check_circleStudy Completed

Type 2 diabetes mellitus, Chronic kidney disease

Bayer Identifier:

21333

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
OREOT – Observational Retrospective pharmaco-Epidemiological French study On CKD in T2DM disease

Trial purpose

L'objectif principal de cette étude est d'évaluer la prévalence et l'incidence des patients atteints de maladie rénale chronique et de diabète de type 2 dans la population française.
Les objectifs secondaires de l’étude sont :
•   D’évaluer la prévalence et l'incidence de sous-populations d'intérêt chez les patients atteints de maladie rénale chronique et de diabète de type 2 ;
•   De décrire chez les patients atteints de maladie rénale chronique et de diabète de type 2 et selon le stade de l’atteinte rénale :
- Les caractéristiques démographiques et cliniques des patients.
- Les traitements médicamenteux.
- L'incidence des complications rénales et cardiovasculaires.
- L'utilisation et les coûts des soins de santé.

Key Participants Requirements

Sex

All

Age

30 - N/A
  • - Patients must fulfill the following criteria to be included in the EMR T2DM sample:
     -- Adults of 30 years of age and more in the EMR
     -- AND identification of T2DM in the EMR by:
     --- At least one GP consultation with a diagnosis of T2DM recorded in the EMR
     --- AND/OR at least 3 prescriptions (at different dates) of a T2DM marker treatment (oral antidiabetic agents, OAD or GLP-1a); and in case of large conditioning with at least 2 prescriptions during the study period
    - Patients must fulfill the following criteria to be included in the SNDS T2DM sample:
     -- Adults over 30 years of age and more in the SNDS
     -- AND covered by the general health insurance plan in the SNDS
     -- AND identification of T2DM in the SNDS by:
     --- Patient receiving oral anti-diabetic treatment: at least 3 deliveries (at different dates) of oral antidiabetic agents (or at least 2 if at least 1 large conditioning) during one year
     --- AND/OR patient having active long term disease (ALD) in year n with a diagnosis code of T2DM
     --- AND/OR patient having at least one hospital stay for which the principal diagnosis (DP) or related diagnosis (DR) indicates T2DM
     --- AND/OR patient having at least one hospital stay for which the DP or DR indicates a complication of T2DM, and T2DM is identified as an associated diagnosis (DA) or as a DP / DR of a medical unit summary (RUM)
  • - Adults under 30 years of age
    - Less than 1 year of history in SNDS prior to index date
    - The beneficiaries who are insufficiently identifiable or who have a technical constraint of the SNDS (pseudonymous, pseudo NIRs, twins, ...)
    - Patients affiliated to a Mayotte settlement institution (an oversea French department [(250 000 inhabitants/67 million in France]) as some variables such as long-term/chronic disease or death are poorly documented

Trial summary

Enrollment Goal
30000
Trial Dates
October 2020 - February 2024
Phase
N/A
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
Many LocationsMany Locations, France

Primary Outcome

  • Prevalence and incidence of Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM) patients in the French population and in sub-populations of interest
    date_rangeTime Frame:
    Secondary data collection between 2014 and 2018

Secondary Outcome

  • Demographic and clinical characteristics of patients at baseline
    date_rangeTime Frame:
    Secondary data collection between 2014 and 2018
  • Description of treatment pattern
    date_rangeTime Frame:
    Secondary data collection between 2014 and 2018
  • Description of time to outcomes: hospitalization for cardiovascular events, end-stage renal disease (ESRD), mortality
    date_rangeTime Frame:
    Secondary data collection between 2014 and 2018
  • Quantify healthcare resources utilization and costs of Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD) patients
    date_rangeTime Frame:
    Secondary data collection between 2014 and 2018
  • Health care workers involved in patients management
    date_rangeTime Frame:
    Secondary data collection between 2014 and 2018
  • Global cost and additional cost of Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM) patients
    date_rangeTime Frame:
    Secondary data collection between 2014 and 2018

Trial design

OREOT – Observational Retrospective pharmaco-Epidemiological French study On CKD in T2DM disease
Trial Type
Observational
Intervention Type
Other
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

OREOT Patient Information (French)Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.