A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in United Kingdom, as Part of Local Clinical Practice (SURE UK)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Semaglutide 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. |
Drug: Semaglutide
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.
|
Outcome Measures
Primary Outcome Measures
- Change in Glycated Haemoglobin A1c (HbA1c) [Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)]
Measured in % points
- Change in HbA1c [Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)]
Measured in mmol/mol
Secondary Outcome Measures
- Change in body weight [Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)]
Measured in kg
- Change in body weight [Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)]
Measured in %
- Change in waist circumference [Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)]
Measured in cm
- HbA1c level at end of study: <8.0% (64 mmol/mol) (yes/no) [At end of study (week 28 to 38)]
Number of participants who achieved/not achieved HbA1c level at end of study: <8.0%
- HbA1c level at end of study: <7.5% (59 mmol/mol) (yes/no) [At end of study (week 28 to 38)]
Number of participants who achieved/not achieved HbA1c level at end of study: <7.5%
- HbA1c level at end of study: <7.0% (53 mmol/mol) (yes/no) [At end of study (week 28 to 38)]
Number of participants who achieved/not achieved HbA1c level at end of study: <7.0%
- Reduction in HbA1c of 1.0% point or more (yes/no) [Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)]
Number of participants who achieved/not achieved reduction in HbA1c of 1.0% point or more
- Weight reduction of 3.0% or more (yes/no) [Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)]
Number of participants who achieved/not achieved weight reduction of 3.0% or more
- Weight reduction of 5.0% or more (yes/no) [Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)]
Number of participants who achieved/not achieved weight reduction of 5.0% or more
- HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more (yes/no) [Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)]
Number of participants who achieved/not achieved HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more
- Patient reported severe or documented hypoglycaemia (yes/no) [Between baseline (week 0), end of study (week 28-38)]
Number of patients who reported/not reported severe or documented hypoglycaemia
- Change in score for Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) (absolute treatment satisfaction): Total treatment satisfaction [Baseline (week 0), end of study (week 28 to 38)]
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.
- Change in score for Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) (relative treatment satisfaction): Total treatment satisfaction [Baseline (week 0), end of study (week 28 to 38)]
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
- Change in score for Short Form (SF)-36 v2: Physical summary component [Baseline (week 0), end of study (week 28 to 38)]
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).
- Change in score for SF-36 v2: Mental summary component [Baseline (week 0), end of study (week 28 to 38)]
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).
- Patient completed the study under treatment with semaglutide (yes/no) [At end of study (week 28 to 38)]
Number of patients who completed/not completed the study under treatment with semaglutide
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
-
The decision to initiate treatment with commercially available semaglutide has been made by the patient/Legally Acceptable Representative and the treating physician before and independently from the decision to include the patient in this study
-
Male or female, age greater than or equal to 18 years at the time of signing informed consent
-
Diagnosed with type 2 diabetes at least 12 weeks prior to inclusion
-
Available and documented haemoglobin A1c (HbA1c) value less than or equal to 12 weeks prior to initiation of semaglutide treatment
Exclusion Criteria:
-
Previous participation in this study. Participation is defined as having given informed consent in this study
-
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
-
Treatment with any investigational drug within 90 days prior to enrolment into the study
-
Hypersensitivity to semaglutide or to any of the excipients
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Atherstone | United Kingdom | CV9 1EU | |
| 2 | Novo Nordisk Investigational Site | Berkshire | United Kingdom | SL2 1HD | |
| 3 | Novo Nordisk Investigational Site | Bradford | United Kingdom | BD14 6ES | |
| 4 | Novo Nordisk Investigational Site | Brighton | United Kingdom | BN2 3EW | |
| 5 | Novo Nordisk Investigational Site | Camberley | United Kingdom | GU16 7UJ | |
| 6 | Novo Nordisk Investigational Site | Cambridgeshire | United Kingdom | PE8 6PL | |
| 7 | Novo Nordisk Investigational Site | Chiswick | United Kingdom | W4 3JL | |
| 8 | Novo Nordisk Investigational Site | Co Durham | United Kingdom | DH9 8AD | |
| 9 | Novo Nordisk Investigational Site | Coventry | United Kingdom | CV6 5BG | |
| 10 | Novo Nordisk Investigational Site | Darlington | United Kingdom | DL2 1BY | |
| 11 | Novo Nordisk Investigational Site | Dudley | United Kingdom | DY1 2HQ | |
| 12 | Novo Nordisk Investigational Site | Durham | United Kingdom | DL3 8SQ | |
| 13 | Novo Nordisk Investigational Site | Greenisland | United Kingdom | BT38 8TP | |
| 14 | Novo Nordisk Investigational Site | Halifax | United Kingdom | HX2 0QL | |
| 15 | Novo Nordisk Investigational Site | Hull | United Kingdom | HU3 2RW | |
| 16 | Novo Nordisk Investigational Site | Kettering | United Kingdom | NN16 8UZ | |
| 17 | Novo Nordisk Investigational Site | Leicestershire | United Kingdom | LE12 6JG | |
| 18 | Novo Nordisk Investigational Site | Leicester | United Kingdom | LE3 1HN | |
| 19 | Novo Nordisk Investigational Site | Lincs | United Kingdom | LN11 7QU | |
| 20 | Novo Nordisk Investigational Site | London | United Kingdom | SW19 2BY | |
| 21 | Novo Nordisk Investigational Site | Machester | United Kingdom | M22 4DH | |
| 22 | Novo Nordisk Investigational Site | Manchester | United Kingdom | M8 5RB | |
| 23 | Novo Nordisk Investigational Site | Merseyside | United Kingdom | CH43 9JW | |
| 24 | Novo Nordisk Investigational Site | Nuneaton | United Kingdom | CV10 7DJ | |
| 25 | Novo Nordisk Investigational Site | Rayleigh | United Kingdom | SS6 7DY | |
| 26 | Novo Nordisk Investigational Site | Rhyl | United Kingdom | LL18 1DA | |
| 27 | Novo Nordisk Investigational Site | South Shields | United Kingdom | NE34 6RE | |
| 28 | Novo Nordisk Investigational Site | Southampton | United Kingdom | SO30 3JB | |
| 29 | Novo Nordisk Investigational Site | Walton on Thames | United Kingdom | Kt12 4HT | |
| 30 | Novo Nordisk Investigational Site | Watford | United Kingdom | WD25 7NL | |
| 31 | Novo Nordisk Investigational Site | Wellingborough | United Kingdom | NN8 4RW |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NN9535-4366
- U1111-1199-9050