Diabetes Mellitus, Type 2
Conditions
Brief summary
This study will compare the effect of semaglutide once weekly to insulin aspart 3 times daily as add on to metformin and insulin glargine in people with type 2 diabetes. Participants will either get insulin glargine and semaglutide or insulin glargine and insulin aspart - which treatment the participant get is decided by chance. Insulin glargine is taken once a day and semaglutide once a week. Insulin aspart is taken three times per day before a meal. All three medicines come in pre-filled pens for injection under the skin. The study will last for about 71 weeks. If participant's blood sugar gets under or over certain values participant will only participate in 14 weeks. The study doctor will inform the participant about this. The participant will have 15 clinic visits and 22 phone calls with the study doctor.
Interventions
DRUGSemaglutide
Subjects will receive subcutaneous (s.c., under the skin) injections of semaglutide once weekly (OW) with a dose of 0.25 mg. The dose should be increased after four weeks to 0.5 mg semaglutide. After 4 more weeks the dose can be increased to 1.0 mg semaglutide if the study doctor decides and further dose adjusted throughout the study.
DRUGInsulin aspart
Subjects should initiate treatment with 4U of Insulin aspart (s.c. injections) before each main meal, three times daily (TID). The dose will be adjusted individually based on pre-prandial and bedtime self measured plasma glucose (SMPG) from the preceding 3 days
Run-in period: Subjects will receive s.c. injections of IGlar U100 OD in accordance with the approved local label of IGlar U100. The dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.0-6.9 mmol/L)
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, age greater than or equal to 18 years at the time of signing informed consent * Diagnosed with type 2 diabetes greater than or equal to 180 days prior to the day of screening * Treated with basal insulin once daily or twice daily for greater than or equal to 90 days prior to the day of screening * Stable daily dose for 90 days prior to the day of screening of the following anti-diabetic drugs or combination regimens: Any metformin formulations (greater than or equal to 1500 mg to less than or equal to 3000 mg or maximum tolerated or effective dose documented in subject's medical record), alone or in combination (including fixed-dose drug combination) with up to one additional of the following oral antidiabetic drugs: sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitors or alpha-glucosidase inhibitors * Glycated haemoglobin (HbA1c) of greater than 7.5% to less than or less than or equal to 10.0% (greater than 58 mmol/mol to less than or equal to 86 mmol/mol)
Exclusion criteria
* History or presence of pancreatitis (acute or chronic) * 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 * 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 bolus insulin treatment for a maximum of 14 days prior to the day of screening is allowed * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (for example, optometrist) within the past 90 days prior to run-in
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycated Haemoglobin (HbA1c) | Baseline (week 0), week 52 | Change from baseline in HbA1c at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52 | From randomization (week 0) up to week 52 | First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \<=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52 | From randomization (week 0) to week 52 | Number of EAC-confirmed severe hypoglycaemic episodes from randomization (week 0) up to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \<=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose (BG) Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose Less Than (<) 3.1 mmol/L (56 mg/dL)) From Randomization to Week 52 | From randomization (week 0) to week 52 | Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG \<3.1 mmol/L (56 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \<=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode, that was BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose <= 3.9 mmol/L (70 mg/dL)) From Randomization to Week 52 | From randomization (week 0) to week 52 | Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG \<=3.9 mmol/L (70 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \<=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode during which symptoms of hypoglycaemia were not accompanied by a PG determination but that was presumably caused by a PG concentration \<= 3.9 mmol/L (70 mg/dL). Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening From Randomization to Week 52 | From randomization (week 0) to week 52 | Number of EAC-confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life-threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \<=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Number of Event Adjudication Committee-confirmed Severe (ADA) or Clinically Significant Hypoglycaemic Episodes (Plasma Glucose < 3.0 mmol/L (54 mg/dL)) From Randomization to Week 52 | From randomization (week 0) to week 52 | Number of EAC-confirmed severe or clinically significant hypoglycaemic episodes (plasma glucose \< 3.0 mmol/L (54 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \<=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Hypoglycaemic episode with plasma glucose \< 3.0 mmol/L (54 mg/dL)) was considered as clinically significant. