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

31 mars 2020 uppdaterad av: 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

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

907

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 100 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AstraZeneca

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

7 augusti 2017

Primärt slutförande (Faktisk)

15 april 2019

Avslutad studie (Faktisk)

15 april 2019

Studieregistreringsdatum

Först inskickad

19 juni 2017

Först inskickad som uppfyllde QC-kriterierna

3 juli 2017

Första postat (Faktisk)

6 juli 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 april 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 mars 2020

Senast verifierad

1 mars 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • D1690R00037

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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