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NCT Number: NCT07658417

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 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.

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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

Beijing Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in glycated haemoglobin (HbA1c)

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

    Measured in percentage (%)-point

Secondary outcomes

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

    Time frame: 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.

  2. Change in Adelphi Adherence Questionnaire (ADAQ) score

    Time frame: 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.

  3. Change in body weight

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

    Measured in kilograms (kg).

  4. Number of self-reported overall severe hypoglycemia episodes

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

    Measured in number of episodes.

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 China

Acronym: ICOSWITCH REAL

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2026
Registry last updated
Jun 22, 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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