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Type 2 Diabetes Mellitus Patients' Characteristics and Management by General Practitioners and Endocrinologists

31. marts 2020 opdateret af: AstraZeneca

A Non-Interventional Study on Type 2 Diabetes Mellitus Patient's Characteristics and Management by General Practitioners and Endocrinologists in the Russian Population (THESEUS)

This is a multi-centre observational, ambispective study, which will retrospectively and prospectively collect clinical variables and socio-demographic data from medical records of patients with type 2 diabetes mellitus (T2DM) initiated with dapagliflozin by general practitioners (GPs) and endocrinologists in real-life setting. It is anticipated that patient recruitment will last 8 months (from Q3 2017 to Q1 2018) and each patient will be followed during the second visit 6±3 months later after the first visit. There are 2 time points:

  • Baseline data: baseline data are defined as data available within 3 months prior to the first dose of dapagliflozin. In case of presence of multiple data values within baseline period the most recent pre-dose value will be selected
  • Follow-up data: any post-baseline data will be considered as follow-up but the primary analysis will be focused on data available at 6±3 months after the first visit. In case of discontinuation dapagliflozin, data will be collected at routine visit within 3-month time frame after the last dose

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Study design:

This is a multi-centre observational, ambispective study, which will retrospectively and prospectively collect clinical variables and socio-demographic data from medical records of patients with T2DM initiated with dapagliflozin by GPs and endocrinologists in real-life setting.

Only patients, who provide written consent to participate in the study will be enrolled into this study. All patients will be unique with no overlap between endocrinologists and GPs. All consecutive patients managed by GPs or endocrinologists who meet inclusion criteria will be included. All GPs and endocrinologists, who manage T2DM on sites, will be participating investigators.

Patients will undergo clinical assessment and receive the standard medical care as usual determined by the treating doctor based on their clinical judgement and national guidelines. Patients will not receive experimental treatment as a consequence of their participation in the observational study.

It is anticipated that patient recruitment will last for 8 months (from Q3 2017 to Q1 2018) and each patient will be followed during the second visit 6±3 months later after the first visit.

There are 2 time points:

  • Baseline data: baseline data are defined as data available within 3 months prior to the first dose of dapagliflozin. In case of presence of multiple data values within baseline period the most recent pre-dose value will be selected
  • Follow-up data: any post-baseline data will be considered as follow-up but the primary analysis will be focused on data available at 6±3 months after the first visit. In case of discontinuation dapagliflozin, data will be collected at routine visit within 3-month time frame after the last dose.

Data Source(s):

Baseline data will be collected during Visit 1 from the T2DM patient medical records, including disease history of patient, and during follow-up data during Visit 2 (after 6±3 months from Visit 1).

Study Population:

It is planned to include 900 male and female T2DM outpatients 18 years and older, who were managed by GPs or endocrinologists in 45 outpatient sites.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

907

Kontakter og lokationer

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

Studiesteder

  • Den Russiske Føderation
      • Belgorod Region, Shebekino, Den Russiske Føderation, D1690R00037
        • Research Site
      • Belgorod Region, Volokonovsky R-n, P. Volokonovka, Den Russiske Føderation, D1690R00037
        • Research Site
      • Gis-Khrustalny, Den Russiske Føderation, D1690R00037
        • Research Site
      • Izhevsk, Den Russiske Føderation, D1690R00037
        • Research Site
      • Kazan, Den Russiske Føderation, D1690R00037
        • Research Site
      • Lipetsk, Den Russiske Føderation, D1690R00037
        • Research Site
      • N. Novgorod, Den Russiske Føderation, D1690R00037
        • Research Site
      • N. Novgorod Region, Den Russiske Føderation, D1690R00037
        • Research Site
      • Novomoskovsk, Den Russiske Føderation, D1690R00037
        • Research Site
      • Novosibirsk, Den Russiske Føderation, D1690R00037
        • Research Site
      • Perm, Den Russiske Føderation, D1690R00037
        • Research Site
      • Ryazan, Den Russiske Føderation, D1690R00037
        • Research Site
      • Samara, Den Russiske Føderation, D1690R00037
        • Research Site
      • St-petersburg, Den Russiske Føderation, D1690R00037
        • Research Site
      • Tambov Region, Den Russiske Føderation, D1690R00037
        • Research Site
      • Volzhsk, Den Russiske Føderation, D1690R00037
        • Research Site
      • Voronezh, Den Russiske Føderation, D1690R00037
        • Research Site
      • Voronezh Region, Novovoronezh, Den Russiske Føderation, D1690R00037
        • Research Site
      • Yaroslavl, Den Russiske Føderation, D1690R00037
        • Research Site
      • Yoshkar-Ola, Den Russiske Føderation, D1690R00037
        • Research Site

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

18 år til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

900 male and female T2DM outpatients, who were managed by GPs or endocrinologists in 45 outpatient sites.

Beskrivelse

Inclusion Criteria:

  • Age 18 and older;
  • Established diagnosis of T2DM (ICD-10 code E11.2-E11.9)
  • The current treatment with dapagliflozin prescribed at least 1 month before the FSI;
  • Written voluntary informed consent has been provided
  • Management in outpatient setting.

Exclusion Criteria:

  • Type 1 diabetes
  • Current participation in a clinical trial
  • Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances).
  • Presence of serious/severe co-morbidities in the opinion of the investigator, which may limit treatment approach as usual.
  • Treatment with drugs affecting glucose homeostasis (e.g., systemic glucocorticosteroids) within 3 months before to the 1st Visit

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Demographic parameters before dapagliflozin initiation in T2DM patients managed by GPs
Tidsramme: 3 months before dapagliflozin initiation
mean age
3 months before dapagliflozin initiation
demographic characteristics of T2DM patients managed by GPs
Tidsramme: 3 months before dapagliflozin initiation
age distribution
3 months before dapagliflozin initiation
demographic characteristics of T2DM patients managed by GPs
Tidsramme: 3 months before dapagliflozin initiation
gender distribution
3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Tidsramme: 3 months before dapagliflozin initiation
mean duration of T2DM
3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Tidsramme: 3 months before dapagliflozin initiation
HbA1c (mean and distribution)
3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Tidsramme: 3 months before dapagliflozin initiation
Weight (mean)
3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Tidsramme: 3 months before dapagliflozin initiation
SBP (mean and distribution)
3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Tidsramme: 3 months before dapagliflozin initiation
DBP (mean and distribution)
3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Tidsramme: 3 months before dapagliflozin initiation
Proportion of T2DM patients with diabetic complications
3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Tidsramme: 3 months before dapagliflozin initiation
Proportion of patients with T2DM treatment intensification during 3 months before inclusion in the study
3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Tidsramme: 3 months before dapagliflozin initiation
Proportion of patients with different treatment regimen
3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Tidsramme: 3 months before dapagliflozin initiation
Proportion of patients on treatment with different classes of antidiabetic therapy
3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Tidsramme: 3 months before dapagliflozin initiation
Proportion of patients on different classes of concomitant therapy
3 months before dapagliflozin initiation

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

Efterforskere

  • Studieleder: Vladimir Bulatov, MD, PhD, AstraZeneca Russia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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 (Faktiske)

7. august 2017

Primær færdiggørelse (Faktiske)

15. april 2019

Studieafslutning (Faktiske)

15. april 2019

Datoer for studieregistrering

Først indsendt

19. juni 2017

Først indsendt, der opfyldte QC-kriterier

3. juli 2017

Først opslået (Faktiske)

6. juli 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D1690R00037

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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 .

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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