{
  "FullStudy":{
    "Rank":218269,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510522",
          "OrgStudyIdInfo":{
            "OrgStudyId":"EMR200084-508"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"2011-002508-34",
                "SecondaryIdType":"EudraCT Number"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Merck KGaA, Darmstadt, Germany",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Evaluate Adherence to Treatment With Glucophage Sachets Versus Tablets in Diabetes Type 2 Patients Previously Treated With Metformin Tablets",
          "OfficialTitle":"Evaluate Adherence to Treatment With Glucophage Sachets Versus Tablets in Diabetes Type 2 Patients, Previously Treated With Metformin Tablets"
        },
        "StatusModule":{
          "StatusVerifiedDate":"February 2014",
          "OverallStatus":"Withdrawn",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"June 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 30, 2011",
          "StudyFirstSubmitQCDate":"January 11, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 3, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"February 4, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Merck KGaA, Darmstadt, Germany",
            "LeadSponsorClass":"INDUSTRY"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Merck, S.L., Spain",
                "CollaboratorClass":"INDUSTRY"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This is an open-label, multicenter, two-arm, parallel, randomized phase 4 study to compare the compliance in diabetes type 2 patients treated with Glucophage sachets versus patients treated with Glucophage tablets."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Diabetes Mellitus Type 2"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Diabetes",
              "Glucophage",
              "Metformin",
              "sachets",
              "tablets"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 4"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"0",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Glucophage sachets",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Patients receive Glucophage sachets, the powder formulation for oral solution in sachets.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Glucophage"
                  ]
                }
              },{
                "ArmGroupLabel":"Glucophage tablets",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Patients received Glucophage tablets.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Glucophage"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Glucophage",
                "InterventionDescription":"Glucophage Powder for oral solution in sachets (metformin hydrochloride in 850mg strengths) Dosing schedule: > 1.700mg/day for 6 month",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Glucophage sachets"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Metformin hydrochloride"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Glucophage",
                "InterventionDescription":"Glucophage tablets (metformin hydrochloride in 850mg strengths)\n\nDosing schedule: > 1.700mg/day for 6 month",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Glucophage tablets"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Metformin hydrochloride"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Change from Baseline of Patient self-reported subjective compliance as assessed by Haynes-Sackett test at Month 6",
                "PrimaryOutcomeTimeFrame":"Month 6"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Objective compliance to treatment",
                "SecondaryOutcomeDescription":"Objective compliance to treatment is assessed by the accountability of medication returned. Patient is assessed as compliant with an adherence of over 80%.",
                "SecondaryOutcomeTimeFrame":"Month 3 and month 6"
              },{
                "SecondaryOutcomeMeasure":"Evaluation of treatment satisfaction and preferences with the Diabetes Treatment Satisfaction Questionnaire (DTSQ)",
                "SecondaryOutcomeTimeFrame":"Baseline, month 3 and month 6"
              },{
                "SecondaryOutcomeMeasure":"Rate of reported adverse events",
                "SecondaryOutcomeTimeFrame":"Month 3 and month 6"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nDiabetes mellitus type 2 diagnosed (Baseline Glycemia > 7,0 mmol/L (126 mg/dL) or overload Glycemia > 11,0 mmol/L (198 mg/dL)\nOn treatment with metformin tablets\nPatients with at least 2 treated co-morbidities\nEstablished dose of Metformin > 1.700 mg/day\nAge > 18 years old\nGiven informed consent\n\nExclusion Criteria:\n\nPatients not able to take medication orally\nAccording to Summary of Product Characteristics (SmPC)\nParticipating in another clinical trial 30 days prior to randomization\nAny other illness or medical or psychiatric condition, severe and uncontrolled that could interfere in the patient's participation or in the assessment of the study results",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Medical Responsible",
                "OverallOfficialAffiliation":"Merck, S.L., Spain",
                "OverallOfficialRole":"Study Director"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020",
          "RemovedCountryList":{
            "RemovedCountry":[
              "Spain"
            ]
          }
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000008687",
                "InterventionMeshTerm":"Metformin"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000007004",
                "InterventionAncestorTerm":"Hypoglycemic Agents"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M10250",
                "InterventionBrowseLeafName":"Metformin",
                "InterventionBrowseLeafAsFound":"Metformin Hydrochloride",
                "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":"Diabetes Mellitus Type 2",
                "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"
              }
            ]
          }
        }
      }
    }
  }
}