Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA1c and the treatment duration was 12 weeks.
Interventions
DRUGsemaglutide
0.1 mg, once weekly, s.c. injection
DRUGplacebo
0.1 mg, once weekly, s.c. injection
DRUGliraglutide
1.2 mg with titration, once daily, s.c. injection
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women-not-of-childbearing potential diagnosed with type 2 diabetes for at least three months * Stable treatment regimen with either metformin (at least 1500 mg) or diet and exercise alone for at least three months * HbA1c: 7.0-10.0 % (both inclusive) * Body weight between 60 kg and 110 kg
Exclusion criteria
* Treatment with insulin, GLP-1 receptor agonists (including liraglutide), dipeptidyl peptidase-4 inhibitors, sulphonylurea, thiazolidinediones, Alpha-GIs, or any investigational drug, within the last three months * Impaired liver or kidney function * Proliferative retinopathy or maculopathy requiring acute treatment * Clinically significant active cardiovascular disease and uncontrolled treated/untreated hypertension * Recurrent major hypoglycaemia or hypoglycaemic unawareness * Present or planned use of any drug which could interfere with the glucose levels (e.g. systemic corticosteroids)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | After 12 weeks of treatment. | Change from baseline in HbA1c was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the last observation carried forward (LOCF) approach. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Hypoglycaemic Episode | After 12 weeks of treatment | The results of hypoglycaemic episode presented here are treatment emergent. Hypoglycaemic episodes were defined as treatment emergent if they had onset on or after the first day of randomised treatment (in week 0) and no later than 5 weeks after the last date on trial product (week 17). Hypoglycaemic episodes are classified as follows: Major: If the subject was not able to treat himself or herself and was needed to be administered food, glucagon or intravenous (i.v.) glucose by another person. Minor: If the subject was able to treat himself or herself and measured plasma glucose was \<3.1 mmol/L (56 mg/dL). Symptoms only: If the subject was able to treat himself or herself and measured plasma glucose was \>=3.1 mmol/L (56 mg/dL) or no plasma glucose measurement was done. |
| Change From Baseline in ECG | Week 0, week 12. | A standard 12 lead electrocardiogram (ECG) with a 10-second rhythm strip was performed at screening (week -2) and at the end of treatment (week 12). The time frame should be read as week -2, week 12. Change from baseline in ECG was measured in terms of number of subjects in each category (normal, abnormal, not clinically significant \[NCS\] or abnormal clinically significant \[CS\]) at week -2 and week 12 (i.e., change in each category in terms of number of subjects from week -2 to week 12). |
| Change From Baseline in Vital Signs (Pulse) | Week 0, week 12 | Change from baseline in pulse was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Vital Signs (Blood Pressure; SBP) | Week 0, week 12 | Change from baseline in systolic blood pressure (SBP) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Vital Signs (Blood Pressure; DBP) | Week 0, week 12 | Change from baseline in diastolic blood pressure (DBP) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils) | Week 0, week 12 | Change from baseline in basophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils) | Week 0, week 12 | Change from baseline in eosinophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit) | Week 0, week 12 | Change from baseline in haematocrit (the proportion of blood that consists of red blood cells) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin) | Week 0, week 12 | Change from baseline in haemoglobin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes) | Week 0, week 12 | Change from baseline in lymphocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes) | Week 0, week 12 | Change from baseline in monocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils) | Week 0, week 12 | Change from baseline in neutrophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes) | Week 0, week 12 | Change from baseline in thrombocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes) | Week 0, week 12 | Change from baseline in erythrocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes) | Week 0, week 12 | Change from baseline in leukocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin) | Week 0, week 12. | Change from baseline in albumin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Percentage of Subjects With an Adverse Events | After 12 weeks of treatment. | The results of adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product. |
| Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST) | Week 0, week 12. | Change from baseline in aspartate aminotransferase (AST) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT) | Week 0, week 12. | Change from baseline in alanine aminotransferase (ALAT) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin) | Week 0, week 12. | Change from baseline in total bilirubin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total) | Week 0, week 12. | Change from baseline in calcium, total was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised) | Week 0, week 12. | Change from baseline in calcium, ionised was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine) | Week 0, week 12. | Change from baseline in creatinine was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium) | Week 0, week 12. | Change from baseline in potassium was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium) | Week 0, week 12. | Change from baseline in sodium was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea) | Week 0, week 12. | Change from baseline in urea was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0, week 12 | Change from baseline in urine-glucose was measured in terms of number of subjects in each category (negative, positive, \>=55 mmol/L, or missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12). |
| Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0, week 12 | Change from baseline in urine-haemoglobin was measured in terms of number of subjects in each category (negative, trace, small, moderate/large and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12). |
| Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0, week 12 | Change from baseline in urine-ketone was measured in terms of number of subjects in each category (negative, positive, \>=55 mmol/L and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12). |
| Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0, week 12 | Change from baseline in urine-pH was measured in terms of number of subjects in each category (pH=6.0, 6.5, 7.0, 7.5, 8.0, \>=8.5 and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12). |
| Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0, week 12 | Change from baseline in urine-protein was measured in terms of number of subjects in each category at week 0 (negative, 0.3 g/L, 1.0 g/L and missing) and week 12 (negative, trace, 0.3 g/L, 1.0 g/L, \>=3.0 g/L and missing). i.e., change in each category in terms of number of subjects from week 0 to week 12. |
| Change From Baseline in Calcitonin | Week 0, week 12. | Change from baseline in calcitonin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
| Percentage of Subjects Developing Anti-semaglutide Antibodies | After 12 weeks of treatment | Antibodies were measured after 12-week of treatment at week 17; percentage of participants with positive anti-semaglutide antibodies are presented here. Assessments of antibodies were not done for subjects allocated to the open-label liraglutide treatment arms. |
| Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase) | Week 0, week 12. | Change from baseline in alkaline phosphatase was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach. |
Countries
Austria, Bulgaria, Finland, France, Germany, Hungary, India, Italy, Serbia and Montenegro, South Africa, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Participant flow
Recruitment details
The trial was conducted at 80 sites in 14 countries: Austria (8), Bulgaria (6), Finland (6), France (5), Germany (7), Hungary (5), India (4), Italy (6), Serbia (3), South Africa (3), Spain (6), Switzerland (4), Turkey (5), and United Kingdom (12).
