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

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus

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.

• Study Type: Observational
• Enrollment (Actual): 907

Contacts and Locations

Study Locations

• Russian Federation
  • Belgorod Region, Shebekino, Russian Federation, D1690R00037
    • Research Site
  • Belgorod Region, Volokonovsky R-n, P. Volokonovka, Russian Federation, D1690R00037
    • Research Site
  • Gis-Khrustalny, Russian Federation, D1690R00037
    • Research Site
  • Izhevsk, Russian Federation, D1690R00037
    • Research Site
  • Kazan, Russian Federation, D1690R00037
    • Research Site
  • Lipetsk, Russian Federation, D1690R00037
    • Research Site
  • N. Novgorod, Russian Federation, D1690R00037
    • Research Site
  • N. Novgorod Region, Russian Federation, D1690R00037
    • Research Site
  • Novomoskovsk, Russian Federation, D1690R00037
    • Research Site
  • Novosibirsk, Russian Federation, D1690R00037
    • Research Site
  • Perm, Russian Federation, D1690R00037
    • Research Site
  • Ryazan, Russian Federation, D1690R00037
    • Research Site
  • Samara, Russian Federation, D1690R00037
    • Research Site
  • St-petersburg, Russian Federation, D1690R00037
    • Research Site
  • Tambov Region, Russian Federation, D1690R00037
    • Research Site
  • Volzhsk, Russian Federation, D1690R00037
    • Research Site
  • Voronezh, Russian Federation, D1690R00037
    • Research Site
  • Voronezh Region, Novovoronezh, Russian Federation, D1690R00037
    • Research Site
  • Yaroslavl, Russian Federation, D1690R00037
    • Research Site
  • Yoshkar-Ola, Russian Federation, D1690R00037
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

900 male and female T2DM outpatients, who were managed by GPs or endocrinologists in 45 outpatient sites.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic parameters before dapagliflozin initiation in T2DM patients managed by GPs	mean age	3 months before dapagliflozin initiation
demographic characteristics of T2DM patients managed by GPs	age distribution	3 months before dapagliflozin initiation
demographic characteristics of T2DM patients managed by GPs	gender distribution	3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs	mean duration of T2DM	3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs	HbA1c (mean and distribution)	3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs	Weight (mean)	3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs	SBP (mean and distribution)	3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs	DBP (mean and distribution)	3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs	Proportion of T2DM patients with diabetic complications	3 months before dapagliflozin initiation
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
clinical characteristics of T2DM patients managed by GPs	Proportion of patients with different treatment regimen	3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs	Proportion of patients on treatment with different classes of antidiabetic therapy	3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs	Proportion of patients on different classes of concomitant therapy	3 months before dapagliflozin initiation

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Vladimir Bulatov, MD, PhD, AstraZeneca Russia

Publications and helpful links

Helpful Links

• D1690R00037 Study Report Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2017
• Primary Completion (Actual): April 15, 2019
• Study Completion (Actual): April 15, 2019

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (Actual): July 6, 2017

Study Record Updates

• Last Update Posted (Actual): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: D1690R00037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO