Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Europe. The aim of the study is to compare the effect of semaglutide subcutaneous (s.c., under the skin) 1.0 mg once-weekly to liraglutide s.c.1.2 mg once-daily on blood sugar levels after 30 weeks of treatment in people with type 2 diabetes. The study will last approximately 9 months (37 weeks). Each participant will have 7 visits at the clinic and 3 phone calls with the study doctor. At the visits, participants will have a number of tests, for example: general health checks, blood samples, heart and eye checks etc. Participants will also fill in some forms about their health and satisfaction with their diabetes treatment.
Interventions
DRUGSemaglutide
Dose gradually increased to 1.0 mg, given s.c. (under the skin), once-weekly for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs (tablets), if any
DRUGLiraglutide
Dose gradually increased to 1.2 mg, given s.c. once-daily for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs, if any
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Male or female, age 18 years or older at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus - HbA1c of 7.0-11.0 % (53 - 97 mmol/mol) (both inclusive) - Stable daily dose(s) including any of the following anti-diabetic drug(s) or combination regimens 90 days prior to the day of screening: a) Biguanides (metformin above or equal to 1500 mg or maximum tolerated dose documented in the subject's medical record). b) Sulphonylureas (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record). c) SGLT-2 inhibitors (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)
Exclusion criteria
- Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative - History or presence of pancreatitis (acute or chronic) - History of diabetic ketoacidosis - Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening - Subjects presently classified as being in New York Heart Association (NYHA) Class IV - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 30 ml/min/1.73 sqm as defined by KDIGO 2012 classification - Impaired liver function, defined as ALT above or equal to 2.5 times upper normal limit at screening - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Week 0, week 30 | Mean change from baseline (week 0) to week 30 in glycosylated haemoglobin (HbA1c) %. The endpoint was evaluated based on the 'on-treatment without rescue medication period' where subjects were considered treated with trial product, but had not yet initiated rescue medication. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Plasma Glucose (FPG) | Week 0, week 30 | Mean change from baseline in fasting plasma glucose measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean 7-point Profile | Week 0, week 30 | Mean change from baseline in 7-point 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. The mean of the 7-point SMPG profile, defined as the area under the profile, was calculated using the trapezoidal method and divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean Post Prandial Increment (Over All Meals) | Week 0, week 30 | Mean post prandial glucose incrememts over all meals. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Change in Fasting Blood Lipids: Total Cholesterol | Week 0, week 30 | The change from baseline in total cholesterol (measured in mmol/L) is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol | Week 0, week 30 | The change from baseline in LDL cholesterol is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Change in Fasting Blood Lipids: High-density Lipoprotein (HDL)-Cholesterol | Week 0, week 30 | The change from baseline in HDL cholesterol is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Change in Fasting Blood Lipids: Triglycerides | Week 0, week 30 | The change from baseline in triglycerides is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Change in Body Mass Index (BMI) | Week 0, week 30 | Mean change from baseline (week 0) to week 30 in BMI. BMI was calculated as 'body weight in kg/(height in meters) x (height in meters)'. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Change in Waist Circumference | Week 0, week 30 | Mean change in waist circumference (cm) from baseline (week 0) to week 30. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Change in Systolic Blood Pressure | Week 0, week 30 | Change in systolic blood pressure from baseline (week 0) to week 30 . Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Change in Diastolic Blood Pressure | Week 0, week 30 | Change in diastolic blood pressure from baseline (week 0) to week 30 . Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Change in Body Weight (%) | Week 0, week 30 | Mean relative change from baseline in body weight measured in percentage. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target | After 30 weeks of treatment | Percentage of subjects who achieved HbA1c less than 7.0% (53 mmol/mol) according to American Diabetes Association (ADA) target, after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target | After 30 weeks of treatment | Percentage of subjects who achieved HbA1c less than 6.5% (48 mmol/mol) according to AACE target,after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Subjects Who Achieve Weight Loss Above or Equal to 3% | After 30 weeks of treatment | Percentage of subjects who achieved weight loss above or equal to 3% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Subjects Who Achieve Weight Loss Above or Equal to 5% | After 30 weeks of treatment | Percentage of subjects who achieved weight loss above or equal to 5% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Subjects Who Achieve Weight Loss Above or Equal to 10% | After 30 weeks of treatment | Percentage of subjects who achieved weight loss above or equal to 10% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain | After 30 weeks of treatment | Percentage of subjects who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain, after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Subjects Who Achieve HbA1c Reduction Above or Equal to 1% | After 30 weeks of treatment | Percentage of subjects who achieved weight loss above or equal to 1% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 3% | After 30 weeks of treatment | Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 3% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 5% | After 30 weeks of treatment | Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 5% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 10% | After 30 weeks of treatment | Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 10% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Week 0, week 30 | Short form-36 version 2 (SF-36v2) is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL). The questionnaire measures the individual overall HRQoL on 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Each domain is scored using the sum of the individual item responses and normalised relative to the 2009 US reference population. Overall, the domain scores range from around 0-100 (higher scores indicated a better HRQoL), where the range of possible scores depends on the 2009 US reference population for each domain. The two total summary scores (mental and physical summary components) are calculated through weighted sums of the 8 domain scores. The presented result is the change from baseline (week 0) to week 30 in SF-36v2 scores. A positive change in score indicates an improvement since baseline. |
