Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
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
DRUGSitagliptin
100 mg sitagliptin tablets taken once-daily for 30 weeks
DRUGSemaglutide placebo 0.5 mg
Semaglutide placebo (0.5 mg) injected subcutaneously once-weekly for 30 weeks
DRUGSemaglutide placebo 1.0 mg
Semaglutide placebo (1.0 mg) injected subcutaneously once-weekly for 30 weeks
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male or female, age equal to or above 18 years at the time of signing informed consent - Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 60 days prior to screening with metformin equal to or above 1500 mg (or maximum tolerated dose equal to or above 1000 mg). Stable is defined as unchanged medication and unchanged daily dose - HbA1c 7.0 - 10.5 % (53-91 mmol/mol) (both inclusive)
Exclusion criteria
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential not using an adequate contraceptive method throughout the trial including the 5 week follow-up period (adequate contraceptive measure as required by local regulation or practice) - Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 60 days before screening. An exception is short-term treatment (equal to or below 7 days in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m\^2 per modification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart Association (NYHA) class IV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Week 0, week 30 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Plasma Glucose (FPG) | Week 0, week 30 | 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. |
| Change in Self-measured Plasma Glucose (SMPG) - Mean 7-point Profile | Week 0, week 30 | 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. |
| Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals | Week 0, week 30 | 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. |
| Change in Fasting Insulin - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Fasting C-peptide - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Fasting Glucagon - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Fasting Proinsulin - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Fasting Proinsulin/Insulin Ratio - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Fasting HOMA-B (Beta-cell Function) - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Fasting HOMA-IR (Insulin Resistence) - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Week 0, week 30 | 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. |
| Change in Patient Reported Outcome Questionnaire: DTSQs Score | Week 0, week 30 | 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. |
| Change in High-sensitivity CRP - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Waist Circumference | Week 0, week 30 | 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. |
| Change in BMI | Week 0, week 30 | 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. |
| Change in Fasting Total Cholesterol - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Fasting LDL Cholesterol - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Fasting VLDL Cholesterol - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Fasting HDL Cholesterol - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Biochemistry Parameter: Amylase - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Fasting Triglycerides - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Free Fatty Acids - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Week 0, week 30 | 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. |
| Percentage of Participants Who Achieved HbA1c <7.0% (53 mmol/Mol), ADA Target, (Yes/no) | Week 30 | 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. |
| Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/Mol), AACE Target, (Yes/no) | Week 30 | 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. |
| 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 | Week 30 | 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. |
| Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥5% | Week 30 | 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. |
| Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥10% | Week 30 | 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. |
| Total Number of Treatment Emergent Adverse Events | Week 0 to week 30 | 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. |
| Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | Week 0 to week 30 | 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. |
| Change in Biochemistry Parameter: Lipase - Ratio to Baseline | Week 0, week 30 | 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. |
| Participants With Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | Week 0 to week 30 | 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. |
| Change in Haematological Parameter: Haemoglobin - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Haematological Parameter: Haematocrit - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Hematological Parameter: Thrombocytes - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Hematological Parameter: Erythrocytes - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Hematological Parameter: Leukocytes - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Hematological Parameter (Differential Cell Count of Leukocytes): Basophils - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Hematological Parameter (Differential Cell Count of Leukocytes): Neutrophils - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Hematological Parameter (Differential Cell Count of Leukocytes): Eosinophils - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Hematological Parameter (Differential Cell Count of Leukocytes): Monocytes - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Hematological Parameter (Differential Cell Count of Leukocytes): Lymphocytes - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Biochemistry Parameter: Alkaline Phosphatase - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Biochemistry Parameter: Alanine Aminotransferase - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Biochemistry Parameter: Aspartate Aminotransferase - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Biochemistry Parameter: Total Bilirubin - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Biochemistry Parameter: Calcium (Corrected)- Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Biochemistry Parameter: Total Calcium - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Biochemistry Parameter: Potassium - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Biochemistry Parameter: Sodium - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Biochemistry Parameter: Albumin - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Biochemistry Parameter: Creatine Kinase - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Biochemistry Parameter: Total Protein- Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Biochemistry Parameter: Creatinine - Ratio to Baseline | Week -2, week 30 | 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. |
| Change in Biochemistry Parameter: Urea - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Biochemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) - Ratio to Baseline | Week 0, week 30 | 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. |
| Change in Calcitonin - Ratio to Baseline | Week -2, week 30 | 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. |
| Change in Urinalysis Parameter - UACR-ratio to Baseline | Week 0, week 30 | 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. |
| Change in Urinalysis Parameter: Glucose | Week 0, week 30 | 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. |
| Change in Urinalysis Parameter: pH | Week 0, week 30 | 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. |
| Change in Urinalysis Parameter: Protein | Week 0, week 30 | 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. |
| Change in Urinalysis Parameter: Ketones | Week 0, week 30 | 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. |
| Change in Urinalysis Parameter: Erythrocytes | Week 0, week 30 | 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. |
| Change in Body Weight | Week 0, week 30 | 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. |
| Change in Clinical Evaluation: ECG | Week 0, week 30 | 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. |
| Change in Clinical Evaluation: Eye Examinations | Week 0, week 30 | 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. |
| Change in Physical Examination | Week -2, week 30 | 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. |
| Anti-semaglutide Antibody Levels | week 30, week 35 | 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. |
| Occurence of Anti-semaglutide Antibodies (Yes/no) | Week 0, week 16, week 30, week 35 | 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. |
| Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) | Week 0, week 16, week 30, week 35 | 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. |
| Occurence of Anti-semaglutide Antibodies Cross Reacting With Endogenous GLP-1 (Yes/no) | Week 35 | 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. |
| Occurence of Cross Reacting Antibodies With in Vitro Neutralising Effect to Endogenous GLP-1 (Yes/no) | Week 35 | 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. |
| Change in Clinical Evaluation: Pulse | Week 0, week 30 | 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. |
Countries
Brazil, China, Hong Kong, South Africa, South Korea, Taiwan, Ukraine
Participant flow
Recruitment details
The trial was conducted at 65 sites in 5 countries/regions as follows: Region China: 42 sites; Brazil: 3 sites; Republic of Korea: 12 sites; South Africa: 5 sites; Ukraine: 3 sites.
Participants by arm
| Arm | Count |
|---|---|
| Semaglutide 0.5 mg Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | 288 |
| Semaglutide 1.0 mg Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | 290 |
| Sitagliptin Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | 290 |
| Total | 868 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 21 | 26 | 9 |
Baseline characteristics
| Characteristic | Semaglutide 0.5 mg | Semaglutide 1.0 mg | Sitagliptin | Total |
|---|---|---|---|---|
| Age, Continuous | 53.0 Years STANDARD_DEVIATION 11.4 | 53.0 Years STANDARD_DEVIATION 10.6 | 53.1 Years STANDARD_DEVIATION 10.4 | 53.1 Years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 28 Participants | 30 Participants | 82 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 264 Participants | 262 Participants | 260 Participants | 786 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 243 Participants | 251 Participants | 244 Participants | 738 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 8 Participants | 9 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 3 Participants | 6 Participants | 16 Participants |
| Race (NIH/OMB) White | 30 Participants | 28 Participants | 31 Participants | 89 Participants |
| Sex: Female, Male Female | 128 Participants | 136 Participants | 105 Participants | 369 Participants |
| Sex: Female, Male Male | 160 Participants | 154 Participants | 185 Participants | 499 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 287 | 1 / 290 | 0 / 290 |
| other Total, other adverse events | 135 / 287 | 139 / 290 | 89 / 290 |
| serious Total, serious adverse events | 18 / 287 | 19 / 290 | 12 / 290 |
Outcome results
Primary
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
Population: Full analysis set comprised of all randomised participants.Number Analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 0.5 mg | Change in HbA1c | On-treatment without rescue medication obs. period | -1.5 Percentage of glycosylated haemoglobin | Standard Deviation 1.1 |
| Semaglutide 0.5 mg | Change in HbA1c | In-trial observation period | -1.5 Percentage of glycosylated haemoglobin | Standard Deviation 1.1 |
| Semaglutide 1.0 mg | Change in HbA1c | On-treatment without rescue medication obs. period | -1.8 Percentage of glycosylated haemoglobin | Standard Deviation 0.9 |
| Semaglutide 1.0 mg | Change in HbA1c | In-trial observation period | -1.7 Percentage of glycosylated haemoglobin | Standard Deviation 1 |
| Sitagliptin | Change in HbA1c | On-treatment without rescue medication obs. period | -1.0 Percentage of glycosylated haemoglobin | Standard Deviation 0.9 |
| Sitagliptin | Change in HbA1c | In-trial observation period | -0.9 Percentage of glycosylated haemoglobin | Standard Deviation 0.9 |
Comparison: The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.p-value: <0.000195% CI: [-1, -0.7]Mixed Models Analysis
Comparison: The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.p-value: <0.000195% CI: [-0.66, -0.36]Mixed Models Analysis
Comparison: The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.p-value: <0.000195% CI: [-1, -0.7]Mixed Models Analysis
Comparison: The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.p-value: <0.000195% CI: [-0.66, -0.36]Mixed Models Analysis
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed=participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 1.0 mg | Anti-semaglutide Antibody Levels | At week 30 | 2.8 %B/T | Standard Deviation 0.2 |
| Semaglutide 1.0 mg | Anti-semaglutide Antibody Levels | At week 35 | 3.3 %B/T | Standard Deviation 0.7 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Biochemistry Parameter: Alanine Aminotransferase - Ratio to Baseline | 0.86 Ratio of alanine aminotransferase | Geometric Coefficient of Variation 55.7 |
| Semaglutide 1.0 mg | Change in Biochemistry Parameter: Alanine Aminotransferase - Ratio to Baseline | 0.83 Ratio of alanine aminotransferase | Geometric Coefficient of Variation 47.1 |
| Sitagliptin | Change in Biochemistry Parameter: Alanine Aminotransferase - Ratio to Baseline | 0.95 Ratio of alanine aminotransferase | Geometric Coefficient of Variation 35.1 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Biochemistry Parameter: Albumin - Ratio to Baseline | 1.02 Ratio of albumin | Geometric Coefficient of Variation 5.4 |
| Semaglutide 1.0 mg | Change in Biochemistry Parameter: Albumin - Ratio to Baseline | 1.02 Ratio of albumin | Geometric Coefficient of Variation 5.4 |
| Sitagliptin | Change in Biochemistry Parameter: Albumin - Ratio to Baseline | 1.01 Ratio of albumin | Geometric Coefficient of Variation 4.8 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Biochemistry Parameter: Alkaline Phosphatase - Ratio to Baseline | 0.92 Ratio of alkaline phosphatase | Geometric Coefficient of Variation 31.3 |
| Semaglutide 1.0 mg | Change in Biochemistry Parameter: Alkaline Phosphatase - Ratio to Baseline | 0.91 Ratio of alkaline phosphatase | Geometric Coefficient of Variation 15.3 |
| Sitagliptin | Change in Biochemistry Parameter: Alkaline Phosphatase - Ratio to Baseline | 0.92 Ratio of alkaline phosphatase | Geometric Coefficient of Variation 20.1 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Biochemistry Parameter: Amylase - Ratio to Baseline | 1.17 Ratio of amylase | Geometric Coefficient of Variation 30.6 |
| Semaglutide 1.0 mg | Change in Biochemistry Parameter: Amylase - Ratio to Baseline | 1.19 Ratio of amylase | Geometric Coefficient of Variation 23.6 |
| Sitagliptin | Change in Biochemistry Parameter: Amylase - Ratio to Baseline | 1.10 Ratio of amylase | Geometric Coefficient of Variation 22.5 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Biochemistry Parameter: Aspartate Aminotransferase - Ratio to Baseline | 0.92 Ratio of aspartate aminotransferase | Geometric Coefficient of Variation 36.9 |
| Semaglutide 1.0 mg | Change in Biochemistry Parameter: Aspartate Aminotransferase - Ratio to Baseline | 0.88 Ratio of aspartate aminotransferase | Geometric Coefficient of Variation 36.7 |
| Sitagliptin | Change in Biochemistry Parameter: Aspartate Aminotransferase - Ratio to Baseline | 0.99 Ratio of aspartate aminotransferase | Geometric Coefficient of Variation 29.3 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Biochemistry Parameter: Calcium (Corrected)- Ratio to Baseline | 1.01 Ratio of calcium | Geometric Coefficient of Variation 3.7 |
| Semaglutide 1.0 mg | Change in Biochemistry Parameter: Calcium (Corrected)- Ratio to Baseline | 1.01 Ratio of calcium | Geometric Coefficient of Variation 3.2 |
| Sitagliptin | Change in Biochemistry Parameter: Calcium (Corrected)- Ratio to Baseline | 1.01 Ratio of calcium | Geometric Coefficient of Variation 3.4 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Biochemistry Parameter: Creatine Kinase - Ratio to Baseline | 1.02 Ratio of creatine kinase | Geometric Coefficient of Variation 49.1 |
| Semaglutide 1.0 mg | Change in Biochemistry Parameter: Creatine Kinase - Ratio to Baseline | 0.96 Ratio of creatine kinase | Geometric Coefficient of Variation 41.8 |
| Sitagliptin | Change in Biochemistry Parameter: Creatine Kinase - Ratio to Baseline | 1.07 Ratio of creatine kinase | Geometric Coefficient of Variation 43.5 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Biochemistry Parameter: Creatinine - Ratio to Baseline | 1.08 Ratio of creatinine | Geometric Coefficient of Variation 12.6 |
| Semaglutide 1.0 mg | Change in Biochemistry Parameter: Creatinine - Ratio to Baseline | 1.07 Ratio of creatinine | Geometric Coefficient of Variation 11.7 |
| Sitagliptin | Change in Biochemistry Parameter: Creatinine - Ratio to Baseline | 1.05 Ratio of creatinine | Geometric Coefficient of Variation 12.1 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Biochemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) - Ratio to Baseline | 0.92 Ratio of eGFR | Geometric Coefficient of Variation 14.6 |
| Semaglutide 1.0 mg | Change in Biochemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) - Ratio to Baseline | 0.92 Ratio of eGFR | Geometric Coefficient of Variation 13.6 |
| Sitagliptin | Change in Biochemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) - Ratio to Baseline | 0.94 Ratio of eGFR | Geometric Coefficient of Variation 14 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Biochemistry Parameter: Lipase - Ratio to Baseline | 1.33 Ratio of lipase | Geometric Coefficient of Variation 43.9 |
| Semaglutide 1.0 mg | Change in Biochemistry Parameter: Lipase - Ratio to Baseline | 1.42 Ratio of lipase | Geometric Coefficient of Variation 51.2 |
| Sitagliptin | Change in Biochemistry Parameter: Lipase - Ratio to Baseline | 1.24 Ratio of lipase | Geometric Coefficient of Variation 47.2 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Biochemistry Parameter: Potassium - Ratio to Baseline | 1.01 Ratio of potassium | Geometric Coefficient of Variation 7.7 |
| Semaglutide 1.0 mg | Change in Biochemistry Parameter: Potassium - Ratio to Baseline | 1.00 Ratio of potassium | Geometric Coefficient of Variation 8.4 |
| Sitagliptin | Change in Biochemistry Parameter: Potassium - Ratio to Baseline | 1.00 Ratio of potassium | Geometric Coefficient of Variation 8.5 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Biochemistry Parameter: Sodium - Ratio to Baseline | 1.01 Ratio of sodium | Geometric Coefficient of Variation 1.5 |
| Semaglutide 1.0 mg | Change in Biochemistry Parameter: Sodium - Ratio to Baseline | 1.00 Ratio of sodium | Geometric Coefficient of Variation 1.5 |
| Sitagliptin | Change in Biochemistry Parameter: Sodium - Ratio to Baseline | 1.00 Ratio of sodium | Geometric Coefficient of Variation 1.4 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Biochemistry Parameter: Total Bilirubin - Ratio to Baseline | 0.93 Ratio of total bilirubin | Geometric Coefficient of Variation 32.8 |
| Semaglutide 1.0 mg | Change in Biochemistry Parameter: Total Bilirubin - Ratio to Baseline | 0.93 Ratio of total bilirubin | Geometric Coefficient of Variation 35.4 |
| Sitagliptin | Change in Biochemistry Parameter: Total Bilirubin - Ratio to Baseline | 0.93 Ratio of total bilirubin | Geometric Coefficient of Variation 36.4 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Biochemistry Parameter: Total Calcium - Ratio to Baseline | 1.02 Ratio of total calcium | Geometric Coefficient of Variation 4.4 |
| Semaglutide 1.0 mg | Change in Biochemistry Parameter: Total Calcium - Ratio to Baseline | 1.01 Ratio of total calcium | Geometric Coefficient of Variation 3.8 |
| Sitagliptin | Change in Biochemistry Parameter: Total Calcium - Ratio to Baseline | 1.01 Ratio of total calcium | Geometric Coefficient of Variation 3.9 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Biochemistry Parameter: Total Protein- Ratio to Baseline | 1.01 Ratio of total protein | Geometric Coefficient of Variation 5 |
| Semaglutide 1.0 mg | Change in Biochemistry Parameter: Total Protein- Ratio to Baseline | 1.00 Ratio of total protein | Geometric Coefficient of Variation 5.3 |
| Sitagliptin | Change in Biochemistry Parameter: Total Protein- Ratio to Baseline | 1.01 Ratio of total protein | Geometric Coefficient of Variation 5.2 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Biochemistry Parameter: Urea - Ratio to Baseline | 1.01 Ratio of urea | Geometric Coefficient of Variation 25.6 |
| Semaglutide 1.0 mg | Change in Biochemistry Parameter: Urea - Ratio to Baseline | 1.02 Ratio of urea | Geometric Coefficient of Variation 26.4 |
| Sitagliptin | Change in Biochemistry Parameter: Urea - Ratio to Baseline | 1.01 Ratio of urea | Geometric Coefficient of Variation 23.6 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 0.5 mg | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Systolic blood pressure | -3.4 Millimeters of mercury (mmHg) | Standard Deviation 14.7 |
| Semaglutide 0.5 mg | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure | -0.7 Millimeters of mercury (mmHg) | Standard Deviation 9.4 |
| Semaglutide 1.0 mg | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Systolic blood pressure | -6.5 Millimeters of mercury (mmHg) | Standard Deviation 13.4 |
| Semaglutide 1.0 mg | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure | -1.5 Millimeters of mercury (mmHg) | Standard Deviation 8.7 |
| Sitagliptin | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Systolic blood pressure | -0.9 Millimeters of mercury (mmHg) | Standard Deviation 13.6 |
| Sitagliptin | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Diastolic blood pressure | -0.8 Millimeters of mercury (mmHg) | Standard Deviation 8.5 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in BMI | -1.1 Kilogram per square meter (kg/m^2) | Standard Deviation 1.4 |
| Semaglutide 1.0 mg | Change in BMI | -1.6 Kilogram per square meter (kg/m^2) | Standard Deviation 1.4 |
| Sitagliptin | Change in BMI | -0.1 Kilogram per square meter (kg/m^2) | Standard Deviation 0.9 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Body Weight | -3.0 Kilogram (kg) | Standard Deviation 3.8 |
