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 (ICOSWITCH REAL)

June 2, 2026 updated by: Novo Nordisk A/S

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

214

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Città di Castello, Italy, 06012
        • Ospedale di Città di Castello
      • Montoro, Italy, 83026
        • ASL Avellino
      • Province of Macerata, Italy, 62100
        • Ospedale Generale provinciale
    • Abruzzo
      • Pescara, Abruzzo, Italy, 65124
        • Azienda Sanitaria Locale Di Pescara
    • Calabria
      • San Giovanni in Fiore (CS), Calabria, Italy, 87027
        • Azienda Ospedaliera-Universitaria Di Cosenza
    • Campania
      • Marano Di Napoli (NA), Campania, Italy, 80016
        • Azienda Sanitaria Locale Napoli 2 Nord
    • Lazio
      • Rome, Lazio, Italy, 00169
        • Policlinico Casilino
      • Rome, Lazio, Italy, 00133
        • Azienda Ospedaliera Policlinico Universitario Tor Vergata
      • Rome, Lazio, Italy, 00189
        • Azienda Ospedaliero - Universitaria Sant'Andrea - UOC Medicina interna
    • Lombardy
      • Milan, Lombardy, Italy, 20159
        • Grande Ospedale Metropolitano Niguarda - Dipartimento Medico Polispecialistico - Diabetologia
      • Milan, Lombardy, Italy, 20142
        • Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
    • Piedmont
      • Cuneo, Piedmont, Italy, 12100
        • Azienda Ospedaliera Santa Croce E Carle
    • Sicily
      • Catania, Sicily, Italy, 95123
        • ARNAS Garibaldi Catania
    • Trentino-Alto Adige
      • Bolzano, Trentino-Alto Adige, Italy, 39100
        • Ospedale centrale L. Bohler Bolzano
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Azienda Ospedaliera di Padova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population comprises participants who are diagnosed with type 2 diabetes and agree to be treated with insulin icodec after consultation with their physician independently from the decision to participate in this study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Insulin icodec
Participants with T2D will be treated with commercially available insulin icodec according to routine clinical practice at the discretion of the treating physician.
Drug: Insulin icodec
Participants with T2D will be treated with commercially available insulin icodec.
Other Names:
  • Awiqli

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glycated haemoglobin (HbA1c)
Time Frame: Baseline (week 0), week 26
Measured as percentage (%) point of HbA1c.
Baseline (week 0), week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (week 0), end of study (week 22-30)
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.
Baseline (week 0), end of study (week 22-30)
Change in body weight
Time Frame: Baseline (week 0), week 26
Measured as kilogram (kg).
Baseline (week 0), week 26
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.
From baseline (week 0) to end of study (week 22-30)
Frequency of titrations
Time Frame: From baseline (week 0) to end of study (week 22-30)
Measured as weeks.
From baseline (week 0) to end of study (week 22-30)
Titration increments/decrements per titration
Time Frame: From baseline (week 0) to end of study (week 22-30)
Measured as unit.
From baseline (week 0) to end of study (week 22-30)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 5, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 8, 2026

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1436-8501
  • U1111-1328-4242 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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