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately | Week 0, week 30 | The DTSQs questionnaire was used to assess subject's treatment satisfaction. This instrument contains 8 items and measures the treatment for diabetes in terms of convenience, flexibility and general feelings regarding treatment. Q 1 = satisfaction with current treatment; Q 2 = hyperglycemia; Q 3 = hypoglycemia; Q 4 = flexibility; Q 5 = convenience; Q 6 = understanding of diabetes; Q 7 = recommend treatment to others; and Q 8 = willingness to continue. Each item is rated on a 7-point Likert scale with a score ranging from 0 (ie, very dissatisfied) to 6 (ie, very satisfied). DTSQ items 2 and 3 are rated differently: 0 reflects 'never' and 6 reflects 'most of the time'. The 'treatment satisfaction' score is the sum of 6 of the 8 DTSQs components (Q 1, 4, 5, 6, 7 and 8) (range 0-36). Higher scores on the DTSQ total score indicate higher treatment satisfaction. The results presented is the change from baseline (week 0) to week 30 in DTSQ scores. |
| Number of Treatment-emergent Adverse Events (TEAE) | Week 0 to week 35 | A TEAE was defined as an adverse event with onset date (or increase in severity) during the on-treatment observation period. The on-treatment observation period represents the time period where subjects were considered exposed to trial product. |
| Change in Pulse Rate | Week 0, week 30 | Mean change from baseline (week 0) to week 30 in pulse rate. Pulse rate is measured as number of heart beats per minute. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes | Week 0 to week 35 | Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, where the subjects were exposed to the trial product. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or blood glucose confirmed by a plasma glucose value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. |
| Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes | Week 0 to week 35 | Number of subjects with treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episodes is presented. Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, where the subjects were exposed to the trial product. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or blood glucose confirmed by a plasma glucose value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. |
| Change in Haematology - Haemoglobin | Week 0, week 30 | Mean change from baseline (week 0) to week 30 in haemoglobin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. |
| Change in Haematology - Haematocrit | Week 0, week 30 | Mean change from baseline (week 0) to week 30 in haematology laboratory parameter haematocrit. Haematocrit is the volume of red blood cells in the total blood. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. |
| Change in Haematology - Thrombocytes and Leukocytes | Week 0, week 30 | Mean change from baseline (week 0) to week 30 in haematology laboratory parameters thrombocytes and leukocytes. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. |
| Change in Haematology - Erythrocytes | Week 0, week 30 | Mean change from baseline (week 0) to week 30 in haematology laboratory parameter erythrocytes. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. |
| Change in Biochemistry - Calcium, Pottassium and Sodium | Week 0, week 30 | Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters calcium, pottassium and sodium. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. |
| Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase. | Week 0, week 30 | Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. |
| Change in Body Weight (kg) | Week 0, week 30 | Mean change from baseline (week 0) to week 30 in body weight measured in kilograms. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. |
| Change in Biochemistry - Creatinine and Bilirubin | Week 0, week 30 | Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters creatinine and bilirubin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. |
| Change in Biochemistry - Albumin | Week 0, week 30 | Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameter albumin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. |
| Change in Biochemistry - Estimated Glomerular Filtration Rate (eGFR). | Week 0, week 30 | Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameter eGFR. eGFR is calculated using the equation from the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) as defined in KDIGO guidelines. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. |
| Change in Calcitonin | Week 0, week 30 | Mean change from baseline (week 0) to week 30 in calcitonin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. |
| Change in Biochemistry - Amylase and Lipase | Week 0, week 30 | Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters amylase and lypase. Observed data with multiple imputation for missing data is presented. Missing data were imputed using observed data from subjects within the same group defined by actual treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. |
Countries
Bulgaria, Czechia, Finland, France, Germany, Hungary, Italy, Poland, Slovenia, Spain, Sweden, United Kingdom
Participant flow
Recruitment details
The trial was conducted at 77 sites in 11 countries as follows (number of sites that screened subjects/ number of sites that randomised subjects): Bulgaria (9/ 9); Czech Republic (5/ 5); Finland (8/ 8); France (8/ 8); Hungary (8/ 8); Italy (4/ 4); Poland (3/ 3); Slovenia (4/ 4); Spain (5/ 5); Sweden (6/ 6); United Kingdom (17/ 17)
Pre-assignment details
After screening, subjects were required to continue their oral anti-diabetic drug (OAD) pre-trial background medication (i.e. metformin, Sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulphonyl ureas, or combinations of these) throughout the entire trial.