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Daily Basal Insulin Dose at Week 52 | At week 52 | Daily basal insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Total Daily Insulin Dose at Week 52 | At week 52 | Total daily insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Change From Baseline to Week 52 in Body Weight (Kilogram (kg)) | Baseline (week 0), week 52 | Change from baseline in body weight at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG) | Baseline (week 0), week 52 | Change from baseline in FPG at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile (SMPG ): Mean 7-point Profile (7-PP) | Baseline (week 0), week 52 | Change from baseline in 7-point self-measured plasma glucose profile: mean 7-PP at week 52 is presented. All participants were instructed to perform 7-point SMPG profiles before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal (dinner), 90 minutes after the start of main evening meal (dinner) and at bedtime. The measurements were to be performed before any injection of bolus insulin and just before the start of the meal (breakfast, lunch or main evening meal), and values measured before breakfast were performed in a fasting condition. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52 | From randomization (week 0) up to week 52 | First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with plasma glucose (PG) less than or equal to (\<=) 3.9 millimoles per liter (mmol/L) (70 milligrams per deciliter (mg/dL)). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Change From Baseline to Week 52 in Body Mass Index (BMI) | Baseline (week 0), week 52 | Change from baseline in BMI at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Change From Baseline to Week 52 in Waist Circumference | Baseline (week 0), week 52 | Change from baseline in waist circumference at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Change From Baseline to Week 52 in Body Weight (Percentage): Ratio to Baseline | Baseline (week 0), week 52 | Change from baseline in body weight (measured in percentage) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Change From Baseline to Week 52 in Fasting Blood Lipids: Total Cholesterol (Ratio to Baseline) | Baseline (week 0), week 52 | Change from baseline in total cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Change From Baseline to Week 52 in Fasting Blood Lipids: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) | Baseline (week 0), week 52 | Change from baseline in LDL cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Change From Baseline to Week 52 in Fasting Blood Lipids: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) | Baseline (week 0), week 52 | Change from baseline in HDL cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Change From Baseline to Week 52 in Fasting Blood Lipids: Triglycerides (Ratio to Baseline) | Baseline (week 0), week 52 | Change from baseline in triglycerides (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Change From Baseline to Week 52 in Systolic and Diastolic Blood Pressure | Baseline (week 0), week 52 | Change from baseline in systolic and diastolic blood pressure at week 52 are presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Change From Baseline to Week 52 in Pulse Rate | Baseline (week 0), week 52 | Change from baseline in pulse rate at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Baseline (week 0), week 52 | SF-36v2 is 36-item patient-reported survey of patient health to measure participant's overall health-related quality of life (HRQoL). It has 36 items: 8 domains of physical, mental health status (physical functioning, role physical health (range:21.23-57.16), bodily pain (range: 21.68-62.00), general health (range: 18.95-66.50), vitality (range: 22.89-70.42), social functioning (range: 17.23-57.34), role emotional problem (range: 14.39-56.17) and mental health (range: 11.63-63.95)) and 2 total summary scores: physical components summary (range: 7.32-70.14) and mental components summary (range: 5.79-69.91) calculated from domain scores. All 10 scores range from 5.79-70.42 . Higher scores indicated a better health state. Change from baseline in SF-36v2, 2 summary and 8 domains scores at week 52 is presented. Data is reported for 'on-treatment' observation period: from date of first dose of trial product (week 0) to last date on trial product with a visit window of +7 days (week 52). |
| Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains | Baseline (week 0), week 52 | The DQLCTQ-R questionnaire was used to assess participants' HRQoL. The DQLCTQ-R questionnaire contains 57 items and measures and provide scores for the 8 domains (physical function, energy or fatigue, health distress, mental health, satisfaction, treatment satisfaction, treatment flexibility and frequency of symptoms). The 8 domain scores related to DQLCTQ-R are measured on a scale from 0-100. For all scores, higher values indicated better health status. Change from baseline in DQLCTQ-R 8 domain scores at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
| Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile: Mean Post-prandial Increment (Over All Meals) | Baseline (week 0), week 52 | Change from baseline in 7-point SMPG profile: mean post-prandial increment (over all meals) at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52). |
Countries
Bosnia and Herzegovina, Bulgaria, Croatia, Czechia, Estonia, Germany, Greece, Hungary, India, Latvia, Lithuania, North Macedonia, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, South Africa, Spain, Turkey (Türkiye)
Participant flow
Recruitment details
The trial was conducted at 209 sites in 21 countries: Bosnia-Herzegovina (3 sites), Bulgaria (9 sites), Croatia (7 sites), Czech Republic (7 sites), Estonia (5 sites), Germany (25 sites), Greece (14 sites), Hungary (8 sites), India (20 sites), Latvia (7 sites), Lithuania (6 sites), Macedonia (3 sites), Poland (20 sites), Portugal (6 sites), Romania (7 sites), Serbia (14 sites), Slovakia (9 sites), Slovenia (6 sites), South Africa (11 sites), Spain (8 sites) and Turkey (14 sites).
