Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 6:02 AM
Study NCT ID:
NCT04916093
Status:
COMPLETED
Last Update Posted:
2021-06-07
First Post:
2021-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Antidiabetic Drugs in Recently Diagnosed Patients With 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': 'D000077597', 'term': 'Vildagliptin'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-04', 'studyFirstSubmitDate': '2021-05-24', 'studyFirstSubmitQcDate': '2021-06-04', 'lastUpdatePostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in glycemic parameters', 'timeFrame': '3-months', 'description': 'serum fasting glucose (mg/dl), and 2-hr postprandial glucose (mg/dl)'}, {'measure': 'Changes in Serum insulin (IU/l)', 'timeFrame': '3-months', 'description': 'using enzyme immunoassay (EIA) kits'}, {'measure': 'Insulin resistance', 'timeFrame': '3-months', 'description': 'measured by HOMA model assessment (HOMA-IR) using the following formula: (Fasting insulin (IU/ml) × Fasting glucose (mg/dl))/405'}, {'measure': 'Beta cell function (HOMA-B)', 'timeFrame': '3-months', 'description': 'measured by (360 ×Fasting Insulin (IU/ ml) )/(Fasting glucose(mg/dl)-63)'}, {'measure': 'Changes in HbA1c (%)', 'timeFrame': '3-months', 'description': 'Changes in HbA1c (%)'}], 'secondaryOutcomes': [{'measure': 'Changes in Lipid profile', 'timeFrame': '3-months', 'description': '(total cholesterol, TG, HDL, and LDL) (mg/dl)'}, {'measure': 'Changes in liver enzymes', 'timeFrame': '3-months', 'description': 'ALT and AST (U/l)'}, {'measure': 'Changes in Renal function tests', 'timeFrame': '3-months', 'description': 'creatinine and urea (mg/dl)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The current study aims to investigate Sitagliptin and vildagliptin efficacy and safety compared to metformin as 1st line options for T2D patients.', 'detailedDescription': 'This is a randomized case-controlled study in which drug-naive type-2 diabetic patients were divided into 3 groups and followed up for three months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recently diagnosed type2 diabetic adult subjects who were not on an oral hypoglycemic drug (OHA) at the screening visit were eligible to participate.\n\nExclusion Criteria:\n\n1. Type1 diabetes or ketoacidosis\n2. End-organ failure as chronic renal failure (estimated serum creatinine level ≥ 1.5mg/dl in male and ≥ 1.4mg/dl in female)\n3. Liver cell failure (elevated alanine transaminase (ALT ) and/or aspartate transaminase (AST) ≥ 2 folds)\n4. Any stage of heart failure\n5. Previous history of pancreatitis\n6. Previous history of taking medication which may alter the efficacy of either drug eg: (other OHA drug, corticosteroids, and oral contraceptives)\n7. Pregnant or lactating females'}, 'identificationModule': {'nctId': 'NCT04916093', 'briefTitle': 'Safety and Efficacy of Antidiabetic Drugs in Recently Diagnosed Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Safety and Efficacy of Sitagliptin, Vildagliptin, and Metformin in Recently Diagnosed Drug-naïve Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'MinyaU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sitagliptin Group', 'description': 'Included 20 recently diagnosed type 2 diabetic subjects. They all received sitagliptin 100 mg therapy once daily before breakfast.', 'interventionNames': ['Drug: Sitagliptin 100mg']}, {'type': 'EXPERIMENTAL', 'label': 'Vildagliptin Group', 'description': 'Included 20 recently diagnosed type 2 diabetic subjects. They all received vildagliptin 50 mg therapy twice daily before breakfast and supper.', 'interventionNames': ['Drug: Vildagliptin 50 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin Group', 'description': 'Included 20 recently diagnosed type 2 diabetic subjects. They all received control 1 gm twice daily', 'interventionNames': ['Drug: MetFORMIN 1000 Mg Oral Tablet']}], 'interventions': [{'name': 'Vildagliptin 50 MG', 'type': 'DRUG', 'description': 'Galvus 50 mg oral tablets', 'armGroupLabels': ['Vildagliptin Group']}, {'name': 'Sitagliptin 100mg', 'type': 'DRUG', 'description': 'Januvia 100mg oral tablets', 'armGroupLabels': ['Sitagliptin Group']}, {'name': 'MetFORMIN 1000 Mg Oral Tablet', 'type': 'DRUG', 'description': 'Glucophage 1000 mg oral tablets', 'armGroupLabels': ['Metformin Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61118', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Minya University Hospital', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'overallOfficials': [{'name': 'Asmaa A Elsayed, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BUC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Minia University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PHD candidate in clinical pharmacy department and PI', 'investigatorFullName': 'Asmaa Abdelfattah Elsayed', 'investigatorAffiliation': 'Beni-Suef University'}}}}