A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice (SURE GERMANY)

Diabetes Mellitus, Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04261933
• Other study ID #: NN9535-4617
• Secondary ID: U1111-1241-6291
• Status: Completed
• Start date: February 13, 2020
• Est. completion date: May 25, 2021

Study information

• Verified date: March 2023
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 789
• Est. completion date: May 25, 2021
• Est. primary completion date: May 25, 2021
• 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 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

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
Germany	Novo Nordisk Investigational Site	Amberg
Germany	Novo Nordisk Investigational Site	Aschaffenburg
Germany	Novo Nordisk Investigational Site	Augsburg
Germany	Novo Nordisk Investigational Site	Bad Mergentheim
Germany	Novo Nordisk Investigational Site	Bad Oeynhausen
Germany	Novo Nordisk Investigational Site	Bautzen
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Bernau bei Berlin
Germany	Novo Nordisk Investigational Site	Bonn
Germany	Novo Nordisk Investigational Site	Bramsche
Germany	Novo Nordisk Investigational Site	Darmstadt
Germany	Novo Nordisk Investigational Site	Dessau-Roßlau
Germany	Novo Nordisk Investigational Site	Dresden
Germany	Novo Nordisk Investigational Site	Dresden
Germany	Novo Nordisk Investigational Site	Duisburg
Germany	Novo Nordisk Investigational Site	Eisenach
Germany	Novo Nordisk Investigational Site	Elsterwerda
Germany	Novo Nordisk Investigational Site	Erdmannhausen
Germany	Novo Nordisk Investigational Site	Erlangen
Germany	Novo Nordisk Investigational Site	Essen
Germany	Novo Nordisk Investigational Site	Essen
Germany	Novo Nordisk Investigational Site	Forst (Lausitz)
Germany	Novo Nordisk Investigational Site	Freisen
Germany	Novo Nordisk Investigational Site	Friedrichsthal
Germany	Novo Nordisk Investigational Site	Fulda
Germany	Novo Nordisk Investigational Site	Gebhardshain
Germany	Novo Nordisk Investigational Site	Gelnhausen
Germany	Novo Nordisk Investigational Site	Grasleben
Germany	Novo Nordisk Investigational Site	Großröhrsdorf
Germany	Novo Nordisk Investigational Site	Grünstadt
Germany	Novo Nordisk Investigational Site	Hainburg
Germany	Novo Nordisk Investigational Site	Halle (Saale)
Germany	Novo Nordisk Investigational Site	Hamburg
Germany	Novo Nordisk Investigational Site	Hammelburg
Germany	Novo Nordisk Investigational Site	Hannover
Germany	Novo Nordisk Investigational Site	Heidenheim an der Brenz
Germany	Novo Nordisk Investigational Site	Herrenberg
Germany	Novo Nordisk Investigational Site	Hof
Germany	Novo Nordisk Investigational Site	Hohenmölsen
Germany	Novo Nordisk Investigational Site	Jena
Germany	Novo Nordisk Investigational Site	Kempten (Allgäu)
Germany	Novo Nordisk Investigational Site	Köln
Germany	Novo Nordisk Investigational Site	Köln
Germany	Novo Nordisk Investigational Site	Leipzig
Germany	Novo Nordisk Investigational Site	Lichtenfels
Germany	Novo Nordisk Investigational Site	Lingen
Germany	Novo Nordisk Investigational Site	Ludwigsburg
Germany	Novo Nordisk Investigational Site	Magdeburg
Germany	Novo Nordisk Investigational Site	Marburg
Germany	Novo Nordisk Investigational Site	Marburg
Germany	Novo Nordisk Investigational Site	Mayen
Germany	Novo Nordisk Investigational Site	Meckesheim
Germany	Novo Nordisk Investigational Site	Mössingen
Germany	Novo Nordisk Investigational Site	Mühldorf Am Inn
Germany	Novo Nordisk Investigational Site	Mülheim
Germany	Novo Nordisk Investigational Site	München
Germany	Novo Nordisk Investigational Site	München
Germany	Novo Nordisk Investigational Site	Münster
Germany	Novo Nordisk Investigational Site	Neustrelitz
Germany	Novo Nordisk Investigational Site	Nürnberg
Germany	Novo Nordisk Investigational Site	Oranienburg
Germany	Novo Nordisk Investigational Site	Osnabrück
Germany	Novo Nordisk Investigational Site	Otterbach
Germany	Novo Nordisk Investigational Site	Pohlheim
Germany	Novo Nordisk Investigational Site	Rellingen
Germany	Novo Nordisk Investigational Site	Rostock
Germany	Novo Nordisk Investigational Site	Saint Ingbert-Oberwürzbach
Germany	Novo Nordisk Investigational Site	Schönhausen (Elbe)
Germany	Novo Nordisk Investigational Site	Schorndorf
Germany	Novo Nordisk Investigational Site	Schwerin
Germany	Novo Nordisk Investigational Site	Seelow
Germany	Novo Nordisk Investigational Site	Soltau
Germany	Novo Nordisk Investigational Site	Sonsbeck
Germany	Novo Nordisk Investigational Site	Speyer
Germany	Novo Nordisk Investigational Site	Spremberg
Germany	Novo Nordisk Investigational Site	Stadtbergen
Germany	Novo Nordisk Investigational Site	Straubing
Germany	Novo Nordisk Investigational Site	Stuttgart
Germany	Novo Nordisk Investigational Site	Stuttgart
Germany	Novo Nordisk Investigational Site	Trier
Germany	Novo Nordisk Investigational Site	Ulm
Germany	Novo Nordisk Investigational Site	Viersen
Germany	Novo Nordisk Investigational Site	Villingen-Schwenningen
Germany	Novo Nordisk Investigational Site	Villingen-Schwenningen
Germany	Novo Nordisk Investigational Site	Wedemark
Germany	Novo Nordisk Investigational Site	Wetzlar
Germany	Novo Nordisk Investigational Site	Wiesloch
Germany	Novo Nordisk Investigational Site	Witzenhausen
Germany	Novo Nordisk Investigational Site	Wolmirstedt
Germany	Novo Nordisk Investigational Site	Wurzen
Germany	Novo Nordisk Investigational Site	Zwenkau

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 Feb 21. doi: 10.1111/dom.15031. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycated Haemoglobin A1c (HbA1c)	Percent point	Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
Primary	Change in HbA1c	mmol/mol	Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
Secondary	Change in body weight (kg)	kg	Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
Secondary	Change in body weight (%)	Percent	Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
Secondary	Change in waist circumference	cm	Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
Secondary	HbA1c level below 8.0% (64 mmol/mol) (yes/no)	Number of participants	At end of study (week 28 to 38)
Secondary	HbA1c level below 7.5% (59 mmol/mol) (yes/no)	Number of participants	At end of study (week 28 to 38)
Secondary	HbA1c level below 7.0% (53 mmol/mol) (yes/no)	Number of participants	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)	Count	Between baseline (week 0), 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)	Count	At end of study (week 28 to 38)