Pre-assignment details
Study Design: This was a 9 armed parallel group trial. Subjects were randomised in a 1:1:1:1:1:1:1:1:1 manner to receive one of five doses of blinded semaglutide once-weekly (0.1 mg, 0.2 mg, 0.4 mg, 0.8 mg, 0.8 mg T \[with titration\] and 1.6 mg T \[with titration\]) or blinded placebo once-weekly or open-label liraglutide 1.2 mg or 1.8 mg once-daily.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Subjects received placebo once-weekly throughout the 12-week treatment period. Placebo was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Placebo was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone. | 46 |
| Semaglutide 0.1 mg Subjects received semaglutide 0.1 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone. | 47 |
| Semaglutide 0.2 mg Subjects received semaglutide 0.2 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone. | 43 |
| Semaglutide 0.4 mg Subjects received semaglutide 0.4 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone. | 48 |
| Semaglutide 0.8 mg Subjects received semaglutide 0.8 mg once-weekly throughout the 12-week treatment period. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone. | 42 |
| Semaglutide 0.8 mg (With Titration) Subjects followed a 1-week titration period (semaglutide 0.4 mg once-weekly at week 1), followed by an 11- week treatment period of fixed doses semaglutide 0.8 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone. | 43 |
| Semaglutide 1.6 mg (With Titration) Subjects followed a 2-week titration period (once-weekly semaglutide 0.4 mg at week 1 and 0.8 mg at week 2), followed by a 10-week treatment period of fixed doses semaglutide 1.6 mg, once-weekly. Semaglutide was injected s.c. in the abdomen, thigh or upper arm by using the NordiPen® on the same day of the week at a convenient time for the subjects. Semaglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone. | 47 |
| Liraglutide 1.2 mg Subjects followed a 1-week titration period (liraglutide 0.6 mg once-daily in week 1), followed by an 11-week treatment period of fixed doses liraglutide 1.2 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone. | 45 |
| Liraglutide 1.8 mg Subjects followed a 2-week titration period (once-daily liraglutide 0.6 mg in week 1 and 1.2 mg in week 2), followed by a 10-week treatment period of fixed doses liraglutide 1.8 mg, once-daily. Liraglutide was injected s.c. in the abdomen, upper arm or thigh by using the Flexpen® in the evening before bedtime. Liraglutide was given in adjunct to previous metformin therapy on a stable dose (minimum 1.5 g daily) or as monotherapy in case the diabetes was controlled by diet and exercise alone. | 50 |
| Total | 411 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 3 | 7 | 6 | 9 | 14 | 2 | 5 |
| Overall Study | Lack of Efficacy | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Overall Study | Unclassified | 0 | 1 | 3 | 2 | 4 | 2 | 0 | 0 | 1 |
| Overall Study | Withdrawal criteria | 1 | 3 | 2 | 2 | 0 | 0 | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | Placebo | Semaglutide 0.1 mg | Semaglutide 0.2 mg | Semaglutide 0.4 mg | Semaglutide 0.8 mg | Semaglutide 0.8 mg (With Titration) | Semaglutide 1.6 mg (With Titration) | Liraglutide 1.2 mg | Liraglutide 1.8 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 55.3 Years STANDARD_DEVIATION 10.6 | 55.2 Years STANDARD_DEVIATION 10.1 | 54.7 Years STANDARD_DEVIATION 10 | 53.8 Years STANDARD_DEVIATION 10.2 | 55.0 Years STANDARD_DEVIATION 9.7 | 55.9 Years STANDARD_DEVIATION 7.9 | 56.4 Years STANDARD_DEVIATION 10.5 | 54.8 Years STANDARD_DEVIATION 9.2 | 54.3 Years STANDARD_DEVIATION 10.1 | 55.0 Years STANDARD_DEVIATION 9.8 |
| Diastolic blood pressure (DBP) | 79.1 mmHg STANDARD_DEVIATION 8.3 | 79.1 mmHg STANDARD_DEVIATION 6.5 | 79.3 mmHg STANDARD_DEVIATION 7.6 | 81.9 mmHg STANDARD_DEVIATION 7.5 | 80.8 mmHg STANDARD_DEVIATION 7.9 | 79.4 mmHg STANDARD_DEVIATION 9.3 | 80.9 mmHg STANDARD_DEVIATION 8.9 | 80.0 mmHg STANDARD_DEVIATION 9.2 | 78.9 mmHg STANDARD_DEVIATION 7.7 | 79.9 mmHg STANDARD_DEVIATION 8.1 |
| Glycosylated haemoglobin (HbA1c) | 8.1 Percentage (%) of HbA1c STANDARD_DEVIATION 0.8 | 8.2 Percentage (%) of HbA1c STANDARD_DEVIATION 0.9 | 8.2 Percentage (%) of HbA1c STANDARD_DEVIATION 0.9 | 8.1 Percentage (%) of HbA1c STANDARD_DEVIATION 0.9 | 8.2 Percentage (%) of HbA1c STANDARD_DEVIATION 0.9 | 8.0 Percentage (%) of HbA1c STANDARD_DEVIATION 0.8 | 8.0 Percentage (%) of HbA1c STANDARD_DEVIATION 0.7 | 8.0 Percentage (%) of HbA1c STANDARD_DEVIATION 0.8 | 8.1 Percentage (%) of HbA1c STANDARD_DEVIATION 0.7 | 8.1 Percentage (%) of HbA1c STANDARD_DEVIATION 0.8 |
| Pulse | 70.4 Beats/min STANDARD_DEVIATION 9.2 | 74.2 Beats/min STANDARD_DEVIATION 8 | 72.8 Beats/min STANDARD_DEVIATION 9 | 74.3 Beats/min STANDARD_DEVIATION 9.2 | 74.7 Beats/min STANDARD_DEVIATION 8.7 | 74.2 Beats/min STANDARD_DEVIATION 10.2 | 73.9 Beats/min STANDARD_DEVIATION 9.7 | 72.3 Beats/min STANDARD_DEVIATION 7.5 | 74.6 Beats/min STANDARD_DEVIATION 10.8 | 73.5 Beats/min STANDARD_DEVIATION 9.2 |
| Sex: Female, Male Female | 18 Participants | 16 Participants | 13 Participants | 11 Participants | 20 Participants | 16 Participants | 21 Participants | 14 Participants | 15 Participants | 144 Participants |
| Sex: Female, Male Male | 28 Participants | 31 Participants | 30 Participants | 37 Participants | 22 Participants | 27 Participants | 26 Participants | 31 Participants | 35 Participants | 267 Participants |
| Systolic blood pressure (SBP) | 130.9 mmHg STANDARD_DEVIATION 13.1 | 129.4 mmHg STANDARD_DEVIATION 11.6 | 129.3 mmHg STANDARD_DEVIATION 13.4 | 134.0 mmHg STANDARD_DEVIATION 12.9 | 132.6 mmHg STANDARD_DEVIATION 13.3 | 130.3 mmHg STANDARD_DEVIATION 13 | 131.1 mmHg STANDARD_DEVIATION 10.7 | 128.0 mmHg STANDARD_DEVIATION 10.2 | 130.4 mmHg STANDARD_DEVIATION 13.9 | 130.7 mmHg STANDARD_DEVIATION 12.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 47 | 0 / 43 | 0 / 48 | 0 / 42 | 0 / 43 | 0 / 47 | 0 / 45 | 0 / 50 |
| other Total, other adverse events | 9 / 46 | 23 / 47 | 14 / 43 | 27 / 48 | 32 / 42 | 29 / 43 | 39 / 47 | 18 / 45 | 21 / 50 |
| serious Total, serious adverse events | 1 / 46 | 1 / 47 | 1 / 43 | 2 / 48 | 0 / 42 | 1 / 43 | 2 / 47 | 0 / 45 | 0 / 50 |
Outcome results
Primary
HbA1c
Change from baseline in HbA1c was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the last observation carried forward (LOCF) approach.
Time frame: After 12 weeks of treatment.
