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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03209089
Other study ID # D1690R00037
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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