Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. Subjects will remain on their pre-trial medication.
Interventions
DRUGSemaglutide
Semaglutide, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks
DRUGPlacebo
Semaglutide placebo, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Male or female, above or equal to 18 years at the time of signing informed consent. For Japan only: Male or female, age equal to or above 20 years at the time of signing informed consent * Diagnosed with type 2 diabetes mellitus * HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive) * Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed-dose drug combination) with a stable dose of metformin (equal to or above 1500 mg or maximum tolerated dose) or a SU for at least 90 days prior to the day of screening. All medications in compliance with current local label
Exclusion criteria
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) * Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed * Subjects with alanine aminotransferase above 2.5 x upper normal limit * Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative * History or presence of pancreatitis (acute or chronic) * History of diabetic ketoacidosis * Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening * Subjects presently classified as being in New York Heart Association Class IV * Planned coronary, carotid or peripheral artery revascularisation known on the day of screening * Renal impairment measured as estimated Glomerular Filtration Rate value of eGFR below 60 ml/min/1.73 m\^2 as defined by KDIGO 2012 classification using isotope dilution mass spectrometry for serum creatinine measured at screening * Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation * Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Week 0, week 30 | Change from baseline (week 0) in HbA1c was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: 1) the last dose of trial product + 7 days or 2) initiation of rescue medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight (kg) | Week 0, week 30 | Change from baseline (week 0) in body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. |
| Change in Fasting Plasma Glucose (FPG) | Week 0, week 30 | Change from baseline (week 0) in FPG was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. |
| Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean 7-point Profile | Week 0, week 30 | Change from baseline (week 0) in mean of the SMPG, 7-point profile was evaluated at week 30. Mean 7-point profile (the area under the profile) was calculated using the trapezoidal method and divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period. Participants measured their plasma glucose at 7 different time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. |
| Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean Post Prandial Increment (Over All Meals) | Week 0, week 30 | Change from baseline (week 0) in mean post prandial increment (over all meals) in the SMPG, 7-point profile was evaluated at week 30. The mean increment over all meals was derived as the mean of all available meal increments. Results are based on the 'on-treatment without rescue medication' observation period. |
| Change in Fasting Blood Lipid, Total Cholesterol | Week 0, week 30 | Change from baseline (week 0) in total cholesterol (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. |
| Change in Fasting Blood Lipid, Low-density Lipoprotein (LDL) Cholesterol | Week 0, week 30 | Change from baseline (week 0) in LDL (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. |
| Change in Fasting Blood Lipid, High-density Lipoprotein (HDL) Cholesterol | Week 0, week 30 | Change from baseline (week 0) in HDL (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. |
| Change in Fasting Blood Lipid, Triglycerides | Week 0, week 30 | Change from baseline (week 0) in triglycerides (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. |
| Change in Body Weight (%) | Week 0, week 30 | Percent (%) change from baseline (week 0) in body weight (measured in kilogram (kg)) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. |
| Change in Body Mass Index | Week 0, week 30 | Change from baseline (week 0) in body mass index (BMI) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. BMI was calculated as 'body weight in kg/(height in meters) x (height in meters)'. |
| Change in Waist Circumference | Week 0, week 30 | Change from baseline (week 0) in waist circumference was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. |
| Change in Systolic Blood Pressure | Week 0, week 30 | Change from baseline (week 0) in systolic blood pressure was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. |
| Change in Diastolic Blood Pressure | Week 0, week 30 | Change from baseline (week 0) in diastolic blood pressure was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. |
| Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Week 0, week 30 | Change from baseline (week 0) in patient reported outcome (PRO) questionnaire, SF-36v2TM was evaluated at week 30. The SF-36v2™ questionnaire was used to assess the overall health related quality of life of participants. This questionnaire contains 36 items and measures the individual overall health related quality of life on 8 domains: 1) Physical functioning, 2) Role functioning, 3) Bodily pain, 4) General health, 5) Vitality, 6) Social functioning, 7) Role emotional and 8) Mental health. Each item is scored on a scale from 1 to either 2, 3, 5, or 6; each item score is then converted to a scale of 0-100, representing the percentage of total possible score achieved and with higher scores indicating a higher health status; items on the same scale are then averaged to obtain the 8 scale scores. Physical component summary (PCS) includes domains 1-4 and mental component summary (MCS) includes domains 5-8. Higher PCS and MCS scores on a scale of 0-100 indicate a higher health status. |
| Change in Biochemistry: Amylase | Week 0, week 30 | Change from baseline (week 0) in amylase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Biochemistry: Lipase | Week 0, week 30 | Change from baseline (week 0) in lipase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately | Week 0, week 30 | Change from baseline (week 0) in PRO questionnaire, DTSQ was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. The DTSQ measures satisfaction with diabetes treatment. The DTSQ consists of 8 items evaluating 6 aspects of treatment satisfaction and 2 perceived recent event rates of hyperglycemia/hypoglycemia. Each item is scored on a 7- point Likert scale ranging from 0 (very dissatisfied) to 6 (very satisfied). Items evaluating 6 aspects (items 3-8) of treatment satisfaction are summed to produce a total treatment satisfaction score; DTSQ status total scores range from 0-36, with higher scores indicating greater satisfaction; the perceived frequency of hyperglycemia/hypoglycemia items are scored separately, with lower scores indicating better perceived blood glucose control. |
| HbA1c Below 7.0% (53 mmol/Mol) | After 30 weeks | Percentage of participants with HbA1c below 7.0% (53 mmol/mol) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. |
| HbA1c Equal to or Below 6.5% (48 mmol/Mol) | After 30 weeks | Percentage of participants with HbA1c equal to or below 6.5% (48 mmol/mol) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. |
| Weight Loss Equal to or Above 3% | After 30 weeks | Percentage of participants with weight loss equal to or above 3% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. |
| Weight Loss Equal to or Above 5% | After 30 weeks | Percentage of participants with weight loss equal to or above 5% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. |
| Weight Loss Equal to or Above 10% | After 30 weeks | Percentage of participants with weight loss equal to or above 10% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. |
| HbA1c Below 7.0% (53 mmol/Mol) Without Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain | After 30 weeks | Percentage of participants with HbA1c below 7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain from their baseline (week 0) body weight was evaluated at week 30. Severe or blood glucose (BG)-confirmed symptomatic hypoglycaemia: an episode that was severe according to the American Diabetes Association (ADA) classification or confirmed by a plasma glucose (PG) value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment without rescue medication' observation period. |
