| Outcome Measures: |
Primary: Change in Glycated Haemoglobin A1c (HbA1c), Measured in % points, Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)|Change in HbA1c, Measured in mmol/mol, Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38) | Secondary: Change in body weight, Measured in kg, Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)|Change in body weight, Measured in %, Baseline (up to 12 weeks prior to treatment initiation at week 0), 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 at end of study: <8.0% (64 mmol/mol) (yes/no), Number of participants who achieved/not achieved HbA1c level at end of study: \<8.0%, At end of study (week 28 to 38)|HbA1c level at end of study: <7.5% (59 mmol/mol) (yes/no), Number of participants who achieved/not achieved HbA1c level at end of study: \<7.5%, At end of study (week 28 to 38)|HbA1c level at end of study: <7.0% (53 mmol/mol) (yes/no), Number of participants who achieved/not achieved HbA1c level at end of study: \<7.0%, 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 who reported/not reported severe or documented hypoglycaemia, 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 who completed/not completed the study under treatment with semaglutide, At end of study (week 28 to 38)
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| Locations: |
Novo Nordisk Investigational Site, Atherstone, CV9 1EU, United Kingdom|Novo Nordisk Investigational Site, Berkshire, SL2 1HD, United Kingdom|Novo Nordisk Investigational Site, Bradford, BD14 6ES, United Kingdom|Novo Nordisk Investigational Site, Brighton, BN2 3EW, United Kingdom|Novo Nordisk Investigational Site, Camberley, GU16 7UJ, United Kingdom|Novo Nordisk Investigational Site, Cambridgeshire, PE8 6PL, United Kingdom|Novo Nordisk Investigational Site, Chiswick, W4 3JL, United Kingdom|Novo Nordisk Investigational Site, Co Durham, DH9 8AD, United Kingdom|Novo Nordisk Investigational Site, Coventry, CV6 5BG, United Kingdom|Novo Nordisk Investigational Site, Darlington, DL2 1BY, United Kingdom|Novo Nordisk Investigational Site, Dudley, DY1 2HQ, United Kingdom|Novo Nordisk Investigational Site, Durham, DL3 8SQ, United Kingdom|Novo Nordisk Investigational Site, Greenisland, BT38 8TP, United Kingdom|Novo Nordisk Investigational Site, Halifax, HX2 0QL, United Kingdom|Novo Nordisk Investigational Site, Hull, HU3 2RW, United Kingdom|Novo Nordisk Investigational Site, Kettering, NN16 8UZ, United Kingdom|Novo Nordisk Investigational Site, Leicestershire, LE12 6JG, United Kingdom|Novo Nordisk Investigational Site, Leicester, LE3 1HN, United Kingdom|Novo Nordisk Investigational Site, Lincs, LN11 7QU, United Kingdom|Novo Nordisk Investigational Site, London, SW19 2BY, United Kingdom|Novo Nordisk Investigational Site, Machester, M22 4DH, United Kingdom|Novo Nordisk Investigational Site, Manchester, M8 5RB, United Kingdom|Novo Nordisk Investigational Site, Merseyside, CH43 9JW, United Kingdom|Novo Nordisk Investigational Site, Nuneaton, CV10 7DJ, United Kingdom|Novo Nordisk Investigational Site, Rayleigh, SS6 7DY, United Kingdom|Novo Nordisk Investigational Site, Rhyl, LL18 1DA, United Kingdom|Novo Nordisk Investigational Site, South Shields, NE34 6RE, United Kingdom|Novo Nordisk Investigational Site, Southampton, SO30 3JB, United Kingdom|Novo Nordisk Investigational Site, Walton on Thames, Kt12 4HT, United Kingdom|Novo Nordisk Investigational Site, Watford, WD25 7NL, United Kingdom|Novo Nordisk Investigational Site, Wellingborough, NN8 4RW, United Kingdom
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