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

SURE SPAIN: 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

The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed to them by their 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 during their normally scheduled visits with their doctor.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Semaglutide

• Study Type: Observational
• Enrollment (Actual): 230

Contacts and Locations

Study Locations

• Spain
  • A Coruña, Spain, 15006
    • Novo Nordisk Investigational Site
  • Baracaldo, Spain, 48903
    • Novo Nordisk Investigational Site
  • Barcelona, Spain, 08036
    • Novo Nordisk Investigational Site
  • Barcelona, Spain, 08007
    • Novo Nordisk Investigational Site
  • Bilbao, Spain, 48013
    • Novo Nordisk Investigational Site
  • Ferrol, Spain, 15401
    • Novo Nordisk Investigational Site
  • Galdakao, Spain, 48960
    • Novo Nordisk Investigational Site
  • Las Palmas de Gran Canaria, Spain, 35001
    • Novo Nordisk Investigational Site
  • Oviedo, Spain, 33011
    • Novo Nordisk Investigational Site
  • Pamplona, Spain, 31008
    • Novo Nordisk Investigational Site
  • Pontevedra, Spain, 36071
    • Novo Nordisk Investigational Site
  • Ribadeo, Spain, 27700
    • Novo Nordisk Investigational Site
  • Salamanca, Spain, 37007
    • Novo Nordisk Investigational Site
  • Valladolid, Spain, 47010
    • Novo Nordisk Investigational Site
  • Vigo, Spain, 36200
    • Novo Nordisk Investigational Site
  • Álava, Spain, 01001
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with type 2 diabetes

Description

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 less than 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Semaglutide; Participants will receive semaglutide at the treating physician's discretion as part of the usual clinical practice. The prescription and use of semaglutide is completely independent of this study. Total study duration for the individual patient will be approximately 30 weeks

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.The decision to initiate treatment with semaglutide is at the treating physician's discretion, and clearly separated from the decision to include the patient in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycated Haemoglobin A1c (HbA1c) (measured in percent)	Measured in % points	Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Change in Glycated Haemoglobin A1c (HbA1c) (measured in mmol/mol)	Measured in mmol/mol	Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
Change in body weight (measured in kg)	Measured in kg	Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Change in body weight (measured in percent)	Measured in %	Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
HbA1c level at end of study: below 8.0% (64 mmol/mol) (yes/no)	Number of participants who achieved/not achieved HbA1c level at end of study: below 8.0%	At end of study (week 28 to 38)
HbA1c level at end of study: below 7.5% (59 mmol/mol) (yes/no)	Number of participants who achieved/not achieved HbA1c level at end of study: below 7.5%	At end of study (week 28 to 38)
HbA1c level at end of study: below 7.0% (53 mmol/mol) (yes/no)	Number of participants who achieved/not achieved HbA1c level at end of study: below 7.0%	At end of study (week 28 to 38)
Reduction in HbA1c from baseline to end of study of 1.0% point or more (Y/N)	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)
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)
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)
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
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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2019
• Primary Completion (Actual): July 19, 2021
• Study Completion (Actual): July 19, 2021

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NN9535-4368; U1111-1217-3546 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No