Clinical trial NCT03648281: 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)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-08-27
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with type 2 diabetes

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 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.


Eligibility 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

Primary outcomes:
measure: Change in Glycated Haemoglobin A1c (HbA1c)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
measure: Change in HbA1c
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Secondary outcomes:
measure: Change in body weight
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
measure: Change in body weight
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
measure: Change in waist circumference
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
measure: HbA1c level at end of study: <8.0% (64 mmol/mol) (yes/no)
timeFrame: At end of study (week 28 to 38)
measure: HbA1c level at end of study: <7.5% (59 mmol/mol) (yes/no)
timeFrame: At end of study (week 28 to 38)
measure: HbA1c level at end of study: <7.0% (53 mmol/mol) (yes/no)
timeFrame: At end of study (week 28 to 38)
measure: Reduction in HbA1c of 1.0% point or more (yes/no)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
measure: Weight reduction of 3.0% or more (yes/no)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
measure: Weight reduction of 5.0% or more (yes/no)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
measure: HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more (yes/no)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
measure: Patient reported severe or documented hypoglycaemia (yes/no)
timeFrame: Between baseline (week 0) and end of study (week 28-38)
measure: Change in score for Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) (absolute treatment satisfaction): Total treatment satisfaction
timeFrame: Baseline (week 0), end of study (week 28 to 38)
measure: Change in score for Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) (relative treatment satisfaction): Total treatment satisfaction
timeFrame: Baseline (week 0), end of study (week 28 to 38)
measure: Change in score for Short Form (SF)-36 v2: Physical summary component
timeFrame: Baseline (week 0), end of study (week 28 to 38)
measure: Change in score for SF-36 v2: Mental summary component
timeFrame: Baseline (week 0), end of study (week 28 to 38)
measure: Patient completed the study under treatment with semaglutide (yes/no)
timeFrame: At end of study (week 28 to 38)
Other outcomes:
Locations:
city: Søborg
country: Denmark
facility: Novo Nordisk Investigational Site
city: Avesta
country: Sweden
facility: Novo Nordisk Investigational Site
city: Bjärred
country: Sweden
facility: Novo Nordisk Investigational Site
city: Bollnäs
country: Sweden
facility: Novo Nordisk Investigational Site
city: Charlottenberg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Eslöv
country: Sweden
facility: Novo Nordisk Investigational Site
city: Falköping
country: Sweden
facility: Novo Nordisk Investigational Site
city: Flen
country: Sweden
facility: Novo Nordisk Investigational Site
city: Göteborg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Helsingborg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Huskvarna
country: Sweden
facility: Novo Nordisk Investigational Site
city: Härnösand
country: Sweden
facility: Novo Nordisk Investigational Site
city: Karlskoga
country: Sweden
facility: Novo Nordisk Investigational Site
city: Kungsbacka
country: Sweden
facility: Novo Nordisk Investigational Site
city: Laholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Luleå
country: Sweden
facility: Novo Nordisk Investigational Site
city: Lund
country: Sweden
facility: Novo Nordisk Investigational Site
city: Mölndal
country: Sweden
facility: Novo Nordisk Investigational Site
city: Nybro
country: Sweden
facility: Novo Nordisk Investigational Site
city: Nässjö
country: Sweden
facility: Novo Nordisk Investigational Site
city: Sala
country: Sweden
facility: Novo Nordisk Investigational Site
city: Staffanstorp
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Sundsvall
country: Sweden
facility: Novo Nordisk Investigational Site
city: Uddevalla
country: Sweden
facility: Novo Nordisk Investigational Site
city: Upplands Väsby
country: Sweden
facility: Novo Nordisk Investigational Site
city: Västerås
country: Sweden
facility: Novo Nordisk Investigational Site
city: Ängelholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Åkersberga
country: Sweden
facility: Novo Nordisk Investigational Site
city: Örebro
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: 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 study. Prim Care Diabetes. 2021 Oct;15(5):871-878. doi: 10.1016/j.pcd.2021.06.008. Epub 2021 Jun 25.
citation: Yale JF, Bodholdt U, Catarig AM, Catrina S, Clark A, Ekberg NR, Erhan U, Holmes P, Knudsen ST, Liutkus J, Sathyapalan T, Schultes B, Rudofsky G. Real-world use of once-weekly semaglutide in patients with type 2 diabetes: pooled analysis of data from four SURE studies by baseline characteristic subgroups. BMJ Open Diabetes Res Care. 2022 Apr;10(2):e002619. doi: 10.1136/bmjdrc-2021-002619.