseline in Diastolic Blood Pressure (Week 52) | -2 mmHg | Standard Deviation 8 |
| Oral Semaglutide 50 mg | Change From Baseline in Diastolic Blood Pressure (Week 52) | -2 mmHg | Standard Deviation 8 |
Secondary
Change From Baseline in Diastolic Blood Pressure (Week 68)
Change from baseline (week 0) in diastolic blood pressure at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Time frame: Baseline (week 0), week 68
Population: SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in Diastolic Blood Pressure (Week 68) | -3 mmHg | Standard Deviation 8 |
| Oral Semaglutide 25 mg | Change From Baseline in Diastolic Blood Pressure (Week 68) | -3 mmHg | Standard Deviation 8 |
| Oral Semaglutide 50 mg | Change From Baseline in Diastolic Blood Pressure (Week 68) | -2 mmHg | Standard Deviation 8 |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) (Week 52)
Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: Baseline (week 0), week 52
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in Fasting Plasma Glucose (FPG) (Week 52) | -2.4 millimole per litre (mmol/L) | Standard Deviation 3.4 |
| Oral Semaglutide 25 mg | Change From Baseline in Fasting Plasma Glucose (FPG) (Week 52) | -3.0 millimole per litre (mmol/L) | Standard Deviation 3.5 |
| Oral Semaglutide 50 mg | Change From Baseline in Fasting Plasma Glucose (FPG) (Week 52) | -3.2 millimole per litre (mmol/L) | Standard Deviation 3.4 |
Secondary
Change From Baseline in FPG (Week 68)
Change from baseline (week 0) in FPG was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: Baseline (week 0), week 68
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in FPG (Week 68) | -2.4 mmol/L | Standard Deviation 3.4 |
| Oral Semaglutide 25 mg | Change From Baseline in FPG (Week 68) | -3.0 mmol/L | Standard Deviation 3.7 |
| Oral Semaglutide 50 mg | Change From Baseline in FPG (Week 68) | -3.2 mmol/L | Standard Deviation 3.4 |
Secondary
Change From Baseline in HbA1c (Week 68)
Change from baseline (week 0) in HbA1c was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.
Time frame: Baseline (week 0), week 68
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in HbA1c (Week 68) | -1.5 Percentage point of HbA1c | Standard Deviation 1.3 |
| Oral Semaglutide 25 mg | Change From Baseline in HbA1c (Week 68) | -1.8 Percentage point of HbA1c | Standard Deviation 1.3 |
| Oral Semaglutide 50 mg | Change From Baseline in HbA1c (Week 68) | -2.0 Percentage point of HbA1c | Standard Deviation 1.4 |
Secondary
Change From Baseline in HDL (Week 68)
Change from baseline (week 0) in HDL was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: Baseline, Week 68
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in HDL (Week 68) | 0.06 mmol/L | Standard Deviation 0.19 |
| Oral Semaglutide 25 mg | Change From Baseline in HDL (Week 68) | 0.08 mmol/L | Standard Deviation 0.21 |
| Oral Semaglutide 50 mg | Change From Baseline in HDL (Week 68) | 0.09 mmol/L | Standard Deviation 0.2 |
Secondary
Change From Baseline in High Density Lipoproteins (HDL) (Week 52)
Change from baseline (week 0) in HDL was evaluated at 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: Baseline, Week 52
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in High Density Lipoproteins (HDL) (Week 52) | 0.06 mmol/L | Standard Deviation 0.18 |
| Oral Semaglutide 25 mg | Change From Baseline in High Density Lipoproteins (HDL) (Week 52) | 0.07 mmol/L | Standard Deviation 0.19 |
| Oral Semaglutide 50 mg | Change From Baseline in High Density Lipoproteins (HDL) (Week 52) | 0.08 mmol/L | Standard Deviation 0.18 |
Secondary
Change From Baseline in LDL (Week 68)
Change from baseline (week 0) in LDL was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: Baseline, Week 68
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in LDL (Week 68) | 0.07 mmol/L | Standard Deviation 0.8 |
| Oral Semaglutide 25 mg | Change From Baseline in LDL (Week 68) | 0.06 mmol/L | Standard Deviation 0.85 |
| Oral Semaglutide 50 mg | Change From Baseline in LDL (Week 68) | 0.08 mmol/L | Standard Deviation 0.79 |
