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Diabetes Mellitus, Type 2ICOSWITCH REALNCT07658417

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 China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. 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
216 participants
Where
15 sitesChina
Study dates
2 Jul 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 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.

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 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)

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 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

China15 sites

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • The Second Affiliated Hospital of Chongqing Medical University-Endocrinology

    Chongqing, Chongqing Municipality, 400010

  • Heilongjiang Provincial Hospital

    Harbin, Heilongjiang, 150036

  • NIS-Huai'an First People's Hospital-Endocrinology

    Huai'an, Jiangsu, 223300

  • The People's Hospital of JiangMen

    Jiangmen, Guangdong, 529020

  • Shandong Provincial Hospital

    Jinan, Shandong, 250098

  • Hebei PetroChina Central Hospital

    Langfang, Hebi, 065099

  • Gansu Provincial People's Hospital

    Lanzhou, Gansu, 730000

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • NIS-Nanjing Jiangning Hospital-Endocrinology

    Nanjing, Jiangsu, 211199

  • Tongren Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200050

  • The Fifth People's Hospital of Shenyang

    Shenyang, Liaoning, 110023

  • Shiyan City People's Hospital

    Shiyan, Hubei, 442099

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

  • The First Affiliated Hospital of Xinjiang Medical University

    Urumuqi, Xinjiang, 830054

Other trials in China

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 China

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.

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

    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.

Study groups in NCT07658417
Study groupRoleWhat they receive
Icodec with/without non-insulin glucose lowering treatmentsParticipants 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.
Receives: Drug: Insulin icodec

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in glycated haemoglobin (HbA1c)

    Measured in percentage (%)-point

    Measured: From baseline (week 0) to week 26

Secondary outcomes (4)

  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.

    Measured: 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.

    Measured: From baseline (week 0) to End of study (week 22-30)

  3. Change in body weight

    Measured in kilograms (kg).

    Measured: From baseline (week 0) to week 26

  4. Number of self-reported overall severe hypoglycemia episodes

    Measured in number of episodes.

    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.

  1. First posted22 Jun 2026
  2. Study start2 Jul 2026
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

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
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07658417
Sponsor's protocol ID
NN1436-8502
Other IDs
U1111-1328-4272
Acronym
ICOSWITCH REAL
Status last verified
Sep 2026
First submitted
13 Jun 2026
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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 China.

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 15 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 China. 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: From baseline (week 0) to week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07658417.

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 15 Sep 2026.

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