| 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 below 7.5% (59 mmol/mol) (yes/no), Number of participants, At end of study (week 28 to 38)|HbA1c level 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 participants, 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 participants, At end of study (week 28 to 38)
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| Locations: |
Novo Nordisk Investigational Site, Angers, 37540, France|Novo Nordisk Investigational Site, Annecy, 74600, France|Novo Nordisk Investigational Site, Auffay, 76720, France|Novo Nordisk Investigational Site, Avignon, 84902, France|Novo Nordisk Investigational Site, Besançon, 25000, France|Novo Nordisk Investigational Site, Bethoncourt, 25200, France|Novo Nordisk Investigational Site, Beze, 21310, France|Novo Nordisk Investigational Site, Bourgoin-jallieu, 38302, France|Novo Nordisk Investigational Site, Bry sur Marne, 94360, France|Novo Nordisk Investigational Site, Caen, 14033, France|Novo Nordisk Investigational Site, Challes les Eaux, 73190, France|Novo Nordisk Investigational Site, Chalon sur Saone, 71100, France|Novo Nordisk Investigational Site, Chalons Sur Saone, 71100, France|Novo Nordisk Investigational Site, Charleville-Mézières, 08000, France|Novo Nordisk Investigational Site, Chelles, 77500, France|Novo Nordisk Investigational Site, Clichy, 92110, France|Novo Nordisk Investigational Site, Colmar, 68000, France|Novo Nordisk Investigational Site, Colmar, 68024, France|Novo Nordisk Investigational Site, DIJON cedex, 21079, France|Novo Nordisk Investigational Site, Dijon, 21000, France|Novo Nordisk Investigational Site, Dole, 39100, France|Novo Nordisk Investigational Site, Doudeville, 76560, France|Novo Nordisk Investigational Site, Elancourt, 78990, France|Novo Nordisk Investigational Site, Guiscard, 60640, France|Novo Nordisk Investigational Site, La Bouëxière, 35340, France|Novo Nordisk Investigational Site, La Madeleine, 59110, France|Novo Nordisk Investigational Site, Lambersart, 59130, France|Novo Nordisk Investigational Site, Le Puy en Velay, 43000, France|Novo Nordisk Investigational Site, Lomme, 59462, France|Novo Nordisk Investigational Site, Lyon, 69007, France|Novo Nordisk Investigational Site, Maison-Alfort, 94700, France|Novo Nordisk Investigational Site, Marseille, 13006, France|Novo Nordisk Investigational Site, MONTPELLIER cedex 5, 34295, France|Novo Nordisk Investigational Site, Montélimar, 26200, France|Novo Nordisk Investigational Site, Nevers, 58000, France|Novo Nordisk Investigational Site, NICE cedex 3, 06202, France|Novo Nordisk Investigational Site, Noisy le Grand, 93160, France|Novo Nordisk Investigational Site, Orry-la-ville, 60560, France|Novo Nordisk Investigational Site, Paris, 75010, France|Novo Nordisk Investigational Site, Paris, 75014, France|Novo Nordisk Investigational Site, Paris, 75877, France|Novo Nordisk Investigational Site, Pessac, 33600, France|Novo Nordisk Investigational Site, Pierre-Bénite, 69495, France|Novo Nordisk Investigational Site, Six Fours les plages, 83140, France|Novo Nordisk Investigational Site, Ste Foy Lès Lyon, 69110, France|Novo Nordisk Investigational Site, Strasbourg, 67000, France|Novo Nordisk Investigational Site, Toulouse, 31300, France|Novo Nordisk Investigational Site, Tours, 37000, France|Novo Nordisk Investigational Site, Valence, 26000, France|Novo Nordisk Investigational Site, Venissieux, 69200, France|Novo Nordisk Investigational Site, Vichy, 03207, France|Novo Nordisk Investigational Site, Vienne, 38500, France|Novo Nordisk Investigational Site, Vitré, 35500, France|Novo Nordisk Investigational Site, Yerres, 91330, France
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