Participants by arm
| Arm | Count |
|---|---|
| Semaglutide 1.0 mg Subjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these). | 290 |
| Liraglutide 1.2 mg Subjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these). | 287 |
| Total | 577 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Liraglutide 1.2 mg | Total | Semaglutide 1.0 mg |
|---|---|---|---|
| Age, Continuous | 58.9 Years STANDARD_DEVIATION 10 | 59.5 Years STANDARD_DEVIATION 10.2 | 60.1 Years STANDARD_DEVIATION 10.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 9 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 269 Participants | 537 Participants | 268 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants | 31 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 31 Participants | 16 Participants |
| Race (NIH/OMB) White | 268 Participants | 532 Participants | 264 Participants |
| Sex: Female, Male Female | 120 Participants | 250 Participants | 130 Participants |
| Sex: Female, Male Male | 167 Participants | 327 Participants | 160 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 289 | 0 / 287 |
| other Total, other adverse events | 139 / 289 | 113 / 287 |
| serious Total, serious adverse events | 17 / 289 | 22 / 287 |
Outcome results
Primary
Change in HbA1c
Mean change from baseline (week 0) to week 30 in glycosylated haemoglobin (HbA1c) %. The endpoint was evaluated based on the 'on-treatment without rescue medication period' where subjects were considered treated with trial product, but had not yet initiated rescue medication. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: Week 0, week 30
Population: Full analysis set (FAS), which included all randomised participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in HbA1c | -1.7 Percentage of glycosylated haemoglobin | Standard Deviation 0.9 |
| Liraglutide 1.2 mg | Change in HbA1c | -1.1 Percentage of glycosylated haemoglobin | Standard Deviation 1 |
Comparison: The responses are analysed using an ANCOVA with treatment and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.p-value: <0.000195% CI: [-0.82, -0.56]ANCOVA
p-value: <0.000195% CI: [-0.82, -0.56]ANCOVA
Secondary
Change in Biochemistry - Albumin
Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameter albumin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time frame: Week 0, week 30
Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Biochemistry - Albumin | 0.2 g/dL | Geometric Coefficient of Variation 56.8 |
| Liraglutide 1.2 mg | Change in Biochemistry - Albumin | 0.2 g/dL | Geometric Coefficient of Variation 55.5 |
Secondary
Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase.
Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time frame: Week 0, week 30
Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 1.0 mg | Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase. | Alkaline phosphatase | 5.5 mmol/L | Geometric Coefficient of Variation 117.5 |
| Semaglutide 1.0 mg | Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase. | Alanine Aminotransferase | 5.3 mmol/L | Geometric Coefficient of Variation 126.1 |
| Semaglutide 1.0 mg | Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase. | Aspartate Aminotransferase | 3.5 mmol/L | Geometric Coefficient of Variation 129.9 |
| Liraglutide 1.2 mg | Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase. | Alkaline phosphatase | 6.4 mmol/L | Geometric Coefficient of Variation 121 |
| Liraglutide 1.2 mg | Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase. | Alanine Aminotransferase | 5.0 mmol/L | Geometric Coefficient of Variation 137.7 |
| Liraglutide 1.2 mg | Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase. | Aspartate Aminotransferase | 3.1 mmol/L | Geometric Coefficient of Variation 119.5 |
Secondary
Change in Biochemistry - Amylase and Lipase
Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters amylase and lypase. Observed data with multiple imputation for missing data is presented. Missing data were imputed using observed data from subjects within the same group defined by actual treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time frame: Week 0, week 30
Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 1.0 mg | Change in Biochemistry - Amylase and Lipase | Amylase | 10.3 U/L | Geometric Coefficient of Variation 124.7 |
| Semaglutide 1.0 mg | Change in Biochemistry - Amylase and Lipase | Lipase | 15.8 U/L | Geometric Coefficient of Variation 154.6 |
| Liraglutide 1.2 mg | Change in Biochemistry - Amylase and Lipase | Amylase | 8.4 U/L | Geometric Coefficient of Variation 138.2 |
| Liraglutide 1.2 mg | Change in Biochemistry - Amylase and Lipase | Lipase | 14.0 U/L | Geometric Coefficient of Variation 154.5 |
Secondary
Change in Biochemistry - Calcium, Pottassium and Sodium
Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters calcium, pottassium and sodium. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time frame: Week 0, week 30
Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 1.0 mg | Change in Biochemistry - Calcium, Pottassium and Sodium | Calcium | 0.07 mmol/L | Geometric Coefficient of Variation 107 |
