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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03209089
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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Belgorod Region, Shebekino, Federación Rusa, D1690R00037
- Research Site
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Belgorod Region, Volokonovsky R-n, P. Volokonovka, Federación Rusa, D1690R00037
- Research Site
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Gis-Khrustalny, Federación Rusa, D1690R00037
- Research Site
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Izhevsk, Federación Rusa, D1690R00037
- Research Site
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Kazan, Federación Rusa, D1690R00037
- Research Site
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Lipetsk, Federación Rusa, D1690R00037
- Research Site
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N. Novgorod, Federación Rusa, D1690R00037
- Research Site
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N. Novgorod Region, Federación Rusa, D1690R00037
- Research Site
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Novomoskovsk, Federación Rusa, D1690R00037
- Research Site
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Novosibirsk, Federación Rusa, D1690R00037
- Research Site
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Perm, Federación Rusa, D1690R00037
- Research Site
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Ryazan, Federación Rusa, D1690R00037
- Research Site
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Samara, Federación Rusa, D1690R00037
- Research Site
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St-petersburg, Federación Rusa, D1690R00037
- Research Site
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Tambov Region, Federación Rusa, D1690R00037
- Research Site
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Volzhsk, Federación Rusa, D1690R00037
- Research Site
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Voronezh, Federación Rusa, D1690R00037
- Research Site
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Voronezh Region, Novovoronezh, Federación Rusa, D1690R00037
- Research Site
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Yaroslavl, Federación Rusa, D1690R00037
- Research Site
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Yoshkar-Ola, Federación Rusa, D1690R00037
- Research Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Demographic parameters before dapagliflozin initiation in T2DM patients managed by GPs
Periodo de tiempo: 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
Periodo de tiempo: 3 months before dapagliflozin initiation
|
age distribution
|
3 months before dapagliflozin initiation
|
demographic characteristics of T2DM patients managed by GPs
Periodo de tiempo: 3 months before dapagliflozin initiation
|
gender distribution
|
3 months before dapagliflozin initiation
|
clinical characteristics of T2DM patients managed by GPs
Periodo de tiempo: 3 months before dapagliflozin initiation
|
mean duration of T2DM
|
3 months before dapagliflozin initiation
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clinical characteristics of T2DM patients managed by GPs
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Vladimir Bulatov, MD, PhD, AstraZeneca Russia
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- D1690R00037
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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