| Semaglutide 1.0 mg | Change in Body Weight | -4.2 Kilogram (kg) | Standard Deviation 3.7 |
| Sitagliptin | Change in Body Weight | -0.4 Kilogram (kg) | Standard Deviation 2.5 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Calcitonin - Ratio to Baseline | 0.96 Ratio of calcitonin | Geometric Coefficient of Variation 37.5 |
| Semaglutide 1.0 mg | Change in Calcitonin - Ratio to Baseline | 1.00 Ratio of calcitonin | Geometric Coefficient of Variation 44.8 |
| Sitagliptin | Change in Calcitonin - Ratio to Baseline | 0.96 Ratio of calcitonin | Geometric Coefficient of Variation 48.4 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Number Analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Semaglutide 0.5 mg | Change in Clinical Evaluation: ECG | At week 30 | Abnormal, NCS | 81 Participants |
| Semaglutide 0.5 mg | Change in Clinical Evaluation: ECG | At week 0 | Abnormal, CS | 23 Participants |
| Semaglutide 0.5 mg | Change in Clinical Evaluation: ECG | At week 30 | Abnormal, CS | 19 Participants |
| Semaglutide 0.5 mg | Change in Clinical Evaluation: ECG | At week 0 | Normal | 191 Participants |
| Semaglutide 0.5 mg | Change in Clinical Evaluation: ECG | At week 30 | Normal | 162 Participants |
| Semaglutide 0.5 mg | Change in Clinical Evaluation: ECG | At week 0 | Abnormal, NCS | 72 Participants |
| Semaglutide 1.0 mg | Change in Clinical Evaluation: ECG | At week 30 | Normal | 172 Participants |
| Semaglutide 1.0 mg | Change in Clinical Evaluation: ECG | At week 30 | Abnormal, NCS | 74 Participants |
| Semaglutide 1.0 mg | Change in Clinical Evaluation: ECG | At week 0 | Abnormal, NCS | 68 Participants |
| Semaglutide 1.0 mg | Change in Clinical Evaluation: ECG | At week 30 | Abnormal, CS | 18 Participants |
| Semaglutide 1.0 mg | Change in Clinical Evaluation: ECG | At week 0 | Normal | 196 Participants |
| Semaglutide 1.0 mg | Change in Clinical Evaluation: ECG | At week 0 | Abnormal, CS | 26 Participants |
| Sitagliptin | Change in Clinical Evaluation: ECG | At week 30 | Abnormal, CS | 26 Participants |
| Sitagliptin | Change in Clinical Evaluation: ECG | At week 0 | Normal | 185 Participants |
| Sitagliptin | Change in Clinical Evaluation: ECG | At week 0 | Abnormal, NCS | 76 Participants |
| Sitagliptin | Change in Clinical Evaluation: ECG | At week 0 | Abnormal, CS | 29 Participants |
| Sitagliptin | Change in Clinical Evaluation: ECG | At week 30 | Normal | 167 Participants |
| Sitagliptin | Change in Clinical Evaluation: ECG | At week 30 | Abnormal, NCS | 85 Participants |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Number Analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Semaglutide 0.5 mg | Change in Clinical Evaluation: Eye Examinations | At week 0, Left eye | Normal | 202 Participants |
| Semaglutide 0.5 mg | Change in Clinical Evaluation: Eye Examinations | At week 0, Left eye | Abnormal, NCS | 40 Participants |
| Semaglutide 0.5 mg | Change in Clinical Evaluation: Eye Examinations | At week 0, Left eye | Abnormal, CS | 44 Participants |
| Semaglutide 0.5 mg | Change in Clinical Evaluation: Eye Examinations | At week 30, Left eye | Normal | 162 Participants |
| Semaglutide 0.5 mg | Change in Clinical Evaluation: Eye Examinations | At week 30, Left eye | Abnormal, NCS | 26 Participants |
| Semaglutide 0.5 mg | Change in Clinical Evaluation: Eye Examinations | At week 30, Left eye | Abnormal, CS | 42 Participants |
| Semaglutide 0.5 mg | Change in Clinical Evaluation: Eye Examinations | At week 0, Right eye | Normal | 210 Participants |
| Semaglutide 0.5 mg | Change in Clinical Evaluation: Eye Examinations | At week 0, Right eye | Abnormal, NCS | 37 Participants |
| Semaglutide 0.5 mg | Change in Clinical Evaluation: Eye Examinations | At week 0, Right eye | Abnormal, CS | 39 Participants |
| Semaglutide 0.5 mg | Change in Clinical Evaluation: Eye Examinations | At week 52, Right eye | Normal | 161 Participants |
| Semaglutide 0.5 mg | Change in Clinical Evaluation: Eye Examinations | At week 52, Right eye | Abnormal, NCS | 27 Participants |
| Semaglutide 0.5 mg | Change in Clinical Evaluation: Eye Examinations | At week 52, Right eye | Abnormal, CS | 42 Participants |
| Semaglutide 1.0 mg | Change in Clinical Evaluation: Eye Examinations | At week 52, Right eye | Abnormal, CS | 34 Participants |
| Semaglutide 1.0 mg | Change in Clinical Evaluation: Eye Examinations | At week 0, Left eye | Normal | 222 Participants |
| Semaglutide 1.0 mg | Change in Clinical Evaluation: Eye Examinations | At week 0, Right eye | Normal | 222 Participants |
| Semaglutide 1.0 mg | Change in Clinical Evaluation: Eye Examinations | At week 0, Right eye | Abnormal, CS | 37 Participants |
| Semaglutide 1.0 mg | Change in Clinical Evaluation: Eye Examinations | At week 0, Left eye | Abnormal, NCS | 32 Participants |
| Semaglutide 1.0 mg | Change in Clinical Evaluation: Eye Examinations | At week 30, Left eye | Abnormal, CS | 31 Participants |
| Semaglutide 1.0 mg | Change in Clinical Evaluation: Eye Examinations | At week 52, Right eye | Abnormal, NCS | 19 Participants |
| Semaglutide 1.0 mg | Change in Clinical Evaluation: Eye Examinations | At week 0, Left eye | Abnormal, CS | 36 Participants |
| Semaglutide 1.0 mg | Change in Clinical Evaluation: Eye Examinations | At week 0, Right eye | Abnormal, NCS | 31 Participants |
| Semaglutide 1.0 mg | Change in Clinical Evaluation: Eye Examinations | At week 30, Left eye | Abnormal, NCS | 18 Participants |
| Semaglutide 1.0 mg | Change in Clinical Evaluation: Eye Examinations | At week 30, Left eye | Normal | 184 Participants |
| Semaglutide 1.0 mg | Change in Clinical Evaluation: Eye Examinations | At week 52, Right eye | Normal | 180 Participants |
| Sitagliptin | Change in Clinical Evaluation: Eye Examinations | At week 30, Left eye | Normal | 174 Participants |
| Sitagliptin | Change in Clinical Evaluation: Eye Examinations | At week 30, Left eye | Abnormal, NCS | 32 Participants |
| Sitagliptin | Change in Clinical Evaluation: Eye Examinations | At week 52, Right eye | Normal | 172 Participants |
| Sitagliptin | Change in Clinical Evaluation: Eye Examinations | At week 30, Left eye | Abnormal, CS | 41 Participants |
| Sitagliptin | Change in Clinical Evaluation: Eye Examinations | At week 0, Right eye | Normal | 201 Participants |
| Sitagliptin | Change in Clinical Evaluation: Eye Examinations | At week 0, Right eye | Abnormal, NCS | 47 Participants |
| Sitagliptin | Change in Clinical Evaluation: Eye Examinations | At week 52, Right eye | Abnormal, NCS | 31 Participants |
| Sitagliptin | Change in Clinical Evaluation: Eye Examinations | At week 0, Left eye | Normal | 202 Participants |
| Sitagliptin | Change in Clinical Evaluation: Eye Examinations | At week 0, Left eye | Abnormal, NCS | 47 Participants |
| Sitagliptin | Change in Clinical Evaluation: Eye Examinations | At week 0, Right eye | Abnormal, CS | 42 Participants |
| Sitagliptin | Change in Clinical Evaluation: Eye Examinations | At week 0, Left eye | Abnormal, CS | 41 Participants |
| Sitagliptin | Change in Clinical Evaluation: Eye Examinations | At week 52, Right eye | Abnormal, CS | 43 Participants |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Clinical Evaluation: Pulse | 3.7 Beats per minute (beats/min) | Standard Deviation 10.1 |
| Semaglutide 1.0 mg | Change in Clinical Evaluation: Pulse | 3.7 Beats per minute (beats/min) | Standard Deviation 9.4 |
| Sitagliptin | Change in Clinical Evaluation: Pulse | 0.2 Beats per minute (beats/min) | Standard Deviation 9 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Fasting C-peptide - Ratio to Baseline | 1.08 Ratio of fasting C-peptide | Geometric Coefficient of Variation 30.3 |
| Semaglutide 1.0 mg | Change in Fasting C-peptide - Ratio to Baseline | 1.05 Ratio of fasting C-peptide | Geometric Coefficient of Variation 32.4 |
| Sitagliptin | Change in Fasting C-peptide - Ratio to Baseline | 1.0 Ratio of fasting C-peptide | Geometric Coefficient of Variation 32.2 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Fasting Glucagon - Ratio to Baseline | 0.89 Ratio of fasting glucagon | Geometric Coefficient of Variation 32.4 |
| Semaglutide 1.0 mg | Change in Fasting Glucagon - Ratio to Baseline | 0.89 Ratio of fasting glucagon | Geometric Coefficient of Variation 28.1 |
| Sitagliptin | Change in Fasting Glucagon - Ratio to Baseline | 0.93 Ratio of fasting glucagon | Geometric Coefficient of Variation 25 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Fasting HDL Cholesterol - Ratio to Baseline | 1.00 Ratio of fasting HDL cholesterol | Geometric Coefficient of Variation 15.8 |
| Semaglutide 1.0 mg | Change in Fasting HDL Cholesterol - Ratio to Baseline | 1.02 Ratio of fasting HDL cholesterol | Geometric Coefficient of Variation 16.3 |
| Sitagliptin | Change in Fasting HDL Cholesterol - Ratio to Baseline | 1.01 Ratio of fasting HDL cholesterol | Geometric Coefficient of Variation 14.1 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Fasting HOMA-B (Beta-cell Function) - Ratio to Baseline | 1.81 Ratio of fasting HOMA-B | Geometric Coefficient of Variation 57.3 |
| Semaglutide 1.0 mg | Change in Fasting HOMA-B (Beta-cell Function) - Ratio to Baseline | 1.95 Ratio of fasting HOMA-B | Geometric Coefficient of Variation 59.1 |
| Sitagliptin | Change in Fasting HOMA-B (Beta-cell Function) - Ratio to Baseline | 1.25 Ratio of fasting HOMA-B | Geometric Coefficient of Variation 46.1 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Fasting HOMA-IR (Insulin Resistence) - Ratio to Baseline | 0.81 Ratio of fasting HOMA-IR | Geometric Coefficient of Variation 60.9 |
| Semaglutide 1.0 mg | Change in Fasting HOMA-IR (Insulin Resistence) - Ratio to Baseline | 0.74 Ratio of fasting HOMA-IR | Geometric Coefficient of Variation 63.2 |
| Sitagliptin | Change in Fasting HOMA-IR (Insulin Resistence) - Ratio to Baseline | 0.90 Ratio of fasting HOMA-IR | Geometric Coefficient of Variation 52 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Fasting Insulin - Ratio to Baseline | 1.06 Ratio of fasting insulin | Geometric Coefficient of Variation 46.6 |
| Semaglutide 1.0 mg | Change in Fasting Insulin - Ratio to Baseline | 1.03 Ratio of fasting insulin | Geometric Coefficient of Variation 51.2 |
| Sitagliptin | Change in Fasting Insulin - Ratio to Baseline | 1.01 Ratio of fasting insulin | Geometric Coefficient of Variation 41.6 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Fasting LDL Cholesterol - Ratio to Baseline | 0.97 Ratio of fasting LDL cholesterol | Geometric Coefficient of Variation 33.2 |
| Semaglutide 1.0 mg | Change in Fasting LDL Cholesterol - Ratio to Baseline | 0.99 Ratio of fasting LDL cholesterol | Geometric Coefficient of Variation 31.6 |
| Sitagliptin | Change in Fasting LDL Cholesterol - Ratio to Baseline | 1.01 Ratio of fasting LDL cholesterol | Geometric Coefficient of Variation 26.1 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed=participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Fasting Plasma Glucose (FPG) | -2.18 Millimoles per liter (mmol/L) | Standard Deviation 2.5 |
| Semaglutide 1.0 mg | Change in Fasting Plasma Glucose (FPG) | -2.62 Millimoles per liter (mmol/L) | Standard Deviation 2.13 |
| Sitagliptin | Change in Fasting Plasma Glucose (FPG) | -1.0 Millimoles per liter (mmol/L) | Standard Deviation 1.74 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Fasting Proinsulin/Insulin Ratio - Ratio to Baseline | 0.63 Ratio of fasting proinsulin/insulin | Geometric Coefficient of Variation 50.2 |