| Semaglutide 1.0 mg | Change in Biochemistry - Calcium, Pottassium and Sodium | Pottassium | 0.3 mmol/L | Geometric Coefficient of Variation 96 |
| Semaglutide 1.0 mg | Change in Biochemistry - Calcium, Pottassium and Sodium | Sodium | 1.8 mmol/L | Geometric Coefficient of Variation 65.3 |
| Liraglutide 1.2 mg | Change in Biochemistry - Calcium, Pottassium and Sodium | Calcium | 0.07 mmol/L | Geometric Coefficient of Variation 103.8 |
| Liraglutide 1.2 mg | Change in Biochemistry - Calcium, Pottassium and Sodium | Pottassium | 0.3 mmol/L | Geometric Coefficient of Variation 77.3 |
| Liraglutide 1.2 mg | Change in Biochemistry - Calcium, Pottassium and Sodium | Sodium | 1.7 mmol/L | Geometric Coefficient of Variation 61.4 |
Secondary
Change in Biochemistry - Creatinine and Bilirubin
Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters creatinine and bilirubin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time frame: Week 0, week 30
Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 1.0 mg | Change in Biochemistry - Creatinine and Bilirubin | Creatinine | 4.1 umol/L | Geometric Coefficient of Variation 150.2 |
| Semaglutide 1.0 mg | Change in Biochemistry - Creatinine and Bilirubin | Bilirubin | 1.9 umol/L | Geometric Coefficient of Variation 167.5 |
| Liraglutide 1.2 mg | Change in Biochemistry - Creatinine and Bilirubin | Creatinine | 3.6 umol/L | Geometric Coefficient of Variation 150 |
| Liraglutide 1.2 mg | Change in Biochemistry - Creatinine and Bilirubin | Bilirubin | 2.0 umol/L | Geometric Coefficient of Variation 126.2 |
Secondary
Change in Biochemistry - Estimated Glomerular Filtration Rate (eGFR).
Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameter eGFR. eGFR is calculated using the equation from the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) as defined in KDIGO guidelines. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time frame: Week 0, week 30
Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Biochemistry - Estimated Glomerular Filtration Rate (eGFR). | 4.0 mL/min/1.73m2 | Geometric Coefficient of Variation 97.7 |
| Liraglutide 1.2 mg | Change in Biochemistry - Estimated Glomerular Filtration Rate (eGFR). | 4.1 mL/min/1.73m2 | Geometric Coefficient of Variation 113.9 |
Secondary
Change in Body Mass Index (BMI)
Mean change from baseline (week 0) to week 30 in BMI. BMI was calculated as 'body weight in kg/(height in meters) x (height in meters)'. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: Week 0, week 30
Population: Full analysis set (FAS), which included all randomised participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Body Mass Index (BMI) | -2.0 kg/sqm | Standard Deviation 1.6 |
| Liraglutide 1.2 mg | Change in Body Mass Index (BMI) | -0.7 kg/sqm | Standard Deviation 1.4 |
Secondary
Change in Body Weight (%)
Mean relative change from baseline in body weight measured in percentage. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: Week 0, week 30
Population: Full analysis set (FAS), which included all randomised participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Body Weight (%) | -6.1 percentage of body weight | Standard Deviation 4.9 |
| Liraglutide 1.2 mg | Change in Body Weight (%) | -2.0 percentage of body weight | Standard Deviation 4.2 |
Secondary
Change in Body Weight (kg)
Mean change from baseline (week 0) to week 30 in body weight measured in kilograms. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: Week 0, week 30
Population: Full analysis set (FAS), which included all randomised participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Body Weight (kg) | -5.8 kg | Standard Deviation 4.7 |
| Liraglutide 1.2 mg | Change in Body Weight (kg) | -2.0 kg | Standard Deviation 4.1 |
p-value: <0.000195% CI: [-4.57, -3.09]ANCOVA
Secondary
Change in Calcitonin
Mean change from baseline (week 0) to week 30 in calcitonin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time frame: Week 0, week 30
Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Calcitonin | 1.3 ng/L | Geometric Coefficient of Variation 165.5 |
| Liraglutide 1.2 mg | Change in Calcitonin | 1.1 ng/L | Geometric Coefficient of Variation 89.7 |
Secondary
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately
The DTSQs questionnaire was used to assess subject's treatment satisfaction. This instrument contains 8 items and measures the treatment for diabetes in terms of convenience, flexibility and general feelings regarding treatment. Q 1 = satisfaction with current treatment; Q 2 = hyperglycemia; Q 3 = hypoglycemia; Q 4 = flexibility; Q 5 = convenience; Q 6 = understanding of diabetes; Q 7 = recommend treatment to others; and Q 8 = willingness to continue. Each item is rated on a 7-point Likert scale with a score ranging from 0 (ie, very dissatisfied) to 6 (ie, very satisfied). DTSQ items 2 and 3 are rated differently: 0 reflects 'never' and 6 reflects 'most of the time'. The 'treatment satisfaction' score is the sum of 6 of the 8 DTSQs components (Q 1, 4, 5, 6, 7 and 8) (range 0-36). Higher scores on the DTSQ total score indicate higher treatment satisfaction. The results presented is the change from baseline (week 0) to week 30 in DTSQ scores.