Population: The full analysis set included all randomised subjects who had been exposed to at least 1 dose of the trial product (placebo/semaglutide/liraglutide). Four subjects mistakenly received a different treatment instead of the randomised treatment. The randomised treatment was applied regardless of the treatment actually received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | HbA1c | -0.5 Percentage (%) of HbA1c | Standard Deviation 0.8 |
| Semaglutide 0.1 mg | HbA1c | -0.6 Percentage (%) of HbA1c | Standard Deviation 0.7 |
| Semaglutide 0.2 mg | HbA1c | -0.9 Percentage (%) of HbA1c | Standard Deviation 0.9 |
| Semaglutide 0.4 mg | HbA1c | -1.0 Percentage (%) of HbA1c | Standard Deviation 0.8 |
| Semaglutide 0.8 mg | HbA1c | -1.4 Percentage (%) of HbA1c | Standard Deviation 0.8 |
| Semaglutide 0.8 mg (With Titration) | HbA1c | -1.4 Percentage (%) of HbA1c | Standard Deviation 1 |
| Semaglutide 1.6 mg (With Titration) | HbA1c | -1.5 Percentage (%) of HbA1c | Standard Deviation 0.8 |
| Liraglutide 1.2 mg | HbA1c | -1.1 Percentage (%) of HbA1c | Standard Deviation 0.7 |
| Liraglutide 1.8 mg | HbA1c | -1.3 Percentage (%) of HbA1c | Standard Deviation 0.7 |
Comparison: The comparison sequence should be read as Semaglutide 1.6 mg (with titration) - Placebo. The estimates are from an analysis of variance (ANOVA) model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.p-value: <0.000195% CI: [-1.58, -0.8]ANOVA
Comparison: The comparison sequence should be read as Semaglutide 0.8 mg (with titration) - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.p-value: <0.000195% CI: [-1.33, -0.57]ANOVA
Comparison: The comparison sequence should be read as Semaglutide 0.8 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.p-value: <0.000195% CI: [-1.35, -0.59]ANOVA
Comparison: The comparison sequence should be read as Semaglutide 0.4 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.p-value: 0.000295% CI: [-0.98, -0.23]ANOVA
Comparison: The comparison sequence should be read as Semaglutide 0.2 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.p-value: 0.032495% CI: [-0.79, -0.02]ANOVA
Comparison: The comparison sequence should be read as Semaglutide 0.1 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.p-value: 0.977295% CI: [-0.46, 0.28]ANOVA
Comparison: The comparison sequence should be read as Semaglutide 1.6 mg (with titration) - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.95% CI: [-0.64, -0.06]ANOVA
Comparison: The comparison sequence should be read as Semaglutide 0.8 mg (with titration) - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.95% CI: [-0.39, 0.18]ANOVA
Comparison: The comparison sequence should be read as Semaglutide 0.8 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.95% CI: [-0.42, 0.16]ANOVA
Comparison: The comparison sequence should be read as Semaglutide 0.4 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.95% CI: [-0.05, 0.52]ANOVA
Comparison: The comparison sequence should be read as Semaglutide 0.2 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.95% CI: [0.15, 0.73]ANOVA
Comparison: The comparison sequence should be read as Semaglutide 0.1 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.95% CI: [0.48, 1.03]ANOVA
Comparison: The comparison sequence should be read as Liraglutide 1.8 mg - Placebo . The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.95% CI: [-1.12, -0.56]ANOVA
Comparison: The comparison sequence should be read as Semaglutide 1.6 mg (with titration) - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.95% CI: [-0.8, -0.22]ANOVA
Comparison: The comparison sequence should be read as Semaglutide 0.8 mg (with titration) - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.95% CI: [-0.56, 0.02]ANOVA
Comparison: The comparison sequence should be read as Semaglutide 0.8 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.95% CI: [-0.58, 0.01]ANOVA
Comparison: The comparison sequence should be read as Semaglutide 0.4 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.95% CI: [-0.22, 0.37]ANOVA
Comparison: The comparison sequence should be read as Semaglutide 0.2 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.95% CI: [-0.02, 0.57]ANOVA
Comparison: The comparison sequence should be read as Semaglutide 0.1 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.95% CI: [0.31, 0.88]ANOVA
Comparison: The comparison sequence should be read as Liraglutide 1.2 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.95% CI: [-0.97, -0.4]ANOVA
Secondary
Change From Baseline in Calcitonin
Change from baseline in calcitonin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12.
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Calcitonin | 0.43 ng/L | Standard Deviation 1.85 |
| Semaglutide 0.1 mg | Change From Baseline in Calcitonin | 0.48 ng/L | Standard Deviation 1.82 |
| Semaglutide 0.2 mg | Change From Baseline in Calcitonin | -0.48 ng/L | Standard Deviation 4.29 |
| Semaglutide 0.4 mg | Change From Baseline in Calcitonin | 0.62 ng/L | Standard Deviation 1.68 |
| Semaglutide 0.8 mg | Change From Baseline in Calcitonin | 0.45 ng/L | Standard Deviation 1.79 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Calcitonin | 0.87 ng/L | Standard Deviation 1.56 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Calcitonin | 0.76 ng/L | Standard Deviation 1.78 |
| Liraglutide 1.2 mg | Change From Baseline in Calcitonin | 0.55 ng/L | Standard Deviation 2.66 |
| Liraglutide 1.8 mg | Change From Baseline in Calcitonin | 0.01 ng/L | Standard Deviation 2.07 |
Secondary
Change From Baseline in ECG
A standard 12 lead electrocardiogram (ECG) with a 10-second rhythm strip was performed at screening (week -2) and at the end of treatment (week 12). The time frame should be read as week -2, week 12. Change from baseline in ECG was measured in terms of number of subjects in each category (normal, abnormal, not clinically significant \[NCS\] or abnormal clinically significant \[CS\]) at week -2 and week 12 (i.e., change in each category in terms of number of subjects from week -2 to week 12).
Time frame: Week 0, week 12.
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Change From Baseline in ECG | Week -2: Abnormal, CS | 0 Participants |
| Placebo | Change From Baseline in ECG | Week 12: ECG not done (ND) | 1 Participants |
| Placebo | Change From Baseline in ECG | Week 12: Normal | 39 Participants |
| Placebo | Change From Baseline in ECG | Week -2: Abnormal, NCS | 4 Participants |
| Placebo | Change From Baseline in ECG | Week 12: Abnormal, NCS | 6 Participants |
| Placebo | Change From Baseline in ECG | Week -2: Normal | 42 Participants |
| Placebo | Change From Baseline in ECG | Week 12: Abnormal, CS | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in ECG | Week 12: ECG not done (ND) | 1 Participants |
| Semaglutide 0.1 mg | Change From Baseline in ECG | Week 12: Abnormal, CS | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in ECG | Week 12: Abnormal, NCS | 14 Participants |
| Semaglutide 0.1 mg | Change From Baseline in ECG | Week -2: Normal | 33 Participants |
| Semaglutide 0.1 mg | Change From Baseline in ECG | Week -2: Abnormal, CS | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in ECG | Week 12: Normal | 32 Participants |
| Semaglutide 0.1 mg | Change From Baseline in ECG | Week -2: Abnormal, NCS | 14 Participants |
| Semaglutide 0.2 mg | Change From Baseline in ECG | Week 12: Abnormal, CS | 1 Participants |
| Semaglutide 0.2 mg | Change From Baseline in ECG | Week 12: Normal | 34 Participants |
| Semaglutide 0.2 mg | Change From Baseline in ECG | Week -2: Abnormal, CS | 0 Participants |
| Semaglutide 0.2 mg | Change From Baseline in ECG | Week -2: Abnormal, NCS | 6 Participants |
| Semaglutide 0.2 mg | Change From Baseline in ECG | Week 12: Abnormal, NCS | 3 Participants |
| Semaglutide 0.2 mg | Change From Baseline in ECG | Week -2: Normal | 37 Participants |
| Semaglutide 0.2 mg | Change From Baseline in ECG | Week 12: ECG not done (ND) | 5 Participants |
| Semaglutide 0.4 mg | Change From Baseline in ECG | Week -2: Abnormal, CS | 2 Participants |
| Semaglutide 0.4 mg | Change From Baseline in ECG | Week 12: ECG not done (ND) | 1 Participants |
| Semaglutide 0.4 mg | Change From Baseline in ECG | Week 12: Normal | 36 Participants |
| Semaglutide 0.4 mg | Change From Baseline in ECG | Week 12: Abnormal, CS | 2 Participants |
| Semaglutide 0.4 mg | Change From Baseline in ECG | Week -2: Abnormal, NCS | 12 Participants |
| Semaglutide 0.4 mg | Change From Baseline in ECG | Week 12: Abnormal, NCS | 7 Participants |
| Semaglutide 0.4 mg | Change From Baseline in ECG | Week -2: Normal | 34 Participants |
| Semaglutide 0.8 mg | Change From Baseline in ECG | Week -2: Abnormal, NCS | 10 Participants |
| Semaglutide 0.8 mg | Change From Baseline in ECG | Week -2: Abnormal, CS | 1 Participants |
| Semaglutide 0.8 mg | Change From Baseline in ECG | Week 12: Normal | 29 Participants |
| Semaglutide 0.8 mg | Change From Baseline in ECG | Week 12: Abnormal, NCS | 7 Participants |
| Semaglutide 0.8 mg | Change From Baseline in ECG | Week 12: Abnormal, CS | 1 Participants |
| Semaglutide 0.8 mg | Change From Baseline in ECG | Week 12: ECG not done (ND) | 3 Participants |
| Semaglutide 0.8 mg | Change From Baseline in ECG | Week -2: Normal | 31 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in ECG | Week 12: Normal | 33 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in ECG | Week 12: Abnormal, CS | 0 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in ECG | Week -2: Abnormal, NCS | 15 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in ECG | Week 12: Abnormal, NCS | 9 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in ECG | Week -2: Abnormal, CS | 0 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in ECG | Week -2: Normal | 28 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in ECG | Week 12: ECG not done (ND) | 1 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in ECG | Week -2: Normal | 37 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in ECG | Week 12: ECG not done (ND) | 2 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in ECG | Week 12: Normal | 36 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in ECG | Week 12: Abnormal, CS | 3 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in ECG | Week -2: Abnormal, NCS | 8 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in ECG | Week -2: Abnormal, CS | 2 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in ECG | Week 12: Abnormal, NCS | 5 Participants |
| Liraglutide 1.2 mg | Change From Baseline in ECG | Week 12: Abnormal, CS | 0 Participants |
| Liraglutide 1.2 mg | Change From Baseline in ECG | Week 12: ECG not done (ND) | 2 Participants |
| Liraglutide 1.2 mg | Change From Baseline in ECG | Week 12: Abnormal, NCS | 6 Participants |
| Liraglutide 1.2 mg | Change From Baseline in ECG | Week -2: Normal | 39 Participants |
| Liraglutide 1.2 mg | Change From Baseline in ECG | Week 12: Normal | 37 Participants |
| Liraglutide 1.2 mg | Change From Baseline in ECG | Week -2: Abnormal, NCS | 6 Participants |
| Liraglutide 1.2 mg | Change From Baseline in ECG | Week -2: Abnormal, CS | 0 Participants |
| Liraglutide 1.8 mg | Change From Baseline in ECG | Week -2: Normal | 41 Participants |
| Liraglutide 1.8 mg | Change From Baseline in ECG | Week 12: Abnormal, NCS | 5 Participants |
| Liraglutide 1.8 mg | Change From Baseline in ECG | Week 12: Abnormal, CS | 0 Participants |
| Liraglutide 1.8 mg | Change From Baseline in ECG | Week -2: Abnormal, NCS | 9 Participants |
| Liraglutide 1.8 mg | Change From Baseline in ECG | Week 12: ECG not done (ND) | 2 Participants |
| Liraglutide 1.8 mg | Change From Baseline in ECG | Week 12: Normal | 42 Participants |
| Liraglutide 1.8 mg | Change From Baseline in ECG | Week -2: Abnormal, CS | 0 Participants |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT)
Change from baseline in alanine aminotransferase (ALAT) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12.
