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Completed

NCT Number: NCT04094415

A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Italy, as Part of Local Clinical Practice

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 your diabetes treatment. Participants will complete these during their normally scheduled visits with their doctor.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Bagno a Ripoli, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semaglutide

Drug

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.

Primary outcomes

  1. Change in Glycated Haemoglobin A1c (HbA1c) (measured in percent)

    Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)

    Measured in % points

  2. Change in HbA1c (measured in mmol/mol)

    Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)

    Measured in mmol/mol

Secondary outcomes

  1. Change in body weight (measured in kg)

    Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)

    Measured in kg

  2. Change in body weight (measured in percent)

    Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)

    Measured in %

  3. Change in waist circumference

    Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)

    Measured in cm

  4. HbA1c level at end of study: below 8.0% (64 mmol/mol) (yes/no)

    Time frame: At end of study (week 28 to 38)

    Number of participants who achieved/not achieved HbA1c level at end of study: below 8.0%

  5. HbA1c level at end of study: below 7.5% (59 mmol/mol) (yes/no)

    Time frame: At end of study (week 28 to 38)

    Number of participants who achieved/not achieved HbA1c level at end of study: below 7.5%

  6. HbA1c level at end of study: below 7.0% (53 mmol/mol) (yes/no)

    Time frame: At end of study (week 28 to 38)

    Number of participants who achieved/not achieved HbA1c level at end of study: below 7.0%

  7. Reduction in HbA1c from baseline to end of study of 1.0% point or more (Y/N)

    Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)

    Number of participants who achieved/not achieved reduction in HbA1c of 1.0% point or more

  8. Weight reduction of 3.0% or more (yes/no)

    Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)

    Number of participants who achieved/not achieved weight reduction of 3.0% or more

  9. Weight reduction of 5.0% or more (yes/no)

    Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)

    Number of participants who achieved/not achieved weight reduction of 5.0% or more

  10. HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more (yes/no)

    Time frame: Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)

    Number of participants who achieved/not achieved HbA1c reduction of 1.0% point or more and weight reduction of 3.0% or more

  11. Patient reported severe or documented hypoglycaemia (yes/no)

    Time frame: Between baseline (week 0) and end of study (week 28-38)

    Number of patients who reported/not reported severe or documented hypoglycaemia

  12. Change in score for Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) (absolute treatment satisfaction): Total treatment satisfaction

    Time frame: Baseline (week 0), end of study (week 28 to 38)

    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.

  13. Change in score for Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) (relative treatment satisfaction): Total treatment satisfaction )

    Time frame: Baseline (week 0), end of study (week 28 to 38

    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.

  14. Change in score for Short Form (SF)-36 v2: Physical summary component

    Time frame: Baseline (week 0), end of study (week 28 to 38)

    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).

  15. Change in score for SF-36 v2: Mental summary component

    Time frame: Baseline (week 0), end of study (week 28 to 38)

    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).

  16. Patient completed the study under treatment with semaglutide (yes/no)

    Time frame: At end of study (week 28 to 38)

    Number of patients who completed/not completed the study under treatment with semaglutide

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

SURE ITALY: 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

Acronym: SURE ITALY

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 19, 2019
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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