Time frame: Week 0, week 30
Population: Full analysis set (FAS), which included all randomised participants. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 1.0 mg | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately | Q5. Convenience | 0.7 scores on a scale | Standard Deviation 1.5 |
| Semaglutide 1.0 mg | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately | Q3. Hypoglycemia | 0.1 scores on a scale | Standard Deviation 1.7 |
| Semaglutide 1.0 mg | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately | Q6. Understanding of diabetes | 0.6 scores on a scale | Standard Deviation 1.4 |
| Semaglutide 1.0 mg | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately | Q2. Hyperglycemia | -2.1 scores on a scale | Standard Deviation 2.1 |
| Semaglutide 1.0 mg | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately | Q7. Recommend treatment to others | 0.7 scores on a scale | Standard Deviation 1.5 |
| Semaglutide 1.0 mg | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately | Q4. Flexibility | 0.7 scores on a scale | Standard Deviation 1.5 |
| Semaglutide 1.0 mg | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately | Q8. Willingness to continue | 1.0 scores on a scale | Standard Deviation 1.8 |
| Semaglutide 1.0 mg | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately | Treatment satisfaction summary score | 4.6 scores on a scale | Standard Deviation 7 |
| Semaglutide 1.0 mg | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately | Q1. Satisfaction with current treatment | 0.9 scores on a scale | Standard Deviation 1.7 |
| Liraglutide 1.2 mg | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately | Treatment satisfaction summary score | 4.2 scores on a scale | Standard Deviation 6.6 |
| Liraglutide 1.2 mg | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately | Q1. Satisfaction with current treatment | 0.9 scores on a scale | Standard Deviation 1.5 |
| Liraglutide 1.2 mg | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately | Q2. Hyperglycemia | -1.6 scores on a scale | Standard Deviation 2.3 |
| Liraglutide 1.2 mg | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately | Q3. Hypoglycemia | 0.1 scores on a scale | Standard Deviation 1.6 |
| Liraglutide 1.2 mg | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately | Q4. Flexibility | 0.6 scores on a scale | Standard Deviation 1.5 |
| Liraglutide 1.2 mg | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately | Q5. Convenience | 0.6 scores on a scale | Standard Deviation 1.5 |
| Liraglutide 1.2 mg | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately | Q6. Understanding of diabetes | 0.5 scores on a scale | Standard Deviation 1.3 |
| Liraglutide 1.2 mg | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately | Q7. Recommend treatment to others | 0.7 scores on a scale | Standard Deviation 1.4 |
| Liraglutide 1.2 mg | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately | Q8. Willingness to continue | 0.9 scores on a scale | Standard Deviation 1.8 |
Secondary
Change in Diastolic Blood Pressure
Change in diastolic blood pressure from baseline (week 0) to week 30 . Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: Week 0, week 30
Population: Full analysis set (FAS), which included all randomised participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Diastolic Blood Pressure | -1.5 mmHg | Standard Deviation 8.6 |
| Liraglutide 1.2 mg | Change in Diastolic Blood Pressure | -1.3 mmHg | Standard Deviation 8.4 |
Secondary
Change in Fasting Blood Lipids: High-density Lipoprotein (HDL)-Cholesterol
The change from baseline in HDL cholesterol is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: Week 0, week 30
