Diabetes Mellitus, Type 2
Conditions
Brief summary
The study will look at how well insulin icodec controls blood sugar levels in participants who have never used it before. Participants with type 2 diabetes (T2D) will be treated with insulin icodec as prescribed to by their doctor, in accordance with usual clinical practice. This study will last for about 22 to 30 weeks.
Interventions
DRUGInsulin icodec
Participants with T2D will be treated with commercially available insulin icodec.
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
* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). * 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 the participant in this study. * Male or female, age above or equal to 18 years at the time of signing informed consent. * Diagnosed with T2D greater than or equal to (≥) 1 year before signing informed consent. * 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. * Available 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. * Treatment-naïve to once-weekly insulin prior to the 'Initiation Visit' (V1).
Exclusion criteria
* Previous participation in this study. Participation is defined as having given informed consent in this study. * Treatment with any investigational drug within 30 days prior to enrolment into the study. * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) | Baseline (week 0), week 26 | Measured as percentage (%) point of HbA1c. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score | Baseline (week 0), end of study (week 22-30) | DTSQs measures how satisfied participants 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). 6 items are scored on a scale of 1 to 7 across 5 different domains and transformed to a 0-100 scale. Higher scores indicate a higher treatment satisfaction. |
| Change in Adelphi Adherence Questionnaire (ADAQ) score | Baseline (week 0), end of study (week 22-30) | The ADAQ measure consists of 11 items scored on a scale of 0 to 4. The mean of the individual items represents the total ADAQ score. At least 8 of the 11 items must be answered to calculate the ADAQ score. The lower the score corresponds to the greater adherence. |
| Change in body weight | Baseline (week 0), week 26 | Measured as kilogram (kg). |
| Number of self-reported overall severe hypoglycemia episodes | From baseline (week 0) to end of study (week 22-30) | Measured as number of episodes. |
| Frequency of titrations | From baseline (week 0) to end of study (week 22-30) | Measured as weeks. |
| Titration increments/decrements per titration | From baseline (week 0) to end of study (week 22-30) | Measured as unit. |
Countries
Italy
Contacts
CONTACTNovo Nordisk
Outcome results
None listed