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Clinical Trial Details

Trial ID: L5842
Source ID: NCT04261933
Associated Drug: Semaglutide
Title: A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice (SURE GERMANY)
Acronym: SURE GERMANY
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: semaglutide
Outcome Measures: Primary: Change in Glycated Haemoglobin A1c (HbA1c), Percent point, Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)|Change in HbA1c, 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 (kg), kg, Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)|Change in body weight (%), Percent, Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)|Change in waist circumference, cm, Baseline (up to 12 weeks prior to treatment initiation (week 0) to 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), Count, 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), Count, At end of study (week 28 to 38)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 789
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2020-02-13
Completion Date: 2021-05-25
Results First Posted:
Last Update Posted: 2023-03-28
Locations: Novo Nordisk Investigational Site, Amberg, 92224, Germany|Novo Nordisk Investigational Site, Aschaffenburg, 63739, Germany|Novo Nordisk Investigational Site, Augsburg, 86179, Germany|Novo Nordisk Investigational Site, Bad Mergentheim, 97980, Germany|Novo Nordisk Investigational Site, Bad Oeynhausen, 32549, Germany|Novo Nordisk Investigational Site, Bautzen, 02625, Germany|Novo Nordisk Investigational Site, Berlin, 10115, Germany|Novo Nordisk Investigational Site, Berlin, 12247, Germany|Novo Nordisk Investigational Site, Berlin, 13086, Germany|Novo Nordisk Investigational Site, Berlin, 13597, Germany|Novo Nordisk Investigational Site, Berlin, 14169, Germany|Novo Nordisk Investigational Site, Bernau bei Berlin, 16321, Germany|Novo Nordisk Investigational Site, Bonn, 53113, Germany|Novo Nordisk Investigational Site, Bramsche, 49565, Germany|Novo Nordisk Investigational Site, Darmstadt, 64283, Germany|Novo Nordisk Investigational Site, Dessau-Roßlau, 06844, Germany|Novo Nordisk Investigational Site, Dresden, 01277, Germany|Novo Nordisk Investigational Site, Dresden, 01279, Germany|Novo Nordisk Investigational Site, Duisburg, 47051, Germany|Novo Nordisk Investigational Site, Eisenach, 99817, Germany|Novo Nordisk Investigational Site, Elsterwerda, 04910, Germany|Novo Nordisk Investigational Site, Erdmannhausen, 71729, Germany|Novo Nordisk Investigational Site, Erlangen, 91052, Germany|Novo Nordisk Investigational Site, Essen, 45279, Germany|Novo Nordisk Investigational Site, Essen, 45335, Germany|Novo Nordisk Investigational Site, Forst (Lausitz), 03149, Germany|Novo Nordisk Investigational Site, Freisen, 66629, Germany|Novo Nordisk Investigational Site, Friedrichsthal, 66299, Germany|Novo Nordisk Investigational Site, Fulda, 36037, Germany|Novo Nordisk Investigational Site, Gebhardshain, 57580, Germany|Novo Nordisk Investigational Site, Gelnhausen, 63571, Germany|Novo Nordisk Investigational Site, Grasleben, 38368, Germany|Novo Nordisk Investigational Site, Großröhrsdorf, 01900, Germany|Novo Nordisk Investigational Site, Grünstadt, 67269, Germany|Novo Nordisk Investigational Site, Hainburg, 63512, Germany|Novo Nordisk Investigational Site, Halle (Saale), 06128, Germany|Novo Nordisk Investigational Site, Hamburg, 20097, Germany|Novo Nordisk Investigational Site, Hammelburg, 97762, Germany|Novo Nordisk Investigational