Population: Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Fasting Blood Lipids: High-density Lipoprotein (HDL)-Cholesterol | 1.01 ratio | Geometric Coefficient of Variation 14.6 |
| Liraglutide 1.2 mg | Change in Fasting Blood Lipids: High-density Lipoprotein (HDL)-Cholesterol | 0.99 ratio | Geometric Coefficient of Variation 12.9 |
Secondary
Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol
The change from baseline in LDL cholesterol is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: Week 0, week 30
Population: Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol | 0.99 ratio | Geometric Coefficient of Variation 28.3 |
| Liraglutide 1.2 mg | Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol | 0.99 ratio | Geometric Coefficient of Variation 27.2 |
Secondary
Change in Fasting Blood Lipids: Total Cholesterol
The change from baseline in total cholesterol (measured in mmol/L) is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: Week 0, week 30
Population: Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Fasting Blood Lipids: Total Cholesterol | 0.96 ratio | Geometric Coefficient of Variation 16.8 |
| Liraglutide 1.2 mg | Change in Fasting Blood Lipids: Total Cholesterol | 0.98 ratio | Geometric Coefficient of Variation 16.9 |
Secondary
Change in Fasting Blood Lipids: Triglycerides
The change from baseline in triglycerides is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: Week 0, week 30
Population: Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Fasting Blood Lipids: Triglycerides | 0.83 Ratio | Geometric Coefficient of Variation 41.5 |
| Liraglutide 1.2 mg | Change in Fasting Blood Lipids: Triglycerides | 0.91 Ratio | Geometric Coefficient of Variation 39.5 |
Secondary
Change in Fasting Plasma Glucose (FPG)
Mean change from baseline in fasting plasma glucose measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: Week 0, week 30
Population: Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Fasting Plasma Glucose (FPG) | -2.65 mmol/L | Standard Deviation 2.19 |
| Liraglutide 1.2 mg | Change in Fasting Plasma Glucose (FPG) | -1.46 mmol/L | Standard Deviation 2.42 |
Secondary
Change in Haematology - Erythrocytes
Mean change from baseline (week 0) to week 30 in haematology laboratory parameter erythrocytes. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time frame: Week 0, week 30
Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Haematology - Erythrocytes | 0.14 10^12 cells/L | Geometric Coefficient of Variation 133.2 |
| Liraglutide 1.2 mg | Change in Haematology - Erythrocytes | 0.14 10^12 cells/L | Geometric Coefficient of Variation 117.3 |
Secondary
Change in Haematology - Haematocrit
Mean change from baseline (week 0) to week 30 in haematology laboratory parameter haematocrit. Haematocrit is the volume of red blood cells in the total blood. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time frame: Week 0, week 30
Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Haematology - Haematocrit | 1.5 percent change | Geometric Coefficient of Variation 111.7 |
| Liraglutide 1.2 mg | Change in Haematology - Haematocrit | 1.1 percent change | Geometric Coefficient of Variation 130.9 |
Secondary
Change in Haematology - Haemoglobin
Mean change from baseline (week 0) to week 30 in haemoglobin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time frame: Week 0, week 30
Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Haematology - Haemoglobin | 1.0 mmol/L | Geometric Coefficient of Variation 16 |
| Liraglutide 1.2 mg | Change in Haematology - Haemoglobin | 1.0 mmol/L | Geometric Coefficient of Variation 0 |
Secondary
Change in Haematology - Thrombocytes and Leukocytes
Mean change from baseline (week 0) to week 30 in haematology laboratory parameters thrombocytes and leukocytes. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.
