Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-31 @ 7:06 PM
Study NCT ID:
NCT02491528
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2015-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III Study of Insulin Aspart Injection to Evaluate the Efficacy and Safety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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': '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 563}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2016-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-17', 'studyFirstSubmitDate': '2015-06-05', 'studyFirstSubmitQcDate': '2015-07-02', 'lastUpdatePostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of relative baseline HbA1c', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, open, parallel group, active-controlled study. The study period is 25 to 26 weeks, including screening period of 1-2 weeks and treatment period of 24 weeks.', 'detailedDescription': 'After the screening visit, all patients who met all inclusion criteria and do not meet any of the exclusion criteria were randomized into the experimental group or the controlled group. The subjects in the experimental arm will receive insulin aspart injection combined with basal insulin (Lantus ®), and the subjects in the controlled arm will receive NovoRapid ® (active control) combined with basal insulin (Lantus ®). The experimental drug or the controlled drug will be administered subcutaneously prior to three meals (or can be administered immediately after meal if necessary), and the basal insulin (Lantus ®) will be administered at bedtime. The treatment period is 24 weeks, during which the subjects will be followed up at the clincic cetres at 1, 2, 4, 8, 12, 18, 24 weeks of treatment. At the end of 24-week treatment, if the adverse events continue, the subjects will be followed until recovery or stabilization of the AEs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients were diagnosed with diabetes；\n* BMI≤35.0 kg/m2；\n* Insulin therapy for at least 3 months before recruitment；\n* HbA1c7\\~13%\n\nExclusion Criteria:\n\n* Patients to study drug allergy；\n* to Liver and kidney impairment；\n* Liver and kidney impairment；\n* used systemic steroid treatment in past 2 months .'}, 'identificationModule': {'nctId': 'NCT02491528', 'briefTitle': 'A Phase III Study of Insulin Aspart Injection to Evaluate the Efficacy and Safety', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tonghua Dongbao Pharmaceutical Co.,Ltd'}, 'officialTitle': 'A Multi-center, Randomized, Open-label, Parallel-group, Phase Ⅲ Study to Evaluate the Efficacy and Safety of Insulin Aspart Injection in Patients With Diabetes Mellitus Compared to NovoRapid®', 'orgStudyIdInfo': {'id': 'DB021L012015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'insulin Aspart injection', 'description': 'Subcutaneous injection of insulin Aspart prior to three meals every day, while subcutaneous injection of Lantus at bedtime.', 'interventionNames': ['Biological: insulin Aspart injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'insulin Aspart injection (NovoRapid)', 'description': 'Subcutaneous injection of insulin Aspart (NovoRapid) prior to three meals every day, while subcutaneous injection of Lantus at bedtime.', 'interventionNames': ['Biological: insulin Aspart injection (NovoRapid)']}], 'interventions': [{'name': 'insulin Aspart injection', 'type': 'BIOLOGICAL', 'description': 'Subcutaneous injection of insulin Aspart prior to three meals every day, while subcutaneous injection of Lantus at bedtime.', 'armGroupLabels': ['insulin Aspart injection']}, {'name': 'insulin Aspart injection (NovoRapid)', 'type': 'BIOLOGICAL', 'description': 'Subcutaneous injection of insulin Aspart injection (NovoRapid) prior to three meals every day, while subcutaneous injection of Lantus at bedtime.', 'armGroupLabels': ['insulin Aspart injection (NovoRapid)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Weifang', 'state': 'Shandong', 'country': 'China', 'facility': 'Affiliated hospital of Weifang Medical University', 'geoPoint': {'lat': 36.71, 'lon': 119.10194}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "The 6th people's hospital of Shanghai", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'WP Jia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The 6th people's hospital of Shanghai"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tonghua Dongbao Pharmaceutical Co.,Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}