Secondary
Change From Baseline in Low Density Lipoproteins (LDL) (Week 52)
Change from baseline (week 0) in LDL was evaluated at 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: Baseline, Week 52
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in Low Density Lipoproteins (LDL) (Week 52) | 0.04 mmol/L | Standard Deviation 0.75 |
| Oral Semaglutide 25 mg | Change From Baseline in Low Density Lipoproteins (LDL) (Week 52) | -0.01 mmol/L | Standard Deviation 0.85 |
| Oral Semaglutide 50 mg | Change From Baseline in Low Density Lipoproteins (LDL) (Week 52) | 0.11 mmol/L | Standard Deviation 0.76 |
Secondary
Change From Baseline in Pulse (Week 52)
Change from baseline (week 0) in pulse at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Time frame: Baseline (week 0), week 52
Population: SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in Pulse (Week 52) | 2 beats per minute (beats/min) | Standard Deviation 10 |
| Oral Semaglutide 25 mg | Change From Baseline in Pulse (Week 52) | 2 beats per minute (beats/min) | Standard Deviation 10 |
| Oral Semaglutide 50 mg | Change From Baseline in Pulse (Week 52) | 3 beats per minute (beats/min) | Standard Deviation 11 |
Secondary
Change From Baseline in Pulse (Week 68)
Change from baseline (week 0) in pulse at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Time frame: Baseline (week 0), week 68
Population: SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in Pulse (Week 68) | 1 beats/min | Standard Deviation 10 |
| Oral Semaglutide 25 mg | Change From Baseline in Pulse (Week 68) | 2 beats/min | Standard Deviation 10 |
| Oral Semaglutide 50 mg | Change From Baseline in Pulse (Week 68) | 2 beats/min | Standard Deviation 10 |
Secondary
Change From Baseline in Systolic Blood Pressure (Week 52)
Change from baseline (week 0) in systolic blood pressure at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Time frame: Baseline (week 0), week 52
Population: SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in Systolic Blood Pressure (Week 52) | -4 millimetres of mercury (mmHg) | Standard Deviation 14 |
| Oral Semaglutide 25 mg | Change From Baseline in Systolic Blood Pressure (Week 52) | -6 millimetres of mercury (mmHg) | Standard Deviation 13 |
| Oral Semaglutide 50 mg | Change From Baseline in Systolic Blood Pressure (Week 52) | -6 millimetres of mercury (mmHg) | Standard Deviation 14 |
Secondary
Change From Baseline in Systolic Blood Pressure (Week 68)
Change from baseline (week 0) in systolic blood pressure at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Time frame: Baseline (week 0), week 68
Population: SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in Systolic Blood Pressure (Week 68) | -4 mmHg | Standard Deviation 13 |
| Oral Semaglutide 25 mg | Change From Baseline in Systolic Blood Pressure (Week 68) | -6 mmHg | Standard Deviation 13 |
| Oral Semaglutide 50 mg | Change From Baseline in Systolic Blood Pressure (Week 68) | -5 mmHg | Standard Deviation 13 |
Secondary
Change From Baseline in Total Cholesterol (Week 52)
Change from baseline (week 0) in total cholesterol was evaluated at 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: Baseline, Week 52
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in Total Cholesterol (Week 52) | -0.04 mmol/L | Standard Deviation 0.96 |
| Oral Semaglutide 25 mg | Change From Baseline in Total Cholesterol (Week 52) | -0.15 mmol/L | Standard Deviation 1.1 |
| Oral Semaglutide 50 mg | Change From Baseline in Total Cholesterol (Week 52) | -0.06 mmol/L | Standard Deviation 0.94 |
Secondary
Change From Baseline in Total Cholesterol (Week 68)
Change from baseline (week 0) in total cholesterol was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: Baseline, Week 68
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in Total Cholesterol (Week 68) | -0.03 mmol/L | Standard Deviation 0.99 |
| Oral Semaglutide 25 mg | Change From Baseline in Total Cholesterol (Week 68) | -0.08 mmol/L | Standard Deviation 1.05 |