Time frame: Week 0, week 30
Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 1.0 mg | Change in Haematology - Thrombocytes and Leukocytes | Thrombocytes | 18.4 10^9 cells/L | Geometric Coefficient of Variation 126 |
| Semaglutide 1.0 mg | Change in Haematology - Thrombocytes and Leukocytes | Leukocytes | 0.14 10^9 cells/L | Geometric Coefficient of Variation 133.2 |
| Liraglutide 1.2 mg | Change in Haematology - Thrombocytes and Leukocytes | Thrombocytes | 21.5 10^9 cells/L | Geometric Coefficient of Variation 138.9 |
| Liraglutide 1.2 mg | Change in Haematology - Thrombocytes and Leukocytes | Leukocytes | 0.14 10^9 cells/L | Geometric Coefficient of Variation 117.3 |
Secondary
Change in Pulse Rate
Mean change from baseline (week 0) to week 30 in pulse rate. Pulse rate is measured as number of heart beats per minute. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: Week 0, week 30
Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Pulse Rate | 2.4 beats/min | Geometric Coefficient of Variation 10.1 |
| Liraglutide 1.2 mg | Change in Pulse Rate | 3.9 beats/min | Geometric Coefficient of Variation 10 |
Secondary
Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean 7-point Profile
Mean change from baseline in 7-point 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. The mean of the 7-point SMPG profile, defined as the area under the profile, was calculated using the trapezoidal method and divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: Week 0, week 30
Population: Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean 7-point Profile | -3.0 mmol/L | Standard Deviation 2 |
| Liraglutide 1.2 mg | Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean 7-point Profile | -2.1 mmol/L | Standard Deviation 2.3 |
Secondary
Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean Post Prandial Increment (Over All Meals)
Mean post prandial glucose incrememts over all meals. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: Week 0, week 30
Population: Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean Post Prandial Increment (Over All Meals) | -1.0 mmol/L | Standard Deviation 1.8 |
| Liraglutide 1.2 mg | Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean Post Prandial Increment (Over All Meals) | -0.4 mmol/L | Standard Deviation 1.9 |
Secondary
Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains
Short form-36 version 2 (SF-36v2) is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL). The questionnaire measures the individual overall HRQoL on 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Each domain is scored using the sum of the individual item responses and normalised relative to the 2009 US reference population. Overall, the domain scores range from around 0-100 (higher scores indicated a better HRQoL), where the range of possible scores depends on the 2009 US reference population for each domain. The two total summary scores (mental and physical summary components) are calculated through weighted sums of the 8 domain scores. The presented result is the change from baseline (week 0) to week 30 in SF-36v2 scores. A positive change in score indicates an improvement since baseline.
Time frame: Week 0, week 30
Population: Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 1.0 mg | Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Physical functioning | 1.8 scores on a scale | Standard Deviation 5.8 |
| Semaglutide 1.0 mg | Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Role-physical | 1.4 scores on a scale | Standard Deviation 7.2 |
| Semaglutide 1.0 mg | Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Bodily pain | 2.2 scores on a scale | Standard Deviation 9.1 |
| Semaglutide 1.0 mg | Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | General health | 2.7 scores on a scale | Standard Deviation 7.9 |
| Semaglutide 1.0 mg | Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Social functioning | 1.7 scores on a scale | Standard Deviation 8.7 |
| Semaglutide 1.0 mg | Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Role-emotional | 1.2 scores on a scale | Standard Deviation 8.5 |
| Semaglutide 1.0 mg | Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Vitality | 3.0 scores on a scale | Standard Deviation 8 |
| Semaglutide 1.0 mg | Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Mental health | 1.7 scores on a scale | Standard Deviation 8.2 |
| Semaglutide 1.0 mg | Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Mental component summary | 1.7 scores on a scale | Standard Deviation 7.9 |
| Semaglutide 1.0 mg | Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Physical component summary | 2.1 scores on a scale | Standard Deviation 6.4 |
| Liraglutide 1.2 mg | Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Social functioning | 0.9 scores on a scale | Standard Deviation 7.7 |
| Liraglutide 1.2 mg | Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Physical component summary | 1.4 scores on a scale | Standard Deviation 5.9 |
| Liraglutide 1.2 mg | Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Physical functioning | 1.4 scores on a scale | Standard Deviation 6.6 |
| Liraglutide 1.2 mg | Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Mental component summary | 0.5 scores on a scale | Standard Deviation 7.5 |
| Liraglutide 1.2 mg | Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Role-physical | 0.6 scores on a scale | Standard Deviation 6.7 |
| Liraglutide 1.2 mg | Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Role-emotional | 1.0 scores on a scale | Standard Deviation 8 |
| Liraglutide 1.2 mg | Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Bodily pain | 1.5 scores on a scale | Standard Deviation 9.8 |
| Liraglutide 1.2 mg | Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Mental health | 0.3 scores on a scale | Standard Deviation 7.2 |
| Liraglutide 1.2 mg | Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | General health | 1.6 scores on a scale | Standard Deviation 7.7 |
| Liraglutide 1.2 mg | Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Vitality | 1.1 scores on a scale | Standard Deviation 8 |
Secondary
Change in Systolic Blood Pressure
Change in systolic blood pressure from baseline (week 0) to week 30 . Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: Week 0, week 30
Population: Full analysis set (FAS), which included all randomised participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Systolic Blood Pressure | -4.3 mmHg | Standard Deviation 13.4 |
| Liraglutide 1.2 mg | Change in Systolic Blood Pressure | -3.7 mmHg | Standard Deviation 13.8 |
Secondary
Change in Waist Circumference
Mean change in waist circumference (cm) from baseline (week 0) to week 30. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: Week 0, week 30
Population: Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Waist Circumference | -5.2 cm | Standard Deviation 5.6 |
| Liraglutide 1.2 mg | Change in Waist Circumference | -2.4 cm | Standard Deviation 4.6 |
Secondary
Number of Treatment-emergent Adverse Events (TEAE)
A TEAE was defined as an adverse event with onset date (or increase in severity) during the on-treatment observation period. The on-treatment observation period represents the time period where subjects were considered exposed to trial product.