| HbA1c Reduction Equal to or Above 1%-Point | After 30 weeks | Percentage of participants with HbA1c reduction equal to or above 1%-point was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. |
| HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 3% | After 30 weeks | Percentage of participants with HbA1c reduction equal to or above 1%-point and weight loss equal to or above 3% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. |
| HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 5% | After 30 weeks | Percentage of participants with HbA1c reduction equal to or above 1%-point and weight loss equal to or above 5% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. |
| HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 10% | After 30 weeks | Percentage of participants with HbA1c reduction equal to or above 1%-point and weight loss equal to or above 10% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. |
| Number of Treatment-emergent Adverse Events (TEAEs) | Week 0 - week 30 | A TEAE was defined as an event that has onset date (or increase in severity) during the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 42 days. |
| Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | Week 0 - week 30 | Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 42 days. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or confirmed by a PG value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. |
| Change in Haematology: Haemoglobin | Week 0, week 30 | Change from baseline (week 0) in haemoglobin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Haematology: Haematocrit | Week 0, week 30 | Change from baseline (week 0) in haematocrit was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Haematology: Thrombocytes | Week 0, week 30 | Change from baseline (week 0) in thrombocytes was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Haematology: Erythrocytes | Week 0, week 30 | Change from baseline (week 0) in erythrocytes was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Biochemistry: Alkaline Phosphatase | Week 0, week 30 | Change from baseline (week 0) in alkaline phosphatase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Biochemistry: Alanine Aminotransferase | Week 0, week 30 | Change from baseline (week 0) in alanine aminotransferase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Biochemistry: Aspartate Aminotransferase | Week 0, week 30 | Change from baseline (week 0) in aspartate aminotransferase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Biochemistry: Total Bilirubin | Week 0, week 30 | Change from baseline (week 0) in total bilirubin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Biochemistry: Albumin | Week 0, week 30 | Change from baseline (week 0) in albumin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Biochemistry: Calcium (Total) | Week 0, week 30 | Change from baseline (week 0) in albumin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Biochemistry: Potassium | Week 0, week 30 | Change from baseline (week 0) in potassium was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Biochemistry: Sodium | Week 0, week 30 | Change from baseline (week 0) in sodium was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Biochemistry: Bicarbonate | Week 0, week 30 | Change from baseline (week 0) in bicarbonate was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Biochemistry: Estimated Glomerular Filtration Rate (eGFR) | Week 0, week 30 | Change from baseline (week 0) in eGFR was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Biochemistry: Creatinine | Week 0, week 30 | Change from baseline (week 0) in creatinine was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Calcitonin | Week 0, week 30 | Change from baseline (week 0) in calcitonin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Pulse | Week 0, week 30 | Change from baseline (week 0) in pulse rate was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Electrocardiogram | Week 0, week 30 | Electrocardiogram (ECG) results are presented for week 0 (baseline) and week 30. ECG finding are presented as percentage of participants with normal, abnormal non-clinically significant (NCS) and abnormal clinically significant (CS) ECG values. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 42 days. |
| Change in Physical Examination: General Appearance | Week -2, week 30 | Physical examination (general appearance) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Physical Examination: Central and Peripheral Nervous System | Week -2, week 30 | Physical examination (central and peripheral nervous system) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Haematology: Leucocytes | Week 0, week 30 | Change from baseline (week 0) in leucocytes was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Physical Examination: Gastrointestinal System Including Mouth | Week -2, week 30 | Physical examination (gastrointestinal system including mouth) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Physical Examination: Skin | Week -2, week 30 | Physical examination (skin) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Physical Examination: Respiratory System | Week -2, week 30 | Physical examination (respiratory system) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Physical Examination: Lymph Node Palpation | Week -2, week 30 | Physical examination (lymph node palpation) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Physical Examination: Thyroid Gland | Week -2, week 30 | Physical examination (thyroid gland) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Fundoscopy | Week 0, week 30 | Fundoscopy results for both left and right eyes are presented for week 0 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
| Change in Physical Examination: Cardiovascular System | Week -2, week 30 | Physical examination (cardiovascular system) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. |
Countries
Austria, Canada, Japan, Norway, Puerto Rico, Russia, United States
Participant flow
Recruitment details
The trial was conducted at 61 sites in 6 countries as follows: Austria (4 sites), Canada (8 sites), Japan (4 sites), Norway (4 sites), Russian Federation (5 sites), United States of America (USA) (36 sites). In addition, 1 site in Norway and 3 sites in the USA screened, but didn't randomise any participant.
Participants by arm
| Arm | Count |
|---|---|
| Semaglutide 1.0 mg Participants received semaglutide in a dose escalation manner for 30 weeks: 0.25 mg (weeks 1 to 4), 0.50 mg (weeks 5 to 8) and 1.0 mg (weeks 9 to 30). Semaglutide was taken once weekly as s.c. injections. | 151 |
| Placebo Participants received matching placebo (for semaglutide) in a dose escalation manner for 30 weeks. Placebo was taken once weekly as s.c. injections. Dose escalation for placebo matched that for semaglutide with regards to volume. | 151 |
| Total | 302 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Placebo | Total | Semaglutide 1.0 mg |
|---|---|---|---|
| Age, Continuous | 56.6 Years STANDARD_DEVIATION 10.1 | 57.0 Years STANDARD_DEVIATION 9.5 | 57.5 Years STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 22 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 138 Participants | 280 Participants | 142 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Glycosylated haemoglobin (HbA1c) | 8.1 Percentage HbA1c STANDARD_DEVIATION 0.8 | 8.0 Percentage HbA1c STANDARD_DEVIATION 0.8 | 8.0 Percentage HbA1c STANDARD_DEVIATION 0.8 |
| Race/Ethnicity, Customized American Indian or Alaska native | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 35 Participants | 71 Participants | 36 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 13 Participants | 9 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 7 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 109 Participants | 209 Participants | 100 Participants |
| Sex: Female, Male Female | 64 Participants | 126 Participants | 62 Participants |
| Sex: Female, Male Male | 87 Participants | 176 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 150 | 0 / 151 |
| other Total, other adverse events | 49 / 150 | 28 / 151 |
| serious Total, serious adverse events | 7 / 150 | 6 / 151 |
Outcome results
Primary
Change in HbA1c
Change from baseline (week 0) in HbA1c was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: 1) the last dose of trial product + 7 days or 2) initiation of rescue medication.
Time frame: Week 0, week 30
Population: Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in HbA1c | -1.6 Percentage of HbA1c | Standard Deviation 0.8 |
| Placebo | Change in HbA1c | -0.2 Percentage of HbA1c | Standard Deviation 0.9 |
Comparison: The responses were analysed using an analysis of covariance (ANCOVA) with treatment, stratification factor and region as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including stratification factor and region as categorical effects and data from baseline and all previous visits as covariates.p-value: <0.000195% CI: [-1.61, -1.24]ANCOVA
Secondary
Change in Biochemistry: Alanine Aminotransferase
Change from baseline (week 0) in alanine aminotransferase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Biochemistry: Alanine Aminotransferase | 4.5 U/L | Geometric Coefficient of Variation 123.2 |
| Placebo | Change in Biochemistry: Alanine Aminotransferase | 4.8 U/L | Geometric Coefficient of Variation 166.7 |
Secondary
Change in Biochemistry: Albumin
Change from baseline (week 0) in albumin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Biochemistry: Albumin | 0.1 g/dL | Geometric Coefficient of Variation 45.4 |
| Placebo | Change in Biochemistry: Albumin | 0.1 g/dL | Geometric Coefficient of Variation 48.6 |
Secondary
Change in Biochemistry: Alkaline Phosphatase
Change from baseline (week 0) in alkaline phosphatase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Biochemistry: Alkaline Phosphatase | 4.6 U/L | Geometric Coefficient of Variation 171.2 |
| Placebo | Change in Biochemistry: Alkaline Phosphatase | 7.2 U/L | Geometric Coefficient of Variation 106.7 |
Secondary
Change in Biochemistry: Amylase
Change from baseline (week 0) in amylase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Biochemistry: Amylase | 10.2 U/L | Geometric Coefficient of Variation 113.8 |
| Placebo | Change in Biochemistry: Amylase | 5.0 U/L | Geometric Coefficient of Variation 121.7 |
Secondary
Change in Biochemistry: Aspartate Aminotransferase
Change from baseline (week 0) in aspartate aminotransferase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Biochemistry: Aspartate Aminotransferase | 3.4 U/L | Geometric Coefficient of Variation 112.3 |
| Placebo | Change in Biochemistry: Aspartate Aminotransferase | 3.5 U/L | Geometric Coefficient of Variation 90.1 |
Secondary
Change in Biochemistry: Bicarbonate
Change from baseline (week 0) in bicarbonate was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Biochemistry: Bicarbonate | 2.2 mmol/L | Geometric Coefficient of Variation 67.6 |
| Placebo | Change in Biochemistry: Bicarbonate | 2.1 mmol/L | Geometric Coefficient of Variation 69 |
Secondary
Change in Biochemistry: Calcium (Total)
Change from baseline (week 0) in albumin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Biochemistry: Calcium (Total) | 0.04 mmol/L | Geometric Coefficient of Variation 125 |
| Placebo | Change in Biochemistry: Calcium (Total) | 0.05 mmol/L | Geometric Coefficient of Variation 88.9 |
Secondary
Change in Biochemistry: Creatinine
Change from baseline (week 0) in creatinine was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Biochemistry: Creatinine | 4.6 umol/L | Geometric Coefficient of Variation 118.8 |
| Placebo | Change in Biochemistry: Creatinine | 2.6 umol/L | Geometric Coefficient of Variation 191.5 |
Secondary
Change in Biochemistry: Estimated Glomerular Filtration Rate (eGFR)
Change from baseline (week 0) in eGFR was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Biochemistry: Estimated Glomerular Filtration Rate (eGFR) | 3.4 mL/min/1.73m2 | Geometric Coefficient of Variation 114.8 |
| Placebo | Change in Biochemistry: Estimated Glomerular Filtration Rate (eGFR) | 3.2 mL/min/1.73m2 | Geometric Coefficient of Variation 105.6 |
Secondary
Change in Biochemistry: Lipase
Change from baseline (week 0) in lipase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Biochemistry: Lipase | 11.6 U/L | Geometric Coefficient of Variation 140.2 |
| Placebo | Change in Biochemistry: Lipase | 4.5 U/L | Geometric Coefficient of Variation 171.8 |
Secondary
Change in Biochemistry: Potassium
Change from baseline (week 0) in potassium was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Biochemistry: Potassium | 0.3 mmol/L | Geometric Coefficient of Variation 89.5 |
| Placebo | Change in Biochemistry: Potassium | 0.2 mmol/L | Geometric Coefficient of Variation 73.7 |
Secondary
Change in Biochemistry: Sodium
Change from baseline (week 0) in sodium was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Biochemistry: Sodium | 1.7 mmol/L | Geometric Coefficient of Variation 55.8 |
| Placebo | Change in Biochemistry: Sodium | 1.5 mmol/L | Geometric Coefficient of Variation 48.4 |
Secondary
Change in Biochemistry: Total Bilirubin
Change from baseline (week 0) in total bilirubin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Biochemistry: Total Bilirubin | 2.3 umol/L | Geometric Coefficient of Variation 128.1 |
| Placebo | Change in Biochemistry: Total Bilirubin | 1.7 umol/L | Geometric Coefficient of Variation 134.8 |
Secondary
Change in Body Mass Index
Change from baseline (week 0) in body mass index (BMI) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. BMI was calculated as 'body weight in kg/(height in meters) x (height in meters)'.
