Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-02-08 @ 12:15 AM
Study NCT ID:
NCT00542620
Status:
COMPLETED
Last Update Posted:
2014-11-03
First Post:
2007-10-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Insulin Detemir and Insulin Aspart in 2 Separate Injections Twice Daily to Extemporaneous Mixing Injection Regimen Twice Daily - The Paediatric Mixing Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069057', 'term': 'Insulin Detemir'}, {'id': 'D061267', 'term': 'Insulin Aspart'}], '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'}, {'id': 'D061266', 'term': 'Insulin, Short-Acting'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'title': 'Public Access to Clinical Trials', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'The Steering Committee has the right to publish the entire results of the trial. Any such scientific paper, presentation, communication, or other information concerning the investigation must be approved by the Steering Committee, and copies submitted in writing to Novo Nordisk 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 are collected during treatment period (8 weeks)', 'description': 'All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subnjects are analysed based on treatments actually received.', 'eventGroups': [{'id': 'EG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed', 'otherNumAtRisk': 12, 'otherNumAffected': 5, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed', 'otherNumAtRisk': 13, 'otherNumAffected': 9, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Enterobiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Orthodontic procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gynaecomastia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Glycosylated Haemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '8.00', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '7.77', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '7.63', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '8.15', 'spread': '0.57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.691', 'ciLowerLimit': '-1.049', 'ciUpperLimit': '-0.334', 'pValueComment': 'If non-inferiority was confirmed, the superiority of the mixed injection group over separate injection group was to be investigated', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Baseline HbA1c as covariate', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.25% or equivalently if the p-value for the one-sided test of H0: D\\>0.25% against HA: D=\\<0.25%, was less than or equal to 2.5%, where D is the mean treatment difference (mixing injections minus separate injections).'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 8', 'description': 'Measured for the Per Protocol (PP) set', 'unitOfMeasure': 'percentage of total haemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol (PP) analysis set consists of all the ITT (Intention-to-Treat) subjects who did not present any significant protocol deviations that could potentially affect the efficacy results. One subject was excluded from PP as subject received separate injections despite being randomised to receive mixed injections.'}, {'type': 'PRIMARY', 'title': 'Glycosylated Haemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '7.93', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '7.77', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '7.65', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '8.15', 'spread': '0.57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.594', 'ciLowerLimit': '-0.970', 'ciUpperLimit': '-0.219', 'pValueComment': 'If non-inferiority was confirmed, the superiority of the mixed injection group over separate injection group was to be investigated.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Baseline HbA1c as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.25% or equivalently if the p-value for the one-sided test of H0: D\\>0.25% against HA: D=\\<0.25%, was less than or equal to 2.5%, where D is the mean treatment difference (mixing injections minus separate injections).'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 8', 'description': 'Measured for the ITT (Intention-to-Treat) set', 'unitOfMeasure': 'percentage of total haemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.'}, {'type': 'SECONDARY', 'title': 'Fructosamine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'title': 'Week 0, n=13, 12', 'categories': [{'measurements': [{'value': '334.8', 'spread': '35.9', 'groupId': 'OG000'}, {'value': '319.8', 'spread': '22.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 8, n=12, 12', 'categories': [{'measurements': [{'value': '316.4', 'spread': '30.1', 'groupId': 'OG000'}, {'value': '334.8', 'spread': '41.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.573', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-8.35', 'ciLowerLimit': '-38.77', 'ciUpperLimit': '22.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.59', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With adjustment on baseline fructosamine and the change in insulin administration mode', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 8', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.'}, {'type': 'SECONDARY', 'title': 'Self-measured Plasma Glucose Profile (Before Breakfast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '190.31', 'spread': '56.80', 'groupId': 'OG000'}, {'value': '165.39', 'spread': '70.28', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '162.96', 'spread': '57.46', 'groupId': 'OG000'}, {'value': '204.75', 'spread': '59.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.063', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With adjustment on baseline value', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 8', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.'