Time frame: Week 0 to week 35
Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | Number of Treatment-emergent Adverse Events (TEAE) | 758 Events |
| Liraglutide 1.2 mg | Number of Treatment-emergent Adverse Events (TEAE) | 691 Events |
Secondary
Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, where the subjects were exposed to the trial product. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or blood glucose confirmed by a plasma glucose value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time frame: Week 0 to week 35
Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes | 8 Episodes of hypoglycaemia |
| Liraglutide 1.2 mg | Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes | 8 Episodes of hypoglycaemia |
Secondary
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target
Percentage of subjects who achieved HbA1c less than 7.0% (53 mmol/mol) according to American Diabetes Association (ADA) target, after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: After 30 weeks of treatment
Population: Full analysis set (FAS), which included all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target | 80.4 percentage of participants |
| Liraglutide 1.2 mg | Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target | 45.9 percentage of participants |
Secondary
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain
Percentage of subjects who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain, after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: After 30 weeks of treatment
Population: Full analysis set (FAS), which included all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain | 75.6 Percentage of participants |
| Liraglutide 1.2 mg | Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain | 36.8 Percentage of participants |
Secondary
Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target
Percentage of subjects who achieved HbA1c less than 6.5% (48 mmol/mol) according to AACE target,after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: After 30 weeks of treatment
Population: Full analysis set (FAS), which included all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target | 58.5 percentage of participants |
| Liraglutide 1.2 mg | Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target | 24.8 percentage of participants |
Secondary
Subjects Who Achieve HbA1c Reduction Above or Equal to 1%
Percentage of subjects who achieved weight loss above or equal to 1% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: After 30 weeks of treatment
Population: Full analysis set (FAS), which included all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | Subjects Who Achieve HbA1c Reduction Above or Equal to 1% | 82.8 Percentage of participants |
| Liraglutide 1.2 mg | Subjects Who Achieve HbA1c Reduction Above or Equal to 1% | 48.3 Percentage of participants |
Secondary
Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 10%
Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 10% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: After 30 weeks of treatment
Population: Full analysis set (FAS), which included all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 10% | 17.1 Percentage of participants |
| Liraglutide 1.2 mg | Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 10% | 3.6 Percentage of participants |
Secondary
Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 3%
Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 3% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: After 30 weeks of treatment
Population: Full analysis set (FAS), which included all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 3% | 62.4 Percentage of participants |
| Liraglutide 1.2 mg | Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 3% | 20.9 Percentage of participants |
Secondary
Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 5%
Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 5% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: After 30 weeks of treatment
Population: Full analysis set (FAS), which included all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 5% | 49.6 Percentage of participants |
| Liraglutide 1.2 mg | Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 5% | 11.9 Percentage of participants |
Secondary
Subjects Who Achieve Weight Loss Above or Equal to 10%
Percentage of subjects who achieved weight loss above or equal to 10% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: After 30 weeks of treatment
Population: Full analysis set (FAS), which included all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | Subjects Who Achieve Weight Loss Above or Equal to 10% | 19.1 Percentage of participants |
| Liraglutide 1.2 mg | Subjects Who Achieve Weight Loss Above or Equal to 10% | 4.4 Percentage of participants |
Secondary
Subjects Who Achieve Weight Loss Above or Equal to 3%
Percentage of subjects who achieved weight loss above or equal to 3% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: After 30 weeks of treatment
Population: Full analysis set (FAS), which included all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | Subjects Who Achieve Weight Loss Above or Equal to 3% | 72.7 percentage of participants |
| Liraglutide 1.2 mg | Subjects Who Achieve Weight Loss Above or Equal to 3% | 33.9 percentage of participants |
Secondary
Subjects Who Achieve Weight Loss Above or Equal to 5%
Percentage of subjects who achieved weight loss above or equal to 5% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Time frame: After 30 weeks of treatment
Population: Full analysis set (FAS), which included all randomised participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | Subjects Who Achieve Weight Loss Above or Equal to 5% | 55.9 Percentage of participants |
| Liraglutide 1.2 mg | Subjects Who Achieve Weight Loss Above or Equal to 5% | 17.7 Percentage of participants |
Secondary
Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes
Number of subjects with treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episodes is presented. Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, where the subjects were exposed to the trial product. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or blood glucose confirmed by a plasma glucose value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time frame: Week 0 to week 35
Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes | 5 Participants |
| Liraglutide 1.2 mg | Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes | 7 Participants |