Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT01511159
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2012-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Liraglutide Inhaled Into the Lungs Compared to Liraglutide Injected Under the Skin in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}, {'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2001-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-25', 'studyFirstSubmitDate': '2012-01-12', 'studyFirstSubmitQcDate': '2012-01-17', 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ratio of the areas under the plasma NN 90-1170 curves'}], 'secondaryOutcomes': [{'measure': 'The maximum concentration (Cmax)'}, {'measure': 'The time to maximum concentration (tmax)'}, {'measure': 'Mean residence time (MRT)'}, {'measure': 'Area under the curve'}, {'measure': 'Terminal rate constant'}, {'measure': 'Adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No clinically important abnormal physical findings\n* No clinically relevant abnormalities in the results of laboratory screening evaluation\n* Normal (or abnormal but not clinically significant) ECG (electrocardiogram)\n* Normal (or abnormal but not clinically significant) blood pressure and heart rate\n* Body Mass Index (BMI) between 20-30 kg/m\\^2 or outwith range but not clinically significant\n* Non-smoker\n* Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) at least 85% of predicted normal for age, gender and height\n* FVC ratio at least 75% of predicted normal for age, gender and height\n\nExclusion Criteria:\n\n* A clinically significant illness or infection requiring treatment within the last two months\n* Any infection involving the respiratory system or adverse event that may, in the opinion of the principal investigator, interfere with blood glucose homeostasis\n* Subjects with first and/or second degree relative(s) with diabetes mellitus\n* Donation or loss of greater than 500 ml of blood in the period 0-12 weeks before trial entry\n* Alcohol 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\n* Current addiction to alcohol or substances of abuse\n* Females\n* Presence of hepatitis B surface antigen, hepatitis C antibody or HIV (human immunodeficiency virus) 1 or 2 antibodies'}, 'identificationModule': {'nctId': 'NCT01511159', 'briefTitle': 'Comparison of Liraglutide Inhaled Into the Lungs Compared to Liraglutide Injected Under the Skin in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, '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', 'orgStudyIdInfo': {'id': 'NN2211-1464'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NNC 90-1170, initial dose', 'interventionNames': ['Drug: liraglutide', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'NNC 90-1170', 'interventionNames': ['Drug: liraglutide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin', 'interventionNames': ['Drug: insulin human']}, {'type': 'EXPERIMENTAL', 'label': 'NNC 90-1170, final dose', 'interventionNames': ['Drug: liraglutide']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'description': 'Single dose of 6 mcg/kg by inhalation. Progression to open-label trial part will be based on safety data', 'armGroupLabels': ['NNC 90-1170, initial dose']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Single dose by inhalation. Progression to open-label trial part will be based on safety data', 'armGroupLabels': ['NNC 90-1170, initial dose']}, {'name': 'liraglutide', 'type': 'DRUG', 'description': 'Single dose of 12 mcg/kg by inhalation. Subjects receive treatment in random order', 'armGroupLabels': ['NNC 90-1170']}, {'name': 'liraglutide', 'type': 'DRUG', 'description': 'Single dose 6 mcg/kg injected subcutaneously. Subjects receive treatment in random order', 'armGroupLabels': ['NNC 90-1170']}, {'name': 'insulin human', 'type': 'DRUG', 'description': 'Single dose 0.4 IU/kg by inhalation. Subjects receive treatment in random order', 'armGroupLabels': ['Insulin']}, {'name': 'insulin human', 'type': 'DRUG', 'description': 'Single dose 0.08 IU/kg injected subcutaneously. Subjects receive treatment in random order', 'armGroupLabels': ['Insulin']}, {'name': 'liraglutide', 'type': 'DRUG', 'otherNames': ['NNC 90-1170'], 'description': '24 mcg/kg by inhalation. Progression to dose level will be based on safety evaluation', 'armGroupLabels': ['NNC 90-1170, final dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH33 2NE', 'city': 'Tranent', 'country': 'United Kingdom', 'geoPoint': {'lat': 55.94439, 'lon': -2.95412}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}