Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

31 maart 2020 bijgewerkt door: 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

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

907

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 100 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Demographic parameters before dapagliflozin initiation in T2DM patients managed by GPs
Tijdsspanne: 3 months before dapagliflozin initiation
mean age
3 months before dapagliflozin initiation
demographic characteristics of T2DM patients managed by GPs
Tijdsspanne: 3 months before dapagliflozin initiation
age distribution
3 months before dapagliflozin initiation
demographic characteristics of T2DM patients managed by GPs
Tijdsspanne: 3 months before dapagliflozin initiation
gender distribution
3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Tijdsspanne: 3 months before dapagliflozin initiation
mean duration of T2DM
3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Tijdsspanne: 3 months before dapagliflozin initiation
HbA1c (mean and distribution)
3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Tijdsspanne: 3 months before dapagliflozin initiation
Weight (mean)
3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Tijdsspanne: 3 months before dapagliflozin initiation
SBP (mean and distribution)
3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Tijdsspanne: 3 months before dapagliflozin initiation
DBP (mean and distribution)
3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 3 months before dapagliflozin initiation
Proportion of patients on different classes of concomitant therapy
3 months before dapagliflozin initiation

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

AstraZeneca

Onderzoekers

  • Studie directeur: Vladimir Bulatov, MD, PhD, AstraZeneca Russia

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 augustus 2017

Primaire voltooiing (Werkelijk)

15 april 2019

Studie voltooiing (Werkelijk)

15 april 2019

Studieregistratiedata

Eerst ingediend

19 juni 2017

Eerst ingediend dat voldeed aan de QC-criteria

3 juli 2017

Eerst geplaatst (Werkelijk)

6 juli 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 april 2020

Laatste update ingediend die voldeed aan QC-criteria

31 maart 2020

Laatst geverifieerd

1 maart 2020

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • D1690R00037

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Diabetes mellitus type 2

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Ireland

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

3
Abonneren