Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-27 @ 10:58 PM
Study NCT ID:
NCT06145360
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2023-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy and Safety of Empagliflozin Addition to Insulin and Oral Antidiabetic Medication (OAD) Regimen in Poorly Controlled Type 2 Diabetes and Obese Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'An adaptive research design was judiciously employed to navigate the complexities of this research. Leveraging a secondary dataset, the study engaged data from registered diabetic patients who had been consistently monitored by SINA over the past six months. These existing datasets formed the foundation for analysis, enabling informed decision-making. Based on rigorous analytical evaluations, a standardized treatment protocol was established, with patients prescribed Empagliflozin 10mg for a duration of three months'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-05', 'studyFirstSubmitDate': '2023-11-17', 'studyFirstSubmitQcDate': '2023-11-17', 'lastUpdatePostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants achieved HbA1c level i.e. <7%', 'timeFrame': '12 weeks', 'description': 'The foremost objective is to determine whether the addition of Empagliflozin to the current treatment regimen leads to a significant improvement in glycemic control i.e. glycated haemoglobin less than 7% among poorly controlled T2DM patients in three months of treatment'}], 'secondaryOutcomes': [{'measure': 'Weight in Kg', 'timeFrame': '12 weeks', 'description': 'Number of participants reduces weight in Kg during the therapy or mean reduction in weight overtime'}, {'measure': 'BMI in kg/m2', 'timeFrame': '12 weeks', 'description': 'Number of participants reduces BMI kg/m2 or mean reduction in BMI overtime'}, {'measure': 'systolic blood pressure and diastolic blood pressure', 'timeFrame': '12 weeks', 'description': 'systolic blood pressure and diastolic blood pressure measure in mmHg during the therapy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Insulin Resistance', 'Type 2 Diabetes', 'Overweight', 'Add-on therapy', 'Glycemic control'], 'conditions': ['Glucose Metabolism Disorders', 'Diabetes Mellitus, Type 2', 'Hypoglycemic Agents', 'Empagliflozin']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to assess the impact of incorporating Empagliflozin, an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor, into the existing therapeutic regimen of Insulin+Metformin+Dipeptidyl peptidase 4 (DPP-4) inhibitors in poorly controlled type 2 diabetes mellitus (T2DM) patients. The study seeks to evaluate its effect on achieving glycemic goals in this patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 35 years or older, diagnosed with Type 2 Diabetes Mellitus,\n* Specifically, individuals with a documented HbA1c level equal to or exceeding 8.5% over the course of the last six months or more are considered eligible candidates.\n* these patients should currently be undergoing treatment involving a combination of Insulin and either Metformin or Sitagliptin.\n\nExclusion Criteria:\n\n* Patients with a history of recurrent urinary tract infections\n* those who are currently pregnant are excluded from participation in the study.\n* patients with an estimated Glomerular Filtration Rate (eGFR) exceeding 40 ml/min/1.73m²,\n* Furthermore, individuals with other concurrent medical conditions, and those who are unable to provide informed consent for the study, have also been excluded.'}, 'identificationModule': {'nctId': 'NCT06145360', 'briefTitle': 'Evaluating the Efficacy and Safety of Empagliflozin Addition to Insulin and Oral Antidiabetic Medication (OAD) Regimen in Poorly Controlled Type 2 Diabetes and Obese Patient', 'organization': {'class': 'OTHER', 'fullName': 'SINA Health Education and Welfare Trust'}, 'officialTitle': 'Effectivity of Empagliflozin Addition to Insulin and Oral Antidiabetic Medication (OAD) Regimen in Poorly Controlled Type 2 Diabetes', 'orgStudyIdInfo': {'id': '00003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Empagliflozin 10mg', 'description': 'Group A: Empagliflozin 10 mg once daily with antidiabetic drugs', 'interventionNames': ['Drug: Empagliflozin 10 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'regimen of Insulin+Metformin+DPP4 inhibitor (DPP4I)', 'description': 'Group B: usual care group \\[Insulin+Metformin+DPP4 inhibitor (DPP4I)\\] but without Empagliflozin with adjustment of therapy as the standard of care.', 'interventionNames': ['Drug: Insulin+Metformin+DPP4 inhibitor (DPP4I)']}], 'interventions': [{'name': 'Empagliflozin 10 MG', 'type': 'DRUG', 'otherNames': ['EMPAA'], 'description': 'the impact of incorporating Empagliflozin, an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor, into the existing therapeutic regimen of Insulin+Metformin+DPP4 inhibitor (DPP4I) in poorly controlled type 2 diabetes mellitus (T2DM', 'armGroupLabels': ['Empagliflozin 10mg']}, {'name': 'Insulin+Metformin+DPP4 inhibitor (DPP4I)', 'type': 'DRUG', 'description': 'Group B: usual care group but without Empagliflozin with adjustment of therapy as the standard of care', 'armGroupLabels': ['regimen of Insulin+Metformin+DPP4 inhibitor (DPP4I)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'country': 'Pakistan', 'facility': 'SINA Shireen Jinnah colony', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Hina Sharif, Pharm-D,MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SINA Health Education & Welfare Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SINA Health Education and Welfare Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Horizon Pharmaceutical Pvt Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}