}, {'type': 'SECONDARY', 'title': 'Self-measured Plasma Glucose Profile (After Breakfast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'title': 'Week 0, n=5, 6', 'categories': [{'measurements': [{'value': '123.00', 'spread': '61.9', 'groupId': 'OG000'}, {'value': '164.89', 'spread': '73.33', 'groupId': 'OG001'}]}]}, {'title': 'Week 8, n=4, 7', 'categories': [{'measurements': [{'value': '208.08', 'spread': '48.19', 'groupId': 'OG000'}, {'value': '167.98', 'spread': '70.64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.389', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With adjustment on baseline value', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 8', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.'}, {'type': 'SECONDARY', 'title': 'Self-measured Plasma Glucose Profile (Before Dinner)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '199.14', 'spread': '42.05', 'groupId': 'OG000'}, {'value': '201.44', 'spread': '57.50', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '185.23', 'spread': '66.30', 'groupId': 'OG000'}, {'value': '181.03', 'spread': '68.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.856', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With adjustment on baseline value', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 8', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.'}, {'type': 'SECONDARY', 'title': 'Self-measured Plasma Glucose Profile (After Dinner)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'title': 'Week 0, n=8, 5', 'categories': [{'measurements': [{'value': '175.38', 'spread': '58.47', 'groupId': 'OG000'}, {'value': '201.80', 'spread': '59.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 8, n=7, 6', 'categories': [{'measurements': [{'value': '198.00', 'spread': '53.85', 'groupId': 'OG000'}, {'value': '187.67', 'spread': '85.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.917', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With adjustment on baseline value', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 8', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation. CGMS® data not available/sufficient for pre-study evaluation in five subjects or at post-study evaluation in four subjects.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Cmax of Free Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '216', 'spread': '542.4', 'groupId': 'OG000'}, {'value': '167', 'spread': '130.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '274', 'spread': '109.2', 'groupId': 'OG000'}, {'value': '186', 'spread': '105.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.209', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With adjustment on baseline value', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2 hours (hrs), T2.5hrs, T3hrs, T3.5hrs, T4hrs', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Tmax of Free Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.98', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.220', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With adjustment on baseline value', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. 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Subjects are analysed based on initial randomisation.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Tmax of Insulin Aspart', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '2', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '2', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '2', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With adjustment on baseline value', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Aspart', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '1546.3', 'spread': '3163.27', 'groupId': 'OG000'}, {'value': '1510.9', 'spread': '963.37', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '2102.4', 'spread': '1378.73', 'groupId': 'OG000'}, {'value': '1540', 'spread': '894.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.166', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With adjustment on baseline value', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs', 'unitOfMeasure': 'pmol.h/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'title': 'Week 0, n=10, 11', 'categories': [{'measurements': [{'value': '3008.1', 'spread': '7689.04', 'groupId': 'OG000'}, {'value': '3006.3', 'spread': '4458.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 8, n=13, 12', 'categories': [{'measurements': [{'value': '5674.3', 'spread': '10668.8', 'groupId': 'OG000'}, {'value': '3019.9', 'spread': '1013.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.023', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With adjustment on baseline value', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs', 'unitOfMeasure': 'pmol.h/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'title': 'Week 0, n=10, 11', 'categories': [{'measurements': [{'value': '2.2', 'spread': '6.75', 'groupId': 'OG000'}, {'value': '2', 'spread': '3.09', 'groupId': 'OG001'}]}]}, {'title': 'Week 8, n=13, 12', 'categories': [{'measurements': [{'value': '3.5', 'spread': '41.88', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.62', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.439', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With adjustment on baseline value', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.'}, {'type': 'SECONDARY', 'title': 'Weight Z Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'title': 'Week 0, n=13, 12', 'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Week 8, n=11, 12', 'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '0.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.202', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With adjustment on baseline value', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 8', 'description': 'Z score of weight. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.'}, {'type': 'SECONDARY', 'title': 'Body Mass Index (BMI) Z Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'title': 'Week 0, n=13, 12', 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'Week 8, n=11, 12', 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '0.