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 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Inscription sur invitation
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Estimé)
216
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Chine, 100730
- Beijing Hospital
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Chine, 400010
- The Second Affiliated Hospital of Chongqing Medical University-Endocrinology
-
-
Gansu
-
Lanzhou, Gansu, Chine, 730000
- Gansu Provincial People's Hospital
-
-
Guangdong
-
Jiangmen, Guangdong, Chine, 529020
- The People's Hospital of JiangMen
-
-
Hebi
-
Langfang, Hebi, Chine, 065099
- Hebei PetroChina Central Hospital
-
-
Heilongjiang
-
Harbin, Heilongjiang, Chine, 150036
- Heilongjiang Provincial Hospital
-
-
Hubei
-
Shiyan, Hubei, Chine, 442099
- Shiyan City People's Hospital
-
-
Jiangsu
-
Huai'an, Jiangsu, Chine, 223300
- NIS-Huai'an First People's Hospital-Endocrinology
-
Nanjing, Jiangsu, Chine, 211199
- NIS-Nanjing Jiangning Hospital-Endocrinology
-
Suzhou, Jiangsu, Chine, 215004
- The Second Affiliated Hospital of Soochow University
-
-
Jiangxi
-
Nanchang, Jiangxi, Chine, 330006
- The Second Affiliated Hospital of Nanchang University
-
-
Liaoning
-
Shenyang, Liaoning, Chine, 110023
- The Fifth People's Hospital of Shenyang
-
-
Shandong
-
Jinan, Shandong, Chine, 250098
- Shandong Provincial Hospital
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Chine, 200050
- Tongren Hospital Shanghai Jiao Tong University School of Medicine
-
-
Xinjiang
-
Urumuqi, Xinjiang, Chine, 830054
- The First Affiliated Hospital of Xinjiang Medical University
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in glycated haemoglobin (HbA1c)
Délai: From baseline (week 0) to week 26
|
Measured in percentage (%)-point
|
From baseline (week 0) to week 26
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score
Délai: 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.
|
From baseline (week 0) to End of study (week 22-30)
|
|
Change in Adelphi Adherence Questionnaire (ADAQ) score
Délai: From baseline (week 0) to End of study (week 22-30)
|
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.
|
From baseline (week 0) to End of study (week 22-30)
|
|
Change in body weight
Délai: From baseline (week 0) to week 26
|
Measured in kilograms (kg).
|
From baseline (week 0) to week 26
|
|
Number of self-reported overall severe hypoglycemia episodes
Délai: From baseline (week 0) to end of study (week 22-30)
|
Measured in number of episodes.
|
From baseline (week 0) to end of study (week 22-30)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
2 juillet 2026
Achèvement primaire (Estimé)
1 décembre 2027
Achèvement de l'étude (Estimé)
1 décembre 2027
Dates d'inscription aux études
Première soumission
13 juin 2026
Première soumission répondant aux critères de contrôle qualité
13 juin 2026
Première publication (Réel)
22 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NN1436-8502
- U1111-1328-4272 (Autre identifiant: World Health Organization (WHO))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .