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NCT Number: NCT07632404

A 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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Sanitaria Locale Di Pescara, Pescara, Abruzzo, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin icodec

Drug

Participants with T2D will be treated with commercially available insulin icodec.

Other names: Awiqli

Primary outcomes

  1. Change in glycated haemoglobin (HbA1c)

    Time frame: Baseline (week 0), week 26

    Measured as percentage (%) point of HbA1c.

Secondary outcomes

  1. Change in Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score

    Time frame: 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.

  2. Change in Adelphi Adherence Questionnaire (ADAQ) score

    Time frame: 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.

  3. Change in body weight

    Time frame: Baseline (week 0), week 26

    Measured as kilogram (kg).

  4. Number of self-reported overall severe hypoglycemia episodes

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

    Measured as number of episodes.

  5. Frequency of titrations

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

    Measured as weeks.

  6. Titration increments/decrements per titration

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

    Measured as unit.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Real-world, Multi-centre, Prospective, Non-interventional, Single-arm Study Investigating Glycaemic Control, Treatment Satisfaction and Adherence Associated With the Switch From Daily Basal Insulin to Insulin Icodec in People Living With Type 2 Diabetes in Italy

Acronym: ICOSWITCH REAL

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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