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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Belgorod Region, Shebekino、ロシア連邦、D1690R00037
- Research Site
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Belgorod Region, Volokonovsky R-n, P. Volokonovka、ロシア連邦、D1690R00037
- Research Site
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Gis-Khrustalny、ロシア連邦、D1690R00037
- Research Site
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Izhevsk、ロシア連邦、D1690R00037
- Research Site
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Kazan、ロシア連邦、D1690R00037
- Research Site
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Lipetsk、ロシア連邦、D1690R00037
- Research Site
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N. Novgorod、ロシア連邦、D1690R00037
- Research Site
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N. Novgorod Region、ロシア連邦、D1690R00037
- Research Site
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Novomoskovsk、ロシア連邦、D1690R00037
- Research Site
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Novosibirsk、ロシア連邦、D1690R00037
- Research Site
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Perm、ロシア連邦、D1690R00037
- Research Site
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Ryazan、ロシア連邦、D1690R00037
- Research Site
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Samara、ロシア連邦、D1690R00037
- Research Site
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St-petersburg、ロシア連邦、D1690R00037
- Research Site
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Tambov Region、ロシア連邦、D1690R00037
- Research Site
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Volzhsk、ロシア連邦、D1690R00037
- Research Site
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Voronezh、ロシア連邦、D1690R00037
- Research Site
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Voronezh Region, Novovoronezh、ロシア連邦、D1690R00037
- Research Site
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Yaroslavl、ロシア連邦、D1690R00037
- Research Site
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Yoshkar-Ola、ロシア連邦、D1690R00037
- Research Site
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Demographic parameters before dapagliflozin initiation in T2DM patients managed by GPs
時間枠：3 months before dapagliflozin initiation
|
mean age
|
3 months before dapagliflozin initiation
|
|
demographic characteristics of T2DM patients managed by GPs
時間枠：3 months before dapagliflozin initiation
|
age distribution
|
3 months before dapagliflozin initiation
|
|
demographic characteristics of T2DM patients managed by GPs
時間枠：3 months before dapagliflozin initiation
|
gender distribution
|
3 months before dapagliflozin initiation
|
|
clinical characteristics of T2DM patients managed by GPs
時間枠：3 months before dapagliflozin initiation
|
mean duration of T2DM
|
3 months before dapagliflozin initiation
|
|
clinical characteristics of T2DM patients managed by GPs
時間枠：3 months before dapagliflozin initiation
|
HbA1c (mean and distribution)
|
3 months before dapagliflozin initiation
|
|
clinical characteristics of T2DM patients managed by GPs
時間枠：3 months before dapagliflozin initiation
|
Weight (mean)
|
3 months before dapagliflozin initiation
|
|
clinical characteristics of T2DM patients managed by GPs
時間枠：3 months before dapagliflozin initiation
|
SBP (mean and distribution)
|
3 months before dapagliflozin initiation
|
|
clinical characteristics of T2DM patients managed by GPs
時間枠：3 months before dapagliflozin initiation
|
DBP (mean and distribution)
|
3 months before dapagliflozin initiation
|
|
clinical characteristics of T2DM patients managed by GPs
時間枠：3 months before dapagliflozin initiation
|
Proportion of T2DM patients with diabetic complications
|
3 months before dapagliflozin initiation
|
|
clinical characteristics of T2DM patients managed by GPs
時間枠：3 months before dapagliflozin initiation
|
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
時間枠：3 months before dapagliflozin initiation
|
Proportion of patients with different treatment regimen
|
3 months before dapagliflozin initiation
|
|
clinical characteristics of T2DM patients managed by GPs
時間枠：3 months before dapagliflozin initiation
|
Proportion of patients on treatment with different classes of antidiabetic therapy
|
3 months before dapagliflozin initiation
|
|
clinical characteristics of T2DM patients managed by GPs
時間枠：3 months before dapagliflozin initiation
|
Proportion of patients on different classes of concomitant therapy
|
3 months before dapagliflozin initiation
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Vladimir Bulatov, MD, PhD、AstraZeneca Russia
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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