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.665', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'With adjustment on baseline value', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 8', 'description': 'Z score of BMI index. To estimate the growth of children, standardised mean BMI values were calculated for each month of age and for each sex', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) analysis set consists of all randomised children with a signed informed consent and at least one HbA1c value determined after randomisation. Subjects are analysed based on initial randomisation.'}, {'type': 'SECONDARY', 'title': 'Incidence of Hypoglycaemic Episodes - All Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'categories': [{'measurements': [{'value': '351', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-8', 'description': "Number of hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose less than 56 mg/dL (3.1 mmol/L). Classified as major, minor or symptoms only. Major if unable to treat her/himself (given the age of the study population, the definition of major hypoglycemia was to be adapted through the investigator's judgment). Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.", 'unitOfMeasure': 'episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.'}, {'type': 'SECONDARY', 'title': 'Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'title': 'With symptoms', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}]}, {'title': 'Without (w/o) symptoms', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'W/o info on presence of symptoms', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-8', 'description': 'Number of minor hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose below 3.1 mmol/L (56 mg/dL) and the child is able to treat her/himself.', 'unitOfMeasure': 'episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.'}, {'type': 'SECONDARY', 'title': 'Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'title': 'With symptoms', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Without (w/o) symptoms', 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'W/o information on presence of symptoms', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-8', 'description': 'Number of "symptoms only" hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose higher than or equal to 3.1 mmol/L (56 mg/dL) or no plasma glucose measurement and the child is able to treat her/himself.', 'unitOfMeasure': 'episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Children Assessing Insulin Therapy Injection Pain as "Sad Face"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 and Week 8', 'description': 'Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Children Assessing Insulin Therapy Injection Pain as "Happy Face"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 and week 8', 'description': 'Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Children Assessing Insulin Therapy Injection Pain as "Very Happy Face"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'OG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 and Week 8', 'description': 'Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised subjects who received at least one treatment dose are taken into account in the safety analysis set. Subjects are analysed based on treatments actually received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'FG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Exposed to Drug', 'achievements': [{'comment': 'One subject randomly assigned to receive mixed injections, but received a separate injection mode', 'groupId': 'FG000', 'numSubjects': '12'}, {'comment': 'One subject randomly assigned to receive mixed injections, but received a separate injection mode', 'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Four centres in France', 'preAssignmentDetails': 'Children with type 1 diabetes currently treated with insulin detemir and insulin aspart and with a good glycaemic control. At trial entry, subjects must be 6-18 years old with a HbA1c (glycosylated haemoglobin) below or equal to 8.6%'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mixed Injection', 'description': 'Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'BG001', 'title': 'Separate Injection', 'description': 'Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '10.9', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '11.3', 'spread': '2.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diabetes history', 'classes': [{'categories': [{'measurements': [{'value': '6.68', 'spread': '3.51', 'groupId': 'BG000'}, {'value': '6.13', 'spread': '2.38', 'groupId': 'BG001'}, {'value': '6.42', 'spread': '2.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of years since diagnosis', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-24', 'studyFirstSubmitDate': '2007-10-10', 'resultsFirstSubmitDate': '2011-12-05', 'studyFirstSubmitQcDate': '2007-10-10', 'lastUpdatePostDateStruct': {'date': '2014-11-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-11', 'studyFirstPostDateStruct': {'date': '2007-10-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycosylated Haemoglobin A1c (HbA1c)', 'timeFrame': 'Week 0 and Week 8', 'description': 'Measured for the Per Protocol (PP) set'}, {'measure': 'Glycosylated Haemoglobin A1c (HbA1c)', 'timeFrame': 'Week 0 and Week 8', 'description': 'Measured for the ITT (Intention-to-Treat) set'}], 'secondaryOutcomes': [{'measure': 'Fructosamine', 'timeFrame': 'Week 0 and Week 8'}, {'measure': 'Self-measured Plasma Glucose Profile (Before Breakfast)', 'timeFrame': 'Week 0 and Week 8'}, {'measure': 'Self-measured Plasma Glucose Profile (After Breakfast)', 'timeFrame': 'Week 0 and Week 8'}, {'measure': 'Self-measured Plasma Glucose Profile (Before Dinner)', 'timeFrame': 'Week 0 and Week 8'}, {'measure': 'Self-measured Plasma Glucose Profile (After Dinner)', 'timeFrame': 'Week 0 and Week 8'}, {'measure': 'Pharmacokinetics: Cmax of Free Insulin', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2 hours (hrs), T2.5hrs, T3hrs, T3.5hrs, T4hrs'}, {'measure': 'Pharmacokinetics: Tmax of Free Insulin', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs'}, {'measure': 'Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Free