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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209089
• Other study ID #: D1690R00037
• Status: Completed
• Start date: August 7, 2017
• Est. completion date: April 15, 2019

Study information

• Verified date: March 2020
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 907
• Est. completion date: April 15, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Russian Federation	Research Site	Belgorod Region, Shebekino
Russian Federation	Research Site	Belgorod Region, Volokonovsky R-n, P. Volokonovka
Russian Federation	Research Site	Gis-Khrustalny
Russian Federation	Research Site	Izhevsk
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Lipetsk
Russian Federation	Research Site	N. Novgorod
Russian Federation	Research Site	N. Novgorod Region
Russian Federation	Research Site	Novomoskovsk
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Perm
Russian Federation	Research Site	Ryazan
Russian Federation	Research Site	Samara
Russian Federation	Research Site	St-petersburg
Russian Federation	Research Site	Tambov Region
Russian Federation	Research Site	Volzhsk
Russian Federation	Research Site	Voronezh
Russian Federation	Research Site	Voronezh Region, Novovoronezh
Russian Federation	Research Site	Yaroslavl
Russian Federation	Research Site	Yoshkar-Ola

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic parameters before dapagliflozin initiation in T2DM patients managed by GPs	mean age	3 months before dapagliflozin initiation
Primary	demographic characteristics of T2DM patients managed by GPs	age distribution	3 months before dapagliflozin initiation
Primary	demographic characteristics of T2DM patients managed by GPs	gender distribution	3 months before dapagliflozin initiation
Primary	clinical characteristics of T2DM patients managed by GPs	mean duration of T2DM	3 months before dapagliflozin initiation
Primary	clinical characteristics of T2DM patients managed by GPs	HbA1c (mean and distribution)	3 months before dapagliflozin initiation
Primary	clinical characteristics of T2DM patients managed by GPs	Weight (mean)	3 months before dapagliflozin initiation
Primary	clinical characteristics of T2DM patients managed by GPs	SBP (mean and distribution)	3 months before dapagliflozin initiation
Primary	clinical characteristics of T2DM patients managed by GPs	DBP (mean and distribution)	3 months before dapagliflozin initiation
Primary	clinical characteristics of T2DM patients managed by GPs	Proportion of T2DM patients with diabetic complications	3 months before dapagliflozin initiation
Primary	clinical characteristics of T2DM patients managed by GPs	Proportion of patients with T2DM treatment intensification during 3 months before inclusion in the study	3 months before dapagliflozin initiation
Primary	clinical characteristics of T2DM patients managed by GPs	Proportion of patients with different treatment regimen	3 months before dapagliflozin initiation
Primary	clinical characteristics of T2DM patients managed by GPs	Proportion of patients on treatment with different classes of antidiabetic therapy	3 months before dapagliflozin initiation
Primary	clinical characteristics of T2DM patients managed by GPs	Proportion of patients on different classes of concomitant therapy	3 months before dapagliflozin initiation

External Links

•   D1690R00037 Study Report Synopsis