| Outcome Measures: |
Primary: Change in Glycated Haemoglobin A1c (HbA1c), Measured in % point, Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)|Change in Glycated Haemoglobin A1c (HbA1c), Measured in mmol/mol, Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38) | Secondary: Change in body weight, Measured in kg, Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)|Change in body weight, Measured in %, Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)|Change in waist circumference, Measured in cm, Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)|HbA1c level below 8.0% (64 mmol/mol) (yes/no), Number of participants, At end of study (week 28 to 38)|HbA1c level at end of study: below 7.5% (59 mmol/mol) (yes/no), Number of participants, At end of study (week 28 to 38)|HbA1c level at end of study: below 7.0% (53 mmol/mol) (yes/no), Number of participants, At end of study (week 28 to 38)|Reduction in HbA1c of 1.0% point or more (yes/no), Number of participants who achieved/not achieved reduction in HbA1c of 1.0% point or more, Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)|Weight reduction of 3.0% or more (yes/no), Number of participants who achieved/not achieved weight reduction of 3.0% or more, Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)|Weight reduction of 5.0% or more (yes/no), Number of participants who achieved/not achieved weight reduction of 5.0% or more, Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)|HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more (yes/no), Number of participants who achieved/not achieved HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more, Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)|Patient reported severe or documented hypoglycaemia (yes/no), Number of patients, Between baseline (week 0), end of study (week 28-38)|Change in score for Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) (absolute treatment satisfaction): Total treatment satisfaction, The status version (DTSQs) provides a measure of how satisfied patients are with their current diabetes treatment. It consists of 8 questions, which are to be answered on a Likert scale from 0 to 6 (0 = very dissatisfied to 6 = very satisfied). Six questions are summed to produce a total Treatment Satisfaction score. The remaining two questions are concerning perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia, respectively, Baseline (week 0), end of study (week 28 to 38)|Change in score for Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) (relative treatment satisfaction): Total treatment satisfaction, The change version (DTSQc) has the same 8 items as the status version, but is reworded to direct the patients to compare the experience of the current treatment with the experience of previous treatment. Each question is scored on a scale of -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change, Baseline (week 0), end of study (week 28 to 38)|Change in score for Short Form (SF)-36 v2: Physical summary component, The SF-36®v2 questionnaire has 36 questions grouped into eight domains termed: physical functioning, bodily pain, role-physical, general health, vitality, social functioning, role-emotional and mental health, which again can be combined to give two summary component scores (overall mental- and physical health)., Baseline (week 0), end of study (week 28 to 38)|Change in score for SF-36 v2: Mental summary component, The SF-36®v2 questionnaire has 36 questions grouped into eight domains termed: physical functioning, bodily pain, role-physical, general health, vitality, social functioning, role-emotional and mental health, which again can be combined to give two summary component scores (overall mental- and physical health)., Baseline (week 0), end of study (week 28 to 38)|Patient completed the study under treatment with semaglutide (yes/no), Number of patients, At end of study (week 28 to 38)
|
| Locations: |
Novo Nordisk Investigational Site, Alkmaar, 1815 JD, Netherlands|Novo Nordisk Investigational Site, Almelo, 7609PT, Netherlands|Novo Nordisk Investigational Site, Almere, 1328 MB, Netherlands|Novo Nordisk Investigational Site, Amersfoort, 3813 TZ, Netherlands|Novo Nordisk Investigational Site, Arnhem, 6815 AD, Netherlands|Novo Nordisk Investigational Site, Bladel, 5531HG, Netherlands|Novo Nordisk Investigational Site, Den Bosch, 5223 KE, Netherlands|Novo Nordisk Investigational Site, Den Haag, 2585EJ, Netherlands|Novo Nordisk Investigational Site, Dordrecht, 3318 AT, Netherlands|Novo Nordisk Investigational Site, Eindhoven, 5623 EJ, Netherlands|Novo Nordisk Investigational Site, Eindhoven, 5631 BM, Netherlands|Novo Nordisk Investigational Site, Emmen, 7811 GW, Netherlands|Novo Nordisk Investigational Site, Enschede, 7544 BA, Netherlands|Novo Nordisk Investigational Site, Gemert, 5421DB, Netherlands|Novo Nordisk Investigational Site, Groningen, 9713 GZ, Netherlands|Novo Nordisk Investigational Site, Heerlen, 6417VV, Netherlands|Novo Nordisk Investigational Site, Hoogeveen, 7909 AA, Netherlands|Novo Nordisk Investigational Site, Leiden, 2332AA, Netherlands|Novo Nordisk Investigational Site, Montfort, 6065 AM, Netherlands|Novo Nordisk Investigational Site, Nijverdal, 7442 LS, Netherlands|Novo Nordisk Investigational Site, Rotterdam, 3083 AN, Netherlands|Novo Nordisk Investigational Site, Sint Anthonis, 5845BL, Netherlands|Novo Nordisk Investigational Site, Utrecht, 3584 CX, Netherlands|Novo Nordisk Investigational Site, Warmenhuizen, 1749 AM, Netherlands|Novo Nordisk Investigational Site, Zaandam, 1506WR, Netherlands|Novo Nordisk Investigational Site, Zevenbergen, 4761 NG, Netherlands|Novo Nordisk Investigational Site, Zwijndrecht, 3331 LZ, Netherlands
|
