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Clinical Trial Details

Trial ID: L6504
Source ID: NCT06719661
Associated Drug: Dapagliflozin 10mg
Title: The Impact of Clinical Pharmacist Intervention and Dapagliflozin As Add-On Therapy in the Management of Type 2 Diabetes Mellitus.
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus (T2DM)
Interventions: DRUG: Dapagliflozin 10mg|OTHER: Clinical Pharmacist-led Intervention|OTHER: Standard therapy group
Outcome Measures: Primary: HbA1c, This measures changes in HbA1c from baseline to the end of the study period., 3 months|Fasting Plasma Glucose Level, This measures changes in fasting plasma glucose level from baseline to the end of the study period., 3 months|Body mass index (BMI), 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., 3 months|Waist circumference, This measures changes in waist circumference in centimeters from baseline to the end of the study period., 3 months|Incidence of adverse events, This measures the reported incidence of adverse events, including urinary tract and genital infections and hypoglycemia., 3 months | Secondary: Modified Hill-bone compliance scale, 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: 1. All of the Time (Four marks) 2. Most of the Time (Three marks) 3. Some of the Time (Two Marks) 4. 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., 3 months|Lipid Profile, This measures changes in lipid profile (Total cholesterol, LDL, HDL and Triglyceride) from baseline to the end of the study period, 3 months|Blood pressure, This measures changes in blood pressure from baseline to the end of the study period, 3 months|Serum creatinine, This measures changes in serum creatinine from baseline to the end of the study period, 3 months
Sponsor/Collaborators: Sponsor: University of Sulaimani
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 138
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2025-06-01
Results First Posted:
Last Update Posted: 2025-03-14
Locations: Endocrine and Diabetes Center, Sulaymaniyah, Kurdistan Region, 46001, Iraq|Ministry of Higher Education and Scientific research, University of Sulaimani, College of Pharmacy, Sulaymaniyah, Kurdistan Region, 46001, Iraq
URL: https://clinicaltrials.gov/show/NCT06719661