The Impact of Clinical Pharmacist Intervention and Dapagliflozin as Add-On Therapy in the Management of Type 2 Diabetes Mellitus.
Overview
- Phase
- Not Applicable
- Intervention
- Dapagliflozin 10mg
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Sponsor
- University of Sulaimani
- Enrollment
- 138
- Locations
- 2
- Primary Endpoint
- HbA1c
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Mohammed Abdalaziz Hama amin
Principal Investigator
University of Sulaimani
Eligibility Criteria
Inclusion Criteria
- •Patients with a diagnosis of type 2 diabetes mellitus having either dual or triple therapy, including (metformin, sulfonylurea, and/or DPP-4 inhibitors).
- •HbA1c level between 7.0% and 10% and patients with HbA1c above 10% but refusing insulin therapy.
- •Willing to provide informed consent.
Exclusion Criteria
- •Presence of comorbidities (e.g., severe renal impairment (eGFR \< 30 mL/min/1.73m²), thyroid dysfunction, liver dysfunction).
- •Presence of type 1 diabetes mellitus.
- •History of diabetic ketoacidosis.
- •Pregnancy or breastfeeding.
- •Cognitive impairment or inability to provide informed consent.
Arms & Interventions
Dapagliflozin as add on therapy group
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.
Intervention: Dapagliflozin 10mg
Clinical pharmacist-led intervention group
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
Intervention: Clinical Pharmacist-led Intervention
Standard therapy group
Patients with uncontrolled type 2 diabetes receiving their standard dual or triple therapy only
Intervention: Standard therapy group
Outcomes
Primary Outcomes
HbA1c
Time Frame: 3 months
This measures changes in HbA1c from baseline to the end of the study period.
Fasting Plasma Glucose Level
Time Frame: 3 months
This measures changes in fasting plasma glucose level from baseline to the end of the study period.
Body mass index (BMI)
Time Frame: 3 months
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.
Waist circumference
Time Frame: 3 months
This measures changes in waist circumference in centimeters from baseline to the end of the study period.
Incidence of adverse events
Time Frame: 3 months
This measures the reported incidence of adverse events, including urinary tract and genital infections and hypoglycemia.
Secondary Outcomes
- Modified Hill-bone compliance scale(3 months)
- Lipid Profile(3 months)
- Blood pressure(3 months)
- Serum creatinine(3 months)