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)
10 de septiembre de 2026 actualizado por: 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 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.
Descripción general del estudio
Estado
Inscripción por invitación
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
216
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100730
- Beijing Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Porcelana, 400010
- The Second Affiliated Hospital of Chongqing Medical University-Endocrinology
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Gansu
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Lanzhou, Gansu, Porcelana, 730000
- Gansu Provincial People's Hospital
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Guangdong
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Jiangmen, Guangdong, Porcelana, 529020
- The People's Hospital of JiangMen
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Hebi
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Langfang, Hebi, Porcelana, 065099
- Hebei PetroChina Central Hospital
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Heilongjiang
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Harbin, Heilongjiang, Porcelana, 150036
- Heilongjiang Provincial Hospital
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Hubei
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Shiyan, Hubei, Porcelana, 442099
- Shiyan City People's Hospital
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Jiangsu
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Huai'an, Jiangsu, Porcelana, 223300
- NIS-Huai'an First People's Hospital-Endocrinology
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Nanjing, Jiangsu, Porcelana, 211199
- NIS-Nanjing Jiangning Hospital-Endocrinology
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Suzhou, Jiangsu, Porcelana, 215004
- The Second Affiliated Hospital of Soochow University
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Jiangxi
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Nanchang, Jiangxi, Porcelana, 330006
- The Second Affiliated Hospital of Nanchang University
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Liaoning
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Shenyang, Liaoning, Porcelana, 110023
- The Fifth People's Hospital of Shenyang
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Shandong
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Jinan, Shandong, Porcelana, 250098
- Shandong Provincial Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200050
- Tongren Hospital Shanghai Jiao Tong University School of Medicine
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Xinjiang
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Urumuqi, Xinjiang, Porcelana, 830054
- The First Affiliated Hospital of Xinjiang Medical University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
Inclusion Criteria:
- 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)
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 study.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in glycated haemoglobin (HbA1c)
Periodo de tiempo: From baseline (week 0) to week 26
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Measured in percentage (%)-point
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From baseline (week 0) to week 26
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score
Periodo de tiempo: From baseline (week 0) to End of study (week 22-30)
|
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.
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From baseline (week 0) to End of study (week 22-30)
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Change in Adelphi Adherence Questionnaire (ADAQ) score
Periodo de tiempo: From baseline (week 0) to End of study (week 22-30)
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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.
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From baseline (week 0) to End of study (week 22-30)
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Change in body weight
Periodo de tiempo: From baseline (week 0) to week 26
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Measured in kilograms (kg).
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From baseline (week 0) to week 26
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Number of self-reported overall severe hypoglycemia episodes
Periodo de tiempo: From baseline (week 0) to end of study (week 22-30)
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Measured in number of episodes.
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From baseline (week 0) to end of study (week 22-30)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
2 de julio de 2026
Finalización primaria (Estimado)
1 de diciembre de 2027
Finalización del estudio (Estimado)
1 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
13 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
13 de junio de 2026
Publicado por primera vez (Actual)
22 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NN1436-8502
- U1111-1328-4272 (Otro identificador: World Health Organization (WHO))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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