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT) | -2.41 U/L | Standard Deviation 11.49 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT) | 0.83 U/L | Standard Deviation 8.23 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT) | 0.68 U/L | Standard Deviation 10.38 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT) | -4.21 U/L | Standard Deviation 15.15 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT) | -2.13 U/L | Standard Deviation 12.48 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT) | -6.19 U/L | Standard Deviation 12.26 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT) | -6.55 U/L | Standard Deviation 12.05 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT) | -0.88 U/L | Standard Deviation 8.96 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT) | -1.83 U/L | Standard Deviation 10.42 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin)
Change from baseline in albumin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12.
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin) | 0.402 g/L | Standard Deviation 2.188 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin) | 0.130 g/L | Standard Deviation 2.505 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin) | -0.091 g/L | Standard Deviation 1.7 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin) | -0.177 g/L | Standard Deviation 2.331 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin) | 0.303 g/L | Standard Deviation 2.207 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin) | 0.607 g/L | Standard Deviation 2.034 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin) | 0.271 g/L | Standard Deviation 2.586 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin) | 0.916 g/L | Standard Deviation 1.933 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin) | 0.846 g/L | Standard Deviation 2.097 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase)
Change from baseline in alkaline phosphatase was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12.
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase) | -0.52 U/L | Standard Deviation 8.78 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase) | -1.66 U/L | Standard Deviation 14.11 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase) | -2.37 U/L | Standard Deviation 11.87 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase) | -2.35 U/L | Standard Deviation 9.87 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase) | -1.39 U/L | Standard Deviation 12.24 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase) | -2.81 U/L | Standard Deviation 7.09 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase) | -3.98 U/L | Standard Deviation 9.02 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase) | -1.89 U/L | Standard Deviation 12.24 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase) | -4.25 U/L | Standard Deviation 10.9 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST)
Change from baseline in aspartate aminotransferase (AST) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12.
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST) | -1.09 U/L | Standard Deviation 5.8 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST) | 1.23 U/L | Standard Deviation 8.93 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST) | 0.24 U/L | Standard Deviation 6.55 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST) | -1.81 U/L | Standard Deviation 9.54 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST) | -0.37 U/L | Standard Deviation 4.75 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST) | -2.60 U/L | Standard Deviation 7.38 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST) | -4.07 U/L | Standard Deviation 8.13 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST) | -0.16 U/L | Standard Deviation 6.12 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST) | -2.13 U/L | Standard Deviation 13.48 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised)
Change from baseline in calcium, ionised was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12.
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised) | 0.00 mmol/L | Standard Deviation 0.09 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised) | -0.01 mmol/L | Standard Deviation 0.11 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised) | -0.04 mmol/L | Standard Deviation 0.14 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised) | -0.01 mmol/L | Standard Deviation 0.07 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised) | -0.01 mmol/L | Standard Deviation 0.13 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised) | 0.01 mmol/L | Standard Deviation 0.09 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised) | -0.02 mmol/L | Standard Deviation 0.13 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised) | -0.02 mmol/L | Standard Deviation 0.11 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised) | -0.01 mmol/L | Standard Deviation 0.14 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total)
Change from baseline in calcium, total was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12.
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total) | 0.0 mmol/L | Standard Deviation 0.1 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total) | -0.0 mmol/L | Standard Deviation 0.1 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total) | -0.0 mmol/L | Standard Deviation 0.1 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total) | -0.0 mmol/L | Standard Deviation 0.1 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total) | 0.0 mmol/L | Standard Deviation 0.1 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total) | 0.0 mmol/L | Standard Deviation 0.1 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total) | -0.0 mmol/L | Standard Deviation 0.1 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total) | -0.0 mmol/L | Standard Deviation 0.1 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total) | 0.0 mmol/L | Standard Deviation 0.2 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine)
Change from baseline in creatinine was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12.
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine) | -1.02 umol/L | Standard Deviation 7.206 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine) | 0.936 umol/L | Standard Deviation 6.291 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine) | -0.349 umol/L | Standard Deviation 11.22 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine) | -2.31 umol/L | Standard Deviation 8.866 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine) | -0.658 umol/L | Standard Deviation 11.08 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine) | -1.67 umol/L | Standard Deviation 9.511 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine) | 2.089 umol/L | Standard Deviation 7.099 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine) | 0.841 umol/L | Standard Deviation 11.21 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine) | -0.917 umol/L | Standard Deviation 6.27 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium)
Change from baseline in potassium was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12.
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium) | 0.07 mmol/L | Standard Deviation 0.37 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium) | 0.08 mmol/L | Standard Deviation 0.57 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium) | 0.06 mmol/L | Standard Deviation 0.42 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium) | -0.02 mmol/L | Standard Deviation 0.44 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium) | 0.04 mmol/L | Standard Deviation 0.61 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium) | -0.02 mmol/L | Standard Deviation 0.48 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium) | -0.07 mmol/L | Standard Deviation 0.46 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium) | 0.10 mmol/L | Standard Deviation 0.5 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium) | -0.12 mmol/L | Standard Deviation 0.47 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium)
Change from baseline in sodium was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12.
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium) | 0.1 mmol/L | Standard Deviation 2.3 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium) | 0.0 mmol/L | Standard Deviation 1.7 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium) | -0.1 mmol/L | Standard Deviation 2.6 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium) | -0.1 mmol/L | Standard Deviation 2.7 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium) | 0.4 mmol/L | Standard Deviation 2.4 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium) | 0.2 mmol/L | Standard Deviation 2.7 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium) | 0.5 mmol/L | Standard Deviation 2.7 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium) | 0.7 mmol/L | Standard Deviation 2.8 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium) | 0.6 mmol/L | Standard Deviation 2.3 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin)
Change from baseline in total bilirubin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12.
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin) | 0.7 umol/L | Standard Deviation 3.6 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin) | -0.4 umol/L | Standard Deviation 2.8 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin) | 0.6 umol/L | Standard Deviation 4.4 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin) | 0.8 umol/L | Standard Deviation 3.7 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin) | 0.7 umol/L | Standard Deviation 3.3 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin) | 1.3 umol/L | Standard Deviation 5.4 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin) | 0.4 umol/L | Standard Deviation 3.8 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin) | -0.5 umol/L | Standard Deviation 4.7 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin) | 0.2 umol/L | Standard Deviation 3.6 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea)
Change from baseline in urea was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12.
