Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-02 @ 5:39 AM
Study NCT ID:
NCT00455858
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2007-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Glycaemic Control With Insulin Detemir as an add-on to Current Oral Anti-diabetic Drug Treatment in Subjects With Type 2 Diabetes in Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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': 'D000069057', 'term': 'Insulin Detemir'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'title': 'Public Access to Clinical Trials', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': "Novo Nordisk acknowledges the Investigator's right to publish the entire results of the trial. Any such scientific paper, presentation, communication or other information concerning the investigation described in this protocol, should be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected in a time span of 22 weeks.', 'description': 'Safety analysis set contains all enrolled subjects exposed to at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Insulin Detemir', 'description': "Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.", 'otherNumAtRisk': 87, 'otherNumAffected': 15, 'seriousNumAtRisk': 87, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pneumonia mycoplasmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Intestinal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': "Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose."}], 'classes': [{'title': 'HbA1c at baseline', 'categories': [{'measurements': [{'value': '9.3', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'HbA1c at week 20', 'categories': [{'measurements': [{'value': '8.2', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Change in HbA1c from baseline to week 20', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000'], 'paramType': 'Least Square Mean', 'ciPctValue': '95', 'paramValue': '-1.356', 'ciLowerLimit': '-1.368', 'ciUpperLimit': '-1.344', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'week 0, week 20', 'description': 'Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20', 'unitOfMeasure': 'percentage change in HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.'}, {'type': 'SECONDARY', 'title': 'Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': "Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose."}], 'classes': [{'title': 'HbA1c at baseline', 'categories': [{'measurements': [{'value': '9.3', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'HbA1c at week 12', 'categories': [{'measurements': [{'value': '8.2', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Change in HbA1c from baseline to week 12', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000'], 'paramType': 'Least Square Mean', 'ciPctValue': '95', 'paramValue': '-1.338', 'ciLowerLimit': '-1.350', 'ciUpperLimit': '-1.327', 'statisticalMethod': 't-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'week 0, week 12', 'description': 'Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline', 'unitOfMeasure': 'percentage change in HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose (FPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': "Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose."}], 'classes': [{'title': 'FPG at baseline, N=81', 'categories': [{'measurements': [{'value': '178', 'spread': '54.2', 'groupId': 'OG000'}]}]}, {'title': 'FPG at week 12, N=77', 'categories': [{'measurements': [{'value': '118', 'spread': '36.3', 'groupId': 'OG000'}]}]}, {'title': 'FPG at week 20, N=78', 'categories': [{'measurements': [{'value': '116', 'spread': '35.8', 'groupId': 'OG000'}]}]}, {'title': 'Change in FPG from baseline to week 12, N=75', 'categories': [{'measurements': [{'value': '-60', 'spread': '55.8', 'groupId': 'OG000'}]}]}, {'title': 'Change in FPG from baseline to week 20, N=73', 'categories': [{'measurements': [{'value': '-62', 'spread': '61.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000'], 'paramType': 'Least Square Mean', 'ciPctValue': '95', 'paramValue': '-69.553', 'ciLowerLimit': '-70.047', 'ciUpperLimit': '-69.060', 'groupDescription': 'Estimated mean decrease in FPG at week 12', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<.0001', 'groupIds': ['OG000'], 'paramType': 'Least Square Mean', 'ciPctValue': '95', 'paramValue': '-72.159', 'ciLowerLimit': '-72.647', 'ciUpperLimit': '-71.671', 'groupDescription': 'Estimated mean decrease in FPG at week 20', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'week 0, week 12, week 20', 'description': 'Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': "Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose."}], 'classes': [{'title': 'Achieving HbA1c < 7% after 12 weeks, N=82', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}]}]}, {'title': 'Not achieving HbA1c < 7% after 12 weeks, N=82', 'categories': [{'measurements': [{'value': '85.4', 'groupId': 'OG000'}]}]}, {'title': 'Achieving HbA1c < 7% after 20 weeks, N=81', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}]}]}, {'title': 'Not achieving HbA1c < 7% after 20 weeks, N=81', 'categories': [{'measurements': [{'value': '87.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 12, week 20', 'description': 'Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0%', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.'}, {'type': 'SECONDARY', 'title': 'Occurence of Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Detemir', 'description': "Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose."}], 'classes': [{'title': 'Occurence of hypoglycaemic episodes: Diurnal', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'Occurence of hypoglycaemic episodes: Nocturnal', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}, {'title': 'Occurence of hypoglycaemic episodes: Total', 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'weeks 0-20', 'description': 'Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment.', 'unitOfMeasure': 'episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'For tabulating the occurence of hypoglycaemic episodes, the safety analysis set of all enrolled subjects exposed to at least one dose of study drug was used. For the adverse events, please refer to details in the adverse events section.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Detemir', 'description': "Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Enrolled in study and exposed to study drug', 'groupId': 'FG000', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Well controlled FPG without insulin', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of eight study sites in South Korea.', 'preAssignmentDetails': 'Between screening and treatment with study drug, subjects were assessed for eligibility. After start of treatment, all subjects were to have their dosage titrated individually based on SMPG (self-monitored plasma glucose) values during the 20-week titration and treatment period to reach and maintain pre-breakfast SMPG below 6.0 mmol/L (108 mg/dL).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Detemir', 'description': "Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.7', 'spread': '9.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2007-04-03', 'resultsFirstSubmitDate': '2009-12-16', 'studyFirstSubmitQcDate': '2007-04-03', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-02-04', 'studyFirstPostDateStruct': {'date': '2007-04-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20', 'timeFrame': 'week 0, week 20', 'description': 'Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20'}], 'secondaryOutcomes': [{'measure': 'Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12', 'timeFrame': 'week 0, week 12', 'description': 'Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline'}, {'measure': 'Change in Fasting Plasma Glucose (FPG)', 'timeFrame': 'week 0, week 12, week 20', 'description': 'Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20'}, {'measure': 'Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%', 'timeFrame': 'week 12, week 20', 'description': 'Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0%'}, {'measure': 'Occurence of Hypoglycaemic Episodes', 'timeFrame': 'weeks 0-20', 'description': 'Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Asia. This trial aims for evaluating the glycaemic control, measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes (diagnosed more than 12 months ago)\n* HbA1c greater than 7.0 and less than 12.0% at screening\n* Currently on any OAD in more than 3 months ago\n* BMI (Body Mass Index) less than 35kg/m2\n\nExclusion Criteria:\n\n* Previous treatment with insulin in more than 7 days within the last 3 months\n* Uncontrolled treated/untreated hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure less than 110mmHg)'}, 'identificationModule': {'nctId': 'NCT00455858', 'briefTitle': 'Evaluation of the Glycaemic Control With Insulin Detemir as an add-on to Current Oral Anti-diabetic Drug Treatment in Subjects With Type 2 Diabetes in Korea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A 20-week, Multi-centre, Open-labelled, Non-comparative Evaluation of the Safety and Efficacy of Insulin Detemir in Combination With Oral Anti-diabetic Drug(s), in Subjects With Type 2 Diabetes Mellitus Who Were Inadequately Controlled on Current Therapy in Korea', 'orgStudyIdInfo': {'id': 'NN304-1762'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'insulin detemir', 'interventionNames': ['Drug: insulin detemir']}], 'interventions': [{'name': 'insulin detemir', 'type': 'DRUG', 'otherNames': ['Levemir®'], 'description': 'Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin).', 'armGroupLabels': ['insulin detemir']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], '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'}}}}