| Oral Semaglutide 50 mg | Change From Baseline in Total Cholesterol (Week 68) | -0.06 mmol/L | Standard Deviation 1 |
Secondary
Change From Baseline in Triglycerides (Week 52)
Change from baseline (week 0) in triglycerides was evaluated at 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: Baseline, Week 52
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in Triglycerides (Week 52) | -0.46 mmol/L | Standard Deviation 1.77 |
| Oral Semaglutide 25 mg | Change From Baseline in Triglycerides (Week 52) | -0.65 mmol/L | Standard Deviation 2.08 |
| Oral Semaglutide 50 mg | Change From Baseline in Triglycerides (Week 52) | -0.71 mmol/L | Standard Deviation 1.4 |
Secondary
Change From Baseline in Triglycerides (Week 68)
Change from baseline (week 0) in triglycerides was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: Baseline, Week 68
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in Triglycerides (Week 68) | -0.51 mmol/L | Standard Deviation 1.77 |
| Oral Semaglutide 25 mg | Change From Baseline in Triglycerides (Week 68) | -0.65 mmol/L | Standard Deviation 2.06 |
| Oral Semaglutide 50 mg | Change From Baseline in Triglycerides (Week 68) | -0.70 mmol/L | Standard Deviation 1.43 |
Secondary
Change From Baseline in Waist Circumference (Week 52)
Change from baseline (week 0) in waist circumference was evaluated at 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: Baseline (week 0), week 52
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in Waist Circumference (Week 52) | -4 centimetre (cm) | Standard Deviation 7 |
| Oral Semaglutide 25 mg | Change From Baseline in Waist Circumference (Week 52) | -5 centimetre (cm) | Standard Deviation 7 |
| Oral Semaglutide 50 mg | Change From Baseline in Waist Circumference (Week 52) | -6 centimetre (cm) | Standard Deviation 7 |
Secondary
Change From Baseline in Waist Circumference (Week 68)
Change from baseline (week 0) in waist circumference was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: Baseline (week 0), week 68
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Baseline in Waist Circumference (Week 68) | -4 cm | Standard Deviation 6 |
| Oral Semaglutide 25 mg | Change From Baseline in Waist Circumference (Week 68) | -6 cm | Standard Deviation 7 |
| Oral Semaglutide 50 mg | Change From Baseline in Waist Circumference (Week 68) | -7 cm | Standard Deviation 8 |
Secondary
Change From Week 12 in HbA1c (Week 52)
Change in HbA1c was evaluated from week 12 to 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 additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.
Time frame: Week 12, Week 52
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Change From Week 12 in HbA1c (Week 52) | -0.4 Percentage point of HbA1c | Standard Deviation 1.2 |
| Oral Semaglutide 25 mg | Change From Week 12 in HbA1c (Week 52) | -0.8 Percentage point of HbA1c | Standard Deviation 1.1 |
| Oral Semaglutide 50 mg | Change From Week 12 in HbA1c (Week 52) | -1.0 Percentage point of HbA1c | Standard Deviation 1.2 |
Secondary
Number of Adverse Events
An adverse event (AE) defined as any unfavourable and unintended sign, including an abnormal laboratory finding, symptom or disease (new or exacerbated) temporally associated with the use of an investigational medicinal products (IMP). Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Time frame: From baseline (week 0) up to week 73
Population: Safety Analysis Set (SAS) which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide 14 mg | Number of Adverse Events | 1641 Events |
| Oral Semaglutide 25 mg | Number of Adverse Events | 2055 Events |
| Oral Semaglutide 50 mg | Number of Adverse Events | 2115 Events |
Secondary
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) or Severe Hypoglycaemic Episodes (Level 3)
Hypoglycaemic episodes were classified according to the American Diabetes Association 2018/ International Hypoglycaemia Study Group 2017, where glycemic criteria for level 2 was \< 3.0 mmol/L (54 mg/dL) and level 3 had no specific glucose threshold. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.
