Clinical trial NCT03929679: A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in The Netherlands, as Part of Local Clinical Practice (SURE NETHERLANDS)
Official title: A Multi-centre, Prospective, Noninterventional Study Investigating the Effectiveness of Onceweekly 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: 2019-04-29
Enrollment: 218
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 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.


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 (week 0) to end of study (week 28 to 38)
measure: Change in Glycated Haemoglobin A1c (HbA1c)
timeFrame: Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
Secondary outcomes:
measure: Change in body weight
timeFrame: Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
measure: Change in body weight
timeFrame: Baseline (up to 12 weeks prior to treatment initiation (week 0) to 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 below 8.0% (64 mmol/mol) (yes/no)
timeFrame: At end of study (week 28 to 38)
measure: HbA1c level at end of study: below 7.5% (59 mmol/mol) (yes/no)
timeFrame: At end of study (week 28 to 38)
measure: HbA1c level at end of study: below 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), 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: Alkmaar
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Almelo
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Almere
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Amersfoort
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Arnhem
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Bladel
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Den Bosch
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Den Haag
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Dordrecht
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Eindhoven
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Eindhoven
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Emmen
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Enschede
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Gemert
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Groningen
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Heerlen
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Hoogeveen
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Leiden
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Montfort
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Nijverdal
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Rotterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Sint Anthonis
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Utrecht
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Warmenhuizen
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Zaandam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Zevenbergen
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Zwijndrecht
country: Netherlands
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Wolffenbuttel BHR, Brugts MP, Catarig AM, Clark A, Kok M, Lieverse AG, van Soest J. Once-Weekly Semaglutide Use in Type 2 Diabetes: Real-World Data from the SURE Netherlands Observational Study. Adv Ther. 2023 Mar;40(3):920-933. doi: 10.1007/s12325-022-02385-x. Epub 2022 Dec 21.