Clinical trial NCT04261933: A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice (SURE GERMANY)
Official title: A Multi-centre, Prospective, Noninterventional 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: 2020-02-10
Enrollment: 789
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 18 years or older 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 equal to or below 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 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 (kg)
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 (week 0) to 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 below 7.5% (59 mmol/mol) (yes/no)
timeFrame: At end of study (week 28 to 38)
measure: HbA1c level 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: Amberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Aschaffenburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Augsburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Mergentheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Oeynhausen
country: Germany
facility: Novo Nordisk Investigational Site
city: Bautzen
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Bernau bei Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Bonn
country: Germany
facility: Novo Nordisk Investigational Site
city: Bramsche
country: Germany
facility: Novo Nordisk Investigational Site
city: Darmstadt
country: Germany
facility: Novo Nordisk Investigational Site
city: Dessau-Roßlau
country: Germany
facility: Novo Nordisk Investigational Site
city: Dresden
country: Germany
facility: Novo Nordisk Investigational Site
city: Dresden
country: Germany
facility: Novo Nordisk Investigational Site
city: Duisburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Eisenach
country: Germany
facility: Novo Nordisk Investigational Site
city: Elsterwerda
country: Germany
facility: Novo Nordisk Investigational Site
city: Erdmannhausen
country: Germany
facility: Novo Nordisk Investigational Site
city: Erlangen
country: Germany
facility: Novo Nordisk Investigational Site
city: Essen
country: Germany
facility: Novo Nordisk Investigational Site
city: Essen
country: Germany
facility: Novo Nordisk Investigational Site
city: Forst (Lausitz)
country: Germany
facility: Novo Nordisk Investigational Site
city: Freisen
country: Germany
facility: Novo Nordisk Investigational Site
city: Friedrichsthal
country: Germany
facility: Novo Nordisk Investigational Site
city: Fulda
country: Germany
facility: Novo Nordisk Investigational Site
city: Gebhardshain
country: Germany
facility: Novo Nordisk Investigational Site
city: Gelnhausen
country: Germany
facility: Novo Nordisk Investigational Site
city: Grasleben
country: Germany
facility: Novo Nordisk Investigational Site
city: Großröhrsdorf
country: Germany
facility: Novo Nordisk Investigational Site
city: Grünstadt
country: Germany
facility: Novo Nordisk Investigational Site
city: Hainburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Halle (Saale)
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hammelburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hannover
country: Germany
facility: Novo Nordisk Investigational Site
city: Heidenheim an der Brenz
country: Germany
facility: Novo Nordisk Investigational Site
city: Herrenberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hof
country: Germany
facility: Novo Nordisk Investigational Site
city: Hohenmölsen
country: Germany
facility: Novo Nordisk Investigational Site
city: Jena
country: Germany
facility: Novo Nordisk Investigational Site
city: Kempten (Allgäu)
country: Germany
facility: Novo Nordisk Investigational Site
city: Köln
country: Germany
facility: Novo Nordisk Investigational Site
city: Köln
country: Germany
facility: Novo Nordisk Investigational Site
city: Leipzig
country: Germany
facility: Novo Nordisk Investigational Site
city: Lichtenfels
country: Germany
facility: Novo Nordisk Investigational Site
city: Lingen
country: Germany
facility: Novo Nordisk Investigational Site
city: Ludwigsburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Magdeburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Marburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Marburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Mayen
country: Germany
facility: Novo Nordisk Investigational Site
city: Meckesheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Mössingen
country: Germany
facility: Novo Nordisk Investigational Site
city: Mühldorf Am Inn
country: Germany
facility: Novo Nordisk Investigational Site
city: Mülheim
country: Germany
facility: Novo Nordisk Investigational Site
city: München
country: Germany
facility: Novo Nordisk Investigational Site
city: München
country: Germany
facility: Novo Nordisk Investigational Site
city: Münster
country: Germany
facility: Novo Nordisk Investigational Site
city: Neustrelitz
country: Germany
facility: Novo Nordisk Investigational Site
city: Nürnberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Oranienburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Osnabrück
country: Germany
facility: Novo Nordisk Investigational Site
city: Otterbach
country: Germany
facility: Novo Nordisk Investigational Site
city: Pohlheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Rellingen
country: Germany
facility: Novo Nordisk Investigational Site
city: Rostock
country: Germany
facility: Novo Nordisk Investigational Site
city: Saint Ingbert-Oberwürzbach
country: Germany
facility: Novo Nordisk Investigational Site
city: Schorndorf
country: Germany
facility: Novo Nordisk Investigational Site
city: Schwerin
country: Germany
facility: Novo Nordisk Investigational Site
city: Schönhausen (Elbe)
country: Germany
facility: Novo Nordisk Investigational Site
city: Seelow
country: Germany
facility: Novo Nordisk Investigational Site
city: Soltau
country: Germany
facility: Novo Nordisk Investigational Site
city: Sonsbeck
country: Germany
facility: Novo Nordisk Investigational Site
city: Speyer
country: Germany
facility: Novo Nordisk Investigational Site
city: Spremberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Stadtbergen
country: Germany
facility: Novo Nordisk Investigational Site
city: Straubing
country: Germany
facility: Novo Nordisk Investigational Site
city: Stuttgart
country: Germany
facility: Novo Nordisk Investigational Site
city: Stuttgart
country: Germany
facility: Novo Nordisk Investigational Site
city: Trier
country: Germany
facility: Novo Nordisk Investigational Site
city: Ulm
country: Germany
facility: Novo Nordisk Investigational Site
city: Viersen
country: Germany
facility: Novo Nordisk Investigational Site
city: Villingen-Schwenningen
country: Germany
facility: Novo Nordisk Investigational Site
city: Villingen-Schwenningen
country: Germany
facility: Novo Nordisk Investigational Site
city: Wedemark
country: Germany
facility: Novo Nordisk Investigational Site
city: Wetzlar
country: Germany
facility: Novo Nordisk Investigational Site
city: Wiesloch
country: Germany
facility: Novo Nordisk Investigational Site
city: Witzenhausen
country: Germany
facility: Novo Nordisk Investigational Site
city: Wolmirstedt
country: Germany
facility: Novo Nordisk Investigational Site
city: Wurzen
country: Germany
facility: Novo Nordisk Investigational Site
city: Zwenkau
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor & Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Vilsboll T, Lindahl CO, Nielsen NF, Tikkanen CK. Real-world impact of once-weekly subcutaneous semaglutide after 2 years of follow-up: Results from a nationwide observational study in people with type 2 diabetes. Diabetes Obes Metab. 2023 Jun;25(6):1740-1749. doi: 10.1111/dom.15031. Epub 2023 Mar 9.