Trial Condition(s):

Type 2 Diabetes Mellitus, Chronic Kidney Disease

OREOT – Observational Retrospective pharmaco-Epidemiological French study On CKD in T2DM disease

Bayer Identifier:

21333

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

Recruitment Complete

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.

Inclusion Criteria
- 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)
Exclusion Criteria
- 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
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Phase
N/A
Could I receive a placebo?
No
Products
No Drug
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many Locations

Many Locations, France

Status
Active, not recruiting
 

Trial Design