Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
Study NCT ID:
NCT07247656
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2025-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Empagliflozin - Linagliptin and Empagliflozin- Metformin Therapy in Reduction of Body Weight in Type 2 Diabetic Patients .
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'D000069476', 'term': 'Linagliptin'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients was be divided two groups on the basis of their treatment option; group A Empagliflozin with Linagliptin group B Empagliflozin with Metformin\n\nThe study was be ethically approved by the Bahria University ethical review committee (BUMDC). Informed consent was taken before initiating the clinical trial in male and female diabetic patients.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-22', 'studyFirstSubmitDate': '2025-09-17', 'studyFirstSubmitQcDate': '2025-11-22', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall improvement in Fasting Blood Glucose', 'timeFrame': '12 weeks', 'description': 'Fasting Blood glucose ( mg / dl ) was measured using Glucometer'}, {'measure': 'Overall change in Body Mass Index ( kg/m2)', 'timeFrame': '12 weeks', 'description': 'Body Mass Index ( kg/m2) was recorded using weighing balance and measuring tape .'}, {'measure': 'Overall improvement in Random Blood Glucose', 'timeFrame': '12 weeks', 'description': 'Random Blood Glucose was measured in mg/dl using Glucometer'}, {'measure': 'Over all improvement in Glycated Hemoglobin ( HbA1c)', 'timeFrame': '12 weeks', 'description': 'Blood sample was taken to assess HbA1c'}, {'measure': 'Overall change in Waist to Hip Ratio', 'timeFrame': '12 weeks', 'description': 'Measuring tape was used to measure'}, {'measure': 'Overall change in Waist Circumference', 'timeFrame': '12 weeks', 'description': 'Was measured in inches using measuring tape'}], 'secondaryOutcomes': [{'measure': 'To observe adverse effects in treatment groups', 'timeFrame': '12 weeks', 'description': '1. To evaluate any incidence of Hypoglycemic events during study period\n2. To evaluate any incidence of Glycosuria during study period'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['liver profile', 'BMI', 'Waist to Hip Ratio', 'Renal Function tests', 'HBA1C'], 'conditions': ['Diabete Mellitus']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is - Comparison of Empagliflozin - Linagliptin with Empagliflozin - Metformin combination therapy in reduction of body weight in T2DM Patients and it included 200 diabetic subjects with total study period of 12 weeks and individual study period of 4 weeks .', 'detailedDescription': 'The goal of this clinical trial is to evaluate the safety and efficacy of both the drugs combination in evaluating weight loss and glycemic parameters .\n\nSPSS version 25 will be used to generate the descriptive statistics. Frequency and percentage figures will be used to represent the qualitative factors.\n\nThe comparison will be done between male of group A with male of group B and female of group A with female of group B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Diabetic men and women of age 40-70 yrs.\n\n * HBA1C -(6.5-9 )percent\n * All diabetic patients were BMI ≥25kg/m2\n * Patient took metformin ≥1000mg/day for ≥ 3 months with uncontrolled DM\n\nExclusion Criteria:\n\n* Male and female type 1 diabetic patients with BMI \\<25\n\n * Diabetic patient taking oral medicine other than metformin for last 12 weeks\n * Subjects with creatinine \\>1.5mg/dl\n * Pregnant or Lactating Women\n * Co-morbidities -\n * CLD\n * Cancer patient'}, 'identificationModule': {'nctId': 'NCT07247656', 'briefTitle': 'The Efficacy and Safety of Empagliflozin - Linagliptin and Empagliflozin- Metformin Therapy in Reduction of Body Weight in Type 2 Diabetic Patients .', 'organization': {'class': 'OTHER', 'fullName': 'Bahria University'}, 'officialTitle': 'Comparison of Empagliflozin- Linagliptin With Empagliflozin- Metformin Combination Therapy in Reduction of Body Weight in Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'ERC 105/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group B received Empagliflozin with Linagliptin', 'description': 'Empagliflozin 10 mg, along with Tab Linagliptin 5mg.', 'interventionNames': ['Drug: (Empagliflozin 10 mg+ Tab Linagliptin 5mg)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group A received Empagliflozin with Metformin', 'description': 'Tab Empagliflozin 10 mg once daily, along with combination of Tab Metformin 500 mg', 'interventionNames': ['Drug: Tab Empagliflozin 10 mg + Tab Metformin 500 mg']}], 'interventions': [{'name': '(Empagliflozin 10 mg+ Tab Linagliptin 5mg)', 'type': 'DRUG', 'otherNames': ['Diampa LT (10/5 ) MG', 'Xenglu- Lin (10 / 5 ) MG', 'Empaa L ( 10 / 5 ) MG'], 'description': '(Empagliflozin 10 mg+ Tab Linagliptin 5mg)was given once Orally daily', 'armGroupLabels': ['Group B received Empagliflozin with Linagliptin']}, {'name': 'Tab Empagliflozin 10 mg + Tab Metformin 500 mg', 'type': 'DRUG', 'otherNames': ['Xenglu - Met XR ( 10 / 500 ) MG'], 'description': 'Tab Empagliflozin 10 mg once daily, along with combination of Tab Metformin 500 mg', 'armGroupLabels': ['Group A received Empagliflozin with Metformin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Bahria University', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'NABILA RAFI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DOCTOR'}]}, 'ipdSharingStatementModule': {'url': 'https://www.bahria.edu.pk/bukc', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '1 year after article publication', 'ipdSharing': 'YES', 'description': 'All collected IPD data will be shared', 'accessCriteria': 'Access to all'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bahria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MBBS , M.PHIL PHARMACOLOGY', 'investigatorFullName': 'Dr. Nabila Rafi', 'investigatorAffiliation': 'Bahria University'}}}}