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<docDscr>
  <citation>
    <titlStmt>
      <titl>Cohort of Elderly Patients with T2D. Comparing the Risk of Hypoglycaemia in DPP4-Inhibitors (iDPP4) with Conventional Oral Antidiabetic Drugs as Add-On Therapy to Metformin.</titl>
      <IDNo>FRESH-PEF73265-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="NOVARTIS PHARMA SAS" role="">Sylvie DEJAGER</producer>
    </prodStmt>
    <verStmt>
      <version></version>
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<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Cohort of Elderly Patients with T2D. Comparing the Risk of Hypoglycaemia in DPP4-Inhibitors (iDPP4) with Conventional Oral Antidiabetic Drugs as Add-On Therapy to Metformin.            </titl>
      <altTitl>
                    HYPOCRAS                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF73265-en            </IDNo>
      <IDNo agency="PEF">
                    73265                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF73265                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Isabelle BOURDEL-MARCHASSON                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX">
        <ExtLink title="ROR" URI="https://ror.org/01hq89f96" role="organisation id"/>
        <ExtLink title="SIREN" URI="263305823" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Alfred PENFORNIS                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CHU BESANCON (CHU)">
        <ExtLink title="ROR" URI="https://ror.org/0084te143" role="organisation id"/>
        <ExtLink title="SIREN" URI="262501760" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Sylvie DEJAGER                                                                                </AuthEnty>
      <AuthEnty affiliation="NOVARTIS PHARMA SAS">
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      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
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    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX                    
                                    </producer>
      <producer role="sponsor">
                                            NOVARTIS PHARMA SAS                    
                                    </producer>
      <producer role="sponsor">
                                            CHU BESANCON (CHU)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            NOVARTIS PHARMA SAS                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX" email="Isabelle.bourdel-marchasson@chu-bordeaux.fr">
                    Isabelle;BOURDEL-MARCHASSON
                                            <ExtLink title="ROR" URI="https://ror.org/01hq89f96" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="263305823" role="organisation id"/>
                                    </contact>
      <contact affiliation="CHU BESANCON (CHU)" email="alfred.penfornis@chsf.fr">
                    Alfred;PENFORNIS
                                            <ExtLink title="ROR" URI="https://ror.org/0084te143" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="262501760" role="organisation id"/>
                                    </contact>
      <contact affiliation="NOVARTIS PHARMA SAS" email="sylvie.dejager@aphp.fr">
                    Sylvie;DEJAGER
                                            <ExtLink title="SIREN" URI="410349070" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    type 2 diabetes</keyword>
      <keyword vocab="" vocabURI="">
                    elderly subject</keyword>
      <keyword vocab="" vocabURI="">
                    DPP4 inhibitors</keyword>
      <keyword vocab="" vocabURI="">
                    oral antidiabetic drugs</keyword>
      <keyword vocab="" vocabURI="">
                    hypoglycaemia</keyword>
      <topcClas vocab="health theme">
                        Endocrinology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D004704"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Type 2 diabetes mellitus                                            </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Eating habits                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">HYPOCRAS aims to compare hypoglycaemic risk in dipeptidyl peptidase-4 inhibitors (iDPP4s) with other oral antidiabetic drugs (OAD) along with metaformin in the real-life treatment of elderly patients with type 2 diabetes (T2D).</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2009-01-01"/>
      <collDate event="end" date="2011-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe clusion="I">Patients eligible for the study were men and women of 65 years of age or over with T2D and HbA1c: ≥6.5% after a course of at least 3 months of metformin alone at a stable, maximum tolerated daily dose, requiring the prescription of a second OAD. Patients who had at least two follow-up visits planned over the next 6 months (± 1 month, 3 months, 6 months ± 1 month).                    </universe>
      <dataKind>Clinical data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health care consumption and services</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through independent healthcare practitioners</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[1000-10000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>1,317</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
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    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
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      <conditions>Contact the principal investigator</conditions>
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    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
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<dataDscr>
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