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.
Study Type
OBSERVATIONAL
Enrollment
214
Participants with T2D will be treated with commercially available insulin icodec.
Azienda Sanitaria Locale Di Pescara
Pescara, Abruzzo, Italy
Azienda Ospedaliera-Universitaria Di Cosenza
San Giovanni in Fiore (CS), Calabria, Italy
Change in glycated haemoglobin (HbA1c)
Measured as percentage (%) point of HbA1c.
Time frame: Baseline (week 0), week 26
Change in Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score
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.
Time frame: Baseline (week 0), end of study (week 22-30)
Change in Adelphi Adherence Questionnaire (ADAQ) score
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.
Time frame: Baseline (week 0), end of study (week 22-30)
Change in body weight
Measured as kilogram (kg).
Time frame: Baseline (week 0), week 26
Number of self-reported overall severe hypoglycemia episodes
Measured as number of episodes.
Time frame: From baseline (week 0) to end of study (week 22-30)
Frequency of titrations
Measured as weeks.
Time frame: From baseline (week 0) to end of study (week 22-30)
Titration increments/decrements per titration
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Azienda Sanitaria Locale Napoli 2 Nord
Marano Di Napoli (NA), Campania, Italy
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Rome, Lazio, Italy
Policlinico Casilino
Rome, Lazio, Italy
Azienda Ospedaliero - Universitaria Sant'Andrea - UOC Medicina interna
Rome, Lazio, Italy
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
Milan, Lombardy, Italy
Grande Ospedale Metropolitano Niguarda - Dipartimento Medico Polispecialistico - Diabetologia
Milan, Lombardy, Italy
Azienda Ospedaliera Santa Croce E Carle
Cuneo, Piedmont, Italy
ARNAS Garibaldi Catania
Catania, Sicily, Italy
...and 5 more locations
Measured as unit.
Time frame: From baseline (week 0) to end of study (week 22-30)