Time frame: From baseline (week 0) up to week 68
Population: SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oral Semaglutide 14 mg | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) or Severe Hypoglycaemic Episodes (Level 3) | Level 2 | 65 Count of episodes |
| Oral Semaglutide 14 mg | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) or Severe Hypoglycaemic Episodes (Level 3) | Level 3 | 0 Count of episodes |
| Oral Semaglutide 25 mg | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) or Severe Hypoglycaemic Episodes (Level 3) | Level 2 | 44 Count of episodes |
| Oral Semaglutide 25 mg | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) or Severe Hypoglycaemic Episodes (Level 3) | Level 3 | 0 Count of episodes |
| Oral Semaglutide 50 mg | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) or Severe Hypoglycaemic Episodes (Level 3) | Level 2 | 35 Count of episodes |
| Oral Semaglutide 50 mg | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) or Severe Hypoglycaemic Episodes (Level 3) | Level 3 | 1 Count of episodes |
Secondary
Percentage Change From Baseline in Body Weight (Week 52)
Percentage change from baseline (week 0) in body weight was evaluated at 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: Baseline (week 0), week 52
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Percentage Change From Baseline in Body Weight (Week 52) | -4.7 Percentage change in body weight | Standard Deviation 5.4 |
| Oral Semaglutide 25 mg | Percentage Change From Baseline in Body Weight (Week 52) | -7.3 Percentage change in body weight | Standard Deviation 6.6 |
| Oral Semaglutide 50 mg | Percentage Change From Baseline in Body Weight (Week 52) | -8.5 Percentage change in body weight | Standard Deviation 7.3 |
Secondary
Percentage Change From Baseline in Body Weight (Week 68)
Percentage change from baseline (week 0) in body weight was evaluated at week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: Baseline (week 0), week 68
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Percentage Change From Baseline in Body Weight (Week 68) | -4.7 Percentage change in body weight | Standard Deviation 5.6 |
| Oral Semaglutide 25 mg | Percentage Change From Baseline in Body Weight (Week 68) | -7.2 Percentage change in body weight | Standard Deviation 7.1 |
| Oral Semaglutide 50 mg | Percentage Change From Baseline in Body Weight (Week 68) | -8.4 Percentage change in body weight | Standard Deviation 7.7 |
Secondary
Percentage Change From Week 12 in Body Weight (Week 52)
Percentage change in body weight was evaluated from week 12 to 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: Week 12, Week 52
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Semaglutide 14 mg | Percentage Change From Week 12 in Body Weight (Week 52) | -1.5 Percentage change in body weight | Standard Deviation 3.6 |
| Oral Semaglutide 25 mg | Percentage Change From Week 12 in Body Weight (Week 52) | -3.8 Percentage change in body weight | Standard Deviation 5.4 |
| Oral Semaglutide 50 mg | Percentage Change From Week 12 in Body Weight (Week 52) | -5.4 Percentage change in body weight | Standard Deviation 6.1 |
Secondary
Percentage of Participants Who Achieved HbA1c <= 6.5 % (Week 68)
Percentage of participants who achieved HbA1c \<=6.5 % at week 68 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: At week 68
Population: FAS which comprised all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide 14 mg | Percentage of Participants Who Achieved HbA1c <= 6.5 % (Week 68) | 23.6 Percentage of Participants |
| Oral Semaglutide 25 mg | Percentage of Participants Who Achieved HbA1c <= 6.5 % (Week 68) | 35.8 Percentage of Participants |
| Oral Semaglutide 50 mg | Percentage of Participants Who Achieved HbA1c <= 6.5 % (Week 68) | 46.2 Percentage of Participants |
Secondary
Percentage of Participants Who Achieved HbA1c < 7.0 % (Week 68)
Percentage of participants who achieved HbA1c \<7.0 % at week 68 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: At week 68
Population: FAS which comprised all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide 14 mg | Percentage of Participants Who Achieved HbA1c < 7.0 % (Week 68) | 39.2 Percentage of Participants |
| Oral Semaglutide 25 mg | Percentage of Participants Who Achieved HbA1c < 7.0 % (Week 68) | 49.9 Percentage of Participants |
| Oral Semaglutide 50 mg | Percentage of Participants Who Achieved HbA1c < 7.0 % (Week 68) | 58.9 Percentage of Participants |
Secondary
Percentage of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Week 52)
