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
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Belgorod Region, Shebekino、俄罗斯联邦、D1690R00037
- Research Site
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Belgorod Region, Volokonovsky R-n, P. Volokonovka、俄罗斯联邦、D1690R00037
- Research Site
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Gis-Khrustalny、俄罗斯联邦、D1690R00037
- Research Site
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Izhevsk、俄罗斯联邦、D1690R00037
- Research Site
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Kazan、俄罗斯联邦、D1690R00037
- Research Site
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Lipetsk、俄罗斯联邦、D1690R00037
- Research Site
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N. Novgorod、俄罗斯联邦、D1690R00037
- Research Site
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N. Novgorod Region、俄罗斯联邦、D1690R00037
- Research Site
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Novomoskovsk、俄罗斯联邦、D1690R00037
- Research Site
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Novosibirsk、俄罗斯联邦、D1690R00037
- Research Site
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Perm、俄罗斯联邦、D1690R00037
- Research Site
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Ryazan、俄罗斯联邦、D1690R00037
- Research Site
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Samara、俄罗斯联邦、D1690R00037
- Research Site
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St-petersburg、俄罗斯联邦、D1690R00037
- Research Site
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Tambov Region、俄罗斯联邦、D1690R00037
- Research Site
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Volzhsk、俄罗斯联邦、D1690R00037
- Research Site
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Voronezh、俄罗斯联邦、D1690R00037
- Research Site
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Voronezh Region, Novovoronezh、俄罗斯联邦、D1690R00037
- Research Site
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Yaroslavl、俄罗斯联邦、D1690R00037
- Research Site
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Yoshkar-Ola、俄罗斯联邦、D1690R00037
- Research Site
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Demographic parameters before dapagliflozin initiation in T2DM patients managed by GPs
大体时间：3 months before dapagliflozin initiation
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mean age
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3 months before dapagliflozin initiation
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demographic characteristics of T2DM patients managed by GPs
大体时间：3 months before dapagliflozin initiation
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age distribution
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3 months before dapagliflozin initiation
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demographic characteristics of T2DM patients managed by GPs
大体时间：3 months before dapagliflozin initiation
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gender distribution
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3 months before dapagliflozin initiation
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clinical characteristics of T2DM patients managed by GPs
大体时间：3 months before dapagliflozin initiation
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mean duration of T2DM
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3 months before dapagliflozin initiation
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clinical characteristics of T2DM patients managed by GPs
大体时间：3 months before dapagliflozin initiation
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HbA1c (mean and distribution)
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3 months before dapagliflozin initiation
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clinical characteristics of T2DM patients managed by GPs
大体时间：3 months before dapagliflozin initiation
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Weight (mean)
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3 months before dapagliflozin initiation
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clinical characteristics of T2DM patients managed by GPs
大体时间：3 months before dapagliflozin initiation
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SBP (mean and distribution)
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3 months before dapagliflozin initiation
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clinical characteristics of T2DM patients managed by GPs
大体时间：3 months before dapagliflozin initiation
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DBP (mean and distribution)
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3 months before dapagliflozin initiation
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clinical characteristics of T2DM patients managed by GPs
大体时间：3 months before dapagliflozin initiation
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Proportion of T2DM patients with diabetic complications
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3 months before dapagliflozin initiation
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clinical characteristics of T2DM patients managed by GPs
大体时间：3 months before dapagliflozin initiation
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Proportion of patients with T2DM treatment intensification during 3 months before inclusion in the study
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3 months before dapagliflozin initiation
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clinical characteristics of T2DM patients managed by GPs
大体时间：3 months before dapagliflozin initiation
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Proportion of patients with different treatment regimen
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3 months before dapagliflozin initiation
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clinical characteristics of T2DM patients managed by GPs
大体时间：3 months before dapagliflozin initiation
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Proportion of patients on treatment with different classes of antidiabetic therapy
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3 months before dapagliflozin initiation
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clinical characteristics of T2DM patients managed by GPs
大体时间：3 months before dapagliflozin initiation
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Proportion of patients on different classes of concomitant therapy
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3 months before dapagliflozin initiation
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合作者和调查者
赞助
调查人员
- 研究主任：Vladimir Bulatov, MD, PhD、AstraZeneca Russia
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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