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NCT Number: NCT03209089

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Belgorod Region, Shebekino, Russian Federation, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Demographic parameters before dapagliflozin initiation in T2DM patients managed by GPs

    Time frame: 3 months before dapagliflozin initiation

    mean age

  2. demographic characteristics of T2DM patients managed by GPs

    Time frame: 3 months before dapagliflozin initiation

    age distribution

  3. demographic characteristics of T2DM patients managed by GPs

    Time frame: 3 months before dapagliflozin initiation

    gender distribution

  4. clinical characteristics of T2DM patients managed by GPs

    Time frame: 3 months before dapagliflozin initiation

    mean duration of T2DM

  5. clinical characteristics of T2DM patients managed by GPs

    Time frame: 3 months before dapagliflozin initiation

    HbA1c (mean and distribution)

  6. clinical characteristics of T2DM patients managed by GPs

    Time frame: 3 months before dapagliflozin initiation

    Weight (mean)

  7. clinical characteristics of T2DM patients managed by GPs

    Time frame: 3 months before dapagliflozin initiation

    SBP (mean and distribution)

  8. clinical characteristics of T2DM patients managed by GPs

    Time frame: 3 months before dapagliflozin initiation

    DBP (mean and distribution)

  9. clinical characteristics of T2DM patients managed by GPs

    Time frame: 3 months before dapagliflozin initiation

    Proportion of T2DM patients with diabetic complications

  10. clinical characteristics of T2DM patients managed by GPs

    Time frame: 3 months before dapagliflozin initiation

    Proportion of patients with T2DM treatment intensification during 3 months before inclusion in the study

  11. clinical characteristics of T2DM patients managed by GPs

    Time frame: 3 months before dapagliflozin initiation

    Proportion of patients with different treatment regimen

  12. clinical characteristics of T2DM patients managed by GPs

    Time frame: 3 months before dapagliflozin initiation

    Proportion of patients on treatment with different classes of antidiabetic therapy

  13. clinical characteristics of T2DM patients managed by GPs

    Time frame: 3 months before dapagliflozin initiation

    Proportion of patients on different classes of concomitant therapy

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 6, 2017
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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