Time frame: Week 0, week 30
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Body Mass Index | -1.7 Kg/sqm | Standard Deviation 1.5 |
| Placebo | Change in Body Mass Index | -0.4 Kg/sqm | Standard Deviation 1.1 |
Secondary
Change in Body Weight (%)
Percent (%) change from baseline (week 0) in body weight (measured in kilogram (kg)) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: Week 0, week 30
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Body Weight (%) | -5.4 Percentage | Standard Deviation 4.8 |
| Placebo | Change in Body Weight (%) | -1.0 Percentage | Standard Deviation 3.1 |
Secondary
Change in Body Weight (kg)
Change from baseline (week 0) in body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: Week 0, week 30
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Body Weight (kg) | -4.7 Kg | Standard Deviation 4.3 |
| Placebo | Change in Body Weight (kg) | -1.0 Kg | Standard Deviation 3.1 |
Comparison: The responses were analysed using an ANCOVA with treatment, stratification factor and region as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including stratification factor and region as categorical effects and data from baseline and all previous visits as covariates.p-value: <0.000195% CI: [-4.7, -2.93]ANCOVA
Secondary
Change in Calcitonin
Change from baseline (week 0) in calcitonin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Calcitonin | 1.3 ng/L | Geometric Coefficient of Variation 172.1 |
| Placebo | Change in Calcitonin | 1.7 ng/L | Geometric Coefficient of Variation 171.1 |
Secondary
Change in Diastolic Blood Pressure
Change from baseline (week 0) in diastolic blood pressure was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: Week 0, week 30
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Diastolic Blood Pressure | -0.1 mmHg | Standard Deviation 8.1 |
| Placebo | Change in Diastolic Blood Pressure | -0.1 mmHg | Standard Deviation 6.7 |
Secondary
Change in Electrocardiogram
Electrocardiogram (ECG) results are presented for week 0 (baseline) and week 30. ECG finding are presented as percentage of participants with normal, abnormal non-clinically significant (NCS) and abnormal clinically significant (CS) ECG values. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 42 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Electrocardiogram | Week 0: Normal | 62.4 Percentage of participants |
| Semaglutide 1.0 mg | Change in Electrocardiogram | Week 0: Abnormal, NCS | 36.9 Percentage of participants |
| Semaglutide 1.0 mg | Change in Electrocardiogram | Week 0: Abnormal, CS | 0.7 Percentage of participants |
| Semaglutide 1.0 mg | Change in Electrocardiogram | Week 30: Normal | 64.3 Percentage of participants |
| Semaglutide 1.0 mg | Change in Electrocardiogram | Week 30: Abnormal, NCS | 34.9 Percentage of participants |
| Semaglutide 1.0 mg | Change in Electrocardiogram | Week 30: Abnormal, CS | 0.8 Percentage of participants |
| Placebo | Change in Electrocardiogram | Week 30: Abnormal, NCS | 32.2 Percentage of participants |
| Placebo | Change in Electrocardiogram | Week 0: Normal | 66.2 Percentage of participants |
| Placebo | Change in Electrocardiogram | Week 30: Normal | 66.4 Percentage of participants |
| Placebo | Change in Electrocardiogram | Week 0: Abnormal, NCS | 32.5 Percentage of participants |
| Placebo | Change in Electrocardiogram | Week 30: Abnormal, CS | 1.4 Percentage of participants |
| Placebo | Change in Electrocardiogram | Week 0: Abnormal, CS | 1.3 Percentage of participants |
Secondary
Change in Fasting Blood Lipid, High-density Lipoprotein (HDL) Cholesterol
Change from baseline (week 0) in HDL (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: Week 0, week 30
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Fasting Blood Lipid, High-density Lipoprotein (HDL) Cholesterol | 0.99 Ratio | Geometric Coefficient of Variation 15.8 |
| Placebo | Change in Fasting Blood Lipid, High-density Lipoprotein (HDL) Cholesterol | 1.01 Ratio | Geometric Coefficient of Variation 13.9 |
Secondary
Change in Fasting Blood Lipid, Low-density Lipoprotein (LDL) Cholesterol
Change from baseline (week 0) in LDL (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: Week 0, week 30
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Fasting Blood Lipid, Low-density Lipoprotein (LDL) Cholesterol | 0.90 Ratio | Geometric Coefficient of Variation 31.6 |
| Placebo | Change in Fasting Blood Lipid, Low-density Lipoprotein (LDL) Cholesterol | 1.04 Ratio | Geometric Coefficient of Variation 27.7 |
Secondary
Change in Fasting Blood Lipid, Total Cholesterol
Change from baseline (week 0) in total cholesterol (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: Week 0, week 30
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Fasting Blood Lipid, Total Cholesterol | 0.91 Ratio | Geometric Coefficient of Variation 19.4 |
| Placebo | Change in Fasting Blood Lipid, Total Cholesterol | 1.02 Ratio | Geometric Coefficient of Variation 18.9 |
Secondary
Change in Fasting Blood Lipid, Triglycerides
Change from baseline (week 0) in triglycerides (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: Week 0, week 30
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Fasting Blood Lipid, Triglycerides | 0.81 Ratio | Geometric Coefficient of Variation 41.3 |
| Placebo | Change in Fasting Blood Lipid, Triglycerides | 0.97 Ratio | Geometric Coefficient of Variation 38.7 |
Secondary
Change in Fasting Plasma Glucose (FPG)
Change from baseline (week 0) in FPG was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: Week 0, week 30
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Fasting Plasma Glucose (FPG) | -2.26 mmol/L | Standard Deviation 2.05 |
| Placebo | Change in Fasting Plasma Glucose (FPG) | 0.07 mmol/L | Standard Deviation 2.07 |
Secondary
Change in Fundoscopy
Fundoscopy results for both left and right eyes are presented for week 0 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Fundoscopy | Left eye: Week 0; abnormal, NCS | 24.7 Percentage of participants |
| Semaglutide 1.0 mg | Change in Fundoscopy | Left eye: Week 30; normal | 79.3 Percentage of participants |
| Semaglutide 1.0 mg | Change in Fundoscopy | Right eye: Week 0; abnormal, NCS | 25.3 Percentage of participants |
| Semaglutide 1.0 mg | Change in Fundoscopy | Left eye: Week 0; normal | 70.7 Percentage of participants |
| Semaglutide 1.0 mg | Change in Fundoscopy | Right eye: Week 0; abnormal, CS | 5.3 Percentage of participants |
| Semaglutide 1.0 mg | Change in Fundoscopy | Left eye: Week 30; abnormal, NCS | 17.1 Percentage of participants |
| Semaglutide 1.0 mg | Change in Fundoscopy | Right eye: Week 30; normal | 75.6 Percentage of participants |
| Semaglutide 1.0 mg | Change in Fundoscopy | Left eye: Week 0; abnormal, CS | 4.7 Percentage of participants |
| Semaglutide 1.0 mg | Change in Fundoscopy | Right eye: Week 30; abnormal, NCS | 19.5 Percentage of participants |
| Semaglutide 1.0 mg | Change in Fundoscopy | Left eye: Week 30; abnormal, CS | 3.7 Percentage of participants |
| Semaglutide 1.0 mg | Change in Fundoscopy | Right eye: Week 30; abnormal, CS | 4.9 Percentage of participants |
| Semaglutide 1.0 mg | Change in Fundoscopy | Right eye: Week 0; normal | 69.3 Percentage of participants |
| Placebo | Change in Fundoscopy | Right eye: Week 30; abnormal, CS | 4.4 Percentage of participants |
| Placebo | Change in Fundoscopy | Left eye: Week 0; normal | 62.0 Percentage of participants |
| Placebo | Change in Fundoscopy | Left eye: Week 0; abnormal, NCS | 32.7 Percentage of participants |
| Placebo | Change in Fundoscopy | Left eye: Week 0; abnormal, CS | 5.3 Percentage of participants |
| Placebo | Change in Fundoscopy | Left eye: Week 30; normal | 64.1 Percentage of participants |
| Placebo | Change in Fundoscopy | Left eye: Week 30; abnormal, NCS | 31.5 Percentage of participants |
| Placebo | Change in Fundoscopy | Left eye: Week 30; abnormal, CS | 4.3 Percentage of participants |
| Placebo | Change in Fundoscopy | Right eye: Week 0; normal | 62.4 Percentage of participants |
