{
  "FullStudy":{
    "Rank":218051,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513369",
          "OrgStudyIdInfo":{
            "OrgStudyId":"CLEVER-2011"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"2011-005224-18",
                "SecondaryIdType":"EudraCT Number"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"GWT-TUD GmbH",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Ferric Carboxymaltose in Type 2 Diabetes Mellitus (T2DM) Patients With Iron Deficiency",
          "OfficialTitle":"Intravenous Ferric Carboxymaltose for Improvement of Metabolic Parameters and Vascular Function in T2DM-patients With Iron Deficiency",
          "Acronym":"CLEVER"
        },
        "StatusModule":{
          "StatusVerifiedDate":"October 2019",
          "OverallStatus":"Active, not recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"August 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"October 2018",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"October 2019",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 3, 2012",
          "StudyFirstSubmitQCDate":"January 16, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"October 8, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"October 9, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"GWT-TUD GmbH",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Vifor Pharma",
                "CollaboratorClass":"INDUSTRY"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to investigate the correlation between HbA1c and iron status in Type 2 Diabetes mellitus patients with iron deficiency by intravenous substitution of iron."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Type 2 Diabetes Mellitus",
              "Iron Deficiency"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Diabetes",
              "iron deficiency"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"152",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"ferric carboxymaltose",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Dose: according to SmPC; Duration: 12 weeks; Frequency: at week 1 and again at week 5 (if again indicated according to principal inclusion criteria); Application: intravenous",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: ferric carboxymaltose"
                  ]
                }
              },{
                "ArmGroupLabel":"NaCl (0,9%)",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"Duration: 12 weeks; Frequency: at week 1 and again at week 5 (if again indicated according to principal inclusion criteria); Application: intravenous",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: NaCl (0,9%)"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"ferric carboxymaltose",
                "InterventionDescription":"Dose:according to SmPC Duration: 12 weeks; Frequency: at week 1 and again at week 5 (if again indicated according to principal inclusion criteria); Application: intravenous",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "ferric carboxymaltose"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Ferinject (marketing authorization number: 66227.00.00)"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"NaCl (0,9%)",
                "InterventionDescription":"Duration: 12 weeks; Frequency: at week 1 and again at week 5 (if again indicated according to principal inclusion criteria); Application: intravenous",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "NaCl (0,9%)"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"reduction in HBA1c-levels",
                "PrimaryOutcomeDescription":"reduction of HbA1c from week 1 (baseline) to week 13",
                "PrimaryOutcomeTimeFrame":"12 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"improvement of haematological and iron status",
                "SecondaryOutcomeDescription":"Hb, MCV, MCH, hypochromic cells, reticulocyte Hb content, ferritin, transferrin, transferrin saturation (TSAT), sTFR, iron, hepcidin",
                "SecondaryOutcomeTimeFrame":"12 weeks"
              },{
                "SecondaryOutcomeMeasure":"improvement in quality of life",
                "SecondaryOutcomeDescription":"potential clinical improvement and improvement in quality of life (EQ5D) of patients with ID T2DM",
                "SecondaryOutcomeTimeFrame":"12 weeks"
              },{
                "SecondaryOutcomeMeasure":"Improvement of metabolic status",
                "SecondaryOutcomeDescription":"measurement of fasting glucose, fructosamine",
                "SecondaryOutcomeTimeFrame":"12 weeks"
              },{
                "SecondaryOutcomeMeasure":"reliability of HbA1c-measurements",
                "SecondaryOutcomeDescription":"measurement of HbA1c in week 0; 5 and 13",
                "SecondaryOutcomeTimeFrame":"12 weeks"
              },{
                "SecondaryOutcomeMeasure":"improvement in vascular function",
                "SecondaryOutcomeDescription":"Improvement in vascular function on the basis of the biomarker ADMA serum level",
                "SecondaryOutcomeTimeFrame":"12 weeks"
              },{
                "SecondaryOutcomeMeasure":"Change in used insulin dosage during study",
                "SecondaryOutcomeDescription":"Change in used insulin dosage during study (via patient diary)",
                "SecondaryOutcomeTimeFrame":"12 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"T2DM patients with diagnosis of ID defined as follows:\n\nserum ferritin <150 ng/mL or TSAT <25% if Hb < 14 g/dL serum ferritin <100 ng/mL or TSAT <20% if Hb ≥ 14 g/dL and ≤ 15g/dL]\nHbA1c: ≥ 6.5 to < 8.5 %\nAge > 18 years\nWritten informed consent has been obtained.\n\nExclusion Criteria:\n\nContinuous subcutaneous insulin infusion (CSII)\nthalassaemia\nHb > 15 g/dL (> 9,31 mmol/L)\nChange of HbA1c of more than ±0,3 % within the last 3 months.\nknown sensitivity to ferric carboxymaltose\nhistory of acquired iron overload\nHistory of erythropoietin stimulating agent, i.v. iron therapy, and/or blood transfusion in previous 12 weeks prior to randomisation\nHistory of oral iron therapy at doses ≥ 100 mg/day 1 week prior to randomisation. Note: Ongoing oral use of multivitamins containing iron < 75 mg/day is permitted.\nBody weight ≤ 40 kg\nCRP > 15 mg/L\nChronic liver disease (including known active hepatitis) and/or screening alanine transaminase (ALAT) or aspartate transaminase (ASAT) > 3 x ULN (upper limit of the normal range).\nSubjects with known hepatitis B surface antigen positivity and/or Hepatitis C virus ribonucleic acid positivity.\nVitamin B12 and/or serum folate deficiency. If deficiency corrected subject may be rescreened for inclusion.