This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to evaluate efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin and/or TZD (thiazolidinedione) in subjects with type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,231
For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.
Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.
Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.
Change in HbA1c (Glycosylated Haemoglobin) From Baseline
Change in HbA1c from baseline until week 56.Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of randomised semaglutide or sitagliptin.
Time frame: Week 0, week 56
Change in Body Weight From Baseline
Change in body weight from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin.
Time frame: Week 0, week 56
Change in Fasting Plasma Glucose (FPG) From Baseline
Change in fasting plasma glucose from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin.
Time frame: Week 0, week 56
Change in Systolic and Diastolic Blood Pressure From Baseline
Change in systolic and diastolic blood pressure from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin
Time frame: Week 0, week 56
Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From Baseline
Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin. The DTSQs questionnaire was used to assess subjects' treatment satisfaction. This questionnaire contained 8 components and evaluates the diabetes treatment (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings towards the treatment. The result presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction.
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For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.
Novo Nordisk Investigational Site
Buenos Aires, Argentina
Novo Nordisk Investigational Site
CABA, Argentina
Novo Nordisk Investigational Site
CABA, Argentina
Novo Nordisk Investigational Site
Mar del Plata, Argentina
Novo Nordisk Investigational Site
Burgas, Bulgaria
Novo Nordisk Investigational Site
Haskovo, Bulgaria
Novo Nordisk Investigational Site
Petrich, Bulgaria
Novo Nordisk Investigational Site
Rousse, Bulgaria
Novo Nordisk Investigational Site
Sliven, Bulgaria
Novo Nordisk Investigational Site
Smolyan, Bulgaria
...and 131 more locations
Time frame: Week 0, week 56
Subjects Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target (Yes/no)
Subjects who achieved HbA1c ≤6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE) target (yes/no) after week 56 weeks of treatment.
Time frame: After 56 weeks treatment