NCT03209089

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
907

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

August 7, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2019

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

1.7 years

First QC Date

June 19, 2017

Last Update Submit

March 31, 2020

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (13)

  • 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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Research Site

Belgorod Region, Shebekino, Russian Federation, D1690R00037, Russia

Location

Research Site

Belgorod Region, Volokonovsky R-n, P. Volokonovka, Russian Federation, D1690R00037, Russia

Location

Research Site

Gis-Khrustalny, Russian Federation, D1690R00037, Russia

Location

Research Site

Izhevsk, Russian Federation, D1690R00037, Russia

Location

Research Site

Kazan', Russian Federation, D1690R00037, Russia

Location

Research Site

Lipetsk, Russian Federation, D1690R00037, Russia

Location

Research Site

N. Novgorod Region, Russian Federation, D1690R00037, Russia

Location

Research Site

Nizhny Novgorod, Russian Federation, D1690R00037, Russia

Location

Research Site

Novomoskovsk, Russian Federation, D1690R00037, Russia

Location

Research Site

Novosibirsk, Russian Federation, D1690R00037, Russia

Location

Research Site

Perm, Russian Federation, D1690R00037, Russia

Location

Research Site

Ryazan, Russian Federation, D1690R00037, Russia

Location

Research Site

Saint Petersburg, Russian Federation, D1690R00037, Russia

Location

Research Site

Samara, Russian Federation, D1690R00037, Russia

Location

Research Site

Tambov Region, Russian Federation, D1690R00037, Russia

Location

Research Site

Volzhsk, Russian Federation, D1690R00037, Russia

Location

Research Site

Voronezh, Russian Federation, D1690R00037, Russia

Location

Research Site

Voronezh Region, Novovoronezh, Russian Federation, D1690R00037, Russia

Location

Research Site

Yaroslavl, Russian Federation, D1690R00037, Russia

Location

Research Site

Yoshkar-Ola, Russian Federation, D1690R00037, Russia

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Vladimir Bulatov, MD, PhD

    AstraZeneca Russia

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2017

First Posted

July 6, 2017

Study Start

August 7, 2017

Primary Completion

April 15, 2019

Study Completion

April 15, 2019

Last Updated

April 1, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(20)