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

Novo Nordisk A/S230 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

230

Conditions

Diabetes Mellitus, Type 2

Interventions

SemaglutideDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (16)

Novo Nordisk Investigational Site

A Coruña, Spain

Novo Nordisk Investigational Site

Álava, Spain

Novo Nordisk Investigational Site

Outcomes

Primary Outcomes

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

Measured in % points

Time frame: 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

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

Secondary Outcomes

Change in body weight (measured in kg)

Measured in kg

Time frame: 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 %

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

Change in waist circumference

Measured in cm

Time frame: 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%

Time frame: 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%

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Novo Nordisk Investigational Site

Barcelona, Spain

Novo Nordisk Investigational Site

Barcelona, Spain

Novo Nordisk Investigational Site

Bilbao, Spain

Novo Nordisk Investigational Site

Ferrol, Spain

Novo Nordisk Investigational Site

Galdakao, Spain

Novo Nordisk Investigational Site

Las Palmas de Gran Canaria, Spain

Novo Nordisk Investigational Site

Oviedo, Spain

...and 6 more locations

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%

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: Baseline (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).

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

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

Time frame: 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

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