Insulin', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs'}, {'measure': 'Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs'}, {'measure': 'Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs'}, {'measure': 'Pharmacokinetics: Cmax of Insulin Detemir', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs'}, {'measure': 'Pharmacokinetics: Tmax of Insulin Detemir', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs'}, {'measure': 'Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Detemir', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs'}, {'measure': 'Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs'}, {'measure': 'Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs'}, {'measure': 'Pharmacokinetics: Cmax of Insulin Aspart', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs'}, {'measure': 'Pharmacokinetics: Tmax of Insulin Aspart', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs'}, {'measure': 'Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Aspart', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs'}, {'measure': 'Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs'}, {'measure': 'Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart', 'timeFrame': 'Week 0 and Week 8', 'description': 'The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs'}, {'measure': 'Weight Z Score', 'timeFrame': 'Week 0 and Week 8', 'description': 'Z score of weight. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex'}, {'measure': 'Body Mass Index (BMI) Z Score', 'timeFrame': 'Week 0 and Week 8', 'description': 'Z score of BMI index. To estimate the growth of children, standardised mean BMI values were calculated for each month of age and for each sex'}, {'measure': 'Incidence of Hypoglycaemic Episodes - All Episodes', 'timeFrame': 'Weeks 0-8', 'description': "Number of hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose less than 56 mg/dL (3.1 mmol/L). Classified as major, minor or symptoms only. Major if unable to treat her/himself (given the age of the study population, the definition of major hypoglycemia was to be adapted through the investigator's judgment). Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L."}, {'measure': 'Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L', 'timeFrame': 'Weeks 0-8', 'description': 'Number of minor hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose below 3.1 mmol/L (56 mg/dL) and the child is able to treat her/himself.'}, {'measure': 'Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L', 'timeFrame': 'Weeks 0-8', 'description': 'Number of "symptoms only" hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose higher than or equal to 3.1 mmol/L (56 mg/dL) or no plasma glucose measurement and the child is able to treat her/himself.'}, {'measure': 'Percentage of Children Assessing Insulin Therapy Injection Pain as "Sad Face"', 'timeFrame': 'Week 0 and Week 8', 'description': 'Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.'}, {'measure': 'Percentage of Children Assessing Insulin Therapy Injection Pain as "Happy Face"', 'timeFrame': 'Week 0 and week 8', 'description': 'Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.'}, {'measure': 'Percentage of Children Assessing Insulin Therapy Injection Pain as "Very Happy Face"', 'timeFrame': 'Week 0 and Week 8', 'description': 'Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of the trial is to compare two methods of injection in basal-bolus insulin regimen in children with type 1 diabetes with insulin detemir associated with insulin aspart given twice daily in either separate or mixed injections and to investigate if there is any clinical impact in choosing one regimen over another.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parents' Informed Consent (IC) obtained before any trial-related activities\n* Obtained child's assent (when possible)\n* Type 1 diabetes\n* Treatment with insulin detemir and insulin aspart either in extemporaneous mixed or separate injections\n* HbA1c (glycosylated haemoglobin A1c) lesser than or equal to 8.6%\n\nExclusion Criteria:\n\n* History of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol\n* Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation\n* Anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)\n* Any other condition that the Investigator (trial physician) feels would interfere with trial participation or evaluation of results"}, 'identificationModule': {'nctId': 'NCT00542620', 'acronym': 'MIXING', 'briefTitle': 'Comparison of Insulin Detemir and Insulin Aspart in 2 Separate Injections Twice Daily to Extemporaneous Mixing Injection Regimen Twice Daily - The Paediatric Mixing Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Randomised, Multicentric, Open Labelled, Parallel Group Trial With Insulin Aspart and Insulin Detemir, Investigating the Glycaemic Effect and Profile in Children With Type 1 Diabetes, of Two Separate Levemir® + NovoRapid® Injections and Extemporaneous Mixing - The Paediatric MIXING Trial', 'orgStudyIdInfo': {'id': 'NN304-1813'}, 'secondaryIdInfos': [{'id': '2006-006715-77', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mixed injection', 'interventionNames': ['Drug: insulin detemir', 'Drug: insulin aspart']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Separate injection', 'interventionNames': ['Drug: insulin detemir', 'Drug: insulin aspart']}], 'interventions': [{'name': 'insulin detemir', 'type': 'DRUG', 'description': 'Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin aspart', 'armGroupLabels': ['Mixed injection']}, {'name': 'insulin aspart', 'type': 'DRUG', 'description': 'Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin detemir', 'armGroupLabels': ['Mixed injection']}, {'name': 'insulin detemir', 'type': 'DRUG', 'description': 'Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, injected separately with insulin aspart', 'armGroupLabels': ['Separate injection']}, {'name': 'insulin aspart', 'type': 'DRUG', 'description': 'Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, injected separately with insulin detemir', 'armGroupLabels': ['Separate injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], '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'}}}}