Pre-assignment details
This trial consisted of 12-week run-in, 52-week treatment period and participants were followed up 5 weeks for safety. Participants were randomized 1:1 to receive treatment with: metformin + insulin glargine (IGlar) U100 + once-weekly semaglutide subcutaneously (s.c). or metformin + insulin glargine U100 + mealtime insulin aspart s.c. three times daily.
Participants by arm
| Arm | Count |
|---|---|
| Semaglutide Participants received metformin, IGlar U100 and semaglutide for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast self-measured plasma glucose (SMPG) values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of semaglutide at an initiation dose of 0.25 mg once weekly, after 4 weeks dose was increased to 0.5 mg, and 1 mg after at least 4 weeks to further improve glycaemic control, at investigator's discretion. Dose reduction from 1 to 0.5 mg was allowed in case of safety concern/unacceptable intolerability. Participants were followed up for 5 weeks (week 57) for safety. | 874 |
| Insulin Aspart Participants received metformin, IGlar U100 and insulin aspart for 52 weeks in treatment period. Metformin dose was maintained at same level and frequency as optimized in run-in period unless safety concern related to background medication arose; IGlar U100 dose was adjusted in run-in period, increases in IGlar U100 dose was based on mean of 3 prebreakfast SMPG values obtained on day of visit/telephone contact and 2 days before contact and dose reduction of IGlar U100 was considered in accordance with approved local label to reduce risk of hypoglycaemia. Participants self-administered s.c. injection of insulin aspart at an initiation dose of 4 units three times daily, dose adjustments were considered twice weekly based on pre-prandial and bedtime SMPG from the preceding 3 days and the individualized goal according to investigator's discretion. Participants were followed up for 5 weeks (week 57) for safety. | 874 |
| Total | 1,748 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Run-in Period (12 Weeks) | Run-in failure | 526 | 0 | 0 |
| Treatment Period (Week 0 to 52) | Death | 0 | 11 | 1 |
| Treatment Period (Week 0 to 52) | Lost to Follow-up | 0 | 3 | 4 |
| Treatment Period (Week 0 to 52) | Withdrawal by Subject | 0 | 10 | 38 |
Baseline characteristics
| Characteristic | Insulin Aspart | Total | Semaglutide |
|---|---|---|---|
| Age, Continuous | 61.5 Years STANDARD_DEVIATION 9.5 | 61.2 Years STANDARD_DEVIATION 9.4 | 60.8 Years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 45 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 852 Participants | 1703 Participants | 851 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 166 Participants | 342 Participants | 176 Participants |
| Race/Ethnicity, Customized Race Black or African American | 14 Participants | 35 Participants | 21 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Race White | 691 Participants | 1365 Participants | 674 Participants |
| Sex: Female, Male Female | 425 Participants | 854 Participants | 429 Participants |
| Sex: Female, Male Male | 449 Participants | 894 Participants | 445 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 12 / 874 | 1 / 864 |
| other Total, other adverse events | 225 / 874 | 65 / 864 |
| serious Total, serious adverse events | 65 / 874 | 84 / 864 |
Outcome results
Primary
Change From Baseline in Glycated Haemoglobin (HbA1c)
Change from baseline in HbA1c at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: Baseline (week 0), week 52
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline in Glycated Haemoglobin (HbA1c) | -1.5 Percentage of HbA1c | Standard Deviation 1 |
| Insulin Aspart | Change From Baseline in Glycated Haemoglobin (HbA1c) | -1.2 Percentage of HbA1c | Standard Deviation 1 |
p-value: <0.000195% CI: [-0.38, -0.2]t-distributed test
Secondary
Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains
SF-36v2 is 36-item patient-reported survey of patient health to measure participant's overall health-related quality of life (HRQoL). It has 36 items: 8 domains of physical, mental health status (physical functioning, role physical health (range:21.23-57.16), bodily pain (range: 21.68-62.00), general health (range: 18.95-66.50), vitality (range: 22.89-70.42), social functioning (range: 17.23-57.34), role emotional problem (range: 14.39-56.17) and mental health (range: 11.63-63.95)) and 2 total summary scores: physical components summary (range: 7.32-70.14) and mental components summary (range: 5.79-69.91) calculated from domain scores. All 10 scores range from 5.79-70.42 . Higher scores indicated a better health state. Change from baseline in SF-36v2, 2 summary and 8 domains scores at week 52 is presented. Data is reported for 'on-treatment' observation period: from date of first dose of trial product (week 0) to last date on trial product with a visit window of +7 days (week 52).
