Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-01 @ 8:57 PM
Study NCT ID:
NCT03631134
Status:
UNKNOWN
Last Update Posted:
2018-08-15
First Post:
2018-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of SGLT2 Inhibitor on Blood Glucose Profile in Type 2 Diabetic Patients Using Basal Insulin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077203', 'term': 'Sodium-Glucose Transporter 2 Inhibitors'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-08-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-12', 'studyFirstSubmitDate': '2018-08-12', 'studyFirstSubmitQcDate': '2018-08-12', 'lastUpdatePostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of glycemic variation', 'timeFrame': 'Week 1-5', 'description': 'Changes of glycemic variation assessed by CGM before and after SGLT2 inhibitor adding'}], 'secondaryOutcomes': [{'measure': 'Change of insulin dose', 'timeFrame': 'Week 1-5', 'description': 'Change of insulin dose before and after SGLT2 inhibitor adding'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The change of glycemic variation and insulin dose after adding SGLT2 inhibitor in type 2 diabetic patients treated with basal insulin was observed in a single center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999;\n2. Patients were using glargine with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 2 month would be recruited into this study;\n3. Patients had relatively constant diet and exercise in 2 month before the study.\n4. Fasting blood glucose was between 6.1 and 16mmolL, and postprandial (or random) blood glucose \\<22.2mmol/L\n\nExclusion Criteria:\n\n1. Patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure;\n2. Patients with severe infectious diseases;\n3. Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis;\n4. Patients with history of psychiatric disorders and were unsuitable to use CGMS;\n5. Patients used GLP-1 analogues，SGLT2 or more than once insulin injection in the past 3 months\n6. Any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.'}, 'identificationModule': {'nctId': 'NCT03631134', 'briefTitle': 'Effect of SGLT2 Inhibitor on Blood Glucose Profile in Type 2 Diabetic Patients Using Basal Insulin', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'Effect of SGLT2 Inhibitor on Blood Glucose Profile in Type 2 Diabetic Patients Using Basal', 'orgStudyIdInfo': {'id': 'KY20170904-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SGLT2i treatment', 'description': 'The patients who are using basal insulin therapy with or without oral hypoglycemic drugs will be added SGLT2 inhibitor treatment', 'interventionNames': ['Drug: SGLT2 inhibitor']}], 'interventions': [{'name': 'SGLT2 inhibitor', 'type': 'DRUG', 'description': 'Patients will be gave SGLT2 inhibitor 10mg per day', 'armGroupLabels': ['SGLT2i treatment']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}