Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT01215435
Status:
COMPLETED
Last Update Posted:
2014-10-30
First Post:
2010-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of Two Biphasic Insulin Aspart 30 Treatment Regimens in Subjects With Type 2 Diabetes Not Achieving HbA1c Treatment Targets on OADs Alone
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': 'C557564', 'term': 'insulin aspart, insulin aspart protamine drug combination 30:70'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'title': 'Public Access to Clinical Trials', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'Novo Nordisk maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The adverse events were collected in a timeframe of 36 weeks +14 days follow-up.', 'description': 'Safety analysis set includes all subjects who received at least one dose of the trial product.', 'eventGroups': [{'id': 'EG000', 'title': 'Pre-breakfast BIAsp 30', 'description': 'Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.', 'otherNumAtRisk': 122, 'otherNumAffected': 16, 'seriousNumAtRisk': 122, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Pre-dinner BIAsp 30', 'description': 'Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.', 'otherNumAtRisk': 123, 'otherNumAffected': 19, 'seriousNumAtRisk': 123, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-breakfast BIAsp 30', 'description': 'Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.'}, {'id': 'OG001', 'title': 'Pre-dinner BIAsp 30', 'description': 'Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.04', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated treatment difference, Mean', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.13', 'groupDescription': 'H0: D \\> 0.4% against H1: D ≤ 0.4% where D is the mean treatment difference for change in HbA1c (pre-breakfast OD minus pre-dinner OD)', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval for the mean HbA1c treatment difference was below or equal to 0.4%. This is equivalent to using a one-sided test of size 2.5%.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 11', 'description': 'Estimated mean change from baseline in HbA1c after 11 weeks of treatment', 'unitOfMeasure': 'percentage of glycosylated haemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) includes all randomised subjects and missing data was imputed using baseline observation carried forward (BOCF)'}, {'type': 'SECONDARY', 'title': 'Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-breakfast BIAsp 30', 'description': 'Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.'}, {'id': 'OG001', 'title': 'Pre-dinner BIAsp 30', 'description': 'Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.'}], 'classes': [{'categories': [{'measurements': [{'value': '-61.57', 'spread': '4.50', 'groupId': 'OG000'}, {'value': '-58.43', 'spread': '4.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6215', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated treatment difference, Mean', 'ciPctValue': '95', 'paramValue': '-3.14', 'ciLowerLimit': '-15.65', 'ciUpperLimit': '9.37', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 36', 'description': 'Estimated mean change from baseline in FPG after 36 weeks of treatment', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) includes all randomised subjects and missing data was imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-breakfast BIAsp 30', 'description': 'Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.'}, {'id': 'OG001', 'title': 'Pre-dinner BIAsp 30', 'description': 'Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.'}], 'classes': [{'categories': [{'measurements': [{'value': '1181', 'groupId': 'OG000'}, {'value': '953', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 36', 'description': 'A hypoglycaemic episode will be defined as treatment emergent if the onset of the episode is on or after the first day of trial product, and no later than the last day on trial product.', 'unitOfMeasure': 'episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set includes all subjects who received at least one dose of the trial product.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pre-breakfast BIAsp 30', 'description': 'Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.'}, {'id': 'FG001', 'title': 'Pre-dinner BIAsp 30', 'description': 'Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '123'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unclassified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'The trial was conducted at 5 sites in Iran', 'preAssignmentDetails': 'Subjects were on a stable antidiabetic regimen which includes a minimum of 2 OADs, daily for at least 3 months prior to screening. OAD doses were at least 50 percent of the maximum recommended dose.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pre-breakfast BIAsp 30', 'description': 'Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.'