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

Type 2 Diabetes Mellitus Clinical Trial

Official 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)

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

• NCT number: NCT03209089
• Study type: Observational
• Source: AstraZeneca
• Status: Completed
• Start date: August 7, 2017
• Completion date: April 15, 2019