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
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
2 other identifiers
observational
216
1 country
15
Brief 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. The study will last for approximately 30 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2026
CompletedStudy Start
First participant enrolled
June 15, 2026
CompletedFirst Posted
Study publicly available on registry
June 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
June 22, 2026
June 1, 2026
1.5 years
June 13, 2026
June 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in glycated haemoglobin (HbA1c)
Measured in percentage (%)-point
From baseline (week 0) to week 26
Secondary Outcomes (4)
Change in Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score
From baseline (week 0) to End of study (week 22-30)
Change in Adelphi Adherence Questionnaire (ADAQ) score
From baseline (week 0) to End of study (week 22-30)
Change in body weight
From baseline (week 0) to week 26
Number of self-reported overall severe hypoglycemia episodes
From baseline (week 0) to end of study (week 22-30)
Study Arms (1)
Icodec with/without non-insulin glucose lowering treatments
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (15)
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
The Second Affiliated Hospital of Chongqing Medical University-Endocrinology
Chongqing, Chongqing Municipality, 400010, China
Gansu Provincial People's Hospital
Lanzhou, Gansu, 730000, China
The People's Hospital of JiangMen
Jiangmen, Guangdong, 529020, China
Hebei PetroChina Central Hospital
Langfang, Hebi, 065099, China
Heilongjiang Provincial Hospital
Harbin, Heilongjiang, 150036, China
Shiyan City People's Hospital
Shiyan, Hubei, 442099, China
NIS-Huai'an First People's Hospital-Endocrinology
Huai'an, Jiangsu, 223300, China
NIS-Nanjing Jiangning Hospital-Endocrinology
Nanjing, Jiangsu, 211199, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The Fifth People's Hospital of Shenyang
Shenyang, Liaoning, 110023, China
Shandong Provincial Hospital
Jinan, Shandong, 250098, China
Tongren Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200050, China
The First Affiliated Hospital of Xinjiang Medical University
Urumuqi, Xinjiang, 830054, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2026
First Posted
June 22, 2026
Study Start
June 15, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
June 22, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com