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea) | -0.1 mmol/L | Standard Deviation 1.2 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea) | 0.1 mmol/L | Standard Deviation 1.4 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea) | -0.1 mmol/L | Standard Deviation 1.3 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea) | -0.4 mmol/L | Standard Deviation 1.3 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea) | -0.3 mmol/L | Standard Deviation 1.6 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea) | -0.5 mmol/L | Standard Deviation 1.3 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea) | -0.5 mmol/L | Standard Deviation 1.3 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea) | -0.1 mmol/L | Standard Deviation 1.3 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea) | -0.4 mmol/L | Standard Deviation 1.1 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils)
Change from baseline in basophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils) | -0.0 Billion cells/litre (10^9/L) | Standard Deviation 0 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils) | 0.0 Billion cells/litre (10^9/L) | Standard Deviation 0 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils) | -0.0 Billion cells/litre (10^9/L) | Standard Deviation 0 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils) | 0.0 Billion cells/litre (10^9/L) | Standard Deviation 0 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils) | -0.0 Billion cells/litre (10^9/L) | Standard Deviation 0 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils) | -0.0 Billion cells/litre (10^9/L) | Standard Deviation 0 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils) | -0.0 Billion cells/litre (10^9/L) | Standard Deviation 0 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils) | 0.0 Billion cells/litre (10^9/L) | Standard Deviation 0 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils) | 0.0 Billion cells/litre (10^9/L) | Standard Deviation 0 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils)
Change from baseline in eosinophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils) | -0.0 Billion cells/litre (10^9/L) | Standard Deviation 0.2 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils) | 0.0 Billion cells/litre (10^9/L) | Standard Deviation 0.2 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils) | -0.0 Billion cells/litre (10^9/L) | Standard Deviation 0.1 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils) | 0.0 Billion cells/litre (10^9/L) | Standard Deviation 0.1 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils) | -0.0 Billion cells/litre (10^9/L) | Standard Deviation 0.2 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils) | 0.0 Billion cells/litre (10^9/L) | Standard Deviation 0.3 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils) | 0.1 Billion cells/litre (10^9/L) | Standard Deviation 0.2 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils) | 0.0 Billion cells/litre (10^9/L) | Standard Deviation 0.2 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils) | -0.0 Billion cells/litre (10^9/L) | Standard Deviation 0.1 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes)
Change from baseline in erythrocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes) | -0.04 Trillion cells/litre (10^12/L) | Standard Deviation 0.21 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes) | -0.06 Trillion cells/litre (10^12/L) | Standard Deviation 0.21 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes) | -0.03 Trillion cells/litre (10^12/L) | Standard Deviation 0.31 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes) | 0.08 Trillion cells/litre (10^12/L) | Standard Deviation 0.32 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes) | -0.05 Trillion cells/litre (10^12/L) | Standard Deviation 0.25 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes) | 0.03 Trillion cells/litre (10^12/L) | Standard Deviation 0.24 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes) | 0.04 Trillion cells/litre (10^12/L) | Standard Deviation 0.24 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes) | 0.04 Trillion cells/litre (10^12/L) | Standard Deviation 0.23 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes) | 0.02 Trillion cells/litre (10^12/L) | Standard Deviation 0.38 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit)
Change from baseline in haematocrit (the proportion of blood that consists of red blood cells) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit) | -0.01 Litre/litre (L/L) | Standard Deviation 0.02 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit) | -0.01 Litre/litre (L/L) | Standard Deviation 0.03 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit) | -0.01 Litre/litre (L/L) | Standard Deviation 0.03 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit) | 0.00 Litre/litre (L/L) | Standard Deviation 0.03 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit) | -0.01 Litre/litre (L/L) | Standard Deviation 0.02 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit) | -0.00 Litre/litre (L/L) | Standard Deviation 0.03 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit) | -0.00 Litre/litre (L/L) | Standard Deviation 0.03 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit) | 0.00 Litre/litre (L/L) | Standard Deviation 0.03 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit) | -0.01 Litre/litre (L/L) | Standard Deviation 0.03 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin)
Change from baseline in haemoglobin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin) | 0.1 Gram/litre (g/L) | Standard Deviation 6.3 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin) | -0.4 Gram/litre (g/L) | Standard Deviation 5.9 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin) | -1.2 Gram/litre (g/L) | Standard Deviation 9.3 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin) | 2.8 Gram/litre (g/L) | Standard Deviation 9.5 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin) | -0.3 Gram/litre (g/L) | Standard Deviation 7.7 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin) | 1.5 Gram/litre (g/L) | Standard Deviation 6.9 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin) | 1.0 Gram/litre (g/L) | Standard Deviation 7.1 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin) | 2.1 Gram/litre (g/L) | Standard Deviation 6.7 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin) | 1.1 Gram/litre (g/L) | Standard Deviation 10.7 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes)
Change from baseline in leukocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes) | 0.05 Billion cells/litre (10^9/L) | Standard Deviation 2 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes) | 0.04 Billion cells/litre (10^9/L) | Standard Deviation 1.39 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes) | -0.16 Billion cells/litre (10^9/L) | Standard Deviation 1.46 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes) | 0.59 Billion cells/litre (10^9/L) | Standard Deviation 1.5 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes) | 0.14 Billion cells/litre (10^9/L) | Standard Deviation 1.78 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes) | 0.41 Billion cells/litre (10^9/L) | Standard Deviation 1.44 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes) | 0.70 Billion cells/litre (10^9/L) | Standard Deviation 1.64 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes) | 0.40 Billion cells/litre (10^9/L) | Standard Deviation 1.15 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes) | 0.26 Billion cells/litre (10^9/L) | Standard Deviation 1.59 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes)
Change from baseline in lymphocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes) | -0.1 Billion cells/litre (10^9/L) | Standard Deviation 0.6 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes) | 0.0 Billion cells/litre (10^9/L) | Standard Deviation 0.4 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes) | -0.1 Billion cells/litre (10^9/L) | Standard Deviation 0.6 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes) | 0.2 Billion cells/litre (10^9/L) | Standard Deviation 0.9 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes) | -0.0 Billion cells/litre (10^9/L) | Standard Deviation 0.7 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes) | -0.1 Billion cells/litre (10^9/L) | Standard Deviation 0.7 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes) | 0.1 Billion cells/litre (10^9/L) | Standard Deviation 0.5 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes) | 0.0 Billion cells/litre (10^9/L) | Standard Deviation 0.4 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes) | -0.1 Billion cells/litre (10^9/L) | Standard Deviation 0.8 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes)
Change from baseline in monocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes) | 0.1 Billion cells/litre (10^9/L) | Standard Deviation 0.1 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes) | 0.0 Billion cells/litre (10^9/L) | Standard Deviation 0.2 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes) | -0.0 Billion cells/litre (10^9/L) | Standard Deviation 0.2 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes) | 0.1 Billion cells/litre (10^9/L) | Standard Deviation 0.1 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes) | 0.1 Billion cells/litre (10^9/L) | Standard Deviation 0.2 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes) | 0.0 Billion cells/litre (10^9/L) | Standard Deviation 0.1 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes) | 0.1 Billion cells/litre (10^9/L) | Standard Deviation 0.2 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes) | 0.1 Billion cells/litre (10^9/L) | Standard Deviation 0.2 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes) | 0.1 Billion cells/litre (10^9/L) | Standard Deviation 0.2 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils)
Change from baseline in neutrophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils) | 0.1 Billion cells/litre (10^9/L) | Standard Deviation 1.7 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils) | 0.0 Billion cells/litre (10^9/L) | Standard Deviation 1.3 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils) | -0.1 Billion cells/litre (10^9/L) | Standard Deviation 1.4 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils) | 0.3 Billion cells/litre (10^9/L) | Standard Deviation 1.3 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils) | -0.1 Billion cells/litre (10^9/L) | Standard Deviation 1.6 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils) | 0.5 Billion cells/litre (10^9/L) | Standard Deviation 1.1 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils) | 0.5 Billion cells/litre (10^9/L) | Standard Deviation 1.4 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils) | 0.3 Billion cells/litre (10^9/L) | Standard Deviation 1 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils) | 0.3 Billion cells/litre (10^9/L) | Standard Deviation 1.4 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes)
Change from baseline in thrombocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes) | 9.0 Billion cells/litre (10^9/L) | Standard Deviation 35.5 |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes) | 16.1 Billion cells/litre (10^9/L) | Standard Deviation 30.2 |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes) | 10.8 Billion cells/litre (10^9/L) | Standard Deviation 38.4 |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes) | 10.7 Billion cells/litre (10^9/L) | Standard Deviation 47.9 |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes) | 5.4 Billion cells/litre (10^9/L) | Standard Deviation 30.7 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes) | 5.5 Billion cells/litre (10^9/L) | Standard Deviation 50.6 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes) | 15.9 Billion cells/litre (10^9/L) | Standard Deviation 51.9 |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes) | 10.1 Billion cells/litre (10^9/L) | Standard Deviation 37.1 |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes) | 16.7 Billion cells/litre (10^9/L) | Standard Deviation 41.9 |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)
Change from baseline in urine-glucose was measured in terms of number of subjects in each category (negative, positive, \>=55 mmol/L, or missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).
