A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Denmark and Sweden, as Part of Local Clinical Practice (SURE DENMARK/SWEDEN)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

SURE DENMARK/SWEDEN: A Multi-centre, Prospective, Non-interventional Study Investigating the Effectiveness of Once-weekly Subcutaneous Semaglutide in a Real World Adult Population With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03648281
• Other study ID #: NN9535-4367
• Secondary ID: U1111-1204-5181
• Status: Completed
• Start date: August 24, 2018
• Est. completion date: January 10, 2020

Study information

• Verified date: November 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by the study doctor. The study will last for about 6 to 8 months. Participants will be asked to complete some questionnaires about their health and diabetes treatment. Participants will complete these questionnaires during their normally scheduled visits with the study doctor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: January 10, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Denmark	Novo Nordisk Investigational Site	Søborg
Sweden	Novo Nordisk Investigational Site	Åkersberga
Sweden	Novo Nordisk Investigational Site	Ängelholm
Sweden	Novo Nordisk Investigational Site	Avesta
Sweden	Novo Nordisk Investigational Site	Bjärred
Sweden	Novo Nordisk Investigational Site	Bollnäs
Sweden	Novo Nordisk Investigational Site	Charlottenberg
Sweden	Novo Nordisk Investigational Site	Eslöv
Sweden	Novo Nordisk Investigational Site	Falköping
Sweden	Novo Nordisk Investigational Site	Flen
Sweden	Novo Nordisk Investigational Site	Göteborg
Sweden	Novo Nordisk Investigational Site	Härnösand
Sweden	Novo Nordisk Investigational Site	Helsingborg
Sweden	Novo Nordisk Investigational Site	Huskvarna
Sweden	Novo Nordisk Investigational Site	Karlskoga
Sweden	Novo Nordisk Investigational Site	Kungsbacka
Sweden	Novo Nordisk Investigational Site	Laholm
Sweden	Novo Nordisk Investigational Site	Luleå
Sweden	Novo Nordisk Investigational Site	Lund
Sweden	Novo Nordisk Investigational Site	Mölndal
Sweden	Novo Nordisk Investigational Site	Nässjö
Sweden	Novo Nordisk Investigational Site	Nybro
Sweden	Novo Nordisk Investigational Site	Örebro
Sweden	Novo Nordisk Investigational Site	Sala
Sweden	Novo Nordisk Investigational Site	Staffanstorp
Sweden	Novo Nordisk Investigational Site	Stockholm
Sweden	Novo Nordisk Investigational Site	Sundsvall
Sweden	Novo Nordisk Investigational Site	Uddevalla
Sweden	Novo Nordisk Investigational Site	Upplands Väsby
Sweden	Novo Nordisk Investigational Site	Västerås

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Denmark,  Sweden, 

References & Publications (1)

Rajamand Ekberg N, Bodholdt U, Catarig AM, Catrina SB, Grau K, Holmberg CN, Klanger B, Knudsen ST. Real-world use of once-weekly semaglutide in patients with type 2 diabetes: Results from the SURE Denmark/Sweden multicentre, prospective, observational stu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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)
Primary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Patient reported severe or documented hypoglycaemia (yes/no)	Number of patients who reported/not reported severe or documented hypoglycaemia	Between baseline (week 0) and end of study (week 28-38)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)