Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-29 @ 12:24 AM
Study NCT ID:
NCT00842894
Status:
COMPLETED
Last Update Posted:
2014-08-15
First Post:
2009-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}, {'id': 'C557564', 'term': 'insulin aspart, insulin aspart protamine drug combination 30:70'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3421}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-13', 'studyFirstSubmitDate': '2009-02-11', 'studyFirstSubmitQcDate': '2009-02-11', 'lastUpdatePostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of serious adverse drug reactions (SADRs)', 'timeFrame': 'after 26 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of all minor hypoglycaemic events', 'timeFrame': 'during 4 weeks preceding each visit'}, {'measure': 'Number of all major hypoglycaemic events', 'timeFrame': 'during 13 weeks preceding each visit'}, {'measure': 'HbA1c', 'timeFrame': 'after 26 weeks'}, {'measure': 'Percentage of subjects to reach HbA1c below 7.0%', 'timeFrame': 'after 13 weeks and 26 weeks'}, {'measure': 'The effect on glycaemic control as measured by FPG (fasting plasma glucose)', 'timeFrame': 'after 13 weeks and 26 weeks'}, {'measure': 'The effect on glycamic control as measured by PG profile', 'timeFrame': 'after 13 weeks and 26 weeks'}, {'measure': 'Change in body weight', 'timeFrame': 'after 13 weeks and 26 weeks'}]}, '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 study is conducted in Europe. The aim of this observational study is to investigate the incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal clinical practice conditions in Macedonia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from speciality practice settings who have been deemed appropriate to receive biphasic insulin aspart 30 or insulin detemir as new treatment and as part of routine out-patient care by the prescribing physician.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* After the physician decision has been made to use biphasic insulin aspart 30 or insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before.Particular attention should be paid to the drug interactions that are listed within the product label\n\nExclusion Criteria:\n\n* Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit\n* Subjects currently being treated with biphasic insulin aspart 30 or insulin detemir\n* Subjects who were previously enrolled in this study\n* Subjects with a hypersensitivity to biphasic insulin aspart 30 or insulin detemir or to any of the excipients\n* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months'}, 'identificationModule': {'nctId': 'NCT00842894', 'briefTitle': 'Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Prospective, Multicentre, Open Label, Non-controlled, Observational, 26-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Macedonia', 'orgStudyIdInfo': {'id': 'NN304-3716'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Insulin detemir', 'interventionNames': ['Drug: insulin detemir']}, {'label': 'Biphasic insulin aspart 30', 'interventionNames': ['Drug: biphasic insulin aspart 30']}], 'interventions': [{'name': 'insulin detemir', 'type': 'DRUG', 'otherNames': ['NN304', 'Levemir®'], 'description': 'Safety and effectiveness data collection in connection with the use of the drug.', 'armGroupLabels': ['Insulin detemir']}, {'name': 'biphasic insulin aspart 30', 'type': 'DRUG', 'description': 'Safety and effectiveness data collection in connection with the use of the drug in daily clinical practice.', 'armGroupLabels': ['Biphasic insulin aspart 30']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'MK-1000', 'city': 'Skopje', 'country': 'North Macedonia', 'geoPoint': {'lat': 41.99646, 'lon': 21.43141}}], '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'}}}}