}, {'id': 'BG001', 'title': 'Pre-dinner BIAsp 30', 'description': 'Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.6', 'spread': '9.32', 'groupId': 'BG000'}, {'value': '54.8', 'spread': '10.32', 'groupId': 'BG001'}, {'value': '55.2', 'spread': '9.82', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Glycosylated haemoglobin (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'spread': '1.07', 'groupId': 'BG000'}, {'value': '9.2', 'spread': '1.00', 'groupId': 'BG001'}, {'value': '9.2', 'spread': '1.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of glycosylated haemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting plasma glucose (FPG)', 'classes': [{'categories': [{'measurements': [{'value': '192.7', 'spread': '68.56', 'groupId': 'BG000'}, {'value': '199.3', 'spread': '63.80', 'groupId': 'BG001'}, {'value': '196.0', 'spread': '66.16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 245}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'dispFirstSubmitDate': '2012-12-19', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-22', 'studyFirstSubmitDate': '2010-10-01', 'dispFirstSubmitQcDate': '2012-12-19', 'resultsFirstSubmitDate': '2013-09-23', 'studyFirstSubmitQcDate': '2010-10-05', 'dispFirstPostDateStruct': {'date': '2012-12-24', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-10-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-23', 'studyFirstPostDateStruct': {'date': '2010-10-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11', 'timeFrame': 'Week 0, Week 11', 'description': 'Estimated mean change from baseline in HbA1c after 11 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36', 'timeFrame': 'Week 0, Week 36', 'description': 'Estimated mean change from baseline in FPG after 36 weeks of treatment'}, {'measure': 'Number of Treatment Emergent Hypoglycaemic Episodes', 'timeFrame': 'Week 0 to Week 36', 'description': 'A hypoglycaemic episode will be defined as treatment emergent if the onset of the episode is on or after the first day of trial product, and no later than the last day on trial product.'}]}, '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. The aim of this trial is to compare the glycaemic control when subjects initiate a biphasic insulin aspart 30 treatment followed by an intensified treatment if treatment target of HbA1c below 7% is not reached by OAD (oral anti-diabetic drugs) alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes for a minimum of 6 months prior to Visit 1\n* HbA1c at least 7.0 % - maximum 11 % at screening\n* Subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed)\n* An antidiabetic regimen that has been stable for at least 3 months prior to screening\n* An antidiabetic regimen that includes a minimum of 2 OADs\n* OADs dosed at least 50% of the maximum recommended dose\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to trial product(s) or related products\n* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)\n* The receipt of any investigational medicinal product within one month prior to this trial\n* Suffer from a life threatening disease (cancer)\n* Cardiac disease: class III or IV congestive heart failure (CHF), unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to screening\n* Hepatic insufficiency (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 2 times the central laboratory's upper reference limit)\n* Renal insufficiency (serum creatinine above 1.6 mg/dl for males; 1.4 mg/dl for females\n* Recurrent hypoglycaemia or hypoglycaemic unawareness\n* Anemia (haemoglobin below 10 mg/dl)"}, 'identificationModule': {'nctId': 'NCT01215435', 'briefTitle': 'Comparison of Two Biphasic Insulin Aspart 30 Treatment Regimens in Subjects With Type 2 Diabetes Not Achieving HbA1c Treatment Targets on OADs Alone', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'An Open Labelled, Randomised, Parallel Trial; Efficacy and Safety Comparison of Two Different Biphasic Insulin Aspart 30 Treatment Initiation Regimens Followed by Intensification in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on OADs Alone in Iran', 'orgStudyIdInfo': {'id': 'BIASP-3858'}, 'secondaryIdInfos': [{'id': 'U1111-1116-2121', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre-breakfast BIAsp 30', 'interventionNames': ['Drug: biphasic insulin aspart 30']}, {'type': 'EXPERIMENTAL', 'label': 'Pre-dinner BIAsp 30', 'interventionNames': ['Drug: biphasic insulin aspart 30']}], 'interventions': [{'name': 'biphasic insulin aspart 30', 'type': 'DRUG', 'description': 'Administered subcutaneously (under the skin) once daily, before breakfast. The trial has 3 treatment phases for both treatment arms', 'armGroupLabels': ['Pre-breakfast BIAsp 30']}, {'name': 'biphasic insulin aspart 30', 'type': 'DRUG', 'description': 'Administered subcutaneously (under the skin) once daily, before dinner. The trial has 3 treatment phases for both treatment arms', 'armGroupLabels': ['Pre-dinner BIAsp 30']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], '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'}}}}