\nSubjects with known seropositivity to human immunodeficiency virus.\nClinical evidence of current malignancy with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia.\nCurrently receiving systemic chemotherapy and/or radiotherapy.\nRenal dialysis (previous, current or planned within the next 6 months).\nRenal function GFR < 30 mL/min/ 1.73m2 (severe)\nUnstable angina pectoris as judged by the Investigator; severe valvular or left ventricular outflow obstruction disease needing intervention; atrial fibrillation/flutter with a mean ventricular response rate at rest >100 beats per minute.\nAcute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months prior to randomisation.\nCoronary-artery bypass graft, percutaneous intervention (e.g., cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months prior to randomisation.\nPatients with a polyneuropathy without ischemia.\nSubject of child-bearing potential who is pregnant (e.g., positive human chorionic gonadotropin test) or is breast feeding.\nAny subject not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.\nParticipation in other interventional trials\nFemale subject of child-bearing potential who is pregnant (e.g., positive human chorionic gonadotropin test) or is breast feeding.\nFailure to use highly-effective contraceptive methods\nPersons with any kind of dependency on the investigator or employed by the sponsor or investigator",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Christoph Schindler, MD",
                "OverallOfficialAffiliation":"on behalf of GWT",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Gemeinschaftspraxis Dres. Grüneberg, Mehring, Stude",
                "LocationCity":"Herne",
                "LocationState":"Nordrhein-Westfalen",
                "LocationZip":"32545",
                "LocationCountry":"Germany"
              },{
                "LocationFacility":"Univesitätsklinikum Carl Gustav Carus",
                "LocationCity":"Dresden",
                "LocationState":"Sachsen",
                "LocationZip":"01307",
                "LocationCountry":"Germany"
              },{
                "LocationFacility":"Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum",
                "LocationCity":"Bad Oeynhausen",
                "LocationZip":"32545",
                "LocationCountry":"Germany"
              },{
                "LocationFacility":"Studienzentrum Professor Hanefeld Abakus Büropark",
                "LocationCity":"Dresden",
                "LocationZip":"01307",
                "LocationCountry":"Germany"
              },{
                "LocationFacility":"Medizinische Hochschule Hannover Klinisches Forschungszentrum CRC",
                "LocationCity":"Hannover",
                "LocationZip":"30625",
                "LocationCountry":"Germany"
              },{
                "LocationFacility":"Diabetesinstitut Heidelberg",
                "LocationCity":"Heidelberg",
                "LocationZip":"69115",
                "LocationCountry":"Germany"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"29134606",
                "ReferenceType":"derived",
                "ReferenceCitation":"Schindler C, Birkenfeld AL, Hanefeld M, Schatz U, Köhler C, Grüneberg M, Tschöpe D, Blüher M, Hasslacher C, Bornstein SR. Intravenous Ferric Carboxymaltose in Patients with Type 2 Diabetes Mellitus and Iron Deficiency: CLEVER Trial Study Design and Protocol. Diabetes Ther. 2018 Feb;9(1):37-47. doi: 10.1007/s13300-017-0330-z. Epub 2017 Nov 13. Erratum in: Diabetes Ther. 2018 Dec 6;:."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000018798",
                "ConditionMeshTerm":"Anemia, Iron-Deficiency"
              },{
                "ConditionMeshId":"D000003920",
                "ConditionMeshTerm":"Diabetes Mellitus"
              },{
                "ConditionMeshId":"D000003924",
                "ConditionMeshTerm":"Diabetes Mellitus, Type 2"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000044882",
                "ConditionAncestorTerm":"Glucose Metabolism Disorders"
              },{
                "ConditionAncestorId":"D000008659",
                "ConditionAncestorTerm":"Metabolic Diseases"
              },{
                "ConditionAncestorId":"D000004700",
                "ConditionAncestorTerm":"Endocrine System Diseases"
              },{
                "ConditionAncestorId":"D000000747",
                "ConditionAncestorTerm":"Anemia, Hypochromic"
              },{
                "ConditionAncestorId":"D000000740",
                "ConditionAncestorTerm":"Anemia"
              },{
                "ConditionAncestorId":"D000006402",
                "ConditionAncestorTerm":"Hematologic Diseases"
              },{
                "ConditionAncestorId":"D000019189",
                "ConditionAncestorTerm":"Iron Metabolism Disorders"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M5702",
                "ConditionBrowseLeafName":"Diabetes Mellitus, Type 2",
                "ConditionBrowseLeafAsFound":"Type 2 Diabetes Mellitus",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5698",
                "ConditionBrowseLeafName":"Diabetes Mellitus",
                "ConditionBrowseLeafAsFound":"Diabetes Mellitus",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M19441",
                "ConditionBrowseLeafName":"Anemia, Iron-Deficiency",
                "ConditionBrowseLeafAsFound":"Iron Deficiency",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M2651",
                "ConditionBrowseLeafName":"Anemia",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10222",
                "ConditionBrowseLeafName":"Metabolic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M23990",
                "ConditionBrowseLeafName":"Glucose Metabolism Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M6445",
                "ConditionBrowseLeafName":"Endocrine System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M2658",
                "ConditionBrowseLeafName":"Anemia, Hypochromic",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8073",
                "ConditionBrowseLeafName":"Hematologic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M19761",
                "ConditionBrowseLeafName":"Iron Metabolism Disorders",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC19",
                "ConditionBrowseBranchName":"Gland and Hormone Related Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC15",
                "ConditionBrowseBranchName":"Blood and Lymph Conditions"
              }
            ]
          }
        }
      }
    }
  }
}