Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT00282451
Status:
COMPLETED
Last Update Posted:
2016-10-31
First Post:
2006-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Biphasic Insulin Compared to Biphasic Insulin Combined With Insulin Aspart, With or Without Metformin in Type 2 Diabetes
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': 'C557564', 'term': 'insulin aspart, insulin aspart protamine drug combination 30:70'}, {'id': 'D061267', 'term': 'Insulin Aspart'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-27', 'studyFirstSubmitDate': '2006-01-25', 'studyFirstSubmitQcDate': '2006-01-25', 'lastUpdatePostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'At Visit 6 (14 weeks)'}], 'secondaryOutcomes': [{'measure': 'Postprandial glucose concentration increments (calculated based on 7-point blood glucose profiles)'}]}, '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 Africa and Middle East. The objective of the study is to compare glycemic control of Biphasic insulin Aspart 30 twice daily with Biphasic insulin Aspart 30 twice daily plus Insulin Aspart, both insulin treatments with or without metformin, in subjects with type 2 diabetes, previously treated with Biphasic Human Insulin 30/70.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '18 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetic subjects\n* Current treatment with Biphasic Human Insulin 30/70 twice daily alone or in combination with any oral hypoglycaemic agent for at least 3 months prior to entering the trial\n* HbA1c at least 12%\n* Willing and able to perform self blood glucose monitoring (SMBG)\n\nExclusion Criteria:\n\n* History of drug or alcohol dependence\n* Receipt of any investigational drug within the last month prior to this trial\n* Anticipated change in dose of prescription medication, which may influence glucose regulation (Mono Amino Oxidase-inhibitors, non selective beta-adrenergic agents, anabolic steroids and systemic glucocorticoids)\n* Severe uncontrolled hypertension\n* Recurrent severe hypoglycemia as judged by investigator\n* Any disease or condition, which the Investigator feels, would interfere with the trial'}, 'identificationModule': {'nctId': 'NCT00282451', 'briefTitle': 'Effect of Biphasic Insulin Compared to Biphasic Insulin Combined With Insulin Aspart, With or Without Metformin in Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Comparison of Biphasic Insulin Aspart 30 Twice Daily With Biphasic Insulin Aspart 30 Twice Daily Plus Lunchtime Injection of Insulin Aspart, in Combination With or Without Metformin (for Both Treatment Groups) in Subjects With Type 2 Diabetes. A Multi-center, Randomized, Open-labeled, Two-armed Parallel Group Trial in Subjects With Type 2 Diabetes Previously Treated With Conventional Biphasic Human Insulin 30/70', 'orgStudyIdInfo': {'id': 'BIASP-3024'}}, 'armsInterventionsModule': {'interventions': [{'name': 'biphasic insulin aspart', 'type': 'DRUG'}, {'name': 'insulin aspart', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aghakhan', 'country': 'Egypt', 'facility': 'Novo Nordisk Investigational Site'}, {'city': 'Giza', 'country': 'Egypt', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}, {'zip': '80215', 'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}, {'zip': '245', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], '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'}}}}