| Placebo | Change in Fundoscopy | Right eye: Week 0; abnormal, NCS | 30.9 Percentage of participants |
| Placebo | Change in Fundoscopy | Right eye: Week 0; abnormal, CS | 6.7 Percentage of participants |
| Placebo | Change in Fundoscopy | Right eye: Week 30; normal | 63.7 Percentage of participants |
| Placebo | Change in Fundoscopy | Right eye: Week 30; abnormal, NCS | 31.9 Percentage of participants |
Secondary
Change in Haematology: Erythrocytes
Change from baseline (week 0) in erythrocytes was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Haematology: Erythrocytes | 0.16 10^12 erythrocytes/L | Geometric Coefficient of Variation 111 |
| Placebo | Change in Haematology: Erythrocytes | 0.11 10^12 erythrocytes/L | Geometric Coefficient of Variation 168.3 |
Secondary
Change in Haematology: Haematocrit
Change from baseline (week 0) in haematocrit was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Haematology: Haematocrit | 1.4 % of red blood cells | Geometric Coefficient of Variation 130.3 |
| Placebo | Change in Haematology: Haematocrit | 1.1 % of red blood cells | Geometric Coefficient of Variation 155.1 |
Secondary
Change in Haematology: Haemoglobin
Change from baseline (week 0) in haemoglobin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Haematology: Haemoglobin | 1.1 mmol/L | Geometric Coefficient of Variation 22.1 |
| Placebo | Change in Haematology: Haemoglobin | 1.1 mmol/L | Geometric Coefficient of Variation 29.3 |
Secondary
Change in Haematology: Leucocytes
Change from baseline (week 0) in leucocytes was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Haematology: Leucocytes | 0.65 10^9 leucocytes/L | Geometric Coefficient of Variation 186.6 |
| Placebo | Change in Haematology: Leucocytes | 0.54 10^9 leucocytes/L | Geometric Coefficient of Variation 146.8 |
Secondary
Change in Haematology: Thrombocytes
Change from baseline (week 0) in thrombocytes was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Haematology: Thrombocytes | 25.3 10^9 thrombocytes/L | Geometric Coefficient of Variation 94.9 |
| Placebo | Change in Haematology: Thrombocytes | 20.2 10^9 thrombocytes/L | Geometric Coefficient of Variation 100.7 |
Secondary
Change in Physical Examination: Cardiovascular System
Physical examination (cardiovascular system) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week -2, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Physical Examination: Cardiovascular System | Week 30: Normal | 98.3 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Cardiovascular System | Week 30: Abnormal, NCS | 1.7 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Cardiovascular System | Week 30: Abnormal, CS | 0 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Cardiovascular System | Week -2: Normal | 98.7 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Cardiovascular System | Week -2: Abnormal, NCS | 1.3 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Cardiovascular System | Week -2: Abnormal, CS | 0 Percentage of participants |
| Placebo | Change in Physical Examination: Cardiovascular System | Week -2: Abnormal, NCS | 6.0 Percentage of participants |
| Placebo | Change in Physical Examination: Cardiovascular System | Week 30: Normal | 92.8 Percentage of participants |
| Placebo | Change in Physical Examination: Cardiovascular System | Week -2: Normal | 93.3 Percentage of participants |
| Placebo | Change in Physical Examination: Cardiovascular System | Week 30: Abnormal, NCS | 7.2 Percentage of participants |
| Placebo | Change in Physical Examination: Cardiovascular System | Week -2: Abnormal, CS | 0.7 Percentage of participants |
| Placebo | Change in Physical Examination: Cardiovascular System | Week 30: Abnormal, CS | 0 Percentage of participants |
Secondary
Change in Physical Examination: Central and Peripheral Nervous System
Physical examination (central and peripheral nervous system) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week -2, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Physical Examination: Central and Peripheral Nervous System | Week -2: Normal | 92.0 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Central and Peripheral Nervous System | Week -2: Abnormal, NCS | 7.3 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Central and Peripheral Nervous System | Week -2: Abnormal, CS | 0.7 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Central and Peripheral Nervous System | Week 30: Normal | 94.2 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Central and Peripheral Nervous System | Week 30: Abnormal, NCS | 5.0 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Central and Peripheral Nervous System | Week 30: Abnormal, CS | 0.8 Percentage of participants |
| Placebo | Change in Physical Examination: Central and Peripheral Nervous System | Week 30: Abnormal, NCS | 12.2 Percentage of participants |
| Placebo | Change in Physical Examination: Central and Peripheral Nervous System | Week -2: Normal | 86.7 Percentage of participants |
| Placebo | Change in Physical Examination: Central and Peripheral Nervous System | Week 30: Normal | 87.8 Percentage of participants |
| Placebo | Change in Physical Examination: Central and Peripheral Nervous System | Week -2: Abnormal, NCS | 12.7 Percentage of participants |
| Placebo | Change in Physical Examination: Central and Peripheral Nervous System | Week 30: Abnormal, CS | 0 Percentage of participants |
| Placebo | Change in Physical Examination: Central and Peripheral Nervous System | Week -2: Abnormal, CS | 0.7 Percentage of participants |
Secondary
Change in Physical Examination: Gastrointestinal System Including Mouth
Physical examination (gastrointestinal system including mouth) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week -2, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Physical Examination: Gastrointestinal System Including Mouth | Week -2: Abnormal, NCS | 6.7 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Gastrointestinal System Including Mouth | Week 30: Abnormal, CS | 0.8 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Gastrointestinal System Including Mouth | Week -2: Abnormal, CS | 0 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Gastrointestinal System Including Mouth | Week -2: Normal | 93.3 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Gastrointestinal System Including Mouth | Week 30: Normal | 95.9 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Gastrointestinal System Including Mouth | Week 30: Abnormal, NCS | 3.3 Percentage of participants |
| Placebo | Change in Physical Examination: Gastrointestinal System Including Mouth | Week 30: Abnormal, CS | 0 Percentage of participants |
| Placebo | Change in Physical Examination: Gastrointestinal System Including Mouth | Week 30: Abnormal, NCS | 5.8 Percentage of participants |
| Placebo | Change in Physical Examination: Gastrointestinal System Including Mouth | Week -2: Normal | 93.3 Percentage of participants |
| Placebo | Change in Physical Examination: Gastrointestinal System Including Mouth | Week -2: Abnormal, NCS | 6.7 Percentage of participants |
| Placebo | Change in Physical Examination: Gastrointestinal System Including Mouth | Week -2: Abnormal, CS | 0 Percentage of participants |
| Placebo | Change in Physical Examination: Gastrointestinal System Including Mouth | Week 30: Normal | 94.2 Percentage of participants |
Secondary
Change in Physical Examination: General Appearance
Physical examination (general appearance) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week -2, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Physical Examination: General Appearance | Week -2: Normal | 90.0 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: General Appearance | Week -2: Abnormal, NCS | 10.0 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: General Appearance | Week -2: Abnormal, CS | 0 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: General Appearance | Week 30: Normal | 87.6 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: General Appearance | Week 30: Abnormal, NCS | 11.6 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: General Appearance | Week 30: Abnormal, CS | 0.8 Percentage of participants |
