Clinical trial NCT03209089: Type 2 Diabetes Mellitus Patients' Characteristics and Management by General Practitioners and Endocrinologists
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-07-06
Enrollment: 907
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Demographic parameters before dapagliflozin initiation in T2DM patients managed by GPs
timeFrame: 3 months before dapagliflozin initiation
measure: demographic characteristics of T2DM patients managed by GPs
timeFrame: 3 months before dapagliflozin initiation
measure: demographic characteristics of T2DM patients managed by GPs
timeFrame: 3 months before dapagliflozin initiation
measure: clinical characteristics of T2DM patients managed by GPs
timeFrame: 3 months before dapagliflozin initiation
measure: clinical characteristics of T2DM patients managed by GPs
timeFrame: 3 months before dapagliflozin initiation
measure: clinical characteristics of T2DM patients managed by GPs
timeFrame: 3 months before dapagliflozin initiation
measure: clinical characteristics of T2DM patients managed by GPs
timeFrame: 3 months before dapagliflozin initiation
measure: clinical characteristics of T2DM patients managed by GPs
timeFrame: 3 months before dapagliflozin initiation
measure: clinical characteristics of T2DM patients managed by GPs
timeFrame: 3 months before dapagliflozin initiation
measure: clinical characteristics of T2DM patients managed by GPs
timeFrame: 3 months before dapagliflozin initiation
measure: clinical characteristics of T2DM patients managed by GPs
timeFrame: 3 months before dapagliflozin initiation
measure: clinical characteristics of T2DM patients managed by GPs
timeFrame: 3 months before dapagliflozin initiation
measure: clinical characteristics of T2DM patients managed by GPs
timeFrame: 3 months before dapagliflozin initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Belgorod Region, Shebekino
country: Russian Federation
facility: Research Site
city: Belgorod Region, Volokonovsky R-n, P. Volokonovka
country: Russian Federation
facility: Research Site
city: Gis-Khrustalny
country: Russian Federation
facility: Research Site
city: Izhevsk
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Lipetsk
country: Russian Federation
facility: Research Site
city: N. Novgorod Region
country: Russian Federation
facility: Research Site
city: N. Novgorod
country: Russian Federation
facility: Research Site
city: Novomoskovsk
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: St-petersburg
country: Russian Federation
facility: Research Site
city: Tambov Region
country: Russian Federation
facility: Research Site
city: Volzhsk
country: Russian Federation
facility: Research Site
city: Voronezh Region, Novovoronezh
country: Russian Federation
facility: Research Site
city: Voronezh
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Yoshkar-Ola
country: Russian Federation
facility: Research Site
Study officials:
affiliation: AstraZeneca Russia
name: Vladimir Bulatov, MD, PhD
role: STUDY_DIRECTOR
References: