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

NCT06719661 | Completed DMC

• 1 other identifier: PH141-24
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Uncontrolled type 2 diabetes; Dapagliflozin; Effects on HbA1c; Effects on body weight; Effects on fasting plasma glucose level

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Modified Hill-bone compliance scale

  3 months

• Lipid Profile

  3 months

• Blood pressure

  3 months

• Serum creatinine

  3 months

Study Arms (3)

Dapagliflozin as add on therapy group

EXPERIMENTAL

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

Clinical pharmacist-led intervention group

EXPERIMENTAL

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

Standard therapy group

OTHER

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

Other: Standard therapy group

Interventions

Dapagliflozin 10mg 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

Dapagliflozin as add on therapy group

Clinical Pharmacist-led Intervention 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.

Clinical pharmacist-led intervention group

Standard therapy group OTHER

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

Standard therapy group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sulaimani: lead

Study Sites (2)

Endocrine and Diabetes Center

Sulaymaniyah, Kurdistan Region, 46001, Iraq

Location

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

Sulaymaniyah, Kurdistan Region, 46001, Iraq

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mohammed A. Hama amin, BSc. Pharmacy

  University of Sulaimani, College of Pharmacy

  PRINCIPAL INVESTIGATOR

• Rawa A. Ratha, Ph.D. Clinical Pharmacy

  University of Sulaimani, College of Pharmacy

  PRINCIPAL INVESTIGATOR

• Taha O. Asaad, Professor

  College of Medicine - University of Sulaimani

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2024
• First Posted: December 6, 2024
• Study Start: December 1, 2024
• Primary Completion: May 5, 2025
• Study Completion: June 1, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

IR (2)