Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-01-06 @ 1:26 PM
Study NCT ID:
NCT06719661
Status:
COMPLETED
Last Update Posted:
2025-06-05
First Post:
2024-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Clinical Pharmacist Intervention and Dapagliflozin as Add-On Therapy in the Management of 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': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2024-11-30', 'studyFirstSubmitQcDate': '2024-12-04', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '3 months', 'description': 'This measures changes in HbA1c from baseline to the end of the study period.'}, {'measure': 'Fasting Plasma Glucose Level', 'timeFrame': '3 months', 'description': 'This measures changes in fasting plasma glucose level from baseline to the end of the study period.'}, {'measure': 'Body mass index (BMI)', 'timeFrame': '3 months', 'description': 'This measures changes in weight in kg and height in meters to calculate changes of BMI (kg/m2) from baseline to the end of the study period.'}, {'measure': 'Waist circumference', 'timeFrame': '3 months', 'description': 'This measures changes in waist circumference in centimeters from baseline to the end of the study period.'}, {'measure': 'Incidence of adverse events', 'timeFrame': '3 months', 'description': 'This measures the reported incidence of adverse events, including urinary tract and genital infections and hypoglycemia.'}], 'secondaryOutcomes': [{'measure': 'Modified Hill-bone compliance scale', 'timeFrame': '3 months', 'description': 'This measures the difference in adherence of patients to their medicines between baseline and the end of the study period. The questionnaire is composed of 14 item questions: appointment-keeping questions (3-items), diet (2-items), and medication adherence (9-items). The response to each question is one of the following:\n\n1. All of the Time (Four marks)\n2. Most of the Time (Three marks)\n3. Some of the Time (Two Marks)\n4. None of the Time (One Mark) The interpretation of the scale is done based on the following: Patients with mark scores of 14-28 will be considered as having good or high compliance, and those with mark scores of 29-42 will be considered as having average or medium compliance, while those having mark scores of 43-56 will be considered as having poor or low compliance.'}, {'measure': 'Lipid Profile', 'timeFrame': '3 months', 'description': 'This measures changes in lipid profile (Total cholesterol, LDL, HDL and Triglyceride) from baseline to the end of the study period'}, {'measure': 'Blood pressure', 'timeFrame': '3 months', 'description': 'This measures changes in blood pressure from baseline to the end of the study period'}, {'measure': 'Serum creatinine', 'timeFrame': '3 months', 'description': 'This measures changes in serum creatinine from baseline to the end of the study period'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uncontrolled type 2 diabetes', 'Dapagliflozin', 'Effects on HbA1c', 'Effects on body weight', 'Effects on fasting plasma glucose level'], 'conditions': ['Type 2 Diabetes Mellitus (T2DM)']}, 'descriptionModule': {'briefSummary': 'Diabetes mellitus is a progressive endocrine disease characterized by insulin deficiency with or without insulin resistance. Management of type 2 diabetes requires a comprehensive team following and monitoring the disease carefully. Dapagliflozin is a sodium-glucose co-transporter-2 (SGLT2) inhibitor, has been shown to be an effective medication for the treatment of T2DM, and has been demonstrated to improve glycemic control. The investigators believe that enrolling clinical pharmacist intervention as a part of a multidisciplinary approach and dapagliflozin is necessary to provide better patient care in patients that are on dual or triple oral hypoglycemic agents other than dapagliflozin. Therefore, the hypothesis of this study is that the impact and tolerability of clinical pharmacist-led intervention can be comparable to add on dapagliflozin alone on glycemic control in the management of T2DM.', 'detailedDescription': 'The study will be a three-arm prospective, randomized, controlled trial conducted in the Diabetes and endocrine center in Sulaymaniyah, Iraq. Participants will be randomly assigned to one of the following three groups. Group 1 receives dapagliflozin 10 mg as add-on therapy along with their standard dual or triple oral hypoglycemic medicines; group 2 receives clinical pharmacist-led intervention including dosage adjustment, dietary modification, education on the importance of adherence, strategies to improve adherence, and regular follow-up along with their standard dual or triple oral hypoglycemic medicines; group 3 is the standard therapy group when patients are receiving their standard dual or triple therapy only; and the duration of the study is 3 months. Glycemic