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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)

13. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

216

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100730
        • Beijing Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina, 400010
        • The Second Affiliated Hospital of Chongqing Medical University-Endocrinology
    • Gansu
      • Lanzhou, Gansu, Kina, 730000
        • Gansu Provincial People's Hospital
    • Guangdong
      • Jiangmen, Guangdong, Kina, 529020
        • The People's Hospital of JiangMen
    • Hebi
      • Langfang, Hebi, Kina, 065099
        • Hebei PetroChina Central Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150036
        • Heilongjiang Provincial Hospital
    • Hubei
      • Shiyan, Hubei, Kina, 442099
        • Shiyan City People's Hospital
    • Jiangsu
      • Huai'an, Jiangsu, Kina, 223300
        • NIS-Huai'an First People's Hospital-Endocrinology
      • Nanjing, Jiangsu, Kina, 211199
        • NIS-Nanjing Jiangning Hospital-Endocrinology
      • Suzhou, Jiangsu, Kina, 215004
        • The Second Affiliated Hospital of Soochow University
    • Jiangxi
      • Nanchang, Jiangxi, Kina, 330006
        • The Second Affiliated Hospital of Nanchang University
    • Liaoning
      • Shenyang, Liaoning, Kina, 110023
        • The Fifth People's Hospital of Shenyang
    • Shandong
      • Jinan, Shandong, Kina, 250098
        • Shandong Provincial Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200050
        • Tongren Hospital Shanghai Jiao Tong University School of Medicine
    • Xinjiang
      • Urumuqi, Xinjiang, Kina, 830054
        • The First Affiliated Hospital of Xinjiang Medical University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in glycated haemoglobin (HbA1c)
Tidsramme: From baseline (week 0) to week 26
Measured in percentage (%)-point
From baseline (week 0) to week 26

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novo Nordisk A/S

Efterforskere

  • Studieleder: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juni 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

13. juni 2026

Først indsendt, der opfyldte QC-kriterier

13. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NN1436-8502
  • U1111-1328-4272 (Anden identifikator: World Health Organization (WHO))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diabetes mellitus, type 2

Kliniske forsøg med Insulin icodec

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Turkmenistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner