Diabetes Mellitus, Type 2ICOSWITCH REALNCT07632404
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
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 15 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin icodec
- How many people
- 214 participants
- Where
- 15 sitesItaly
- Study dates
- 28 May 2026to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
Italy15 sites
Ospedale centrale L. Bohler Bolzano
Bolzano, Trentino-Alto Adige, 39100
ARNAS Garibaldi Catania
Catania, Sicily, 95123
Ospedale di Città di Castello
Città di Castello, 06012
Azienda Ospedaliera Santa Croce E Carle
Cuneo, Piedmont, 12100
Azienda Sanitaria Locale Napoli 2 Nord
Marano Di Napoli (NA), Campania, 80016
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
Milan, Lombardy, 20142
Grande Ospedale Metropolitano Niguarda - Dipartimento Medico Polispecialistico - Diabetologia
Milan, Lombardy, 20159
ASL Avellino
Montoro, 83026
Azienda Ospedaliera di Padova
Padova, Veneto, 35128
Azienda Sanitaria Locale Di Pescara
Pescara, Abruzzo, 65124
Ospedale Generale provinciale
Province of Macerata, 62100
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Rome, Lazio, 00133
Policlinico Casilino
Rome, Lazio, 00169
Azienda Ospedaliero - Universitaria Sant'Andrea - UOC Medicina interna
Rome, Lazio, 00189
IRCCS Multimedica Sesto San Giovanni
San Giovanni in Fiore (CS), Calabria, 87027
About this study
Official 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
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin icodec
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin icodecDrug
Also called Awiqli
Participants with T2D will be treated with commercially available insulin icodec.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Insulin icodec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycated haemoglobin (HbA1c)
Measured as percentage (%) point of HbA1c.
Measured: Baseline (week 0), week 26
Secondary outcomes (6)
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.
Measured: 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.
Measured: Baseline (week 0), end of study (week 22-30)
Change in body weight
Measured as kilogram (kg).
Measured: Baseline (week 0), week 26
Number of self-reported overall severe hypoglycemia episodes
Measured as number of episodes.
Measured: From baseline (week 0) to end of study (week 22-30)
Frequency of titrations
Measured as weeks.
Measured: From baseline (week 0) to end of study (week 22-30)
Titration increments/decrements per titration
Measured as unit.
Measured: From baseline (week 0) to end of study (week 22-30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start28 May 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632404
- Sponsor's protocol ID
- NN1436-8501
- Other IDs
- U1111-1328-4242
- Acronym
- ICOSWITCH REAL
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07632404
- Acronym / sponsor ID
- ICOSWITCH REAL / NN1436-8501
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 28 May 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin icodec | – | Drug: Insulin icodecParticipants with T2D will be treated with commercially available insulin icodec according to routine clinical practice at the discretion of the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin icodecAlso: AwiqliParticipants with T2D will be treated with commercially available insulin icodec. | Drug | Insulin icodec |
Primary outcome
Change in glycated haemoglobin (HbA1c)
Time frame: Baseline (week 0), week 26
Measured as percentage (%) point of HbA1c.
6 secondary outcomes
Change in Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score
Time frame: Baseline (week 0), end of study (week 22-30)
Change in Adelphi Adherence Questionnaire (ADAQ) score
Time frame: Baseline (week 0), end of study (week 22-30)
Change in body weight
Time frame: 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)
Frequency of titrations
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 15 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycated haemoglobin (HbA1c) (time frame: Baseline (week 0), week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.