{ "FullStudy":{ "Rank":218221, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511159", "OrgStudyIdInfo":{ "OrgStudyId":"NN2211-1464" }, "Organization":{ "OrgFullName":"Novo Nordisk A/S", "OrgClass":"INDUSTRY" }, "BriefTitle":"Comparison of Liraglutide Inhaled Into the Lungs Compared to Liraglutide Injected Under the Skin in Healthy Male Volunteers", "OfficialTitle":"A Single-Centre, Open-Label, Five-Period Crossover Trial In Healthy Male Volunteers Investigating the Relative Bioavailability of NNC 90-1170 By Pulmonary Administration Compared To A Subcutaneous Injection" }, "StatusModule":{ "StatusVerifiedDate":"March 2015", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"October 2001" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2001", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2001", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"March 25, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 26, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Novo Nordisk A/S", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This trial is conducted in Europe. The aim of this trial is to determine the relative bioavailability of NNC 90-1170 (liraglutide) when inhaled compared to NNC 90-1170 when injected under the skin." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Diabetes", "Healthy" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"32", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"NNC 90-1170, initial dose", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: liraglutide", "Drug: placebo" ] } },{ "ArmGroupLabel":"NNC 90-1170", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: liraglutide" ] } },{ "ArmGroupLabel":"Insulin", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: insulin human" ] } },{ "ArmGroupLabel":"NNC 90-1170, final dose", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: liraglutide" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"liraglutide", "InterventionDescription":"Single dose of 6 mcg/kg by inhalation. Progression to open-label trial part will be based on safety data", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "NNC 90-1170, initial dose" ] } },{ "InterventionType":"Drug", "InterventionName":"placebo", "InterventionDescription":"Single dose by inhalation. Progression to open-label trial part will be based on safety data", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "NNC 90-1170, initial dose" ] } },{ "InterventionType":"Drug", "InterventionName":"liraglutide", "InterventionDescription":"Single dose of 12 mcg/kg by inhalation. Subjects receive treatment in random order", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "NNC 90-1170" ] } },{ "InterventionType":"Drug", "InterventionName":"liraglutide", "InterventionDescription":"Single dose 6 mcg/kg injected subcutaneously. Subjects receive treatment in random order", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "NNC 90-1170" ] } },{ "InterventionType":"Drug", "InterventionName":"insulin human", "InterventionDescription":"Single dose 0.4 IU/kg by inhalation. Subjects receive treatment in random order", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Insulin" ] } },{ "InterventionType":"Drug", "InterventionName":"insulin human", "InterventionDescription":"Single dose 0.08 IU/kg injected subcutaneously. Subjects receive treatment in random order", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Insulin" ] } },{ "InterventionType":"Drug", "InterventionName":"liraglutide", "InterventionDescription":"24 mcg/kg by inhalation. Progression to dose level will be based on safety evaluation", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "NNC 90-1170, final dose" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "NNC 90-1170" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Ratio of the areas under the plasma NN 90-1170 curves" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"The maximum concentration (Cmax)" },{ "SecondaryOutcomeMeasure":"The time to maximum concentration (tmax)" },{ "SecondaryOutcomeMeasure":"Mean residence time (MRT)" },{ "SecondaryOutcomeMeasure":"Area under the curve" },{ "SecondaryOutcomeMeasure":"Terminal rate constant" },{ "SecondaryOutcomeMeasure":"Adverse events" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nNo clinically important abnormal physical findings\nNo clinically relevant abnormalities in the results of laboratory screening evaluation\nNormal (or abnormal but not clinically significant) ECG (electrocardiogram)\nNormal (or abnormal but not clinically significant) blood pressure and heart rate\nBody Mass Index (BMI) between 20-30 kg/m^2 or outwith range but not clinically significant\nNon-smoker\nForced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) at least 85% of predicted normal for age, gender and height\nFVC ratio at least 75% of predicted normal for age, gender and height\n\nExclusion Criteria:\n\nA clinically significant illness or infection requiring treatment within the last two months\nAny infection involving the respiratory system or adverse event that may, in the opinion of the principal investigator, interfere with blood glucose homeostasis\nSubjects with first and/or second degree relative(s) with diabetes mellitus\nDonation or loss of greater than 500 ml of blood in the period 0-12 weeks before trial entry\nAlcohol use in excess of 28 units of alcohol per week. A unit of alcohol is equivalent to half a pint of average strength beer, a glass (125 ml) of wine or a pub measure (25 ml) of spirits, sherry or port\nCurrent addiction to alcohol or substances of abuse\nFemales\nPresence of hepatitis B surface antigen, hepatitis C antibody or HIV (human immunodeficiency virus) 1 or 2 antibodies", "HealthyVolunteers":"No", "Gender":"Male", "MinimumAge":"18 Years", "MaximumAge":"45 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Global Clinical Registry (GCR, 1452)", "OverallOfficialAffiliation":"Novo Nordisk A/S", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Tranent", "LocationZip":"EH33 2NE", "LocationCountry":"United Kingdom" } ] } }, "ReferencesModule":{ "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"Clinical Trials at Novo Nordisk", "SeeAlsoLinkURL":"http://novonordisk-trials.com" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000007328", "InterventionMeshTerm":"Insulin" },{ "InterventionMeshId":"C000557859", "InterventionMeshTerm":"Insulin, Globin Zinc" },{ "InterventionMeshId":"D000069450", "InterventionMeshTerm":"Liraglutide" } ] }, "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" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M8948", "InterventionBrowseLeafName":"Insulin", "InterventionBrowseLeafAsFound":"Insulin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M419", "InterventionBrowseLeafName":"Liraglutide", "InterventionBrowseLeafAsFound":"Liraglutide", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M178017", "InterventionBrowseLeafName":"Insulin, Globin Zinc", "InterventionBrowseLeafAsFound":"Insulin human", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M16351", "InterventionBrowseLeafName":"Zinc", "InterventionBrowseLeafRelevance":"low" },{ "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" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Hypo", "InterventionBrowseBranchName":"Hypoglycemic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"Micro", "InterventionBrowseBranchName":"Micronutrients" } ] } }, "ConditionBrowseModule":{ "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M25724", "ConditionBrowseLeafName":"Respiratory Aspiration", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5698", "ConditionBrowseLeafName":"Diabetes Mellitus", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "ConditionBrowseBranchAbbrev":"BC19", "ConditionBrowseBranchName":"Gland and Hormone Related Diseases" } ] } } } } } }