Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-01-02 @ 3:38 AM
Study NCT ID:
NCT05359432
Status:
COMPLETED
Last Update Posted:
2022-05-03
First Post:
2022-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Empaglifozin and Vildagliptin in Type 2 Diabetes Mellitus
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': 'C570240', 'term': 'empagliflozin'}, {'id': 'D000077597', 'term': 'Vildagliptin'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-28', 'studyFirstSubmitDate': '2022-04-28', 'studyFirstSubmitQcDate': '2022-04-28', 'lastUpdatePostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycosylated hemoglobin A1c (HbA1c)', 'timeFrame': '24 weeks'}, {'measure': 'High-density lipoprotein (HDL) levels', 'timeFrame': '24 weeks'}, {'measure': 'Systolic blood pressure', 'timeFrame': '24 weeks'}, {'measure': 'Fasting blood sugars', 'timeFrame': '24 weeks'}, {'measure': 'Bodyweight', 'timeFrame': '24 weeks'}, {'measure': 'Serum creatinine', 'timeFrame': '24 weeks'}, {'measure': 'Serum glutamic-pyruvic transaminase (SGPT)', 'timeFrame': '24 weeks'}, {'measure': 'Low-density lipoprotein cholesterol', 'timeFrame': '24 weeks'}, {'measure': 'Total cholesterols', 'timeFrame': '24 weeks'}, {'measure': 'Serum triglycerides', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus', 'Empagliflozin', 'Vildagliptin', 'Efficacy', 'Safety'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '31518657', 'type': 'BACKGROUND', 'citation': 'Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.'}, {'pmid': '18801858', 'type': 'BACKGROUND', 'citation': 'Deshpande AD, Harris-Hayes M, Schootman M. Epidemiology of diabetes and diabetes-related complications. Phys Ther. 2008 Nov;88(11):1254-64. doi: 10.2522/ptj.20080020. Epub 2008 Sep 18.'}, {'pmid': '15618111', 'type': 'BACKGROUND', 'citation': 'American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2005 Jan;28 Suppl 1:S37-42. doi: 10.2337/diacare.28.suppl_1.s37. No abstract available.'}, {'pmid': '16584801', 'type': 'BACKGROUND', 'citation': 'Strodl E, Kenardy J. Psychosocial and non-psychosocial risk factors for the new diagnosis of diabetes in elderly women. Diabetes Res Clin Pract. 2006 Oct;74(1):57-65. doi: 10.1016/j.diabres.2006.02.011. Epub 2006 Apr 11.'}, {'pmid': '33835284', 'type': 'BACKGROUND', 'citation': 'Lin YK, Gao B, Liu L, Ang L, Mizokami-Stout K, Pop-Busui R, Zhang L. The Prevalence of Diabetic Microvascular Complications in China and the USA. Curr Diab Rep. 2021 Apr 9;21(6):16. doi: 10.1007/s11892-021-01387-3.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to perform a comparison of the efficacy and safety of empagliflozin and vildagliptin in patients with Type 2 Diabetes Mellitus\n\nopen labelled, multi-centric, parallel, randomized control trial\n\nIn Type 2 Diabetes patients, impact of empagliflozin (10 mg once or twice daily) versus vildagliptin (50 mg once or twice daily) assessed for Efficacy \\& safety parameters to be measured at both the baseline and 24-week visits.', 'detailedDescription': 'Background:\n\nDiabetes is a rampant disease that keeps on getting more and more people affected each year. Over 200 million people have been affected worldwide due to this disorder, and many have contracted various cardiovascular complications due to uncontrolled diabetes. Though an easily manageable disease, if left untreated, diabetes can be fatal. Therefore, it is necessary to have drugs available which control diabetes and also limit the progression of complications that could arise due to it.\n\nObjective:\n\nThe aim of this study is to perform a comparison of the efficacy and safety of empagliflozin and vildagliptin in patients with Type 2 Diabetes Mellitus\n\nMethods:\n\nopen labelled, multi-centric, parallel, randomized control trial to be conducted at the Department of Diabetes \\& Endocrinology of two tertiary care hospitals in Karachi, Pakistan.\n\nThe Participants will undergo screening and then were randomized into two groups. The first group received empagliflozin (10 mg once or twice daily), and the second group received vildagliptin (50 mg once or twice daily. HbA1c, High-density lipoprotein (HDL) levels., Systolic blood pressure, fasting blood glucose, and body weight will be measured at both the baseline and 24-week visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFemale and Male Patients of age 30-65 years with confirmed diagnosis of "type 2 diabetes mellitus".\n\nUncontrolled type 2 diabetes mellitus (\\> 7% HbA1c patients on monotherapy of metformin for the past three months on a fixed dose of 1500 mg /day along with lifestyle modifications were included in this study.\n\nBMI ranges from 18-45 kg/m2 were considered fit for this study. eGFR ≥ 60 ml/min/1.73 m2\n\nExclusion Criteria:\n\nPregnant female or female patients planning to conceive during the study period were excluded from this study.\n\n"Type 1 diabetes" or "secondary diabetes" resulting from specific causes Patients with advanced diabetic complications. Patients with any other terminal disease(s) requiring long-term medications. Patients involved in other trials on therapy with SGLT-2i or DPP4-I 3 months before study enrollment Patients on insulin or any other oral hypoglycemic drugs except metformin. Serum creatinine levels ≥ 1.3 mg/dl in women and ≥ 1.4 mg/dl in men'}, 'identificationModule': {'nctId': 'NCT05359432', 'briefTitle': 'Comparison of Empaglifozin and Vildagliptin in Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Getz Pharma'}, 'officialTitle': 'Comparison of Empaglifozin and Vildagliptin in Efficacy and Safety in Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'AK_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Empagliflozin', 'interventionNames': ['Drug: Empagliflozin']}, {'type': 'EXPERIMENTAL', 'label': 'Vildagliptin', 'interventionNames': ['Drug: Vildagliptin']}], 'interventions': [{'name': 'Empagliflozin', 'type': 'DRUG', 'description': 'Receiving allocated drug dosage as per clinical needs', 'armGroupLabels': ['Empagliflozin']}, {'name': 'Vildagliptin', 'type': 'DRUG', 'description': 'Receiving allocated drug dosage as per clinical needs', 'armGroupLabels': ['Vildagliptin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75330', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Department of Diabetes and Endocrinology at Sindh Government Hospital New Karachi & Dr. Riasat Medical Center Allah Wala Town, Karachi, Pakistan', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'In 1 month for 1 year', 'ipdSharing': 'YES', 'description': 'Study data with CRF'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Getz Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Asima Niazi', 'investigatorFullName': 'Jaffer Bin Baqar', 'investigatorAffiliation': 'Dow University of Health Sciences'}}}}