A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Canada, as Part of Local Clinical Practice
- Registration Number
- NCT03457012
- 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 by the study doctor. The study will last for about 6 to 8 months. Participants will be asked to complete some questionnaires about the health and the diabetes treatment. Participants will complete these during the normally scheduled visits with the study doctor.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 462
- 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 (LAR) and the treating physician before and independently from the decision to include the patient in this study
- Male or female, age greater than or equal to 18 years at the time of signing informed consent
- Diagnosed with type 2 diabetes at least 12 weeks prior to inclusion
- Available and documented HbA1c value less than or equal to 12 weeks prior to initiation of semaglutide treatment
- 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
Group Intervention Description Semaglutide 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
- Primary Outcome Measures
Name Time Method Change in HbA1c Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38) Measured in mmol/mol
Change in Glycated Haemoglobin A1c (HbA1c) Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38) Measured in % points
- Secondary Outcome Measures
Name Time Method Patient completed the study under treatment with semaglutide (yes/no) At end of study (week 28-38) Number of patients who completed/not completed the study under treatment with semaglutide
HbA1c level at end of study: <7.5% (59 mmol/mol) (yes/no) At end of study (week 28-38) Number of participants who achieved/not achieved HbA1c level at end of study: \<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 28-38) 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 Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) (absolute treatment satisfaction): Total treatment satisfaction Baseline (week 0), end of study (week 28-38) 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.
Change in Short Form (SF)-36 v2: Physical summary component Baseline (week 0), end of study (week 28-38) 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).
Change in body weight Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38) Measured in %
Change in waist circumference Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38) Measured in cm
HbA1c level at end of study: < 8.0% (64 mmol/mol) (yes/no) At end of study (week 28-38) Number of participants who achieved/not achieved HbA1c level at end of study: \<8.0%
HbA1c level at end of study: <7.0% (53 mmol/mol) (yes/no) At end of study (week 28-38) Number of participants who achieved/not achieved HbA1c level at end of study: \<7.0%
Reduction in HbA1c of 1.0% point or more (yes/no) Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28-38) Number of participants who achieved/not achieved reduction in HbA1c of 1.0% point or more
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 28-38) Number of participants who achieved/not achieved weight reduction of 3.0% or more
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 28-38) Number of participants who achieved/not achieved weight reduction of 5.0% or more
Patient reported severe or documented hypoglycaemia (yes/no) Between baseline (week 0) and end of study (week 28-38) Number of participants who reported/not reported severe or documented hypogycaemia
Change in Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) (relative treatment satisfaction): Total treatment satisfaction Baseline (week 0), end of study (week 28-38) 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 SF-36 v2: Mental summary component Baseline (week 0), end of study (week 28-38) 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).
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇨🇦Cambridge, Ontario, Canada