Time frame: Week 0, week 12
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: >=55 mmol/L | 1 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Positive | 13 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Negative | 31 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Missing | 1 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Negative | 34 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Positive | 8 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: >=55 mmol/L | 2 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Missing | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Negative | 26 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Positive | 15 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Positive | 18 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: >=55 mmol/L | 3 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: >=55 mmol/L | 2 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Missing | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Missing | 1 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Negative | 28 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: >=55 mmol/L | 3 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Negative | 23 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Positive | 8 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Negative | 28 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Positive | 15 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: >=55 mmol/L | 5 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Missing | 0 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Missing | 2 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Missing | 0 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: >=55 mmol/L | 2 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Negative | 35 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Positive | 11 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Negative | 35 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Positive | 8 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Missing | 1 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: >=55 mmol/L | 1 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: >=55 mmol/L | 2 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: >=55 mmol/L | 3 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Missing | 3 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Positive | 2 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Negative | 23 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Positive | 15 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Missing | 0 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Negative | 30 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: >=55 mmol/L | 0 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Positive | 10 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: >=55 mmol/L | 3 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Negative | 28 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Missing | 2 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Negative | 39 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Positive | 1 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Missing | 1 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Negative | 39 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: >=55 mmol/L | 0 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Missing | 1 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: >=55 mmol/L | 2 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Negative | 32 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Missing | 1 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Positive | 12 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Positive | 3 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Positive | 7 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Positive | 10 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Missing | 0 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: >=55 mmol/L | 3 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Missing | 2 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Negative | 35 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: >=55 mmol/L | 1 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Negative | 30 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Positive | 6 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Negative | 22 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Negative | 39 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Missing | 3 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: Missing | 2 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: >=55 mmol/L | 5 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 0: Positive | 20 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) | Week 12: >=55 mmol/L | 0 Participants |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)
Change from baseline in urine-haemoglobin was measured in terms of number of subjects in each category (negative, trace, small, moderate/large and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).
Time frame: Week 0, week 12
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Missing | 1 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Large | 1 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Moderate | 0 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Missing | 0 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Small | 0 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Trace | 0 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Small | 1 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Negative | 45 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Negative | 42 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Trace | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Negative | 45 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Small | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Trace | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Moderate | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Trace | 2 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Missing | 1 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Small | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Large | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Missing | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Negative | 45 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Small | 1 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Negative | 41 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Large | 0 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Trace | 1 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Moderate | 0 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Trace | 1 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Missing | 0 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Negative | 38 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Missing | 2 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Small | 0 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Negative | 42 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Missing | 1 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Large | 0 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Trace | 1 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Moderate | 2 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Negative | 45 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Small | 0 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Trace | 2 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Missing | 0 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Small | 0 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Small | 2 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Negative | 38 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Trace | 2 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Moderate | 1 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Missing | 0 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Negative | 30 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Trace | 1 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Large | 1 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Missing | 3 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Small | 0 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Negative | 38 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Moderate | 0 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Trace | 1 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Negative | 39 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Large | 1 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Missing | 2 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Trace | 1 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Missing | 1 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Small | 0 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Small | 1 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Negative | 43 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Trace | 2 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Missing | 1 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Moderate | 0 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Small | 1 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Large | 0 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Trace | 2 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Missing | 1 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Small | 1 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Negative | 39 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Small | 0 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Missing | 0 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Negative | 43 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Trace | 0 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Negative | 43 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Missing | 2 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Large | 0 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Small | 0 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Moderate | 0 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Trace | 0 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Trace | 1 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Trace | 1 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Small | 0 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Missing | 3 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Missing | 2 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Moderate | 0 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Small | 1 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 0: Negative | 45 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Negative | 44 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) | Week 12: Large | 0 Participants |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones)
Change from baseline in urine-ketone was measured in terms of number of subjects in each category (negative, positive, \>=55 mmol/L and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).
Time frame: Week 0, week 12
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Missing | 1 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Missing | 0 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Positive | 0 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Negative | 45 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Positive | 1 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Negative | 43 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Missing | 1 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Positive | 1 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Positive | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Negative | 44 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Missing | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Negative | 47 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Missing | 0 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Positive | 4 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Missing | 2 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Negative | 35 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Negative | 39 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Positive | 4 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Positive | 2 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Negative | 46 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Missing | 0 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Negative | 44 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Positive | 0 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Missing | 1 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Negative | 41 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Positive | 0 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Missing | 0 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Negative | 34 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Missing | 3 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Positive | 0 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Negative | 40 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Negative | 41 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Positive | 0 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Missing | 1 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Missing | 2 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Positive | 0 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Missing | 1 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Positive | 1 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Missing | 1 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Negative | 38 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Positive | 4 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Negative | 45 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Positive | 2 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Negative | 41 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Missing | 2 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Positive | 1 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Missing | 0 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Negative | 42 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Missing | 2 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Positive | 2 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Negative | 46 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 12: Negative | 43 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Missing | 3 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) | Week 0: Positive | 1 Participants |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)
Change from baseline in urine-pH was measured in terms of number of subjects in each category (pH=6.0, 6.5, 7.0, 7.5, 8.0, \>=8.5 and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).
