Type 2 Diabetes Mellitus Patients' Characteristics and Management by General Practitioners and Endocrinologists
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      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
    

Detailed description: 
      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.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        900 male and female T2DM outpatients, who were managed by GPs or endocrinologists in 45
        outpatient sites.