| Semaglutide 1.0 mg | Change in Fasting Proinsulin/Insulin Ratio - Ratio to Baseline | 0.57 Ratio of fasting proinsulin/insulin | Geometric Coefficient of Variation 52.1 |
| Sitagliptin | Change in Fasting Proinsulin/Insulin Ratio - Ratio to Baseline | 0.80 Ratio of fasting proinsulin/insulin | Geometric Coefficient of Variation 45.4 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Fasting Proinsulin - Ratio to Baseline | 0.68 Ratio of fasting proinsulin | Geometric Coefficient of Variation 62.7 |
| Semaglutide 1.0 mg | Change in Fasting Proinsulin - Ratio to Baseline | 0.59 Ratio of fasting proinsulin | Geometric Coefficient of Variation 65.3 |
| Sitagliptin | Change in Fasting Proinsulin - Ratio to Baseline | 0.81 Ratio of fasting proinsulin | Geometric Coefficient of Variation 58.2 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Fasting Total Cholesterol - Ratio to Baseline | 0.95 Ratio of fasting total cholesterol | Geometric Coefficient of Variation 20.2 |
| Semaglutide 1.0 mg | Change in Fasting Total Cholesterol - Ratio to Baseline | 0.95 Ratio of fasting total cholesterol | Geometric Coefficient of Variation 17.7 |
| Sitagliptin | Change in Fasting Total Cholesterol - Ratio to Baseline | 1.00 Ratio of fasting total cholesterol | Geometric Coefficient of Variation 16.8 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Fasting Triglycerides - Ratio to Baseline | 0.86 Ratio of fasting triglycerides | Geometric Coefficient of Variation 47.5 |
| Semaglutide 1.0 mg | Change in Fasting Triglycerides - Ratio to Baseline | 0.81 Ratio of fasting triglycerides | Geometric Coefficient of Variation 41.9 |
| Sitagliptin | Change in Fasting Triglycerides - Ratio to Baseline | 0.93 Ratio of fasting triglycerides | Geometric Coefficient of Variation 49.1 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Fasting VLDL Cholesterol - Ratio to Baseline | 0.86 Ratio of fasting VLDL cholesterol | Geometric Coefficient of Variation 44.8 |
| Semaglutide 1.0 mg | Change in Fasting VLDL Cholesterol - Ratio to Baseline | 0.82 Ratio of fasting VLDL cholesterol | Geometric Coefficient of Variation 38.8 |
| Sitagliptin | Change in Fasting VLDL Cholesterol - Ratio to Baseline | 0.93 Ratio of fasting VLDL cholesterol | Geometric Coefficient of Variation 46.3 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Free Fatty Acids - Ratio to Baseline | 0.78 Ratio of free fatty acids | Geometric Coefficient of Variation 70.4 |
| Semaglutide 1.0 mg | Change in Free Fatty Acids - Ratio to Baseline | 0.78 Ratio of free fatty acids | Geometric Coefficient of Variation 65.8 |
| Sitagliptin | Change in Free Fatty Acids - Ratio to Baseline | 0.87 Ratio of free fatty acids | Geometric Coefficient of Variation 61.8 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Haematological Parameter: Haematocrit - Ratio to Baseline | 1.00 Ratio of haematocrit | Geometric Coefficient of Variation 6.3 |
| Semaglutide 1.0 mg | Change in Haematological Parameter: Haematocrit - Ratio to Baseline | 1.00 Ratio of haematocrit | Geometric Coefficient of Variation 6.3 |
| Sitagliptin | Change in Haematological Parameter: Haematocrit - Ratio to Baseline | 1.00 Ratio of haematocrit | Geometric Coefficient of Variation 6.3 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Haematological Parameter: Haemoglobin - Ratio to Baseline | 1.00 Ratio of haemoglobin | Geometric Coefficient of Variation 6 |
| Semaglutide 1.0 mg | Change in Haematological Parameter: Haemoglobin - Ratio to Baseline | 1.00 Ratio of haemoglobin | Geometric Coefficient of Variation 5.6 |
| Sitagliptin | Change in Haematological Parameter: Haemoglobin - Ratio to Baseline | 1.00 Ratio of haemoglobin | Geometric Coefficient of Variation 5.4 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Hematological Parameter (Differential Cell Count of Leukocytes): Basophils - Ratio to Baseline | 0.91 Ratio of basophils | Geometric Coefficient of Variation 68.1 |
| Semaglutide 1.0 mg | Change in Hematological Parameter (Differential Cell Count of Leukocytes): Basophils - Ratio to Baseline | 0.80 Ratio of basophils | Geometric Coefficient of Variation 71.3 |
| Sitagliptin | Change in Hematological Parameter (Differential Cell Count of Leukocytes): Basophils - Ratio to Baseline | 0.83 Ratio of basophils | Geometric Coefficient of Variation 69.6 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Hematological Parameter (Differential Cell Count of Leukocytes): Eosinophils - Ratio to Baseline | 0.98 Ratio of eosinophils | Geometric Coefficient of Variation 57.9 |
| Semaglutide 1.0 mg | Change in Hematological Parameter (Differential Cell Count of Leukocytes): Eosinophils - Ratio to Baseline | 1.04 Ratio of eosinophils | Geometric Coefficient of Variation 64.7 |
| Sitagliptin | Change in Hematological Parameter (Differential Cell Count of Leukocytes): Eosinophils - Ratio to Baseline | 1.00 Ratio of eosinophils | Geometric Coefficient of Variation 65.9 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Hematological Parameter (Differential Cell Count of Leukocytes): Lymphocytes - Ratio to Baseline | 1.01 Ratio of lymphocytes | Geometric Coefficient of Variation 22.7 |
| Semaglutide 1.0 mg | Change in Hematological Parameter (Differential Cell Count of Leukocytes): Lymphocytes - Ratio to Baseline | 0.98 Ratio of lymphocytes | Geometric Coefficient of Variation 23.6 |
| Sitagliptin | Change in Hematological Parameter (Differential Cell Count of Leukocytes): Lymphocytes - Ratio to Baseline | 0.97 Ratio of lymphocytes | Geometric Coefficient of Variation 24.2 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Hematological Parameter (Differential Cell Count of Leukocytes): Monocytes - Ratio to Baseline | 0.96 Ratio of monocytes | Geometric Coefficient of Variation 33.7 |
| Semaglutide 1.0 mg | Change in Hematological Parameter (Differential Cell Count of Leukocytes): Monocytes - Ratio to Baseline | 0.98 Ratio of monocytes | Geometric Coefficient of Variation 34.7 |
| Sitagliptin | Change in Hematological Parameter (Differential Cell Count of Leukocytes): Monocytes - Ratio to Baseline | 1.04 Ratio of monocytes | Geometric Coefficient of Variation 36.1 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Hematological Parameter (Differential Cell Count of Leukocytes): Neutrophils - Ratio to Baseline | 1.01 Ratio of neutrophils | Geometric Coefficient of Variation 12.9 |
| Semaglutide 1.0 mg | Change in Hematological Parameter (Differential Cell Count of Leukocytes): Neutrophils - Ratio to Baseline | 1.02 Ratio of neutrophils | Geometric Coefficient of Variation 20.2 |
| Sitagliptin | Change in Hematological Parameter (Differential Cell Count of Leukocytes): Neutrophils - Ratio to Baseline | 1.02 Ratio of neutrophils | Geometric Coefficient of Variation 13.7 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Hematological Parameter: Erythrocytes - Ratio to Baseline | 0.99 Ratio of erythrocytes | Geometric Coefficient of Variation 5.6 |
| Semaglutide 1.0 mg | Change in Hematological Parameter: Erythrocytes - Ratio to Baseline | 0.99 Ratio of erythrocytes | Geometric Coefficient of Variation 5.4 |
| Sitagliptin | Change in Hematological Parameter: Erythrocytes - Ratio to Baseline | 0.99 Ratio of erythrocytes | Geometric Coefficient of Variation 5 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Hematological Parameter: Leukocytes - Ratio to Baseline | 1.03 Ratio of leukocytes | Geometric Coefficient of Variation 21.1 |
| Semaglutide 1.0 mg | Change in Hematological Parameter: Leukocytes - Ratio to Baseline | 1.01 Ratio of leukocytes | Geometric Coefficient of Variation 23.7 |
| Sitagliptin | Change in Hematological Parameter: Leukocytes - Ratio to Baseline | 1.08 Ratio of leukocytes | Geometric Coefficient of Variation 24.9 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Hematological Parameter: Thrombocytes - Ratio to Baseline | 1.01 Ratio of thrombocytes | Geometric Coefficient of Variation 21.3 |
| Semaglutide 1.0 mg | Change in Hematological Parameter: Thrombocytes - Ratio to Baseline | 1.01 Ratio of thrombocytes | Geometric Coefficient of Variation 21.2 |
| Sitagliptin | Change in Hematological Parameter: Thrombocytes - Ratio to Baseline | 0.99 Ratio of thrombocytes | Geometric Coefficient of Variation 17.9 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in High-sensitivity CRP - Ratio to Baseline | 0.73 Ratio of high-sensitivity CRP | Geometric Coefficient of Variation 121.2 |
| Semaglutide 1.0 mg | Change in High-sensitivity CRP - Ratio to Baseline | 0.64 Ratio of high-sensitivity CRP | Geometric Coefficient of Variation 108.6 |
| Sitagliptin | Change in High-sensitivity CRP - Ratio to Baseline | 0.96 Ratio of high-sensitivity CRP | Geometric Coefficient of Variation 128.2 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 0.5 mg | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 4) Convenience of treatment | 0.7 Score on a scale | Standard Deviation 1.6 |
| Semaglutide 0.5 mg | Change in Patient Reported Outcome Questionnaire: DTSQs Score | Total Diabetic Treatment Satisfaction score | 4.9 Score on a scale | Standard Deviation 7.2 |
| Semaglutide 0.5 mg | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 6) Satisfaction with understanding of diabetes | 0.9 Score on a scale | Standard Deviation 1.7 |
| Semaglutide 0.5 mg | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 5) Flexibility of current treatment | 0.7 Score on a scale | Standard Deviation 1.6 |
| Semaglutide 0.5 mg | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 1) Feeling of unacceptably high blood sugars | -1.4 Score on a scale | Standard Deviation 2.2 |
| Semaglutide 0.5 mg | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 8) Satisfaction to continue with present treatment | 0.7 Score on a scale | Standard Deviation 1.6 |
| Semaglutide 0.5 mg | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 3) Satisfaction with treatment | 1.1 Score on a scale | Standard Deviation 1.8 |
| Semaglutide 0.5 mg | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 2) Feeling of unacceptably low blood sugars | -0.1 Score on a scale | Standard Deviation 1.9 |
| Semaglutide 0.5 mg | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 7) Recommending treatment to others | 0.9 Score on a scale | Standard Deviation 1.8 |
| Semaglutide 1.0 mg | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 5) Flexibility of current treatment | 0.8 Score on a scale | Standard Deviation 1.4 |
| Semaglutide 1.0 mg | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 1) Feeling of unacceptably high blood sugars | -1.6 Score on a scale | Standard Deviation 2.2 |
| Semaglutide 1.0 mg | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 2) Feeling of unacceptably low blood sugars | -0.3 Score on a scale | Standard Deviation 2 |
| Semaglutide 1.0 mg | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 3) Satisfaction with treatment | 1.3 Score on a scale | Standard Deviation 1.7 |
| Semaglutide 1.0 mg | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 4) Convenience of treatment | 0.7 Score on a scale | Standard Deviation 1.5 |
| Semaglutide 1.0 mg | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 6) Satisfaction with understanding of diabetes | 0.8 Score on a scale | Standard Deviation 1.5 |
| Semaglutide 1.0 mg | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 7) Recommending treatment to others | 0.9 Score on a scale | Standard Deviation 1.6 |
| Semaglutide 1.0 mg | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 8) Satisfaction to continue with present treatment | 0.7 Score on a scale | Standard Deviation 1.6 |
| Semaglutide 1.0 mg | Change in Patient Reported Outcome Questionnaire: DTSQs Score | Total Diabetic Treatment Satisfaction score | 5.1 Score on a scale | Standard Deviation 6.3 |
| Sitagliptin | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 3) Satisfaction with treatment | 0.7 Score on a scale | Standard Deviation 1.7 |
| Sitagliptin | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 1) Feeling of unacceptably high blood sugars | -1.0 Score on a scale | Standard Deviation 2.2 |
| Sitagliptin | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 7) Recommending treatment to others | 0.7 Score on a scale | Standard Deviation 1.7 |
| Sitagliptin | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 2) Feeling of unacceptably low blood sugars | -0.1 Score on a scale | Standard Deviation 1.7 |
| Sitagliptin | Change in Patient Reported Outcome Questionnaire: DTSQs Score | Total Diabetic Treatment Satisfaction score | 3.7 Score on a scale | Standard Deviation 7.2 |
| Sitagliptin | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 5) Flexibility of current treatment | 0.4 Score on a scale | Standard Deviation 1.5 |
| Sitagliptin | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 4) Convenience of treatment | 0.5 Score on a scale | Standard Deviation 1.8 |
| Sitagliptin | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 8) Satisfaction to continue with present treatment | 0.6 Score on a scale | Standard Deviation 1.6 |
| Sitagliptin | Change in Patient Reported Outcome Questionnaire: DTSQs Score | 6) Satisfaction with understanding of diabetes | 0.7 Score on a scale | Standard Deviation 1.8 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Semaglutide 0.5 mg | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Physical component summary (PCS) | 1.3 Score on a scale | Standard Deviation 5.9 |
| Semaglutide 0.5 mg | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Physical functioning | 0.6 Score on a scale | Standard Deviation 5.6 |
| Semaglutide 0.5 mg | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Role-physical | 1.4 Score on a scale | Standard Deviation 7.6 |
| Semaglutide 0.5 mg | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Bodily pain | 0.6 Score on a scale | Standard Deviation 8.4 |
| Semaglutide 0.5 mg | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | General health | 3.3 Score on a scale | Standard Deviation 8.8 |
| Semaglutide 0.5 mg | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Mental component summary (MCS) | 1.2 Score on a scale | Standard Deviation 8 |
| Semaglutide 0.5 mg | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Social functioning | 1.3 Score on a scale | Standard Deviation 7 |
| Semaglutide 0.5 mg | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Role-emotional | 1.3 Score on a scale | Standard Deviation 8.5 |
| Semaglutide 0.5 mg | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Vitality | 1.2 Score on a scale | Standard Deviation 9.8 |
| Semaglutide 0.5 mg | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Mental health | 0.9 Score on a scale | Standard Deviation 8.7 |
| Semaglutide 1.0 mg | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Vitality | 1.4 Score on a scale | Standard Deviation 10.1 |
| Semaglutide 1.0 mg | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Physical component summary (PCS) | 1.1 Score on a scale | Standard Deviation 6 |
| Semaglutide 1.0 mg | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Mental component summary (MCS) | 0.5 Score on a scale | Standard Deviation 8.4 |
| Semaglutide 1.0 mg | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | General health | 2.9 Score on a scale | Standard Deviation 9.4 |
| Semaglutide 1.0 mg | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Physical functioning | 0.9 Score on a scale | Standard Deviation 7.4 |
| Semaglutide 1.0 mg | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Mental health | 0.4 Score on a scale | Standard Deviation 9.1 |
| Semaglutide 1.0 mg | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Role-emotional | 0.9 Score on a scale | Standard Deviation 8.9 |
| Semaglutide 1.0 mg | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Role-physical | 0.2 Score on a scale | Standard Deviation 6.9 |
| Semaglutide 1.0 mg | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Social functioning | -0.4 Score on a scale | Standard Deviation 7.8 |
| Semaglutide 1.0 mg | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Bodily pain | 0.4 Score on a scale | Standard Deviation 9.9 |
| Sitagliptin | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Role-emotional | 1.0 Score on a scale | Standard Deviation 8.6 |
| Sitagliptin | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Bodily pain | 0.0 Score on a scale | Standard Deviation 9.8 |
| Sitagliptin | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | General health | 2.2 Score on a scale | Standard Deviation 9 |
| Sitagliptin | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Mental component summary (MCS) | 1.5 Score on a scale | Standard Deviation 7.7 |
| Sitagliptin | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Vitality | 1.1 Score on a scale | Standard Deviation 9.1 |
| Sitagliptin | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Social functioning | 0.8 Score on a scale | Standard Deviation 7.6 |
| Sitagliptin | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Physical component summary (PCS) | 0.0 Score on a scale | Standard Deviation 5.8 |
| Sitagliptin | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Mental health | 1.1 Score on a scale | Standard Deviation 7.9 |
| Sitagliptin | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Physical functioning | -0.3 Score on a scale | Standard Deviation 5.5 |
| Sitagliptin | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Role-physical | -0.0 Score on a scale | Standard Deviation 7 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Number Analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Head,Ears,Eyes,Nose, Throat, Neck | Abnormal, CS | 2 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Lymph Node Palpation | Abnormal, CS | 0 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Head,Ears,Eyes,Nose, Throat, Neck | Abnormal, NCS | 9 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Gastrointestinal System | Normal | 251 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Nervous System | Abnormal, NCS | 5 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Head,Ears,Eyes,Nose, Throat, Neck | Normal | 245 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Gastrointestinal System | Abnormal, NCS | 5 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, General Appearance | Abnormal, CS | 2 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Head,Ears,Eyes,Nose, Throat, Neck | Abnormal, CS | 2 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Gastrointestinal System | Abnormal, CS | 0 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Gastrointestinal System | Abnormal, CS | 1 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Head,Ears,Eyes,Nose, Throat, Neck | Abnormal, NCS | 12 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Musculoskeletal System | Normal | 281 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Lymph Node Palpation | Abnormal, NCS | 1 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Head,Ears,Eyes,Nose, Throat, Neck | Normal | 273 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Musculoskeletal System | Abnormal, NCS | 6 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Nervous System | Abnormal, CS | 5 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Skin | Abnormal, CS | 5 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Musculoskeletal System | Abnormal, CS | 0 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Thyroid Gland | Abnormal, CS | 1 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Skin | Abnormal, NCS | 25 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Musculoskeletal System | Normal | 252 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Lymph Node Palpation | Normal | 255 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Skin | Normal | 226 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Musculoskeletal System | Abnormal, NCS | 3 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Nervous System | Normal | 247 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Skin | Abnormal, CS | 6 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Musculoskeletal System | Abnormal, CS | 1 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Thyroid Gland | Abnormal, CS | 1 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Skin | Abnormal, NCS | 28 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Skin | Normal | 253 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Lymph Node Palpation | Abnormal, CS | 1 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Nervous System | Abnormal, NCS | 4 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, General Appearance | Normal | 252 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Lymph Node Palpation | Abnormal, NCS | 2 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Nervous System | Abnormal, CS | 5 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Thyroid Gland | Abnormal, NCS | 2 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Lymph Node Palpation | Normal | 284 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Cardiovascular System | Normal | 276 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, General Appearance | Abnormal, NCS | 3 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Respiratory System | Abnormal, CS | 0 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Cardiovascular System | Abnormal, NCS | 9 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, General Appearance | Abnormal, NCS | 3 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Respiratory System | Abnormal, NCS | 1 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Cardiovascular System | Abnormal, CS | 2 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Thyroid Gland | Abnormal, NCS | 6 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Respiratory System | Normal | 255 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Cardiovascular System | Normal | 245 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, General Appearance | Abnormal, CS | 1 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Cardiovascular System | Abnormal, NCS | 8 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, General Appearance | Normal | 282 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Respiratory System | Abnormal, CS | 0 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Cardiovascular System | Abnormal, CS | 3 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Thyroid Gland | Normal | 280 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Respiratory System | Abnormal, NCS | 0 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Gastrointestinal System | Normal | 280 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Nervous System | Normal | 277 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Respiratory System | Normal | 287 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week -2, Gastrointestinal System | Abnormal, NCS | 6 Participants |
