Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT05667220
Status:
UNKNOWN
Last Update Posted:
2023-01-03
First Post:
2022-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sitagliptin in Combination With Beidougen Capsule for Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-29', 'studyFirstSubmitDate': '2022-12-19', 'studyFirstSubmitQcDate': '2022-12-27', 'lastUpdatePostDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting blood glucose change', 'timeFrame': 'Changes in fasting blood glucose from baseline to 1 week treatment', 'description': 'Fasting blood glucose (FBG) levels (mmol/L) were analyzed by an autoanalyzer (Hitachi 747, Roche Diagnostics, Germany) at the Central Chemistry Laboratory of Beijing Chaoyang Hospital affiliated with Capital Medical University.'}], 'secondaryOutcomes': [{'measure': 'Serum GLP-1 change', 'timeFrame': 'Changes in serum GLP-1 from baseline to 1 week treatment', 'description': 'The serum active GLP-1 contents were measured using an active GLP-1 assay kit (EZGLPHS-35K, Millipore) according to the specification.'}, {'measure': 'Fecal DPP4 activity change', 'timeFrame': 'Changes in fecal DPP4 activity from baseline to 1 week treatment', 'description': 'For measurement of fecal DPP4 activity, 60 mg feces were homogenized in RIPA lysis buffer (with final concentration at 1 mg/mL) was added to 50 mM sodium phosphate buffer (pH = 7.4, OD600 = 0.5), and the reaction was started by the addition of 250 μM H-A-pNA. After incubation for 30 min at 37 °C, the absorbance was measured at 405 nm.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The study was an interventional non-randomized controlled study and was divided into a Sitagliptin monotherapy (100 mg Qd) group and a Sitagliptin (100mg Qd)+Beidougen capsule (60mg Tid) combination treatment group for one week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18-65 years with a first diagnosis of type 2 diabetes\n* Diagnostic criteria HbA1c ≥ 7%\n\nExclusion Criteria:\n\n* The positive of diabetes antibodies\n* Anti-diabetic drugs therapy before participation\n* Pancreatitis\n* Coronary artery disease\n* Liver function impairment\n* Renal function impairment\n* History of intestinal surgery\n* Chronic hypoxic diseases (emphysema and cor pulmonale)\n* Infectious disease\n* Hematological disease\n* Systemic inflammatory disease\n* Cancer\n* Pregnant\n* Ingesting agents known to influence glucose or lipid metabolism\n* Any antibiotics or probiotics in the past three months prior to the study'}, 'identificationModule': {'nctId': 'NCT05667220', 'briefTitle': 'Sitagliptin in Combination With Beidougen Capsule for Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'Efficacy of Combination Therapy With Sitagliptin and Beidougen Capsule in Chinese Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '2022-Sitagliptin-Beidougen'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sitagliptin monotherapy group (Group A)', 'interventionNames': ['Drug: Sitagliptin']}, {'type': 'EXPERIMENTAL', 'label': 'Sitagliptin combined with Beidougen capsule treatment group (Group B)', 'interventionNames': ['Drug: Sitagliptin combined with Beidougen capsule']}], 'interventions': [{'name': 'Sitagliptin', 'type': 'DRUG', 'description': 'Sitagliptin monotherapy group (Group A): 20 eligible patients were planned to be included and given Sitagliptin 100 mg Qd orally; the treatment period was 1 week.', 'armGroupLabels': ['Sitagliptin monotherapy group (Group A)']}, {'name': 'Sitagliptin combined with Beidougen capsule', 'type': 'DRUG', 'description': 'Sitagliptin combined with Beidougen capsule treatment group (Group B): 20 eligible patients were planned to be included and given sitagliptin 100mg Qd orally combined with Beidougen capsule 60mg Tid orally. The treatment period was 1 week.', 'armGroupLabels': ['Sitagliptin combined with Beidougen capsule treatment group (Group B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jia Liu, MD', 'role': 'CONTACT', 'email': 'liujia0116@126.com', 'phone': '010-8523161710'}], 'facility': 'Beijing Chao-yang Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jia Liu, MD', 'role': 'CONTACT', 'email': 'liujia0116@126.com', 'phone': '010-85231710'}, {'name': 'Yan Duan, MD', 'role': 'CONTACT', 'phone': '010-85231711'}], 'overallOfficials': [{'name': 'Guang Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Chao Yang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Beijing Chao Yang Hospital', 'investigatorFullName': 'Guang Wang', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}