{"doc_desc":{"title":"Cohorte de patients \u00e2g\u00e9s atteints de DT2. Risque hypoglyc\u00e9mique des inhibiteurs de la DPP4 (DPP4-i) compar\u00e9s \u00e0 d\u2019autres antidiab\u00e9tiques oraux en addition \u00e0 la metformine","idno":"FRESH-PEF73265-fr","producers":[{"name":"Sylvie DEJAGER","affiliation":"NOVARTIS PHARMA SAS"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73265-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73265"},{"agency":"FReSH","code":"FRESH-PEF73265"}]},"title":"Cohorte de patients \u00e2g\u00e9s atteints de DT2. Risque hypoglyc\u00e9mique des inhibiteurs de la DPP4 (DPP4-i) compar\u00e9s \u00e0 d\u2019autres antidiab\u00e9tiques oraux en addition \u00e0 la metformine","alternate_title":"HYPOCRAS"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Isabelle;BOURDEL-MARCHASSON","PILabo":"Bordeaux University Hospital","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"059620641","role":"pi id"},{"title":"SIREN","uri":"263305823","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"Isabelle.bourdel-marchasson@chu-bordeaux.fr","isContact":"Oui"},{"type":"investigator","name":"Alfred;PENFORNIS","PILabo":"Jean-Minjoz Hospital \/ EA 3920","affiliationName":"CHU BESANCON (CHU)","extlink":[{"title":"ORCID","uri":"0000-0002-9635-7674","role":"pi id"},{"title":"IdRef","uri":"034191720","role":"pi 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Alimentation","vocab":"health determinant"},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"HYPOCRAS est destin\u00e9e \u00e0 \u00e9valuer \u00ab en vie r\u00e9elle \u00bb le risque hypoglyc\u00e9mique des inhibiteurs de la dipeptidylpeptidase IV (iDPP4) versus autres antidiab\u00e9tiques oraux (AADO) en addition \u00e0 la metformine chez des patients \u00e2g\u00e9s diab\u00e9tiques de type 2 (DT2)","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2011-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Les patients admissibles \u00e0 l'\u00e9tude \u00e9taient des hommes et des femmes de 65 ans ou plus atteints de DT2 et HbA1c \u2265 6,5% avec un traitement d'au moins 3 mois de la metformine seule \u00e0 une dose quotidienne stable maximale tol\u00e9r\u00e9e, n\u00e9cessitant la prescription d'un second antidiab\u00e9tique oral  Patients avec au moins deux visites de suivi pr\u00e9vues au cours des 6 prochains mois (\u00b1 1 mois 3 mois et 6 mois \u00b1 1 mois).\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Consommation de soins\/services de 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