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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Change in glycated haemoglobin (HbA1c) [Срок оценки: From baseline (week 0) to week 26]

Вторичные конечные точки (4)

• Change in Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score [Срок оценки: From baseline (week 0) to End of study (week 22-30)]
• Change in Adelphi Adherence Questionnaire (ADAQ) score [Срок оценки: From baseline (week 0) to End of study (week 22-30)]
• Change in body weight [Срок оценки: From baseline (week 0) to week 26]
• Number of self-reported overall severe hypoglycemia episodes [Срок оценки: From baseline (week 0) to end of study (week 22-30)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 15 центров

• Beijing Hospital — Пекин
• The Second Affiliated Hospital of Chongqing Medical University-Endocrinology — Чунцин
• Gansu Provincial People's Hospital — Lanzhou
• The People's Hospital of JiangMen — Jiangmen
• Hebei PetroChina Central Hospital — Langfang
• Heilongjiang Provincial Hospital — Харбин
• Shiyan City People's Hospital — Shiyan
• NIS-Huai'an First People's Hospital-Endocrinology — Huai'an
• … и ещё 7 центров

Идентификаторы

NCT: NCT07658417 · NN1436-8502 · U1111-1328-4272

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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