Time frame: Baseline (week 0), week 52
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure and Number Analyzed = participants with available data for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide | Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Physical Component Summary | 1.4 Scores on a scale | Standard Deviation 6.4 |
| Semaglutide | Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Mental Component Summary | 0.1 Scores on a scale | Standard Deviation 8.6 |
| Semaglutide | Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Physical Functioning | 1.4 Scores on a scale | Standard Deviation 7.7 |
| Semaglutide | Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Role Physical Health | 0.1 Scores on a scale | Standard Deviation 7.8 |
| Semaglutide | Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Bodily Pain | 1.5 Scores on a scale | Standard Deviation 9 |
| Semaglutide | Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | General Health | 1.6 Scores on a scale | Standard Deviation 8 |
| Semaglutide | Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Vitality | 1.1 Scores on a scale | Standard Deviation 8.6 |
| Semaglutide | Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Social Functioning | 0.2 Scores on a scale | Standard Deviation 9.5 |
| Semaglutide | Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Role Emotional Problem | 0.0 Scores on a scale | Standard Deviation 9.4 |
| Semaglutide | Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Mental Health | 0.6 Scores on a scale | Standard Deviation 8.7 |
| Insulin Aspart | Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Bodily Pain | 0.8 Scores on a scale | Standard Deviation 9.8 |
| Insulin Aspart | Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Role Physical Health | -0.2 Scores on a scale | Standard Deviation 8 |
| Insulin Aspart | Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Physical Component Summary | 0.4 Scores on a scale | Standard Deviation 6.7 |
| Insulin Aspart | Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Role Emotional Problem | -0.2 Scores on a scale | Standard Deviation 9.8 |
| Insulin Aspart | Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Mental Component Summary | -0.3 Scores on a scale | Standard Deviation 8.4 |
| Insulin Aspart | Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | General Health | 0.3 Scores on a scale | Standard Deviation 8 |
| Insulin Aspart | Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Physical Functioning | 0.2 Scores on a scale | Standard Deviation 7.8 |
| Insulin Aspart | Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Social Functioning | -0.6 Scores on a scale | Standard Deviation 9.1 |
| Insulin Aspart | Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Mental Health | 0.1 Scores on a scale | Standard Deviation 8.7 |
| Insulin Aspart | Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains | Vitality | 0.1 Scores on a scale | Standard Deviation 7.9 |
Secondary
Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile: Mean Post-prandial Increment (Over All Meals)
Change from baseline in 7-point SMPG profile: mean post-prandial increment (over all meals) at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: Baseline (week 0), week 52
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure .
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile: Mean Post-prandial Increment (Over All Meals) | -0.7 mmol/L | Standard Deviation 1.8 |
| Insulin Aspart | Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile: Mean Post-prandial Increment (Over All Meals) | -0.9 mmol/L | Standard Deviation 2.1 |
Secondary
Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile (SMPG ): Mean 7-point Profile (7-PP)
Change from baseline in 7-point self-measured plasma glucose profile: mean 7-PP at week 52 is presented. All participants were instructed to perform 7-point SMPG profiles before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal (dinner), 90 minutes after the start of main evening meal (dinner) and at bedtime. The measurements were to be performed before any injection of bolus insulin and just before the start of the meal (breakfast, lunch or main evening meal), and values measured before breakfast were performed in a fasting condition. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: Baseline (week 0), week 52
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile (SMPG ): Mean 7-point Profile (7-PP) | -2.1 mmol/L | Standard Deviation 2 |
| Insulin Aspart | Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile (SMPG ): Mean 7-point Profile (7-PP) | -2.1 mmol/L | Standard Deviation 2 |
Secondary
Change From Baseline to Week 52 in Body Mass Index (BMI)
Change from baseline in BMI at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: Baseline (week 0), week 52
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline to Week 52 in Body Mass Index (BMI) | -1.5 kilograms per meter square (kg/m^2) | Standard Deviation 1.7 |
| Insulin Aspart | Change From Baseline to Week 52 in Body Mass Index (BMI) | 1.0 kilograms per meter square (kg/m^2) | Standard Deviation 1.5 |
Secondary
Change From Baseline to Week 52 in Body Weight (Kilogram (kg))
Change from baseline in body weight at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: Baseline (week 0), week 52
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline to Week 52 in Body Weight (Kilogram (kg)) | -4.2 kilograms | Standard Deviation 4.6 |
| Insulin Aspart | Change From Baseline to Week 52 in Body Weight (Kilogram (kg)) | 2.9 kilograms | Standard Deviation 4.1 |
Secondary
Change From Baseline to Week 52 in Body Weight (Percentage): Ratio to Baseline
Change from baseline in body weight (measured in percentage) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: Baseline (week 0), week 52
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline to Week 52 in Body Weight (Percentage): Ratio to Baseline | 1.0 Ratio of body weight | Standard Deviation 0.1 |
| Insulin Aspart | Change From Baseline to Week 52 in Body Weight (Percentage): Ratio to Baseline | 1.0 Ratio of body weight | Standard Deviation 0 |
Secondary
Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains
The DQLCTQ-R questionnaire was used to assess participants' HRQoL. The DQLCTQ-R questionnaire contains 57 items and measures and provide scores for the 8 domains (physical function, energy or fatigue, health distress, mental health, satisfaction, treatment satisfaction, treatment flexibility and frequency of symptoms). The 8 domain scores related to DQLCTQ-R are measured on a scale from 0-100. For all scores, higher values indicated better health status. Change from baseline in DQLCTQ-R 8 domain scores at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: Baseline (week 0), week 52
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure and Number Analyzed = participants with available data for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide | Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains | Mental health | 7.2 Scores on a scale | Standard Deviation 18.5 |
| Semaglutide | Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains | Satisfaction | 4.1 Scores on a scale | Standard Deviation 18.6 |
| Semaglutide | Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains | Treatment satisfaction | 9.9 Scores on a scale | Standard Deviation 23.9 |
| Semaglutide | Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains | Treatment flexibility | 4.2 Scores on a scale | Standard Deviation 20.1 |
| Semaglutide | Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains | Frequency of symptoms | 4.1 Scores on a scale | Standard Deviation 15.5 |
| Semaglutide | Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains | Physical function | 2.4 Scores on a scale | Standard Deviation 24.6 |
| Semaglutide | Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains | Energy or fatigue | 2.3 Scores on a scale | Standard Deviation 13 |
| Semaglutide | Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains | Health distress | -0.2 Scores on a scale | Standard Deviation 12.4 |
| Insulin Aspart | Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains | Health distress | 0.3 Scores on a scale | Standard Deviation 13.2 |
| Insulin Aspart | Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains | Mental health | 0.5 Scores on a scale | Standard Deviation 20.2 |
| Insulin Aspart | Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains | Frequency of symptoms | 1.8 Scores on a scale | Standard Deviation 14.7 |
| Insulin Aspart | Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains | Satisfaction | -0.2 Scores on a scale | Standard Deviation 16.2 |
| Insulin Aspart | Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains | Energy or fatigue | 0.4 Scores on a scale | Standard Deviation 12.9 |
| Insulin Aspart | Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains | Treatment satisfaction | 0.8 Scores on a scale | Standard Deviation 24.4 |
