This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus sitagliptin 100 mg once-daily on glycaemic control after 30 weeks of treatment. Subjects will remain on their stable pre-trial metformin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
868
Up to 0.5 mg semaglutide injected subcutaneously (s.c., under the skin) once-weekly (OW) for 30 weeks
Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 30 weeks
Sitagliptin placebo tablets taken once-daily for 30 weeks
Change in HbA1c
Change from baseline (week 0) to week 30 in glycosylated haemoglobin (HbA1c) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period and 'in trial' observation period. 'On-treatment without rescue medication' observation period: started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. 'In-trial' observation period: started when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation.
Time frame: Week 0, week 30
Change in Body Weight
Change from baseline (week 0) to week 30 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 0, week 30
Change in Fasting Plasma Glucose (FPG)
Change from baseline (week 0) to week 30 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 0, week 30
Change in Self-measured Plasma Glucose (SMPG) - Mean 7-point Profile
Change from baseline (week 0) to week 30 in SMPG mean 7-point profile was evaluated. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
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100 mg sitagliptin tablets taken once-daily for 30 weeks
Semaglutide placebo (0.5 mg) injected subcutaneously once-weekly for 30 weeks
Semaglutide placebo (1.0 mg) injected subcutaneously once-weekly for 30 weeks
Novo Nordisk Investigational Site
Aparecida de Goiânia, Goiás, Brazil
Novo Nordisk Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
Novo Nordisk Investigational Site
São Paulo, São Paulo, Brazil
Novo Nordisk Investigational Site
Hefei, Anhui, China
Novo Nordisk Investigational Site
Hefei, Anhui, China
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China
...and 57 more locations
Time frame: Week 0, week 30
Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals
Change from baseline (week 0) to week 30 in SMPG mean postprandial increment over all meals was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 0, week 30
Change in Fasting Insulin - Ratio to Baseline
Change in fasting insulin from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting insulin was measured in picomoles per liter (pmol/L). Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 0, week 30
Change in Fasting C-peptide - Ratio to Baseline
Change in fasting C-peptide from baseline (week 0) to week 30 is presented as ratio to baseline. C-peptide was measured in nanomoles per liter (nmol/L). Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 0, week 30
Change in Fasting Glucagon - Ratio to Baseline
Change in fasting glucagon from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting glucagon was measured in picogram per mililiter (pg/mL). Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 0, week 30
Change in Fasting Proinsulin - Ratio to Baseline
Change in fasting proinsulin from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting proinsulin was measured in picomole per liter (pmol/L). Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 0, week 30
Change in Fasting Proinsulin/Insulin Ratio - Ratio to Baseline
Change in fasting proinsulin/insulin ratio from baseline (week 0) to week 30 is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 0, week 30
Change in Fasting HOMA-B (Beta-cell Function) - Ratio to Baseline
Change in fasting HOMA-B (homeostasis model assessment beta-cell function) from baseline (week 0) to week 30 is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 0, week 30
Change in Fasting HOMA-IR (Insulin Resistence) - Ratio to Baseline
Change in fasting HOMA-IR (homeostasis model assessment insulin resistence) from baseline (week 0) to week 30 is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 0, week 30
Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score
Short Form (SF)-36 is a 36-item patient-reported survey that measures patient's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured 8 domains of functional health \& well-being and 2 component summary scores (physical component summary-PCS and mental component summary-MCS). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 30. A positive change score indicates an improvement since baseline. Results are based on the data from the 'on-treatment without rescue medication' observation period.
Time frame: Week 0, week 30
Change in Patient Reported Outcome Questionnaire: DTSQs Score
Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire (DTSQs) was evaluated at week 30. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 3 -8. For items 1 and 2 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being "none of the time" unacceptably high (item 1) or low (item 2). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 3-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the 'on-treatment without rescue medication' observation period.
