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

Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Registration Number
NCT04067999
Lead Sponsor
Novo Nordisk A/S
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
230
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
SemaglutideSemaglutideParticipants 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
Primary Outcome Measures
NameTimeMethod
Change in Glycated Haemoglobin A1c (HbA1c) (measured in percent)Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)

Measured in % points

Change in Glycated Haemoglobin A1c (HbA1c) (measured in mmol/mol)Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)

Measured in mmol/mol

Secondary Outcome Measures
NameTimeMethod
Change in body weight (measured in percent)Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)

Measured in %

HbA1c level at end of study: below 7.0% (53 mmol/mol) (yes/no)At end of study (week 28 to 38)

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

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

Patient reported severe or documented hypoglycaemia (yes/no)Between baseline (week 0) and end of study (week 28-38)

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

HbA1c level at end of study: below 7.5% (59 mmol/mol) (yes/no)At end of study (week 28 to 38)

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

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

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

HbA1c level at end of study: below 8.0% (64 mmol/mol) (yes/no)At end of study (week 28 to 38)

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

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

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

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

Change in body weight (measured in kg)Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)

Measured in kg

Change in waist circumferenceBaseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)

Measured in cm

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

Change in score for SF-36 v2: Mental summary componentBaseline (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).

Patient completed the study under treatment with semaglutide (yes/no)At end of study (week 28 to 38)

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site

🇪🇸

Álava, Spain

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