| Placebo | Change in Physical Examination: General Appearance | Week 30: Abnormal, NCS | 12.2 Percentage of participants |
| Placebo | Change in Physical Examination: General Appearance | Week -2: Normal | 86.0 Percentage of participants |
| Placebo | Change in Physical Examination: General Appearance | Week 30: Normal | 87.1 Percentage of participants |
| Placebo | Change in Physical Examination: General Appearance | Week -2: Abnormal, NCS | 14.0 Percentage of participants |
| Placebo | Change in Physical Examination: General Appearance | Week 30: Abnormal, CS | 0.7 Percentage of participants |
| Placebo | Change in Physical Examination: General Appearance | Week -2: Abnormal, CS | 0 Percentage of participants |
Secondary
Change in Physical Examination: Lymph Node Palpation
Physical examination (lymph node palpation) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week -2, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Physical Examination: Lymph Node Palpation | Week -2: Normal | 99.3 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Lymph Node Palpation | Week -2: Abnormal, NCS | 0.7 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Lymph Node Palpation | Week -2: Abnormal, CS | 0 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Lymph Node Palpation | Week 30: Normal | 99.2 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Lymph Node Palpation | Week 30: Abnormal, NCS | 0 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Lymph Node Palpation | Week 30: Abnormal, CS | 0.8 Percentage of participants |
| Placebo | Change in Physical Examination: Lymph Node Palpation | Week 30: Abnormal, NCS | 0 Percentage of participants |
| Placebo | Change in Physical Examination: Lymph Node Palpation | Week -2: Normal | 100 Percentage of participants |
| Placebo | Change in Physical Examination: Lymph Node Palpation | Week 30: Normal | 100 Percentage of participants |
| Placebo | Change in Physical Examination: Lymph Node Palpation | Week -2: Abnormal, NCS | 0 Percentage of participants |
| Placebo | Change in Physical Examination: Lymph Node Palpation | Week 30: Abnormal, CS | 0 Percentage of participants |
| Placebo | Change in Physical Examination: Lymph Node Palpation | Week -2: Abnormal, CS | 0 Percentage of participants |
Secondary
Change in Physical Examination: Respiratory System
Physical examination (respiratory system) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week -2, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Physical Examination: Respiratory System | Week -2: Normal | 100 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Respiratory System | Week -2: Abnormal, NCS | 0 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Respiratory System | Week -2: Abnormal, CS | 0 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Respiratory System | Week 30: Normal | 100 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Respiratory System | Week 30: Abnormal, NCS | 0 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Respiratory System | Week 30: Abnormal, CS | 0 Percentage of participants |
| Placebo | Change in Physical Examination: Respiratory System | Week 30: Abnormal, NCS | 0.7 Percentage of participants |
| Placebo | Change in Physical Examination: Respiratory System | Week -2: Normal | 98.7 Percentage of participants |
| Placebo | Change in Physical Examination: Respiratory System | Week 30: Normal | 99.3 Percentage of participants |
| Placebo | Change in Physical Examination: Respiratory System | Week -2: Abnormal, NCS | 1.3 Percentage of participants |
| Placebo | Change in Physical Examination: Respiratory System | Week 30: Abnormal, CS | 0 Percentage of participants |
| Placebo | Change in Physical Examination: Respiratory System | Week -2: Abnormal, CS | 0 Percentage of participants |
Secondary
Change in Physical Examination: Skin
Physical examination (skin) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week -2, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Physical Examination: Skin | Week 30: Abnormal, CS | 0 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Skin | Week -2: Normal | 91.3 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Skin | Week -2: Abnormal, NCS | 8.7 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Skin | Week -2: Abnormal, CS | 0 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Skin | Week 30: Normal | 93.4 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Skin | Week 30: Abnormal, NCS | 6.6 Percentage of participants |
| Placebo | Change in Physical Examination: Skin | Week 30: Normal | 95.0 Percentage of participants |
| Placebo | Change in Physical Examination: Skin | Week 30: Abnormal, CS | 0.7 Percentage of participants |
| Placebo | Change in Physical Examination: Skin | Week -2: Abnormal, CS | 0 Percentage of participants |
| Placebo | Change in Physical Examination: Skin | Week -2: Normal | 93.3 Percentage of participants |
| Placebo | Change in Physical Examination: Skin | Week 30: Abnormal, NCS | 4.3 Percentage of participants |
| Placebo | Change in Physical Examination: Skin | Week -2: Abnormal, NCS | 6.7 Percentage of participants |
Secondary
Change in Physical Examination: Thyroid Gland
Physical examination (thyroid gland) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week -2, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Physical Examination: Thyroid Gland | Week -2: Normal | 98.0 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Thyroid Gland | Week -2: Abnormal, NCS | 2.0 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Thyroid Gland | Week -2: Abnormal, CS | 0 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Thyroid Gland | Week 30: Normal | 99.2 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Thyroid Gland | Week 30: Abnormal, NCS | 0.8 Percentage of participants |
| Semaglutide 1.0 mg | Change in Physical Examination: Thyroid Gland | Week 30: Abnormal, CS | 0 Percentage of participants |
| Placebo | Change in Physical Examination: Thyroid Gland | Week 30: Abnormal, NCS | 2.9 Percentage of participants |
| Placebo | Change in Physical Examination: Thyroid Gland | Week -2: Normal | 96.7 Percentage of participants |
| Placebo | Change in Physical Examination: Thyroid Gland | Week 30: Normal | 97.1 Percentage of participants |
| Placebo | Change in Physical Examination: Thyroid Gland | Week -2: Abnormal, NCS | 3.3 Percentage of participants |
| Placebo | Change in Physical Examination: Thyroid Gland | Week 30: Abnormal, CS | 0 Percentage of participants |
| Placebo | Change in Physical Examination: Thyroid Gland | Week -2: Abnormal, CS | 0 Percentage of participants |
Secondary
Change in Pulse
Change from baseline (week 0) in pulse rate was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Time frame: Week 0, week 30
Population: SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Pulse | 4.0 beats/min | Standard Deviation 9.6 |
| Placebo | Change in Pulse | 0.1 beats/min | Standard Deviation 8.4 |
Secondary
Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately
Change from baseline (week 0) in PRO questionnaire, DTSQ was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. The DTSQ measures satisfaction with diabetes treatment. The DTSQ consists of 8 items evaluating 6 aspects of treatment satisfaction and 2 perceived recent event rates of hyperglycemia/hypoglycemia. Each item is scored on a 7- point Likert scale ranging from 0 (very dissatisfied) to 6 (very satisfied). Items evaluating 6 aspects (items 3-8) of treatment satisfaction are summed to produce a total treatment satisfaction score; DTSQ status total scores range from 0-36, with higher scores indicating greater satisfaction; the perceived frequency of hyperglycemia/hypoglycemia items are scored separately, with lower scores indicating better perceived blood glucose control.