| Insulin Aspart | Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains | Physical function | -0.4 Scores on a scale | Standard Deviation 26.4 |
| Insulin Aspart | Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains | Treatment flexibility | -1.2 Scores on a scale | Standard Deviation 19.8 |
Secondary
Change From Baseline to Week 52 in Fasting Blood Lipids: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)
Change from baseline in HDL cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: Baseline (week 0), week 52
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline to Week 52 in Fasting Blood Lipids: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) | 1.0 Ratio of HDL cholesterol | Geometric Coefficient of Variation 16.7 |
| Insulin Aspart | Change From Baseline to Week 52 in Fasting Blood Lipids: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) | 1.0 Ratio of HDL cholesterol | Geometric Coefficient of Variation 16.4 |
Secondary
Change From Baseline to Week 52 in Fasting Blood Lipids: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)
Change from baseline in LDL cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: Baseline (week 0), week 52
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline to Week 52 in Fasting Blood Lipids: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) | 1.0 Ratio of LDL cholesterol | Geometric Coefficient of Variation 36.2 |
| Insulin Aspart | Change From Baseline to Week 52 in Fasting Blood Lipids: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) | 1.0 Ratio of LDL cholesterol | Geometric Coefficient of Variation 35.2 |
Secondary
Change From Baseline to Week 52 in Fasting Blood Lipids: Total Cholesterol (Ratio to Baseline)
Change from baseline in total cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: Baseline (week 0), week 52
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline to Week 52 in Fasting Blood Lipids: Total Cholesterol (Ratio to Baseline) | 1.0 Ratio of total cholesterol | Geometric Coefficient of Variation 19.6 |
| Insulin Aspart | Change From Baseline to Week 52 in Fasting Blood Lipids: Total Cholesterol (Ratio to Baseline) | 1.0 Ratio of total cholesterol | Geometric Coefficient of Variation 20.9 |
Secondary
Change From Baseline to Week 52 in Fasting Blood Lipids: Triglycerides (Ratio to Baseline)
Change from baseline in triglycerides (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: Baseline (week 0), week 52
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline to Week 52 in Fasting Blood Lipids: Triglycerides (Ratio to Baseline) | 0.9 Ratio of triglycerides | Geometric Coefficient of Variation 40.4 |
| Insulin Aspart | Change From Baseline to Week 52 in Fasting Blood Lipids: Triglycerides (Ratio to Baseline) | 1.0 Ratio of triglycerides | Geometric Coefficient of Variation 42 |
Secondary
Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)
Change from baseline in FPG at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: Baseline (week 0), week 52
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG) | -1.3 millimoles per liter (mmol/L) | Standard Deviation 2.9 |
| Insulin Aspart | Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG) | -0.8 millimoles per liter (mmol/L) | Standard Deviation 3.1 |
Secondary
Change From Baseline to Week 52 in Pulse Rate
Change from baseline in pulse rate at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: Baseline (week 0), week 52
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline to Week 52 in Pulse Rate | 2.2 Beats per minute (beats/min) | Standard Deviation 8.7 |
| Insulin Aspart | Change From Baseline to Week 52 in Pulse Rate | 1.1 Beats per minute (beats/min) | Standard Deviation 8.7 |
Secondary
Change From Baseline to Week 52 in Systolic and Diastolic Blood Pressure
Change from baseline in systolic and diastolic blood pressure at week 52 are presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: Baseline (week 0), week 52
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide | Change From Baseline to Week 52 in Systolic and Diastolic Blood Pressure | Diastolic Blood Pressure | -1.4 millimeter of mercury (mmHg) | Standard Deviation 8.7 |
| Semaglutide | Change From Baseline to Week 52 in Systolic and Diastolic Blood Pressure | Systolic Blood Pressure | -2.8 millimeter of mercury (mmHg) | Standard Deviation 13.8 |
| Insulin Aspart | Change From Baseline to Week 52 in Systolic and Diastolic Blood Pressure | Diastolic Blood Pressure | -0.4 millimeter of mercury (mmHg) | Standard Deviation 9 |
| Insulin Aspart | Change From Baseline to Week 52 in Systolic and Diastolic Blood Pressure | Systolic Blood Pressure | 1.0 millimeter of mercury (mmHg) | Standard Deviation 14 |
Secondary
Change From Baseline to Week 52 in Waist Circumference
Change from baseline in waist circumference at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: Baseline (week 0), week 52
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Change From Baseline to Week 52 in Waist Circumference | -3.3 centimeters (cm) | Standard Deviation 5.6 |
| Insulin Aspart | Change From Baseline to Week 52 in Waist Circumference | 2.1 centimeters (cm) | Standard Deviation 4.9 |
Secondary
Daily Basal Insulin Dose at Week 52
Daily basal insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: At week 52
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Daily Basal Insulin Dose at Week 52 | 35.8 Units of insulin | Standard Deviation 19.4 |
| Insulin Aspart | Daily Basal Insulin Dose at Week 52 | 40.7 Units of insulin | Standard Deviation 22 |
Secondary
Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose (BG) Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose Less Than (<) 3.1 mmol/L (56 mg/dL)) From Randomization to Week 52
Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG \<3.1 mmol/L (56 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \<=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode, that was BG confirmed by PG value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: From randomization (week 0) to week 52
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide | Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose (BG) Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose Less Than (<) 3.1 mmol/L (56 mg/dL)) From Randomization to Week 52 | 254 Episodes |
| Insulin Aspart | Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose (BG) Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose Less Than (<) 3.1 mmol/L (56 mg/dL)) From Randomization to Week 52 | 1744 Episodes |
Secondary
Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose <= 3.9 mmol/L (70 mg/dL)) From Randomization to Week 52
Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG \<=3.9 mmol/L (70 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \<=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode during which symptoms of hypoglycaemia were not accompanied by a PG determination but that was presumably caused by a PG concentration \<= 3.9 mmol/L (70 mg/dL). Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: From randomization (week 0) to week 52
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide | Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose <= 3.9 mmol/L (70 mg/dL)) From Randomization to Week 52 | 1420 Episodes |
| Insulin Aspart | Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose <= 3.9 mmol/L (70 mg/dL)) From Randomization to Week 52 | 5616 Episodes |
Secondary
Number of Event Adjudication Committee-confirmed Severe (ADA) or Clinically Significant Hypoglycaemic Episodes (Plasma Glucose < 3.0 mmol/L (54 mg/dL)) From Randomization to Week 52
Number of EAC-confirmed severe or clinically significant hypoglycaemic episodes (plasma glucose \< 3.0 mmol/L (54 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \<=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Hypoglycaemic episode with plasma glucose \< 3.0 mmol/L (54 mg/dL)) was considered as clinically significant. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: From randomization (week 0) to week 52
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide | Number of Event Adjudication Committee-confirmed Severe (ADA) or Clinically Significant Hypoglycaemic Episodes (Plasma Glucose < 3.0 mmol/L (54 mg/dL)) From Randomization to Week 52 | 339 Episodes |
| Insulin Aspart | Number of Event Adjudication Committee-confirmed Severe (ADA) or Clinically Significant Hypoglycaemic Episodes (Plasma Glucose < 3.0 mmol/L (54 mg/dL)) From Randomization to Week 52 | 2270 Episodes |
Secondary
Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52
Number of EAC-confirmed severe hypoglycaemic episodes from randomization (week 0) up to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \<=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: From randomization (week 0) to week 52
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide | Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52 | 4 Episodes |
| Insulin Aspart | Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52 | 7 Episodes |
Secondary
Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening From Randomization to Week 52
Number of EAC-confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life-threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \<=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: From randomization (week 0) to week 52
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide | Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening From Randomization to Week 52 | 2 Episodes |
| Insulin Aspart | Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening From Randomization to Week 52 | 4 Episodes |
Secondary
Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52
First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG \<=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: From randomization (week 0) up to week 52
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide | Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52 | 0.2 First event per 100 years of exposure |
| Insulin Aspart | Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52 | 0.4 First event per 100 years of exposure |
Secondary
Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52
First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with plasma glucose (PG) less than or equal to (\<=) 3.9 millimoles per liter (mmol/L) (70 milligrams per deciliter (mg/dL)). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: From randomization (week 0) up to week 52
Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide | Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52 | 0.4 First event per 100 years of exposure |
| Insulin Aspart | Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52 | 0.7 First event per 100 years of exposure |
Secondary
Total Daily Insulin Dose at Week 52
Total daily insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).
Time frame: At week 52
Population: Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide | Total Daily Insulin Dose at Week 52 | 35.8 Units of insulin | Standard Deviation 19.4 |
| Insulin Aspart | Total Daily Insulin Dose at Week 52 | 77.7 Units of insulin | Standard Deviation 40 |