Percentage of participants who achieved HbA1c \<7.0 % at 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: At week 52
Population: FAS which comprised all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide 14 mg | Percentage of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Week 52) | 39 Percentage of Participants |
| Oral Semaglutide 25 mg | Percentage of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Week 52) | 50.5 Percentage of Participants |
| Oral Semaglutide 50 mg | Percentage of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Week 52) | 63 Percentage of Participants |
Secondary
Percentage of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 % (Week 52)
Percentage of participants who achieved HbA1c \<=6.5 % at 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: At week 52
Population: FAS which comprised all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide 14 mg | Percentage of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 % (Week 52) | 25.8 Percentage of Participants |
| Oral Semaglutide 25 mg | Percentage of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 % (Week 52) | 39.6 Percentage of Participants |
| Oral Semaglutide 50 mg | Percentage of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 % (Week 52) | 51.2 Percentage of Participants |
Secondary
Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 52)
Percentage of participants who achieved weight loss \>= 10 % at 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: At week 52
Population: FAS which comprised all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide 14 mg | Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 52) | 13.9 Percentage of participants |
| Oral Semaglutide 25 mg | Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 52) | 29 Percentage of participants |
| Oral Semaglutide 50 mg | Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 52) | 37.2 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 68)
Percentage of participants who achieved weight loss \>= 10 % at week 68 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: At week 68
Population: FAS which comprised all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide 14 mg | Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 68) | 14.3 Percentage of participants |
| Oral Semaglutide 25 mg | Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 68) | 29.4 Percentage of participants |
| Oral Semaglutide 50 mg | Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 68) | 34.7 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Weight Loss >= 5 % (Week 68)
Percentage of participants who achieved weight loss \>= 5 % at week 68 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: At week 68
Population: FAS which comprised all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide 14 mg | Percentage of Participants Who Achieved Weight Loss >= 5 % (Week 68) | 42.2 Percentage of participants |
| Oral Semaglutide 25 mg | Percentage of Participants Who Achieved Weight Loss >= 5 % (Week 68) | 58.5 Percentage of participants |
| Oral Semaglutide 50 mg | Percentage of Participants Who Achieved Weight Loss >= 5 % (Week 68) | 65.7 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Weight Loss Greater Than or Equal to (>=) 5 % (Week 52)
Percentage of participants who achieved weight loss \>= 5 % at 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: At week 52
Population: FAS which comprised all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Semaglutide 14 mg | Percentage of Participants Who Achieved Weight Loss Greater Than or Equal to (>=) 5 % (Week 52) | 41 Percentage of participants |
| Oral Semaglutide 25 mg | Percentage of Participants Who Achieved Weight Loss Greater Than or Equal to (>=) 5 % (Week 52) | 60 Percentage of participants |
| Oral Semaglutide 50 mg | Percentage of Participants Who Achieved Weight Loss Greater Than or Equal to (>=) 5 % (Week 52) | 67.5 Percentage of participants |
Secondary
Time to Event Analyses of Rescue Medication
Time to event analyses of rescue medication was evaluated from baseline (week 0) to week 68. 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 additional anti-diabetic medication or discontinuation of trial treatment.
Time frame: Baseline (week 0), week 68
Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oral Semaglutide 14 mg | Time to Event Analyses of Rescue Medication | NA Weeks |
| Oral Semaglutide 25 mg | Time to Event Analyses of Rescue Medication | NA Weeks |
| Oral Semaglutide 50 mg | Time to Event Analyses of Rescue Medication | NA Weeks |