control will be measured by measurement of HbA1c and fasting plasma glucose level after 3 months. Changes in body weight and BMI will also be done; in addition, compliance will be measured using a hill-bone compliance scale for high blood pressure medication applied to diabetic medication. The expected outcome includes improving both HbA1c and fasting plasma glucose levels in both groups compared to baseline and comparable improvement in parameters between the clinical pharmacist-led intervention group and dapagliflozin 10 mg add-on therapy group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of type 2 diabetes mellitus having either dual or triple therapy, including (metformin, sulfonylurea, and/or DPP-4 inhibitors).\n* HbA1c level between 7.0% and 10% and patients with HbA1c above 10% but refusing insulin therapy.\n* Willing to provide informed consent.\n\nExclusion Criteria:\n\n* Presence of comorbidities (e.g., severe renal impairment (eGFR \\< 30 mL/min/1.73m²), thyroid dysfunction, liver dysfunction).\n* Presence of type 1 diabetes mellitus.\n* History of diabetic ketoacidosis.\n* Pregnancy or breastfeeding.\n* Cognitive impairment or inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT06719661', 'briefTitle': 'The Impact of Clinical Pharmacist Intervention and Dapagliflozin as Add-On Therapy in the Management of Type 2 Diabetes Mellitus.', 'organization': {'class': 'OTHER', 'fullName': 'University of Sulaimani'}, 'officialTitle': 'The Impact of Clinical Pharmacist Intervention and Dapagliflozin as Add-On Therapy in the Management of Type 2 Diabetes Mellitus.', 'orgStudyIdInfo': {'id': 'PH141-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dapagliflozin as add on therapy group', 'description': 'Patients with uncontrolled type 2 diabetes receive dapagliflozin 10 mg once daily for 3 months as add-on therapy to their dual or triple standard therapy without receiving clinical pharmacist-led intervention.', 'interventionNames': ['Drug: Dapagliflozin 10mg']}, {'type': 'EXPERIMENTAL', 'label': 'Clinical pharmacist-led intervention group', 'description': 'Patients with uncontrolled type 2 diabetes receive clinical pharmacist-led intervention, including dosage adjustment, dietary modification, education on the importance of adherence, strategies to improve adherence, and regular follow-up along with their standard dual or triple oral hypoglycemic medicines', 'interventionNames': ['Other: Clinical Pharmacist-led Intervention']}, {'type': 'OTHER', 'label': 'Standard therapy group', 'description': 'Patients with uncontrolled type 2 diabetes receiving their standard dual or triple therapy only', 'interventionNames': ['Other: Standard therapy group']}], 'interventions': [{'name': 'Dapagliflozin 10mg', 'type': 'DRUG', 'description': 'Uncontrolled type 2 diabetic patients receive dapagliflozin 10 mg tablet once daily. They are asked to take it for 3 months, then return for their final assessment after 3 months', 'armGroupLabels': ['Dapagliflozin as add on therapy group']}, {'name': 'Clinical Pharmacist-led Intervention', 'type': 'OTHER', 'description': 'Patients with uncontrolled type 2 diabetes will undergo dosage intensification of their dual or triple oral hypoglycemic medicines up to maximum daily doses. Further, they will be advised on specific dietary modification, education on the importance of adherence, strategies to improve adherence, including giving pill boxes, and regular follow-up every month via telephone-based communication.', 'armGroupLabels': ['Clinical pharmacist-led intervention group']}, {'name': 'Standard therapy group', 'type': 'OTHER', 'description': 'Patients are receiving their standard dual or triple oral hypoglycemic therapy only.', 'armGroupLabels': ['Standard therapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46001', 'city': 'Sulaymaniyah', 'state': 'Kurdistan Region', 'country': 'Iraq', 'facility': 'Endocrine and Diabetes Center', 'geoPoint': {'lat': 35.56496, 'lon': 45.4329}}, {'zip': '46001', 'city': 'Sulaymaniyah', 'state': 'Kurdistan Region', 'country': 'Iraq', 'facility': 'Ministry of Higher Education and Scientific research, University of Sulaimani, College of Pharmacy', 'geoPoint': {'lat': 35.56496, 'lon': 45.4329}}], 'overallOfficials': [{'name': 'Mohammed A. Hama amin, BSc. Pharmacy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sulaimani, College of Pharmacy'}, {'name': 'Rawa A. Ratha, Ph.D. Clinical Pharmacy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sulaimani, College of Pharmacy'}, {'name': 'Taha O. Asaad, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'College of Medicine - University of Sulaimani'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sulaimani', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohammed Abdalaziz Hama amin', 'investigatorAffiliation': 'University of Sulaimani'}}}}