Time frame: Week 0, week 30
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 1.0 mg | Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately | 2) Feeling of unacceptably low blood sugars | 0.3 Scores on a scale | Standard Deviation 1.5 |
| Semaglutide 1.0 mg | Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately | 5) Flexibility of current treatment | 0.7 Scores on a scale | Standard Deviation 1.5 |
| Semaglutide 1.0 mg | Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately | 3) Satisfaction with current treatment | 0.8 Scores on a scale | Standard Deviation 1.6 |
| Semaglutide 1.0 mg | Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately | 6) Satisfaction with understanding of diabetes | 0.5 Scores on a scale | Standard Deviation 1.2 |
| Semaglutide 1.0 mg | Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately | Total treatment satisfaction score (Sum of 3-8) | 4.2 Scores on a scale | Standard Deviation 6.6 |
| Semaglutide 1.0 mg | Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately | 7) Recommending treatment to others | 0.8 Scores on a scale | Standard Deviation 1.3 |
| Semaglutide 1.0 mg | Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately | 4) Convenience of current treatment | 0.7 Scores on a scale | Standard Deviation 1.3 |
| Semaglutide 1.0 mg | Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately | 8) Satisfaction to continue with present treatment | 0.8 Scores on a scale | Standard Deviation 1.7 |
| Semaglutide 1.0 mg | Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately | 1) Feeling of unacceptably high blood sugars | -2.2 Scores on a scale | Standard Deviation 1.9 |
| Placebo | Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately | 8) Satisfaction to continue with present treatment | 0.2 Scores on a scale | Standard Deviation 1.7 |
| Placebo | Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately | 1) Feeling of unacceptably high blood sugars | -0.8 Scores on a scale | Standard Deviation 2.2 |
| Placebo | Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately | 2) Feeling of unacceptably low blood sugars | -0.4 Scores on a scale | Standard Deviation 1.5 |
| Placebo | Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately | Total treatment satisfaction score (Sum of 3-8) | 1.9 Scores on a scale | Standard Deviation 7 |
| Placebo | Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately | 3) Satisfaction with current treatment | 0.2 Scores on a scale | Standard Deviation 1.4 |
| Placebo | Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately | 4) Convenience of current treatment | 0.5 Scores on a scale | Standard Deviation 1.3 |
| Placebo | Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately | 5) Flexibility of current treatment | 0.4 Scores on a scale | Standard Deviation 1.7 |
| Placebo | Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately | 6) Satisfaction with understanding of diabetes | 0.5 Scores on a scale | Standard Deviation 1.5 |
| Placebo | Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately | 7) Recommending treatment to others | 0.2 Scores on a scale | Standard Deviation 1.8 |
Secondary
Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains
Change from baseline (week 0) in patient reported outcome (PRO) questionnaire, SF-36v2TM was evaluated at week 30. The SF-36v2™ questionnaire was used to assess the overall health related quality of life of participants. This questionnaire contains 36 items and measures the individual overall health related quality of life on 8 domains: 1) Physical functioning, 2) Role functioning, 3) Bodily pain, 4) General health, 5) Vitality, 6) Social functioning, 7) Role emotional and 8) Mental health. Each item is scored on a scale from 1 to either 2, 3, 5, or 6; each item score is then converted to a scale of 0-100, representing the percentage of total possible score achieved and with higher scores indicating a higher health status; items on the same scale are then averaged to obtain the 8 scale scores. Physical component summary (PCS) includes domains 1-4 and mental component summary (MCS) includes domains 5-8. Higher PCS and MCS scores on a scale of 0-100 indicate a higher health status.
Time frame: Week 0, week 30
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data. Results are based on the 'on-treatment without rescue medication' observation period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 1.0 mg | Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Physical component summary | 1.9 Scores on a scale | Standard Deviation 4.9 |
| Semaglutide 1.0 mg | Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | 1) Physical functioning | 1.3 Scores on a scale | Standard Deviation 4.1 |
| Semaglutide 1.0 mg | Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | 2) Role functioning | 1.5 Scores on a scale | Standard Deviation 6.1 |
| Semaglutide 1.0 mg | Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | 3) Bodily pain | 0.9 Scores on a scale | Standard Deviation 7.4 |
| Semaglutide 1.0 mg | Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | 4) General health | 2.7 Scores on a scale | Standard Deviation 6.8 |
| Semaglutide 1.0 mg | Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Mental component summary | 0.1 Scores on a scale | Standard Deviation 5.6 |
| Semaglutide 1.0 mg | Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | 5) Vitality | 1.5 Scores on a scale | Standard Deviation 6.2 |
| Semaglutide 1.0 mg | Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | 6) Social functioning | 0.3 Scores on a scale | Standard Deviation 7.3 |
| Semaglutide 1.0 mg | Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | 7) Role emotional | 0.1 Scores on a scale | Standard Deviation 6.7 |
| Semaglutide 1.0 mg | Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | 8) Mental health | 0.5 Scores on a scale | Standard Deviation 5.2 |
| Placebo | Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | 6) Social functioning | -1.0 Scores on a scale | Standard Deviation 7.4 |
| Placebo | Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Physical component summary | 0.7 Scores on a scale | Standard Deviation 5.4 |
| Placebo | Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Mental component summary | -0.9 Scores on a scale | Standard Deviation 6.3 |
| Placebo | Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | 1) Physical functioning | 1.1 Scores on a scale | Standard Deviation 5.2 |
| Placebo | Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | 8) Mental health | -0.6 Scores on a scale | Standard Deviation 6 |
| Placebo | Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | 2) Role functioning | 0.0 Scores on a scale | Standard Deviation 6 |
| Placebo | Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | 5) Vitality | 0.2 Scores on a scale | Standard Deviation 6.7 |
| Placebo | Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | 3) Bodily pain | 0.1 Scores on a scale | Standard Deviation 8.1 |
| Placebo | Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | 7) Role emotional | -0.2 Scores on a scale | Standard Deviation 7.5 |
| Placebo | Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains | 4) General health | 0.1 Scores on a scale | Standard Deviation 6.8 |
Secondary
Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean 7-point Profile
Change from baseline (week 0) in mean of the SMPG, 7-point profile was evaluated at week 30. Mean 7-point profile (the area under the profile) was calculated using the trapezoidal method and divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period. Participants measured their plasma glucose at 7 different time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime.
