{
  "FullStudy":{
    "Rank":218300,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510093",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2011/1811"
          },
          "Organization":{
            "OrgFullName":"Aarhus University Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Diurnal Variation of Exogenous Peptides (Endogenous Insulin Jurgita II)",
          "OfficialTitle":"Interactions Between Exogenous Insulin Aspart, Endogenous Insulin and Plasma Glucose in Type 2 Diabetes Mellitus Patients"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"May 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"January 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 11, 2012",
          "StudyFirstSubmitQCDate":"January 11, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 13, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 28, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 29, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Jurgita Janukonyte",
            "ResponsiblePartyInvestigatorTitle":"Medical doctor",
            "ResponsiblePartyInvestigatorAffiliation":"Aarhus University Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Aarhus University Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"This is an exploratory trial with two cross-over arms investigating pharmacokinetic profiles of endogenous and exogenous insulin in type 2 diabetes mellitus patients treated with continuous subcutaneous Insulin Aspart infusion and combined with or without intravenous glucose infusion. The order of treatment session will be randomised.\n\nHypotheses:\n\nSecretion of endogenous insulin depends on exogenous insulin supply\nSecretion of endogenous insulin is depends on plasma glucose levels",
          "DetailedDescription":"There are a screening visit and two treatment sessions:\n\nSession A: Treatment with Insulin Aspart 1.5 IE/time overnight without intravenous glucose infusion Session B: Treatment with Insulin Aspart 1.5 IE/time overnight with intravenous glucose infusion."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Type 2 Diabetes Mellitus"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "type 2 diabetes mellitus, endogenous insulin"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"10",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Insulin Aspart without glucose supply",
                "ArmGroupType":"Other",
                "ArmGroupDescription":"Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight without intravenous glucose supply",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Insulin Aspart 100 IE/ml"
                  ]
                }
              },{
                "ArmGroupLabel":"Insulin Aspart with glucose supply",
                "ArmGroupType":"Other",
                "ArmGroupDescription":"Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight combined with intravenous glucose supply",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Insulin Aspart 100 IE/ml"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Insulin Aspart 100 IE/ml",
                "InterventionDescription":"1.5 IE/hour/subject/visit. Each vist takes 10 hours",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Insulin Aspart with glucose supply",
                    "Insulin Aspart without glucose supply"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "NovoRapid 100 IE/ml"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Pharmacokinetic profiles of endogenous insulin and Insulin Aspart",
                "PrimaryOutcomeDescription":"Pharmacokinetic profiles of endogenous insulin and Insulin Aspart in type 2 diabetes melitus patients treated with continuous subcutaneous Insulin Aspart infusion by insulin pump and combined with or without intravenous supply of glucose",
                "PrimaryOutcomeTimeFrame":"10 hours"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Pharmacodynamic glucose profiles",
                "SecondaryOutcomeDescription":"Pharmacodynamic glucose profiles after treatment with Insulin Aspart administred by insulin pump as a continuous subcutaneous infusion .",
                "SecondaryOutcomeTimeFrame":"10 hours"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nSubjects with type 2 diabetes mellitus\nInsulin-naive patients\nHbA1C < 9%\nWomen and men >= 35 and <= 75 years old\nBMI 25-42 kg/m2, both values are included\n\nExclusion Criteria:\n\nSuspected or known allergy to the trial drug or similar medications\nTreatment with hte drugs that after Investigator judgment could potentially interfere with plasma glucose levels\nHeart: Unstable angina pectoris, acute myocardial infarction within the last 12 months\nSevere uncontrolled hypertension with blood pressure in lying position > 180/110 mmHg\nImpaired liver function with liver parameters more than 2 times above the upper normal limit according to the local laboratory\nImpaired kidney function with eGFR < 50 ml/min according to the local laboratory\nPregnancy, lactation or desire for pregnancy in the study period and for women in childbearing age without adequate contraception-adequate contraception is: sterilisation, hysterectomy or current use of contraceptive pills, coil, gestagen depot injection, subdermal implantation, hormonal vaginal ring and transdermal depot patch.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"35 Years",
          "MaximumAge":"75 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Jurgita Janukonyte, MD",
                "OverallOfficialAffiliation":"University of Aarhus",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Department of Endocrinology and Internal Diseases",
                "LocationCity":"Aarhus C",
                "LocationState":"Central Denmark Region",
                "LocationZip":"8000",
                "LocationCountry":"Denmark"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"25785658",
                "ReferenceType":"derived",
                "ReferenceCitation":"Janukonyté J, Parkner T, Bruun NH, Lauritzen T, Christiansen JS, Laursen T. Interaction between exogenous insulin, endogenous insulin, and glucose in type 2 diabetes patients. Diabetes Technol Ther. 2015 May;17(5):335-42. doi: 10.1089/dia.2014.0326. Epub 2015 Mar 18."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000061267",
                "InterventionMeshTerm":"Insulin Aspart"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000007004",
                "InterventionAncestorTerm":"Hypoglycemic Agents"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M8948",
                "InterventionBrowseLeafName":"Insulin",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M178017",
                "InterventionBrowseLeafName":"Insulin, Globin Zinc",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M28388",
                "InterventionBrowseLeafName":"Insulin Aspart",
                "InterventionBrowseLeafAsFound":"Insulin aspart",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M8637",
                "InterventionBrowseLeafName":"Hypoglycemic Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Hypo",
                "InterventionBrowseBranchName":"Hypoglycemic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "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"
              }
            ]
          },
          "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":"M10222",
                "ConditionBrowseLeafName":"Metabolic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M23990",
                "ConditionBrowseLeafName":"Glucose Metabolism Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M6445",
                "ConditionBrowseLeafName":"Endocrine System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC19",
                "ConditionBrowseBranchName":"Gland and Hormone Related Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}