Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Type 2 Diabetes Mellitus Patients' Characteristics and Management by General Practitioners and Endocrinologists

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209089
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease
Type 2 Diabetes Mellitus

Detailed 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 907 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: A Non-Interventional Study on Type 2 Diabetes Mellitus Patient's Characteristics and Management by General Practitioners and Endocrinologists in the Russian Population (THESEUS)
Actual Study Start Date : August 7, 2017
Actual Primary Completion Date : April 15, 2019
Actual Study Completion Date : April 15, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Demographic parameters before dapagliflozin initiation in T2DM patients managed by GPs [ Time Frame: 3 months before dapagliflozin initiation ]
    mean age

  2. demographic characteristics of T2DM patients managed by GPs [ Time Frame: 3 months before dapagliflozin initiation ]
    age distribution

  3. demographic characteristics of T2DM patients managed by GPs [ Time Frame: 3 months before dapagliflozin initiation ]
    gender distribution

  4. clinical characteristics of T2DM patients managed by GPs [ Time Frame: 3 months before dapagliflozin initiation ]
    mean duration of T2DM

  5. clinical characteristics of T2DM patients managed by GPs [ Time Frame: 3 months before dapagliflozin initiation ]
    HbA1c (mean and distribution)

  6. clinical characteristics of T2DM patients managed by GPs [ Time Frame: 3 months before dapagliflozin initiation ]
    Weight (mean)

  7. clinical characteristics of T2DM patients managed by GPs [ Time Frame: 3 months before dapagliflozin initiation ]
    SBP (mean and distribution)

  8. clinical characteristics of T2DM patients managed by GPs [ Time Frame: 3 months before dapagliflozin initiation ]
    DBP (mean and distribution)

  9. clinical characteristics of T2DM patients managed by GPs [ Time Frame: 3 months before dapagliflozin initiation ]
    Proportion of T2DM patients with diabetic complications

  10. clinical characteristics of T2DM patients managed by GPs [ Time Frame: 3 months before dapagliflozin initiation ]
    Proportion of patients with T2DM treatment intensification during 3 months before inclusion in the study

  11. clinical characteristics of T2DM patients managed by GPs [ Time Frame: 3 months before dapagliflozin initiation ]
    Proportion of patients with different treatment regimen

  12. clinical characteristics of T2DM patients managed by GPs [ Time Frame: 3 months before dapagliflozin initiation ]
    Proportion of patients on treatment with different classes of antidiabetic therapy

  13. clinical characteristics of T2DM patients managed by GPs [ Time Frame: 3 months before dapagliflozin initiation ]
    Proportion of patients on different classes of concomitant therapy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
900 male and female T2DM outpatients, who were managed by GPs or endocrinologists in 45 outpatient sites.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209089


Locations
Layout table for location information
Russian Federation
Research Site
Belgorod Region, Shebekino, Russian Federation, D1690R00037
Research Site
Belgorod Region, Volokonovsky R-n, P. Volokonovka, Russian Federation, D1690R00037
Research Site
Gis-Khrustalny, Russian Federation, D1690R00037
Research Site
Izhevsk, Russian Federation, D1690R00037
Research Site
Kazan, Russian Federation, D1690R00037
Research Site
Lipetsk, Russian Federation, D1690R00037
Research Site
N. Novgorod Region, Russian Federation, D1690R00037
Research Site
N. Novgorod, Russian Federation, D1690R00037
Research Site
Novomoskovsk, Russian Federation, D1690R00037
Research Site
Novosibirsk, Russian Federation, D1690R00037
Research Site
Perm, Russian Federation, D1690R00037
Research Site
Ryazan, Russian Federation, D1690R00037
Research Site
Samara, Russian Federation, D1690R00037
Research Site
St-petersburg, Russian Federation, D1690R00037
Research Site
Tambov Region, Russian Federation, D1690R00037
Research Site
Volzhsk, Russian Federation, D1690R00037
Research Site
Voronezh Region, Novovoronezh, Russian Federation, D1690R00037
Research Site
Voronezh, Russian Federation, D1690R00037
Research Site
Yaroslavl, Russian Federation, D1690R00037
Research Site
Yoshkar-Ola, Russian Federation, D1690R00037
Sponsors and Collaborators
AstraZeneca
Investigators
Layout table for investigator information
Study Director: Vladimir Bulatov, MD, PhD AstraZeneca Russia
Additional Information:
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03209089    
Other Study ID Numbers: D1690R00037
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases