Diabetes Mellitus, Type 2
Conditions
Brief summary
The purpose of this study is to investigate the use of insulin icodec in the real-world setting in a population that broadly reflects people living with T2D and for whom switching to a once-weekly insulin icodec has been deemed relevant and beneficial by the treating physician. The study will last for approximately 30 weeks.
Interventions
DRUGInsulin icodec
Participants will initiate the treatment with insulin icodec at the treating physician's discretion according to the local label, and it will be clearly separated from the decision to include the participant in the study.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to protocol). 2. The decision to initiate treatment with commercially available insulin icodec has been made by the participant/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include participant in this study. 3. Male or female, age above or equal to 18 years at the time of signing informed consent. 4. Diagnosed with T2D greater than or equal to (≥) 1 year before signing informed consent. 5. Treated with once- or twice-daily basal insulin injections ≥ 6 months before signing informed consent. Any other antidiabetic medications are allowed, except for bolus insulin during the 90 days prior to switching to icodec for a period of 14 days or more. 6. Available glycated haemoglobin (HbA1c) within 90 days prior to the 'Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Initiation visit' (V1) if in line with local clinical practice. 7. Treatment-naïve to once-weekly insulin prior to the 'Initiation Visit' (V1)
Exclusion criteria
1. Previous participation in this study. Participation is defined as having given informed consent in this study. 2. Treatment with any investigational drug within 30 days prior to enrolment into study. 3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) | From baseline (week 0) to week 26 | Measured in percentage (%)-point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score | From baseline (week 0) to End of study (week 22-30) | The DTSQs measures how satisfied patients are with their current diabetes treatment. It consists of 8 questions, rated on a Likert scale from 0 to 6 (0 = verydissatisfied to 6 = very satisfied). Six questions are summed to produce a total TreatmentSatisfaction score. Transformed to a 0-100 scale with higher scores indicating a higher treatment satisfaction. The remaining two questions are concerning perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia, respectively. |
| Change in Adelphi Adherence Questionnaire (ADAQ) score | From baseline (week 0) to End of study (week 22-30) | The ADAQ measures medication adherence. The measure consists of 11 items, all of which are scored from 0 to 4. At least 8 of the 11 items must be completed to calculate the ADAQ score. The ADAQ score is calculated as the mean of the completed item scores. The lower the score, the greater the adherence. |
| Change in body weight | From baseline (week 0) to week 26 | Measured in kilograms (kg). |
| Number of self-reported overall severe hypoglycemia episodes | From baseline (week 0) to end of study (week 22-30) | Measured in number of episodes. |
Countries
China
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed