{
  "FullStudy":{
    "Rank":217750,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517321",
          "OrgStudyIdInfo":{
            "OrgStudyId":"ONO-5435-17"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"Japic CTI-111668",
                "SecondaryIdType":"Registry Identifier",
                "SecondaryIdDomain":"Japan Pharmaceutical Information Center"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Ono Pharmaceutical Co. Ltd",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes",
          "OfficialTitle":"MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes"
        },
        "StatusModule":{
          "StatusVerifiedDate":"July 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StudyFirstSubmitDate":"November 2, 2011",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"July 7, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"July 9, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Ono Pharmaceutical Co. Ltd",
            "LeadSponsorClass":"INDUSTRY"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"MSD K.K.",
                "CollaboratorClass":"UNKNOWN"
              }
            ]
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"This Phase III clinical trial will examine the safety, tolerability, and efficacy of the addition of MK-0431/ONO-5435 to Japanese patients with Type 2 Diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue monotherapy."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Type 2 Diabetes"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Investigator"
                ]
              }
            }
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"E",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: MK-0431/ONO-5435"
                  ]
                }
              },{
                "ArmGroupLabel":"P",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Placebo, MK-0431/ONO-5435"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"MK-0431/ONO-5435",
                "InterventionDescription":"Double-blind period (12 wk); 50 mg QD. The double-blind period will be followed by a 40 week open label extension period where MK-0431/ONO-5435 could be titrated from 50 mg to 100 mg QD.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "E"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Placebo, MK-0431/ONO-5435",
                "InterventionDescription":"Double-blind period (12 wks); placebo QD. The double-blind period will be followed by a 40 wk open label extension period where MK-0431/ONO-5435 could be titrated from 50 mg to 100 mg QD.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "P"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Incidences of adverse experiences and change in vital sign, safety lab etc. as parameters of safety and tolerability",
                "PrimaryOutcomeTimeFrame":"12 weeks and 52 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"HbA1c",
                "SecondaryOutcomeTimeFrame":"12 weeks"
              },{
                "SecondaryOutcomeMeasure":"2-hour postmeal glucose",
                "SecondaryOutcomeTimeFrame":"12 weeks"
              },{
                "SecondaryOutcomeMeasure":"Fasting plasma glucose",
                "SecondaryOutcomeTimeFrame":"12 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nJapanese patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue monotherapy\n\nExclusion Criteria:\n\nPatients with Type 1 Diabetes Mellitus",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"20 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Akiteru Seki",
                "OverallOfficialAffiliation":"First Division Clinical Development Planning 1",
                "OverallOfficialRole":"Study Chair"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Chubu Region Clinical Site",
                "LocationCity":"Chubu",
                "LocationCountry":"Japan"
              },{
                "LocationFacility":"Chugoku Region Clinical Site",
                "LocationCity":"Chugoku",
                "LocationCountry":"Japan"
              },{
                "LocationFacility":"Kanto Region Clinical Site",
                "LocationCity":"Kanto",
                "LocationCountry":"Japan"
              },{
                "LocationFacility":"Kinki Region Clinical Site",
                "LocationCity":"Kinki",
                "LocationCountry":"Japan"
              },{
                "LocationFacility":"Kyusyu Region Clinical Site",
                "LocationCity":"Kyusyu",
                "LocationCountry":"Japan"
              },{
                "LocationFacility":"Tohoku Region Clinical Site",
                "LocationCity":"Tohoku",
                "LocationCountry":"Japan"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000068900",
                "InterventionMeshTerm":"Sitagliptin Phosphate"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000007004",
                "InterventionAncestorTerm":"Hypoglycemic Agents"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000054795",
                "InterventionAncestorTerm":"Incretins"
              },{
                "InterventionAncestorId":"D000006728",
                "InterventionAncestorTerm":"Hormones"
              },{
                "InterventionAncestorId":"D000006730",
                "InterventionAncestorTerm":"Hormones, Hormone Substitutes, and Hormone Antagonists"
              },{
                "InterventionAncestorId":"D000054873",
                "InterventionAncestorTerm":"Dipeptidyl-Peptidase IV Inhibitors"
              },{
                "InterventionAncestorId":"D000011480",
                "InterventionAncestorTerm":"Protease Inhibitors"
              },{
                "InterventionAncestorId":"D000004791",
                "InterventionAncestorTerm":"Enzyme Inhibitors"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M335",
                "InterventionBrowseLeafName":"Sitagliptin Phosphate",
                "InterventionBrowseLeafAsFound":"MK0431",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M8637",
                "InterventionBrowseLeafName":"Hypoglycemic Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M26492",
                "InterventionBrowseLeafName":"Incretins",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8372",
                "InterventionBrowseLeafName":"Hormones",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8371",
                "InterventionBrowseLeafName":"Hormone Antagonists",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M26544",
                "InterventionBrowseLeafName":"Dipeptidyl-Peptidase IV Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M12926",
                "InterventionBrowseLeafName":"Protease Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M18192",
                "InterventionBrowseLeafName":"HIV Protease Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Hypo",
                "InterventionBrowseBranchName":"Hypoglycemic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"Infe",
                "InterventionBrowseBranchName":"Anti-Infective Agents"
              }
            ]
          }
        },
        "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",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5698",
                "ConditionBrowseLeafName":"Diabetes Mellitus",
                "ConditionBrowseLeafAsFound":"Diabetes",
                "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"
              }
            ]
          }
        }
      }
    }
  }
}