Time frame: Week 0, week 12
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 7.5 | 4 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 6.0 | 11 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 8.0 | 0 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 7.0 | 15 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 7.0 | 11 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: Missing | 0 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 7.5 | 3 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 8.0 | 0 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: >=8.5 | 1 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 6.5 | 13 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: Missing | 1 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 6.5 | 15 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 6.0 | 16 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: >=8.5 | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 6.5 | 18 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: >=8.5 | 1 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: Missing | 1 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: >=8.5 | 1 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: Missing | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 8.0 | 1 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 7.0 | 12 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 6.0 | 13 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 7.5 | 2 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 7.0 | 13 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 7.5 | 3 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 6.5 | 14 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 6.0 | 14 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 8.0 | 0 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 8.0 | 1 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 7.5 | 0 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 6.0 | 19 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 6.5 | 9 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: Missing | 2 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 6.5 | 15 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 6.0 | 19 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: >=8.5 | 0 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: >=8.5 | 0 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 7.0 | 8 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 7.0 | 6 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: Missing | 0 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 7.5 | 4 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 8.0 | 1 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 7.5 | 5 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 6.0 | 11 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 6.5 | 21 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 7.0 | 10 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 8.0 | 1 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: >=8.5 | 0 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: Missing | 0 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 6.0 | 9 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 6.5 | 14 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 7.0 | 11 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 7.5 | 7 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 8.0 | 2 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: >=8.5 | 1 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: Missing | 1 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: Missing | 3 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 7.0 | 11 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 7.0 | 12 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: >=8.5 | 0 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 8.0 | 0 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: >=8.5 | 1 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 6.0 | 10 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 6.0 | 10 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: Missing | 1 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 6.5 | 13 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 7.5 | 5 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 8.0 | 2 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 6.5 | 7 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 7.5 | 3 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 6.5 | 13 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 8.0 | 1 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 7.0 | 15 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: >=8.5 | 1 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 8.0 | 0 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 7.0 | 8 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 7.5 | 8 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 7.5 | 5 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: >=8.5 | 1 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 6.0 | 11 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: Missing | 1 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 6.5 | 10 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 6.0 | 8 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: Missing | 2 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 7.5 | 7 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: Missing | 1 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 6.0 | 13 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 6.5 | 11 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 7.0 | 12 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 7.0 | 10 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 7.5 | 5 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 6.5 | 10 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: Missing | 1 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 8.0 | 1 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: >=8.5 | 2 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 6.0 | 14 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: >=8.5 | 0 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 8.0 | 3 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 7.5 | 4 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 6.5 | 16 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 6.5 | 13 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: Missing | 2 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: Missing | 0 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 8.0 | 2 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 8.0 | 0 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 6.0 | 9 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 6.0 | 8 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 7.5 | 3 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: >=8.5 | 0 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: >=8.5 | 1 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 7.0 | 16 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 7.0 | 14 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 7.5 | 3 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 7.5 | 2 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: Missing | 3 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 7.0 | 19 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 6.5 | 14 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: >=8.5 | 1 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 6.0 | 10 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 8.0 | 1 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 7.0 | 15 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: 8.0 | 2 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: >=8.5 | 2 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 6.0 | 12 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 0: 6.5 | 11 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) | Week 12: Missing | 2 Participants |
Secondary
Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)
Change from baseline in urine-protein was measured in terms of number of subjects in each category at week 0 (negative, 0.3 g/L, 1.0 g/L and missing) and week 12 (negative, trace, 0.3 g/L, 1.0 g/L, \>=3.0 g/L and missing). i.e., change in each category in terms of number of subjects from week 0 to week 12.
Time frame: Week 0, week 12
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: Negative | 45 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: 1.0 | 0 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: >=3.0 | 0 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Missing | 0 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Trace | 0 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: 1.0 | 0 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Negative | 40 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: 0.3 | 0 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: 0.3 | 4 Participants |
| Placebo | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: Missing | 1 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: 1.0 | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: Missing | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: 0.3 | 2 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: 1.0 | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: Negative | 47 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Trace | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Missing | 1 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Negative | 43 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: >=3.0 | 0 Participants |
| Semaglutide 0.1 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: 0.3 | 0 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: >=3.0 | 0 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: 1.0 | 1 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Negative | 35 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: Negative | 41 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: Missing | 0 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: 0.3 | 2 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: 0.3 | 3 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Missing | 2 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Trace | 0 Participants |
| Semaglutide 0.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: 1.0 | 0 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Missing | 1 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Trace | 0 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: Negative | 44 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: >=3.0 | 0 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: 0.3 | 4 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: 1.0 | 0 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: 1.0 | 0 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: Missing | 0 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: 0.3 | 3 Participants |
| Semaglutide 0.4 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Negative | 41 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: 1.0 | 0 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: 0.3 | 3 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Negative | 31 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Missing | 3 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: 0.3 | 2 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: Negative | 39 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: >=3.0 | 0 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: 1.0 | 0 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Trace | 0 Participants |
| Semaglutide 0.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: Missing | 0 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: 0.3 | 3 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Missing | 1 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: Negative | 40 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: 0.3 | 0 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: 1.0 | 1 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: Missing | 2 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Negative | 36 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Trace | 0 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: 1.0 | 1 Participants |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: >=3.0 | 0 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: Negative | 46 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: 0.3 | 0 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Trace | 1 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: 1.0 | 0 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: 1.0 | 0 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: Missing | 1 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Missing | 1 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Negative | 39 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: 0.3 | 2 Participants |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: >=3.0 | 0 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: 0.3 | 2 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Negative | 40 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: Missing | 2 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: >=3.0 | 1 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: 0.3 | 1 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: 1.0 | 0 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Trace | 0 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: 1.0 | 1 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: Negative | 41 Participants |
| Liraglutide 1.2 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Missing | 0 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: 1.0 | 1 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: Negative | 45 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Trace | 0 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: 0.3 | 3 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Missing | 2 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: >=3.0 | 0 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: Missing | 3 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 0: 0.3 | 1 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: Negative | 41 Participants |
| Liraglutide 1.8 mg | Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) | Week 12: 1.0 | 1 Participants |
Secondary
Change From Baseline in Vital Signs (Blood Pressure; DBP)
Change from baseline in diastolic blood pressure (DBP) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Vital Signs (Blood Pressure; DBP) | -2.3 mmHg | Standard Deviation 9.8 |
| Semaglutide 0.1 mg | Change From Baseline in Vital Signs (Blood Pressure; DBP) | 1.5 mmHg | Standard Deviation 7.9 |
| Semaglutide 0.2 mg | Change From Baseline in Vital Signs (Blood Pressure; DBP) | -0.4 mmHg | Standard Deviation 8.5 |
| Semaglutide 0.4 mg | Change From Baseline in Vital Signs (Blood Pressure; DBP) | -1.5 mmHg | Standard Deviation 9.7 |
| Semaglutide 0.8 mg | Change From Baseline in Vital Signs (Blood Pressure; DBP) | -1.5 mmHg | Standard Deviation 7.9 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Vital Signs (Blood Pressure; DBP) | -2.3 mmHg | Standard Deviation 9.7 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Vital Signs (Blood Pressure; DBP) | -3.0 mmHg | Standard Deviation 7.7 |
| Liraglutide 1.2 mg | Change From Baseline in Vital Signs (Blood Pressure; DBP) | -2.1 mmHg | Standard Deviation 10 |
| Liraglutide 1.8 mg | Change From Baseline in Vital Signs (Blood Pressure; DBP) | -0.0 mmHg | Standard Deviation 8.8 |
Secondary
Change From Baseline in Vital Signs (Blood Pressure; SBP)
Change from baseline in systolic blood pressure (SBP) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Vital Signs (Blood Pressure; SBP) | -3.2 mmHg | Standard Deviation 14.8 |
| Semaglutide 0.1 mg | Change From Baseline in Vital Signs (Blood Pressure; SBP) | 3.3 mmHg | Standard Deviation 11 |
| Semaglutide 0.2 mg | Change From Baseline in Vital Signs (Blood Pressure; SBP) | -2.5 mmHg | Standard Deviation 14.1 |
| Semaglutide 0.4 mg | Change From Baseline in Vital Signs (Blood Pressure; SBP) | -3.6 mmHg | Standard Deviation 13.1 |
| Semaglutide 0.8 mg | Change From Baseline in Vital Signs (Blood Pressure; SBP) | -6.7 mmHg | Standard Deviation 14.9 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Vital Signs (Blood Pressure; SBP) | -7.7 mmHg | Standard Deviation 13 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Vital Signs (Blood Pressure; SBP) | -5.9 mmHg | Standard Deviation 11.6 |
| Liraglutide 1.2 mg | Change From Baseline in Vital Signs (Blood Pressure; SBP) | -2.9 mmHg | Standard Deviation 12 |
| Liraglutide 1.8 mg | Change From Baseline in Vital Signs (Blood Pressure; SBP) | -5.4 mmHg | Standard Deviation 14 |
Secondary
Change From Baseline in Vital Signs (Pulse)
Change from baseline in pulse was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.
Time frame: Week 0, week 12
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Vital Signs (Pulse) | 0.5 Beats/minute | Standard Deviation 8.9 |
| Semaglutide 0.1 mg | Change From Baseline in Vital Signs (Pulse) | -0.0 Beats/minute | Standard Deviation 7.6 |
| Semaglutide 0.2 mg | Change From Baseline in Vital Signs (Pulse) | 0.5 Beats/minute | Standard Deviation 13.8 |
| Semaglutide 0.4 mg | Change From Baseline in Vital Signs (Pulse) | 1.5 Beats/minute | Standard Deviation 8.5 |
| Semaglutide 0.8 mg | Change From Baseline in Vital Signs (Pulse) | 1.5 Beats/minute | Standard Deviation 9.6 |
| Semaglutide 0.8 mg (With Titration) | Change From Baseline in Vital Signs (Pulse) | 2.9 Beats/minute | Standard Deviation 11.9 |
| Semaglutide 1.6 mg (With Titration) | Change From Baseline in Vital Signs (Pulse) | 3.9 Beats/minute | Standard Deviation 12.6 |
| Liraglutide 1.2 mg | Change From Baseline in Vital Signs (Pulse) | 4.4 Beats/minute | Standard Deviation 10.2 |
| Liraglutide 1.8 mg | Change From Baseline in Vital Signs (Pulse) | 2.1 Beats/minute | Standard Deviation 10.1 |
Secondary
Percentage of Subjects Developing Anti-semaglutide Antibodies
Antibodies were measured after 12-week of treatment at week 17; percentage of participants with positive anti-semaglutide antibodies are presented here. Assessments of antibodies were not done for subjects allocated to the open-label liraglutide treatment arms.
Time frame: After 12 weeks of treatment
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Subjects Developing Anti-semaglutide Antibodies | 0 Percentage (%) of participants |
| Semaglutide 0.1 mg | Percentage of Subjects Developing Anti-semaglutide Antibodies | 0 Percentage (%) of participants |
| Semaglutide 0.2 mg | Percentage of Subjects Developing Anti-semaglutide Antibodies | 0 Percentage (%) of participants |
| Semaglutide 0.4 mg | Percentage of Subjects Developing Anti-semaglutide Antibodies | 0 Percentage (%) of participants |
| Semaglutide 0.8 mg | Percentage of Subjects Developing Anti-semaglutide Antibodies | 0 Percentage (%) of participants |
| Semaglutide 0.8 mg (With Titration) | Percentage of Subjects Developing Anti-semaglutide Antibodies | 0 Percentage (%) of participants |
| Semaglutide 1.6 mg (With Titration) | Percentage of Subjects Developing Anti-semaglutide Antibodies | 3 Percentage (%) of participants |
Secondary
Percentage of Subjects With an Adverse Events
The results of adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.
Time frame: After 12 weeks of treatment.
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Subjects With an Adverse Events | 43.5 Percentage (%) of subjects |
| Semaglutide 0.1 mg | Percentage of Subjects With an Adverse Events | 59.6 Percentage (%) of subjects |
| Semaglutide 0.2 mg | Percentage of Subjects With an Adverse Events | 55.8 Percentage (%) of subjects |
| Semaglutide 0.4 mg | Percentage of Subjects With an Adverse Events | 72.9 Percentage (%) of subjects |
| Semaglutide 0.8 mg | Percentage of Subjects With an Adverse Events | 85.7 Percentage (%) of subjects |
| Semaglutide 0.8 mg (With Titration) | Percentage of Subjects With an Adverse Events | 72.1 Percentage (%) of subjects |
| Semaglutide 1.6 mg (With Titration) | Percentage of Subjects With an Adverse Events | 93.6 Percentage (%) of subjects |
| Liraglutide 1.2 mg | Percentage of Subjects With an Adverse Events | 55.6 Percentage (%) of subjects |
| Liraglutide 1.8 mg | Percentage of Subjects With an Adverse Events | 62.0 Percentage (%) of subjects |
Secondary
Percentage of Subjects With Hypoglycaemic Episode
The results of hypoglycaemic episode presented here are treatment emergent. Hypoglycaemic episodes were defined as treatment emergent if they had onset on or after the first day of randomised treatment (in week 0) and no later than 5 weeks after the last date on trial product (week 17). Hypoglycaemic episodes are classified as follows: Major: If the subject was not able to treat himself or herself and was needed to be administered food, glucagon or intravenous (i.v.) glucose by another person. Minor: If the subject was able to treat himself or herself and measured plasma glucose was \<3.1 mmol/L (56 mg/dL). Symptoms only: If the subject was able to treat himself or herself and measured plasma glucose was \>=3.1 mmol/L (56 mg/dL) or no plasma glucose measurement was done.
Time frame: After 12 weeks of treatment
Population: The safety analysis set included all randomised subjects who were exposed to at least 1 dose of trial product. 2 subjects randomised to semaglutide 0.8mg were mistakenly titrated, so actual treatment was semaglutide 0.8mg T. 2 subjects randomised to semaglutide 0.8mg T were mistakenly titrated to 1.6mg T, so actual treatment was semaglutide 1.6mg T
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Subjects With Hypoglycaemic Episode | Major | 0 Percentage (%) of subjects |
| Placebo | Percentage of Subjects With Hypoglycaemic Episode | Symptoms only | 2.2 Percentage (%) of subjects |
| Placebo | Percentage of Subjects With Hypoglycaemic Episode | Minor | 0 Percentage (%) of subjects |
| Semaglutide 0.1 mg | Percentage of Subjects With Hypoglycaemic Episode | Symptoms only | 2.1 Percentage (%) of subjects |
| Semaglutide 0.1 mg | Percentage of Subjects With Hypoglycaemic Episode | Minor | 4.3 Percentage (%) of subjects |
| Semaglutide 0.1 mg | Percentage of Subjects With Hypoglycaemic Episode | Major | 0 Percentage (%) of subjects |
| Semaglutide 0.2 mg | Percentage of Subjects With Hypoglycaemic Episode | Minor | 0 Percentage (%) of subjects |
| Semaglutide 0.2 mg | Percentage of Subjects With Hypoglycaemic Episode | Major | 0 Percentage (%) of subjects |
| Semaglutide 0.2 mg | Percentage of Subjects With Hypoglycaemic Episode | Symptoms only | 2.3 Percentage (%) of subjects |
| Semaglutide 0.4 mg | Percentage of Subjects With Hypoglycaemic Episode | Symptoms only | 0 Percentage (%) of subjects |
| Semaglutide 0.4 mg | Percentage of Subjects With Hypoglycaemic Episode | Major | 0 Percentage (%) of subjects |
| Semaglutide 0.4 mg | Percentage of Subjects With Hypoglycaemic Episode | Minor | 4.2 Percentage (%) of subjects |
| Semaglutide 0.8 mg | Percentage of Subjects With Hypoglycaemic Episode | Minor | 0 Percentage (%) of subjects |
| Semaglutide 0.8 mg | Percentage of Subjects With Hypoglycaemic Episode | Major | 0 Percentage (%) of subjects |
| Semaglutide 0.8 mg | Percentage of Subjects With Hypoglycaemic Episode | Symptoms only | 0 Percentage (%) of subjects |
| Semaglutide 0.8 mg (With Titration) | Percentage of Subjects With Hypoglycaemic Episode | Minor | 2.3 Percentage (%) of subjects |
| Semaglutide 0.8 mg (With Titration) | Percentage of Subjects With Hypoglycaemic Episode | Major | 0 Percentage (%) of subjects |
| Semaglutide 0.8 mg (With Titration) | Percentage of Subjects With Hypoglycaemic Episode | Symptoms only | 0 Percentage (%) of subjects |
| Semaglutide 1.6 mg (With Titration) | Percentage of Subjects With Hypoglycaemic Episode | Symptoms only | 6.4 Percentage (%) of subjects |
| Semaglutide 1.6 mg (With Titration) | Percentage of Subjects With Hypoglycaemic Episode | Major | 0 Percentage (%) of subjects |
| Semaglutide 1.6 mg (With Titration) | Percentage of Subjects With Hypoglycaemic Episode | Minor | 0 Percentage (%) of subjects |
| Liraglutide 1.2 mg | Percentage of Subjects With Hypoglycaemic Episode | Minor | 4.4 Percentage (%) of subjects |
| Liraglutide 1.2 mg | Percentage of Subjects With Hypoglycaemic Episode | Symptoms only | 8.9 Percentage (%) of subjects |
| Liraglutide 1.2 mg | Percentage of Subjects With Hypoglycaemic Episode | Major | 0 Percentage (%) of subjects |
| Liraglutide 1.8 mg | Percentage of Subjects With Hypoglycaemic Episode | Minor | 2.0 Percentage (%) of subjects |
| Liraglutide 1.8 mg | Percentage of Subjects With Hypoglycaemic Episode | Symptoms only | 2.0 Percentage (%) of subjects |
| Liraglutide 1.8 mg | Percentage of Subjects With Hypoglycaemic Episode | Major | 0 Percentage (%) of subjects |