Time frame: Week 0, week 30
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean 7-point Profile | -2.6 mmol/L | Standard Deviation 1.9 |
| Placebo | Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean 7-point Profile | -0.3 mmol/L | Standard Deviation 2 |
Secondary
Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean Post Prandial Increment (Over All Meals)
Change from baseline (week 0) in mean post prandial increment (over all meals) in the SMPG, 7-point profile was evaluated at week 30. The mean increment over all meals was derived as the mean of all available meal increments. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: Week 0, week 30
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean Post Prandial Increment (Over All Meals) | -1.2 mmol/L | Standard Deviation 2 |
| Placebo | Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean Post Prandial Increment (Over All Meals) | 0.0 mmol/L | Standard Deviation 2.2 |
Secondary
Change in Systolic Blood Pressure
Change from baseline (week 0) in systolic blood pressure was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: Week 0, week 30
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Systolic Blood Pressure | -4.3 mmHg | Standard Deviation 14.5 |
| Placebo | Change in Systolic Blood Pressure | 1.1 mmHg | Standard Deviation 12.3 |
Secondary
Change in Waist Circumference
Change from baseline (week 0) in waist circumference was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: Week 0, week 30
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 1.0 mg | Change in Waist Circumference | -4.4 cm | Standard Deviation 5.5 |
| Placebo | Change in Waist Circumference | -1.8 cm | Standard Deviation 4.5 |
Secondary
HbA1c Below 7.0% (53 mmol/Mol)
Percentage of participants with HbA1c below 7.0% (53 mmol/mol) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: After 30 weeks
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | HbA1c Below 7.0% (53 mmol/Mol) | 82.5 Percentage of participants |
| Placebo | HbA1c Below 7.0% (53 mmol/Mol) | 20.5 Percentage of participants |
Secondary
HbA1c Below 7.0% (53 mmol/Mol) Without Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain
Percentage of participants with HbA1c below 7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain from their baseline (week 0) body weight was evaluated at week 30. Severe or blood glucose (BG)-confirmed symptomatic hypoglycaemia: an episode that was severe according to the American Diabetes Association (ADA) classification or confirmed by a plasma glucose (PG) value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: After 30 weeks
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | HbA1c Below 7.0% (53 mmol/Mol) Without Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain | 72.5 Percentage of participants |
| Placebo | HbA1c Below 7.0% (53 mmol/Mol) Without Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain | 17.3 Percentage of participants |
Secondary
HbA1c Equal to or Below 6.5% (48 mmol/Mol)
Percentage of participants with HbA1c equal to or below 6.5% (48 mmol/mol) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: After 30 weeks
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | HbA1c Equal to or Below 6.5% (48 mmol/Mol) | 60.0 Percentage of participants |
| Placebo | HbA1c Equal to or Below 6.5% (48 mmol/Mol) | 3.9 Percentage of participants |
Secondary
HbA1c Reduction Equal to or Above 1%-Point
Percentage of participants with HbA1c reduction equal to or above 1%-point was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: After 30 weeks
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | HbA1c Reduction Equal to or Above 1%-Point | 80.8 Percentage of participants |
| Placebo | HbA1c Reduction Equal to or Above 1%-Point | 15.0 Percentage of participants |
Secondary
HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 10%
Percentage of participants with HbA1c reduction equal to or above 1%-point and weight loss equal to or above 10% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: After 30 weeks
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 10% | 15.0 Percentage of participants |
| Placebo | HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 10% | 1.6 Percentage of participants |
Secondary
HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 3%
Percentage of participants with HbA1c reduction equal to or above 1%-point and weight loss equal to or above 3% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: After 30 weeks
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 3% | 56.7 Percentage of participants |
| Placebo | HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 3% | 7.9 Percentage of participants |
Secondary
HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 5%
Percentage of participants with HbA1c reduction equal to or above 1%-point and weight loss equal to or above 5% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: After 30 weeks
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 5% | 41.7 Percentage of participants |
| Placebo | HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 5% | 4.7 Percentage of participants |
Secondary
Number of Treatment-emergent Adverse Events (TEAEs)
A TEAE was defined as an event that has onset date (or increase in severity) during the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 42 days.
Time frame: Week 0 - week 30
Population: Safety analysis set (SAS), which included all participants exposed to at least one dose of trial product (semaglutide or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 356 Events |
| Placebo | Number of Treatment-emergent Adverse Events (TEAEs) | 247 Events |
Secondary
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 42 days. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or confirmed by a PG value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Time frame: Week 0 - week 30
Population: SAS, which included all participants exposed to at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | 4 Episodes |
| Placebo | Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | 0 Episodes |
Secondary
Weight Loss Equal to or Above 10%
Percentage of participants with weight loss equal to or above 10% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: After 30 weeks
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | Weight Loss Equal to or Above 10% | 15.7 Percentage of participants |
| Placebo | Weight Loss Equal to or Above 10% | 1.6 Percentage of participants |
Secondary
Weight Loss Equal to or Above 3%
Percentage of participants with weight loss equal to or above 3% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: After 30 weeks
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | Weight Loss Equal to or Above 3% | 69.4 Percentage of participants |
| Placebo | Weight Loss Equal to or Above 3% | 21.1 Percentage of participants |
Secondary
Weight Loss Equal to or Above 5%
Percentage of participants with weight loss equal to or above 5% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: After 30 weeks
Population: FAS which included all randomised participants. Number analyzed = number of participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 1.0 mg | Weight Loss Equal to or Above 5% | 50.4 Percentage of participants |
| Placebo | Weight Loss Equal to or Above 5% | 7.8 Percentage of participants |