The Impact of Clinical Pharmacist Intervention and Dapagliflozin as Add-On Therapy in the Management of Type 2 Diabetes Mellitus.

NCT ID: NCT06719661

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-06-01

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dapagliflozin 10mg

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Clinical Pharmacist-led Intervention

Intervention Type: OTHER

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.

Standard therapy group

Patients with uncontrolled type 2 diabetes receiving their standard dual or triple therapy only

Group Type: OTHER

Standard therapy group

Intervention Type: OTHER

Patients are receiving their standard dual or triple oral hypoglycemic therapy only.

Interventions

Dapagliflozin 10mg

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

Intervention Type: DRUG

Clinical Pharmacist-led Intervention

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.

Intervention Type: OTHER

Standard therapy group

Patients are receiving their standard dual or triple oral hypoglycemic therapy only.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sulaimani

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Abdalaziz Hama amin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed A. Hama amin, BSc. Pharmacy

Role: PRINCIPAL_INVESTIGATOR

University of Sulaimani, College of Pharmacy

Rawa A. Ratha, Ph.D. Clinical Pharmacy

Role: PRINCIPAL_INVESTIGATOR

University of Sulaimani, College of Pharmacy

Taha O. Asaad, Professor

Role: PRINCIPAL_INVESTIGATOR

College of Medicine - University of Sulaimani

Locations

Endocrine and Diabetes Center

Sulaymaniyah, Kurdistan Region, Iraq

Ministry of Higher Education and Scientific research, University of Sulaimani, College of Pharmacy

Sulaymaniyah, Kurdistan Region, Iraq

Countries

Iraq

Other Identifiers

PH141-24

Identifier Type: -

Identifier Source: org_study_id