Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-13 @ 2:03 PM
Study NCT ID:
NCT03563794
Status:
UNKNOWN
Last Update Posted:
2018-06-20
First Post:
2018-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Vildagliptin Added to Continuous Subcutaneous Insulin Infusion in Uncontrolled Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-10', 'studyFirstSubmitDate': '2018-06-10', 'studyFirstSubmitQcDate': '2018-06-10', 'lastUpdatePostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood glucose', 'timeFrame': '7 days', 'description': 'changes from baseline in FPG and 2hPBG'}], 'secondaryOutcomes': [{'measure': 'hypoglycemia', 'timeFrame': '7 days', 'description': 'frequancy of hypoglycemia'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['T2DM']}, 'descriptionModule': {'briefSummary': 'The randomized, controlled clinical trial investigate the efficacy and safety of vildagliptin added to continuous subcutaneous insulin infusion in uncontrolled type 2 diabetes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* T2DM\n* 30≤ age≤70 years old\n* BMI 18.0-28.0 Kg/m2\n* HbA1c ≥8.5%\n* Negtive GAD、ICA、IAA\n* Patients do not use antihyperglycemia drugs\n* Patients use antihyperglycemia drugs for ≥8 weeks(exclusion of DPP-4 inhibitors and GLP-1 receptor agonist)\n\nExclusion Criteria:\n\n* T1DM,GDM\n* Congestive heart failure (New York Heart Association Functional Classification III-IV)\n* ALT or AST\\> 2 times above normal,GFR \\<50ml/min\n* Severe infection in the previous 3 months\n* Severely acute or chronic diabetic complications\n* Patients who were taking medications,known to affect glycaemic control, such as glucocorticoids(aside from antidiabetic medications)\n* History of pancreatitis\n* Trauma or patients operating at a scheduled time\n* Any mental health condition'}, 'identificationModule': {'nctId': 'NCT03563794', 'briefTitle': 'Efficacy and Safety of Vildagliptin Added to Continuous Subcutaneous Insulin Infusion in Uncontrolled Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Xiamen University'}, 'officialTitle': 'Efficacy and Safety of Vildagliptin Added to Continuous Subcutaneous Insulin Infusion in Uncontrolled Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'CSII vs CSII+DPP-4 inhibitor'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CSII(insulin Lispro)+Vildagliptin', 'description': 'Vildagliptin(50mg b.i.d po.) will be added to Continuous Subcutaneous Insulin Infusion(insulin Lispro) treatment in T2DM. Doses of insulin Lispro will be instructed on a titration schedule, adjusted every 2 days.', 'interventionNames': ['Drug: CSII+Vildagliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CSII(insulin Lispro)', 'description': 'T2DM patients will receive Continuous Subcutaneous Insulin Infusion(insulin Lispro) treatment. Doses of insulin Lispro will be instructed on a titration schedule, adjusted every 2 days.', 'interventionNames': ['Drug: CSII(insulin Lispro)']}], 'interventions': [{'name': 'CSII+Vildagliptin', 'type': 'DRUG', 'description': 'Vildagliptin(50mg b.i.d po.) will be added to Continuous Subcutaneous Insulin Infusion(insulin Lispro) treatment in T2DM. Doses of insulin Lispro will be instructed on a titration schedule, adjusted every 2 days.', 'armGroupLabels': ['CSII(insulin Lispro)+Vildagliptin']}, {'name': 'CSII(insulin Lispro)', 'type': 'DRUG', 'description': 'T2DM patients will receive Continuous Subcutaneous Insulin Infusion(insulin Lispro) treatment. Doses of insulin Lispro will be instructed on a titration schedule, adjusted every 2 days.', 'armGroupLabels': ['CSII(insulin Lispro)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '361003', 'city': 'Xiamen', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xue-jun Li, MD,PHD', 'role': 'CONTACT', 'email': 'lixuejue99@yahoo.com.cn', 'phone': '13860451316'}, {'name': 'Xue-jun Li, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The first afilliated hospital of Xiamen university', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}], 'centralContacts': [{'name': 'Xiulin Shi, MD', 'role': 'CONTACT', 'email': 'shixiulin2002@163.com', 'phone': '13959284763'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}