Time frame: Week 0, week 30
Change in High-sensitivity CRP - Ratio to Baseline
Change in high-sensitivity C-reactive protein (CRP) from baseline (week 0) to week 30 is presented as ratio to baseline. High-sensitivity CRP was measured in mg/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 0, week 30
Change in Waist Circumference
Change in waist circumference from baseline (week 0) to week 30 was measured. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 0, week 30
Change in BMI
Change in body mass index (BMI) from baseline (week 0) to week 30 was measured. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 0, week 30
Change in Fasting Total Cholesterol - Ratio to Baseline
Change in fasting total cholesterol from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting total cholesterol was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 0, week 30
Change in Fasting LDL Cholesterol - Ratio to Baseline
Change in fasting low density lipoprotein (LDL) from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting LDL was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 0, week 30
Change in Fasting VLDL Cholesterol - Ratio to Baseline
Change in fasting very low density lipoprotein (VLDL) from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting VLDL was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 0, week 30
Change in Fasting HDL Cholesterol - Ratio to Baseline
Change in fasting high density lipoprotein (HDL) from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting HDL was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 0, week 30
Change in Fasting Triglycerides - Ratio to Baseline
Change in fasting triglycerides from baseline (week 0) to week 30 is presented as ratio to baseline. Triglycerides was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 0, week 30
Change in Free Fatty Acids - Ratio to Baseline
Change in free fatty acids from baseline (week 0) to week 30 is presented as ratio to baseline. Free fatty acids was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 0, week 30
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Change from baseline (week 0) to week 30 in systolic blood pressure and diastolic blood pressure were evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 0, week 30
Percentage of Participants Who Achieved HbA1c <7.0% (53 mmol/Mol), ADA Target, (Yes/no)
Percentage of participants who achieved HbA1c \< 7.0% (53 millimoles per mole \[mmol/mol\]), American Diabetes Association (ADA) target (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 30
Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/Mol), AACE Target, (Yes/no)
Percentage of participants who achieved HbA1c ≤6.5% (48 millimoles per mole \[mmol/mol\]), American Association of Clinical Endocrinologists (AACE) target (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 30
Percentage of Participants That Achieved (Yes/no): HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemia and no Weight Gain
Severe or blood glucose (BG)-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 milligrams per deciliter \[mg/dL\]) with symptoms consistent with hypoglycaemia. Percentage of participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 30
Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥5%
Percentage of participants losing ≥5% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 30
Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥10%
Percentage of participants losing ≥10% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.
Time frame: Week 30
Total Number of Treatment Emergent Adverse Events
A treatment emergent adverse event (TEAE) is defined as an adverse event with onset in the on-treatment observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0 to week 30
Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Hypoglycaemic episodes are defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0 to week 30
Participants With Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Number of participants with treatment emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes. Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0 to week 30
Change in Haematological Parameter: Haemoglobin - Ratio to Baseline
Change in haemoglobin from baseline (week 0) to week 30 is presented as ratio to baseline. Haemoglobin was measured in mmol/L. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Haematological Parameter: Haematocrit - Ratio to Baseline
Change in haematocrit from baseline (week 0) to week 30 is presented as ratio to baseline. Haematocrit was measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Hematological Parameter: Thrombocytes - Ratio to Baseline
Change in thrombocytes from baseline (week 0) to week 30 is presented as ratio to baseline. Thrombocytes was measured in 10\^9 cells per liter. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Hematological Parameter: Erythrocytes - Ratio to Baseline
Change in erythrocytes from baseline (week 0) to week 30 is presented as ratio to baseline. Erythrocytes were measured in 10\^12 cells per liter. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Hematological Parameter: Leukocytes - Ratio to Baseline
Change in leukocytes from baseline (week 0) to week 30 is presented as ratio to baseline. Leukocytes were measured in 10\^9 cells per liter. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Hematological Parameter (Differential Cell Count of Leukocytes): Basophils - Ratio to Baseline
Change in basophils from baseline (week 0) to week 30 is presented as ratio to baseline. Basophils were measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Hematological Parameter (Differential Cell Count of Leukocytes): Neutrophils - Ratio to Baseline
Change in neutrophils from baseline (week 0) to week 30 is presented as ratio to baseline. Neutrophils were measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Hematological Parameter (Differential Cell Count of Leukocytes): Eosinophils - Ratio to Baseline
Change in eosinophils from baseline (week 0) to week 30 is presented as ratio to baseline. Eosinophils were measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Hematological Parameter (Differential Cell Count of Leukocytes): Monocytes - Ratio to Baseline
Change in monocytes from baseline (week 0) to week 30 is presented as ratio to baseline. Monocytes were measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Hematological Parameter (Differential Cell Count of Leukocytes): Lymphocytes - Ratio to Baseline
Change in lymphocytes from baseline (week 0) to week 30 is presented as ratio to baseline. Lymphocytes were measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Biochemistry Parameter: Amylase - Ratio to Baseline
Change in amylase from baseline (week 0) to week 30 is presented as ratio to baseline. Amylase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Biochemistry Parameter: Lipase - Ratio to Baseline
Change in lipase from baseline (week 0) to week 30 is presented as ratio to baseline. Lipase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Biochemistry Parameter: Alkaline Phosphatase - Ratio to Baseline
Change in alkaline phosphatase from baseline (week 0) to week 30 is presented as ratio to baseline. Alkaline phosphatase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Biochemistry Parameter: Alanine Aminotransferase - Ratio to Baseline
Change in alanine aminotransferase from baseline (week 0) to week 30 is presented as ratio to baseline. Alanine aminotransferase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Biochemistry Parameter: Aspartate Aminotransferase - Ratio to Baseline
Change in aspartate aminotransferase from baseline (week 0) to week 30 is presented as ratio to baseline. Aspartate aminotransferase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Biochemistry Parameter: Total Bilirubin - Ratio to Baseline
Change in total bilirubin from baseline (week 0) to week 30 is presented as ratio to baseline. Total bilirubin was measured in micromoles per liter (umol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Biochemistry Parameter: Calcium (Corrected)- Ratio to Baseline
Change in calcium (corrected) from baseline (week 0) to week 30 is presented as ratio to baseline. Calcium was measured in millimoles per litre (mmol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Biochemistry Parameter: Total Calcium - Ratio to Baseline
Change in total calcium from baseline (week 0) to week 30 is presented as ratio to baseline. Calcium was measured in millimoles per litre (mmol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Biochemistry Parameter: Potassium - Ratio to Baseline
Change in potassium from baseline (week 0) to week 30 is presented as ratio to baseline. Potassium was measured in millimoles per liter (mmol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Biochemistry Parameter: Sodium - Ratio to Baseline
Change in sodium from baseline (week 0) to week 30 is presented as ratio to baseline. Sodium was measured in millimoles per litre (mmol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Biochemistry Parameter: Albumin - Ratio to Baseline
Change in albumin from baseline (week 0) to week 30 is presented as ratio to baseline. Albumin was measured in grams per deciliter (g/dL). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Biochemistry Parameter: Creatine Kinase - Ratio to Baseline
Change in creatine kinase from baseline (week 0) to week 30 is presented as ratio to baseline. Creatine kinase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Biochemistry Parameter: Total Protein- Ratio to Baseline
Change in Total protein from baseline (week 0) to week 30 is presented as ratio to baseline. Total Protein was measured in grams per deciliter (g/dL). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Biochemistry Parameter: Creatinine - Ratio to Baseline
Change in creatinine from baseline (week -2) to week 30 is presented as ratio to baseline. Creatinine was measured in micromoles per lier (umol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week -2, week 30
Change in Biochemistry Parameter: Urea - Ratio to Baseline
Change in urea from baseline (week 0) to week 30 is presented as ratio to baseline. Urea was measured in millimoles per liter (mmol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Biochemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) - Ratio to Baseline
Change in estimated glomerular filtration rate (eGFR) from baseline (week 0) to week 30 is presented as ratio to baseline. Glomerular filtration rate was measured in milliliter/minute/specific surface area (mL/min/SSA). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Calcitonin - Ratio to Baseline
Change in calcitonin from baseline (week -2) to week 30 is presented as ratio to baseline. Calcitonin was measured in nanogram per liter (ng/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week -2, week 30
Change in Urinalysis Parameter - UACR-ratio to Baseline
Change in urin albumin to creatinine ratio (UACR) from baseline (week 0) to week 30 is presented as ratio to baseline. UACR was measured in milligram/millimole (mg/mmol). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Urinalysis Parameter: Glucose
Glucose in urine was assessed by the investigator and categorised as negative, \[100-249\], \[250-499\], \[500-999\] and \>= 1000. Number of participants in each category at baseline (week 0) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Urinalysis Parameter: pH
pH in urine was assessed by the investigator and categorised as 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, \>=9. Number of participants in each category at baseline (week 0) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Urinalysis Parameter: Protein
Protein in urine was assessed by the investigator and categorised as negative, trace, 30-99, 100-299, Approximately 300, \>=300. Number of participants in each category at baseline (week 0) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Urinalysis Parameter: Ketones
Ketones in urine was assessed by the investigator and categorised as negative, trace, 15-39, 40-79, Approximately 80, \>= 80. Number of participants in each category at baseline (week 0) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Urinalysis Parameter: Erythrocytes
Erythrocytes in urine was assessed by the investigator and categorised as negative, trace, small, moderate, large. Number of participants in each category at baseline (week 0) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Clinical Evaluation: Pulse
Change in pulse from baseline (week 0) to week 30 is presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Clinical Evaluation: ECG
The electrocardiogram (ECG) was assessed by the investigator and categorised as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Number of participants in each ECG category at baseline and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Clinical Evaluation: Eye Examinations
Eye examination was performed by the investigator and the results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Number of participants in each category at baseline (week 0) and at week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week 0, week 30
Change in Physical Examination
Physical examination parameters are categorised as general appearance; nervous system (central and peripheral); cardiovascular system; gastrointestinal system; skin; respiratory system; lymph node palpation; thyroid gland; left foot; right foot; left leg and right leg. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -2) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time frame: Week -2, week 30
Anti-semaglutide Antibody Levels
This outcome measure is only applicable for the semaglutide arms. Anti-semaglutide antibody level at week 30 and week 35 are presented. Antibody levels were measured in percentage of bound radioactivity-labelled semaglutide/total added radioactivity-labelled semaglutide (%B/T; B =Bound, T = Total). Evaluation was based on 'in trial' observation period, which is the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation.
Time frame: week 30, week 35
Occurence of Anti-semaglutide Antibodies (Yes/no)
This outcome measure is only applicable for the semaglutide arms. Development of anti-semaglutide antibodies was evaluated in participants during the study. The number of participants who were positive/ negative for anti-semaglutide antibodies were presented. Evaluation was based on 'in trial' observation period, which is the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation.
Time frame: Week 0, week 16, week 30, week 35
Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no)
This outcome measure is only applicable for the semaglutide arms. Development of anti-semaglutide antibodies with in-vitro neutralising effect was evaluated in participants during the study. The number of participants who were positive/ negative for anti-semaglutide antibodies with in vitro neutralising effect are presented. Evaluation was based on in-trial observation period, which is the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation.
Time frame: Week 0, week 16, week 30, week 35
Occurence of Anti-semaglutide Antibodies Cross Reacting With Endogenous GLP-1 (Yes/no)
This outcome measure is only applicable for the semaglutide arms. Development of anti-semaglutide antibodies cross reacting with endogenous glucagon-like peptide-1 (GLP-1) was evaluated in participants. The number of participants who were positive/ negative for anti-semaglutide antibodies cross reacting with endogenous GLP-1 are presented. Evaluation was based on in-trial observation period, which is the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation.
Time frame: Week 35
Occurence of Cross Reacting Antibodies With in Vitro Neutralising Effect to Endogenous GLP-1 (Yes/no)
This outcome measure is only applicable for the semaglutide arms. Development of cross reacting antibodies with in-vitro neutralising effect to endogenous glucagon-like peptide-1 (GLP-1) was evaluated in participants. The number of participants who were positive/ negative for anti-semaglutide antibodies with in vitro neutralising effect to endogenous GLP-1 are presented. Evaluation was based on in-trial observation period, which is the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation.
Time frame: Week 35