Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1222-5620 | Other Identifier | World Health Organization (WHO) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by their study doctor. The study will last for about 6 to 8 months. The participants will be asked to complete some questionnaires about their health and their diabetes treatment. Participants will complete these during their normally scheduled visits with their study doctor.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide s.c. once-weekly | Participants will receive semaglutide at the treating physician's discretion as part of the usual clinical practice. The prescription and use of semaglutide is completely independent of this study. Total study duration for the individual patient will be approximately 30 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | Patients will be treated with commercially available semaglutide in a prefilled pen injector (FlexTouch® variant) according to routine local clinical practice at the discretion of the treating physician. Other anti-hyperglycaemic treatments will be prescribed at the physician's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 % |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Participants with type 2 diabetes
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Angers | 37540 | France | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36869853 | Background | Mohammedi K, Belhatem N, Berentzen TL, Catarig AM, Potier L. Once-weekly semaglutide use in patients with type 2 diabetes: Results from the SURE France multicentre, prospective, observational study. Diabetes Obes Metab. 2023 Jul;25(7):1855-1864. doi: 10.1111/dom.15045. Epub 2023 Mar 28. |
Not provided
Not provided
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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) |
| 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 | Bèze | 21310 | France |
| Novo Nordisk Investigational Site | Bourgoin | 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-Saône | 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 | 21000 | France |
| Novo Nordisk Investigational Site | Dijon | 21079 | France |
| Novo Nordisk Investigational Site | Dole | 39100 | France |
| Novo Nordisk Investigational Site | Doudeville | 76560 | France |
| Novo Nordisk Investigational Site | Élancourt | 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 | Montélimar | 26200 | France |
| Novo Nordisk Investigational Site | Montpellier | 34295 | France |
| Novo Nordisk Investigational Site | Nevers | 58000 | France |
| Novo Nordisk Investigational Site | Nice | 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 | Vénissieux | 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591245 | semaglutide |
Not provided
Not provided
Not provided