An observational study in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 95 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-28.
Sponsored by Novo Nordisk A/S · Observational
The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by their study doctor. The study will last for about 6 to 8 months. The participants will be asked to complete some questionnaires about their health and their diabetes treatment. Participants will complete these during their normally scheduled visits with their study doctor.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 789 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with type 2 diabetes
Exclusion Criteria:
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.
Change in Glycated Haemoglobin A1c (HbA1c)
Percent point
Time frame: Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
Change in HbA1c
mmol/mol
Time frame: Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
Change in body weight (kg)
kg
Time frame: Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
Change in body weight (%)
Percent
Time frame: Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
Change in waist circumference
cm
Time frame: Baseline (up to 12 weeks prior to treatment initiation (week 0) to end of study (week 28 to 38)
HbA1c level below 8.0% (64 mmol/mol) (yes/no)
Number of participants
Time frame: At end of study (week 28 to 38)
HbA1c level below 7.5% (59 mmol/mol) (yes/no)
Number of participants
Time frame: At end of study (week 28 to 38)
HbA1c level below 7.0% (53 mmol/mol) (yes/no)
Number of participants
Time frame: At end of study (week 28 to 38)
Reduction in HbA1c of 1.0% point or more (yes/no)
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)
Count
Time frame: Between baseline (week 0), 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
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)
Patient completed the study under treatment with semaglutide (yes/no)
Count
Time frame: At end of study (week 28 to 38)
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S