An interventional study of Dapagliflozin 10mg and Clinical Pharmacist-led Intervention in Type 2 Diabetes Mellitus (T2DM), sponsored by University of Sulaimani. Completed at 2 sites in Iraq. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-06-05.
Sponsored by University of Sulaimani · Not applicable, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 138 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
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.
Drug: Dapagliflozin 10mg
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
Other: Clinical Pharmacist-led Intervention
Patients with uncontrolled type 2 diabetes receiving their standard dual or triple therapy only
Other: Standard therapy group
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
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.
Patients are receiving their standard dual or triple oral hypoglycemic therapy only.
HbA1c
This measures changes in HbA1c from baseline to the end of the study period.
Time frame: 3 months
Fasting Plasma Glucose Level
This measures changes in fasting plasma glucose level from baseline to the end of the study period.
Time frame: 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.
Time frame: 3 months
Waist circumference
This measures changes in waist circumference in centimeters from baseline to the end of the study period.
Time frame: 3 months
Incidence of adverse events
This measures the reported incidence of adverse events, including urinary tract and genital infections and hypoglycemia.
Time frame: 3 months
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.
Time frame: 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
Time frame: 3 months
Blood pressure
This measures changes in blood pressure from baseline to the end of the study period
Time frame: 3 months
Serum creatinine
This measures changes in serum creatinine from baseline to the end of the study period
Time frame: 3 months
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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University of Sulaimani