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
Insulin icodec: 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 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to protocol).
2. 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.
3. Male or female, age above or equal to 18 years at the time of signing informed consent.
4. Diagnosed with T2D greater than or equal to (≥) 1 year before signing informed consent.
5. 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.
6. 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.
7. Treatment-naïve to once-weekly insulin prior to the 'Initiation Visit' (V1)
Exclusion Criteria:
1. Previous participation in this study. Participation is defined as having given informed consent in this study.
2. Treatment with any investigational drug within 30 days prior to enrolment into study.
3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Primary outcome measure(s)
Change in glycated haemoglobin (HbA1c) — From baseline (week 0) to week 26 Measured in percentage (%)-point
Trial sites (15)
Facility
City
Region
Status
Beijing Hospital
Beijing
Beijing Municipality
The Second Affiliated Hospital of Chongqing Medical University-Endocrinology
Chongqing
Chongqing Municipality
Gansu Provincial People's Hospital
Lanzhou
Gansu
The People's Hospital of JiangMen
Jiangmen
Guangdong
Hebei PetroChina Central Hospital
Langfang
Hebi
Heilongjiang Provincial Hospital
Harbin
Heilongjiang
Shiyan City People's Hospital
Shiyan
Hubei
NIS-Huai'an First People's Hospital-Endocrinology
Huai'an
Jiangsu
NIS-Nanjing Jiangning Hospital-Endocrinology
Nanjing
Jiangsu
The Second Affiliated Hospital of Soochow University
Suzhou
Jiangsu
The Second Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
The Fifth People's Hospital of Shenyang
Shenyang
Liaoning
Shandong Provincial Hospital
Jinan
Shandong
Tongren Hospital Shanghai Jiao Tong University School of Medicine
Shanghai
Shanghai Municipality
The First Affiliated Hospital of Xinjiang Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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