Research Study to Examine Blood Sugar Control, Treatment Satisfaction and Adherence in People With Type 2 Diabetes After Switching From Daily Basal Insulin to Once-weekly Insulin Icodec

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNovo Nordisk A/S

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to 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 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.

Disqualifiers

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 study.

Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Trial population

The study population consists of adult participants (≥18 years) with type 2 diabetes who have been diagnosed for at least one year and are currently being treated with once- or twice-daily basal insulin. The study includes approximately 216 participants across multiple centres in Canada, Italy, and China, reflecting a real-world population of individuals with type 2 diabetes receiving standard clinical care.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Insulin icodec

    Drug

    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.

Treatment groups

216 Participants
are divided into 1 treatment group
Group A: Icodec with/without non-insulin glucose lowering treatments1 intervention

Trial outcomes

Primary outcomes

1

Change in glycated haemoglobin (HbA1c)

Measured in percentage (%)-point

Time frame
From baseline (week 0) to week 26

Secondary outcomes

1

Change in Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score

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.

Time frame
From baseline (week 0) to End of study (week 22-30)
2

Change in Adelphi Adherence Questionnaire (ADAQ) score

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.

Time frame
From baseline (week 0) to End of study (week 22-30)
3

Change in body weight

Measured in kilograms (kg).

Time frame
From baseline (week 0) to week 26
4

Number of self-reported overall severe hypoglycemia episodes

Measured in number of episodes.

Time frame
From baseline (week 0) to end of study (week 22-30)

Other outcomes

Sponsors and contacts

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