| Semaglutide 0.5 mg | Change in Physical Examination | At week 30, Thyroid Gland | Normal | 253 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Lymph Node Palpation | Abnormal, NCS | 3 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, General Appearance | Normal | 283 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, General Appearance | Abnormal, NCS | 7 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, General Appearance | Abnormal, CS | 0 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, General Appearance | Normal | 250 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, General Appearance | Abnormal, NCS | 3 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, General Appearance | Abnormal, CS | 0 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Nervous System | Normal | 287 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Nervous System | Abnormal, NCS | 1 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Nervous System | Abnormal, CS | 2 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Nervous System | Normal | 250 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Nervous System | Abnormal, NCS | 1 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Nervous System | Abnormal, CS | 2 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Cardiovascular System | Normal | 281 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Cardiovascular System | Abnormal, NCS | 6 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Cardiovascular System | Abnormal, CS | 3 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Cardiovascular System | Normal | 246 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Cardiovascular System | Abnormal, NCS | 4 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Cardiovascular System | Abnormal, CS | 3 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Gastrointestinal System | Normal | 285 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Gastrointestinal System | Abnormal, NCS | 5 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Gastrointestinal System | Abnormal, CS | 0 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Gastrointestinal System | Normal | 250 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Gastrointestinal System | Abnormal, NCS | 2 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Gastrointestinal System | Abnormal, CS | 1 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Musculoskeletal System | Normal | 283 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Musculoskeletal System | Abnormal, NCS | 5 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Musculoskeletal System | Abnormal, CS | 2 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Musculoskeletal System | Normal | 247 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Musculoskeletal System | Abnormal, NCS | 4 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Musculoskeletal System | Abnormal, CS | 2 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Skin | Normal | 252 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Skin | Abnormal, NCS | 37 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Skin | Abnormal, CS | 1 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Skin | Normal | 217 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Skin | Abnormal, NCS | 33 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Skin | Abnormal, CS | 3 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Head,Ears,Eyes,Nose, Throat, Neck | Normal | 281 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Head,Ears,Eyes,Nose, Throat, Neck | Abnormal, NCS | 7 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Head,Ears,Eyes,Nose, Throat, Neck | Abnormal, CS | 2 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Head,Ears,Eyes,Nose, Throat, Neck | Normal | 244 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Head,Ears,Eyes,Nose, Throat, Neck | Abnormal, NCS | 7 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Head,Ears,Eyes,Nose, Throat, Neck | Abnormal, CS | 2 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Respiratory System | Normal | 288 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Respiratory System | Abnormal, NCS | 1 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Respiratory System | Abnormal, CS | 1 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Respiratory System | Normal | 250 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Respiratory System | Abnormal, NCS | 2 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Respiratory System | Abnormal, CS | 1 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Lymph Node Palpation | Normal | 284 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Lymph Node Palpation | Abnormal, NCS | 5 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Lymph Node Palpation | Abnormal, CS | 1 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Lymph Node Palpation | Normal | 250 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Lymph Node Palpation | Abnormal, CS | 0 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Thyroid Gland | Normal | 285 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Thyroid Gland | Abnormal, NCS | 3 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week -2, Thyroid Gland | Abnormal, CS | 2 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Thyroid Gland | Normal | 249 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Thyroid Gland | Abnormal, NCS | 2 Participants |
| Semaglutide 1.0 mg | Change in Physical Examination | At week 30, Thyroid Gland | Abnormal, CS | 2 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Gastrointestinal System | Abnormal, CS | 0 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Lymph Node Palpation | Abnormal, CS | 0 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Head,Ears,Eyes,Nose, Throat, Neck | Abnormal, NCS | 8 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Gastrointestinal System | Abnormal, NCS | 10 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, General Appearance | Abnormal, CS | 1 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Head,Ears,Eyes,Nose, Throat, Neck | Abnormal, CS | 5 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Gastrointestinal System | Normal | 280 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, General Appearance | Normal | 281 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Respiratory System | Normal | 287 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Cardiovascular System | Abnormal, CS | 1 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Thyroid Gland | Normal | 281 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Respiratory System | Abnormal, NCS | 2 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Cardiovascular System | Abnormal, NCS | 10 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, General Appearance | Abnormal, NCS | 5 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Respiratory System | Abnormal, CS | 1 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Cardiovascular System | Abnormal, CS | 2 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Thyroid Gland | Abnormal, CS | 1 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Respiratory System | Normal | 274 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Cardiovascular System | Abnormal, NCS | 10 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Thyroid Gland | Abnormal, NCS | 9 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Respiratory System | Abnormal, NCS | 2 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Cardiovascular System | Normal | 278 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, General Appearance | Abnormal, CS | 1 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Respiratory System | Abnormal, CS | 0 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Nervous System | Abnormal, CS | 3 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Thyroid Gland | Abnormal, NCS | 5 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Lymph Node Palpation | Normal | 285 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Nervous System | Abnormal, NCS | 5 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Thyroid Gland | Abnormal, CS | 0 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Lymph Node Palpation | Abnormal, NCS | 4 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Nervous System | Normal | 268 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, General Appearance | Abnormal, NCS | 8 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Skin | Normal | 254 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Musculoskeletal System | Abnormal, CS | 3 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Lymph Node Palpation | Abnormal, CS | 1 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Skin | Abnormal, NCS | 29 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Musculoskeletal System | Abnormal, NCS | 3 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Nervous System | Abnormal, CS | 3 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Skin | Abnormal, CS | 7 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Musculoskeletal System | Normal | 270 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, General Appearance | Normal | 270 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Skin | Normal | 240 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Musculoskeletal System | Abnormal, CS | 2 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Lymph Node Palpation | Normal | 271 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Skin | Abnormal, NCS | 31 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Musculoskeletal System | Abnormal, NCS | 6 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Nervous System | Abnormal, NCS | 8 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Skin | Abnormal, CS | 5 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Musculoskeletal System | Normal | 282 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Cardiovascular System | Normal | 265 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Head,Ears,Eyes,Nose, Throat, Neck | Normal | 277 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Gastrointestinal System | Abnormal, CS | 1 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Lymph Node Palpation | Abnormal, NCS | 5 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Head,Ears,Eyes,Nose, Throat, Neck | Abnormal, NCS | 7 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Gastrointestinal System | Abnormal, NCS | 11 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Nervous System | Normal | 279 Participants |
| Sitagliptin | Change in Physical Examination | At week -2, Head,Ears,Eyes,Nose, Throat, Neck | Abnormal, CS | 6 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Gastrointestinal System | Normal | 264 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Thyroid Gland | Normal | 270 Participants |
| Sitagliptin | Change in Physical Examination | At week 30, Head,Ears,Eyes,Nose, Throat, Neck | Normal | 263 Participants |
Secondary
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.