Site, Hannover, 30165, Germany|Novo Nordisk Investigational Site, Heidenheim an der Brenz, 89518, Germany|Novo Nordisk Investigational Site, Herrenberg, 71083, Germany|Novo Nordisk Investigational Site, Hof, 95030, Germany|Novo Nordisk Investigational Site, Hohenmölsen, 06679, Germany|Novo Nordisk Investigational Site, Jena, 07743, Germany|Novo Nordisk Investigational Site, Kempten (Allgäu), 87439, Germany|Novo Nordisk Investigational Site, Köln, 50674, Germany|Novo Nordisk Investigational Site, Köln, 50968, Germany|Novo Nordisk Investigational Site, Leipzig, 04159, Germany|Novo Nordisk Investigational Site, Lichtenfels, 96215, Germany|Novo Nordisk Investigational Site, Lingen, 49808, Germany|Novo Nordisk Investigational Site, Ludwigsburg, 71634, Germany|Novo Nordisk Investigational Site, Magdeburg, 39104, Germany|Novo Nordisk Investigational Site, Marburg, 35037, Germany|Novo Nordisk Investigational Site, Marburg, 35039, Germany|Novo Nordisk Investigational Site, Mayen, 56727, Germany|Novo Nordisk Investigational Site, Meckesheim, 74909, Germany|Novo Nordisk Investigational Site, Mössingen, 72116, Germany|Novo Nordisk Investigational Site, Mühldorf Am Inn, 84453, Germany|Novo Nordisk Investigational Site, Mülheim, 45468, Germany|Novo Nordisk Investigational Site, München, 80331, Germany|Novo Nordisk Investigational Site, München, 81477, Germany|Novo Nordisk Investigational Site, Münster, 48153, Germany|Novo Nordisk Investigational Site, Neustrelitz, 17235, Germany|Novo Nordisk Investigational Site, Nürnberg, 90480, Germany|Novo Nordisk Investigational Site, Oranienburg, 16515, Germany|Novo Nordisk Investigational Site, Osnabrück, 49080, Germany|Novo Nordisk Investigational Site, Otterbach, 67731, Germany|Novo Nordisk Investigational Site, Pohlheim, 35415, Germany|Novo Nordisk Investigational Site, Rellingen, 25462, Germany|Novo Nordisk Investigational Site, Rostock, 18109, Germany|Novo Nordisk Investigational Site, Saint Ingbert-Oberwürzbach, 66386, Germany|Novo Nordisk Investigational Site, Schorndorf, 73614, Germany|Novo Nordisk Investigational Site, Schwerin, 19053, Germany|Novo Nordisk Investigational Site, Schönhausen (Elbe), 39524, Germany|Novo Nordisk Investigational Site, Seelow, 15306, Germany|Novo Nordisk Investigational Site, Soltau, 29614, Germany|Novo Nordisk Investigational Site, Sonsbeck, 47665, Germany|Novo Nordisk Investigational Site, Speyer, 67346, Germany|Novo Nordisk Investigational Site, Spremberg, 03130, Germany|Novo Nordisk Investigational Site, Stadtbergen, 86391, Germany|Novo Nordisk Investigational Site, Straubing, 94315, Germany|Novo Nordisk Investigational Site, Stuttgart, 70184, Germany|Novo Nordisk Investigational Site, Stuttgart, 70378, Germany|Novo Nordisk Investigational Site, Trier, 54292, Germany|Novo Nordisk Investigational Site, Ulm, 89073, Germany|Novo Nordisk Investigational Site, Viersen, 41747, Germany|Novo Nordisk Investigational Site, Villingen-Schwenningen, 78048, Germany|Novo Nordisk Investigational Site, Villingen-Schwenningen, 78054, Germany|Novo Nordisk Investigational Site, Wedemark, 30900, Germany|Novo Nordisk Investigational Site, Wetzlar, 35578, Germany|Novo Nordisk Investigational Site, Wiesloch, 69168, Germany|Novo Nordisk Investigational Site, Witzenhausen, 37213, Germany|Novo Nordisk Investigational Site, Wolmirstedt, 39326, Germany|Novo Nordisk Investigational Site, Wurzen, 04808, Germany|Novo Nordisk Investigational Site, Zwenkau, 04442, Germany
URL: https://clinicaltrials.gov/show/NCT04261933