Time frame: Week 0, week 30
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Self-measured Plasma Glucose (SMPG) - Mean 7-point Profile | -2.5 Millimoles per liter (mmol/L) | Standard Deviation 2.4 |
| Semaglutide 1.0 mg | Change in Self-measured Plasma Glucose (SMPG) - Mean 7-point Profile | -3.3 Millimoles per liter (mmol/L) | Standard Deviation 2.2 |
| Sitagliptin | Change in Self-measured Plasma Glucose (SMPG) - Mean 7-point Profile | -1.6 Millimoles per liter (mmol/L) | Standard Deviation 2 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals | -1.0 Millimoles per liter (mmol/L) | Standard Deviation 2.2 |
| Semaglutide 1.0 mg | Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals | -1.2 Millimoles per liter (mmol/L) | Standard Deviation 2.1 |
| Sitagliptin | Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals | -0.7 Millimoles per liter (mmol/L) | Standard Deviation 2.2 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Erythrocytes | At week 0 | Negative | 251 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Erythrocytes | At week 0 | Trace | 25 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Erythrocytes | At week 0 | Small | 5 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Erythrocytes | At week 0 | Moderate | 1 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Erythrocytes | At week 0 | Large | 4 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Erythrocytes | At week 30 | Negative | 258 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Erythrocytes | At week 30 | Trace | 18 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Erythrocytes | At week 30 | Small | 4 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Erythrocytes | At week 30 | Moderate | 2 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Erythrocytes | At week 30 | Large | 4 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Erythrocytes | At week 30 | Moderate | 6 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Erythrocytes | At week 0 | Negative | 250 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Erythrocytes | At week 30 | Negative | 259 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Erythrocytes | At week 0 | Large | 8 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Erythrocytes | At week 0 | Trace | 20 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Erythrocytes | At week 30 | Large | 6 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Erythrocytes | At week 30 | Small | 5 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Erythrocytes | At week 0 | Small | 8 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Erythrocytes | At week 30 | Trace | 13 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Erythrocytes | At week 0 | Moderate | 3 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Erythrocytes | At week 30 | Small | 9 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Erythrocytes | At week 0 | Moderate | 3 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Erythrocytes | At week 0 | Large | 3 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Erythrocytes | At week 30 | Negative | 252 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Erythrocytes | At week 30 | Moderate | 1 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Erythrocytes | At week 30 | Trace | 22 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Erythrocytes | At week 0 | Negative | 253 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Erythrocytes | At week 30 | Large | 3 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Erythrocytes | At week 0 | Trace | 19 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Erythrocytes | At week 0 | Small | 9 Participants |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Glucose | At week 0 | Negative | 189 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Glucose | At week 0 | 100-249 | 28 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Glucose | At week 0 | 250-499 | 12 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Glucose | At week 0 | 500-999 | 20 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Glucose | At week 0 | >= 1000 | 37 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Glucose | At week 30 | Negative | 244 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Glucose | At week 30 | 100-249 | 7 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Glucose | At week 30 | 250-499 | 10 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Glucose | At week 30 | 500-999 | 11 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Glucose | At week 30 | >= 1000 | 14 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Glucose | At week 30 | 500-999 | 4 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Glucose | At week 0 | Negative | 187 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Glucose | At week 30 | Negative | 258 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Glucose | At week 0 | >= 1000 | 30 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Glucose | At week 0 | 100-249 | 27 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Glucose | At week 30 | >= 1000 | 7 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Glucose | At week 30 | 250-499 | 5 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Glucose | At week 0 | 250-499 | 20 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Glucose | At week 30 | 100-249 | 15 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Glucose | At week 0 | 500-999 | 25 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Glucose | At week 30 | 250-499 | 5 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Glucose | At week 0 | 500-999 | 21 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Glucose | At week 0 | >= 1000 | 23 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Glucose | At week 30 | Negative | 233 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Glucose | At week 30 | 500-999 | 12 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Glucose | At week 30 | 100-249 | 23 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Glucose | At week 0 | Negative | 176 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Glucose | At week 30 | >= 1000 | 14 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Glucose | At week 0 | 100-249 | 42 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Glucose | At week 0 | 250-499 | 25 Participants |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Ketones | At week 0 | Negative | 267 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Ketones | At week 0 | Trace | 11 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Ketones | At week 0 | 15-39 | 8 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Ketones | At week 0 | 40- 79 | 0 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Ketones | At week 0 | Approximately 80 | 0 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Ketones | At week 0 | >=80 | 0 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Ketones | At week 30 | Negative | 268 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Ketones | At week 30 | Trace | 12 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Ketones | At week 30 | 15-39 | 6 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Ketones | At week 30 | 40- 79 | 0 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Ketones | At week 30 | Approximately 80 | 0 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Ketones | At week 30 | >=80 | 0 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Ketones | At week 30 | >=80 | 0 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Ketones | At week 0 | Negative | 268 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Ketones | At week 30 | Negative | 274 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Ketones | At week 30 | 15-39 | 3 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Ketones | At week 0 | Trace | 17 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Ketones | At week 0 | >=80 | 0 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Ketones | At week 30 | Approximately 80 | 0 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Ketones | At week 0 | 15-39 | 3 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Ketones | At week 30 | Trace | 12 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Ketones | At week 0 | Approximately 80 | 0 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Ketones | At week 0 | 40- 79 | 1 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Ketones | At week 30 | 40- 79 | 0 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Ketones | At week 0 | 40- 79 | 0 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Ketones | At week 0 | Approximately 80 | 1 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Ketones | At week 30 | 40- 79 | 1 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Ketones | At week 0 | >=80 | 0 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Ketones | At week 30 | Negative | 274 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Ketones | At week 30 | Trace | 11 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Ketones | At week 30 | Approximately 80 | 0 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Ketones | At week 0 | Negative | 274 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Ketones | At week 0 | Trace | 9 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Ketones | At week 30 | 15-39 | 1 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Ketones | At week 0 | 15-39 | 3 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Ketones | At week 30 | >=80 | 0 Participants |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: pH | At week 0 | 7 | 13 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: pH | At week 0 | 5.5 | 17 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: pH | At week 0 | 6 | 220 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: pH | At week 0 | 6.5 | 31 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: pH | At week 0 | 5 | 0 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: pH | At week 0 | 7.5 | 3 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: pH | At week 0 | 8 | 0 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: pH | At week 0 | 8.5 | 1 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: pH | At week 0 | >= 9 | 1 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: pH | At week 30 | 5 | 0 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: pH | At week 30 | 5.5 | 16 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: pH | At week 30 | 6 | 209 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: pH | At week 30 | 6.5 | 33 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: pH | At week 30 | 7 | 24 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: pH | At week 30 | 7.5 | 2 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: pH | At week 30 | 8 | 1 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: pH | At week 30 | 8.5 | 1 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: pH | At week 30 | >= 9 | 0 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: pH | At week 30 | >= 9 | 0 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: pH | At week 0 | 5 | 0 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: pH | At week 30 | 5 | 0 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: pH | At week 30 | 7.5 | 3 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: pH | At week 0 | 5.5 | 15 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: pH | At week 30 | 8 | 1 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: pH | At week 30 | 6.5 | 40 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: pH | At week 0 | 6 | 214 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: pH | At week 30 | 5.5 | 21 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: pH | At week 0 | >= 9 | 0 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: pH | At week 0 | 6.5 | 40 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: pH | At week 0 | 8.5 | 0 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: pH | At week 30 | 8.5 | 0 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: pH | At week 0 | 7 | 14 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: pH | At week 30 | 6 | 194 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: pH | At week 30 | 7 | 30 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: pH | At week 0 | 7.5 | 4 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: pH | At week 0 | 8 | 2 Participants |
| Sitagliptin | Change in Urinalysis Parameter: pH | At week 0 | 7.5 | 1 Participants |
| Sitagliptin | Change in Urinalysis Parameter: pH | At week 0 | 8 | 1 Participants |
| Sitagliptin | Change in Urinalysis Parameter: pH | At week 30 | 8.5 | 0 Participants |
| Sitagliptin | Change in Urinalysis Parameter: pH | At week 0 | 8.5 | 1 Participants |
| Sitagliptin | Change in Urinalysis Parameter: pH | At week 0 | >= 9 | 0 Participants |
| Sitagliptin | Change in Urinalysis Parameter: pH | At week 30 | >= 9 | 0 Participants |
| Sitagliptin | Change in Urinalysis Parameter: pH | At week 30 | 5 | 0 Participants |
| Sitagliptin | Change in Urinalysis Parameter: pH | At week 30 | 5.5 | 30 Participants |
| Sitagliptin | Change in Urinalysis Parameter: pH | At week 30 | 8 | 5 Participants |
| Sitagliptin | Change in Urinalysis Parameter: pH | At week 30 | 6 | 201 Participants |
| Sitagliptin | Change in Urinalysis Parameter: pH | At week 0 | 5 | 0 Participants |
| Sitagliptin | Change in Urinalysis Parameter: pH | At week 30 | 7.5 | 5 Participants |
| Sitagliptin | Change in Urinalysis Parameter: pH | At week 0 | 5.5 | 14 Participants |
| Sitagliptin | Change in Urinalysis Parameter: pH | At week 0 | 6 | 222 Participants |
| Sitagliptin | Change in Urinalysis Parameter: pH | At week 30 | 6.5 | 24 Participants |
| Sitagliptin | Change in Urinalysis Parameter: pH | At week 0 | 6.5 | 33 Participants |
| Sitagliptin | Change in Urinalysis Parameter: pH | At week 0 | 7 | 15 Participants |
| Sitagliptin | Change in Urinalysis Parameter: pH | At week 30 | 7 | 22 Participants |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Protein | At week 0 | 100-299 | 6 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Protein | At week 0 | Approximately 300 | 0 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Protein | At week 30 | Approximately 300 | 0 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Protein | At week 30 | 30-99 | 13 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Protein | At week 0 | >=300 | 1 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Protein | At week 30 | 100-299 | 4 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Protein | At week 0 | 30-99 | 17 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Protein | At week 30 | >=300 | 0 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Protein | At week 30 | Negative | 247 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Protein | At week 0 | Trace | 31 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Protein | At week 0 | Negative | 231 Participants |
| Semaglutide 0.5 mg | Change in Urinalysis Parameter: Protein | At week 30 | Trace | 22 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Protein | At week 0 | Trace | 32 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Protein | At week 30 | 100-299 | 4 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Protein | At week 30 | Approximately 300 | 0 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Protein | At week 0 | 100-299 | 4 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Protein | At week 30 | >=300 | 0 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Protein | At week 30 | Trace | 28 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Protein | At week 0 | Approximately 300 | 0 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Protein | At week 0 | Negative | 233 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Protein | At week 0 | >=300 | 2 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Protein | At week 30 | 30-99 | 9 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Protein | At week 30 | Negative | 248 Participants |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter: Protein | At week 0 | 30-99 | 18 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Protein | At week 30 | >=300 | 1 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Protein | At week 0 | Negative | 235 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Protein | At week 0 | Trace | 30 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Protein | At week 0 | 30-99 | 15 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Protein | At week 0 | 100-299 | 6 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Protein | At week 0 | Approximately 300 | 0 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Protein | At week 0 | >=300 | 1 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Protein | At week 30 | Negative | 239 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Protein | At week 30 | Trace | 24 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Protein | At week 30 | 30-99 | 12 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Protein | At week 30 | 100-299 | 11 Participants |
| Sitagliptin | Change in Urinalysis Parameter: Protein | At week 30 | Approximately 300 | 0 Participants |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed=participants with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Urinalysis Parameter - UACR-ratio to Baseline | 0.77 Ratio of UACR | Geometric Coefficient of Variation 83.5 |
| Semaglutide 1.0 mg | Change in Urinalysis Parameter - UACR-ratio to Baseline | 0.69 Ratio of UACR | Geometric Coefficient of Variation 78.4 |
| Sitagliptin | Change in Urinalysis Parameter - UACR-ratio to Baseline | 0.89 Ratio of UACR | Geometric Coefficient of Variation 76 |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 0.5 mg | Change in Waist Circumference | -2.7 Centimeter (cm) | Standard Deviation 5 |
| Semaglutide 1.0 mg | Change in Waist Circumference | -4.0 Centimeter (cm) | Standard Deviation 4.8 |
| Sitagliptin | Change in Waist Circumference | -0.7 Centimeter (cm) | Standard Deviation 4.4 |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 0.5 mg | Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | 3 Episodes |
| Semaglutide 1.0 mg | Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | 7 Episodes |
| Sitagliptin | Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | 5 Episodes |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 0.5 mg | Occurence of Anti-semaglutide Antibodies Cross Reacting With Endogenous GLP-1 (Yes/no) | Yes (positive for antibody) | 0 Participants |
| Semaglutide 0.5 mg | Occurence of Anti-semaglutide Antibodies Cross Reacting With Endogenous GLP-1 (Yes/no) | No (negative for antibody) | 262 Participants |
| Semaglutide 1.0 mg | Occurence of Anti-semaglutide Antibodies Cross Reacting With Endogenous GLP-1 (Yes/no) | Yes (positive for antibody) | 1 Participants |
| Semaglutide 1.0 mg | Occurence of Anti-semaglutide Antibodies Cross Reacting With Endogenous GLP-1 (Yes/no) | No (negative for antibody) | 263 Participants |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Semaglutide 0.5 mg | Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) | At week 0 | Yes (positive for antibody) | 0 Participants |
| Semaglutide 0.5 mg | Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) | At week 0 | No (negative for antibody) | 285 Participants |
| Semaglutide 0.5 mg | Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) | At week 16 | Yes (positive for antibody) | 0 Participants |
| Semaglutide 0.5 mg | Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) | At week 16 | No (negative for antibody) | 285 Participants |
| Semaglutide 0.5 mg | Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) | At week 30 | Yes (positive for antibody) | 0 Participants |
| Semaglutide 0.5 mg | Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) | At week 30 | No (negative for antibody) | 257 Participants |
| Semaglutide 0.5 mg | Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) | At week 35 | Yes (positive for antibody) | 0 Participants |
| Semaglutide 0.5 mg | Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) | At week 35 | No (negative for antibody) | 262 Participants |
| Semaglutide 1.0 mg | Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) | At week 35 | No (negative for antibody) | 264 Participants |
| Semaglutide 1.0 mg | Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) | At week 0 | Yes (positive for antibody) | 0 Participants |
| Semaglutide 1.0 mg | Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) | At week 30 | Yes (positive for antibody) | 0 Participants |
| Semaglutide 1.0 mg | Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) | At week 0 | No (negative for antibody) | 289 Participants |
| Semaglutide 1.0 mg | Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) | At week 35 | Yes (positive for antibody) | 0 Participants |
| Semaglutide 1.0 mg | Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) | At week 16 | Yes (positive for antibody) | 0 Participants |
| Semaglutide 1.0 mg | Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) | At week 30 | No (negative for antibody) | 263 Participants |
| Semaglutide 1.0 mg | Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) | At week 16 | No (negative for antibody) | 290 Participants |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Semaglutide 0.5 mg | Occurence of Anti-semaglutide Antibodies (Yes/no) | At week 0 | Yes (positive for antibody) | 0 Participants |
| Semaglutide 0.5 mg | Occurence of Anti-semaglutide Antibodies (Yes/no) | At week 0 | No (negative for antibody) | 285 Participants |
| Semaglutide 0.5 mg | Occurence of Anti-semaglutide Antibodies (Yes/no) | At week 16 | Yes (positive for antibody) | 1 Participants |
| Semaglutide 0.5 mg | Occurence of Anti-semaglutide Antibodies (Yes/no) | At week 16 | No (negative for antibody) | 284 Participants |
| Semaglutide 0.5 mg | Occurence of Anti-semaglutide Antibodies (Yes/no) | At week 30 | Yes (positive for antibody) | 0 Participants |
| Semaglutide 0.5 mg | Occurence of Anti-semaglutide Antibodies (Yes/no) | At week 30 | No (negative for antibody) | 257 Participants |
| Semaglutide 0.5 mg | Occurence of Anti-semaglutide Antibodies (Yes/no) | At week 35 | Yes (positive for antibody) | 0 Participants |
| Semaglutide 0.5 mg | Occurence of Anti-semaglutide Antibodies (Yes/no) | At week 35 | No (negative for antibody) | 262 Participants |
| Semaglutide 1.0 mg | Occurence of Anti-semaglutide Antibodies (Yes/no) | At week 35 | No (negative for antibody) | 261 Participants |
| Semaglutide 1.0 mg | Occurence of Anti-semaglutide Antibodies (Yes/no) | At week 0 | Yes (positive for antibody) | 1 Participants |
| Semaglutide 1.0 mg | Occurence of Anti-semaglutide Antibodies (Yes/no) | At week 30 | Yes (positive for antibody) | 2 Participants |
| Semaglutide 1.0 mg | Occurence of Anti-semaglutide Antibodies (Yes/no) | At week 0 | No (negative for antibody) | 288 Participants |
| Semaglutide 1.0 mg | Occurence of Anti-semaglutide Antibodies (Yes/no) | At week 35 | Yes (positive for antibody) | 3 Participants |
| Semaglutide 1.0 mg | Occurence of Anti-semaglutide Antibodies (Yes/no) | At week 16 | Yes (positive for antibody) | 0 Participants |
| Semaglutide 1.0 mg | Occurence of Anti-semaglutide Antibodies (Yes/no) | At week 30 | No (negative for antibody) | 261 Participants |
| Semaglutide 1.0 mg | Occurence of Anti-semaglutide Antibodies (Yes/no) | At week 16 | No (negative for antibody) | 290 Participants |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 0.5 mg | Occurence of Cross Reacting Antibodies With in Vitro Neutralising Effect to Endogenous GLP-1 (Yes/no) | Yes (positive for antibody) | 0 Participants |
| Semaglutide 0.5 mg | Occurence of Cross Reacting Antibodies With in Vitro Neutralising Effect to Endogenous GLP-1 (Yes/no) | No (negative for antibody) | 262 Participants |
| Semaglutide 1.0 mg | Occurence of Cross Reacting Antibodies With in Vitro Neutralising Effect to Endogenous GLP-1 (Yes/no) | Yes (positive for antibody) | 0 Participants |
| Semaglutide 1.0 mg | Occurence of Cross Reacting Antibodies With in Vitro Neutralising Effect to Endogenous GLP-1 (Yes/no) | No (negative for antibody) | 264 Participants |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Semaglutide 0.5 mg | Participants With Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | 2 Participants |
| Semaglutide 1.0 mg | Participants With Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | 6 Participants |
| Sitagliptin | Participants With Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | 4 Participants |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 0.5 mg | Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥10% | Yes | 9.7 Percentage of participants |
| Semaglutide 0.5 mg | Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥10% | No | 90.3 Percentage of participants |
| Semaglutide 1.0 mg | Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥10% | Yes | 17.2 Percentage of participants |
| Semaglutide 1.0 mg | Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥10% | No | 82.8 Percentage of participants |
| Sitagliptin | Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥10% | Yes | 0.4 Percentage of participants |
| Sitagliptin | Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥10% | No | 99.6 Percentage of participants |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 0.5 mg | Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥5% | Yes | 36.6 Percentage of participants |
| Semaglutide 0.5 mg | Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥5% | No | 63.4 Percentage of participants |
| Semaglutide 1.0 mg | Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥5% | Yes | 52.7 Percentage of participants |
| Semaglutide 1.0 mg | Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥5% | No | 47.3 Percentage of participants |
| Sitagliptin | Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥5% | Yes | 5.9 Percentage of participants |
| Sitagliptin | Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥5% | No | 94.1 Percentage of participants |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 0.5 mg | 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 | Yes | 66.0 Percentage of participants |
| Semaglutide 0.5 mg | 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 | No | 34.0 Percentage of participants |
| Semaglutide 1.0 mg | 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 | Yes | 76.9 Percentage of participants |
| Semaglutide 1.0 mg | 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 | No | 23.1 Percentage of participants |
| Sitagliptin | 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 | Yes | 33.7 Percentage of participants |
| Sitagliptin | 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 | No | 66.3 Percentage of participants |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 0.5 mg | Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/Mol), AACE Target, (Yes/no) | Yes | 60.4 Percentage of participants |
| Semaglutide 0.5 mg | Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/Mol), AACE Target, (Yes/no) | No | 39.6 Percentage of participants |
| Semaglutide 1.0 mg | Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/Mol), AACE Target, (Yes/no) | Yes | 70.6 Percentage of participants |
| Semaglutide 1.0 mg | Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/Mol), AACE Target, (Yes/no) | No | 29.4 Percentage of participants |
| Sitagliptin | Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/Mol), AACE Target, (Yes/no) | Yes | 31.6 Percentage of participants |
| Sitagliptin | Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/Mol), AACE Target, (Yes/no) | No | 68.4 Percentage of participants |
Secondary
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
Population: Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 0.5 mg | Percentage of Participants Who Achieved HbA1c <7.0% (53 mmol/Mol), ADA Target, (Yes/no) | Yes | 74.5 Percentage of participants |
| Semaglutide 0.5 mg | Percentage of Participants Who Achieved HbA1c <7.0% (53 mmol/Mol), ADA Target, (Yes/no) | No | 25.5 Percentage of participants |
| Semaglutide 1.0 mg | Percentage of Participants Who Achieved HbA1c <7.0% (53 mmol/Mol), ADA Target, (Yes/no) | Yes | 84.0 Percentage of participants |
| Semaglutide 1.0 mg | Percentage of Participants Who Achieved HbA1c <7.0% (53 mmol/Mol), ADA Target, (Yes/no) | No | 16.0 Percentage of participants |
| Sitagliptin | Percentage of Participants Who Achieved HbA1c <7.0% (53 mmol/Mol), ADA Target, (Yes/no) | Yes | 49.6 Percentage of participants |
| Sitagliptin | Percentage of Participants Who Achieved HbA1c <7.0% (53 mmol/Mol), ADA Target, (Yes/no) | No | 50.4 Percentage of participants |
Secondary
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
Population: Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 0.5 mg | Total Number of Treatment Emergent Adverse Events | 729 Events |
| Semaglutide 1.0 mg | Total Number of Treatment Emergent Adverse Events | 788 Events |
| Sitagliptin | Total Number of Treatment Emergent Adverse Events | 596 Events |