MedTrace Logo

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

NCT06719661 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2025-06-05

No results posted yet for this study

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)

Interventions

DRUG

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

OTHER

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.

OTHER

Standard therapy group

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

Sponsors & Collaborators

  • University of Sulaimani

    lead OTHER

Principal Investigators

  • Mohammed A. Hama amin, BSc. Pharmacy · University of Sulaimani, College of Pharmacy

  • Rawa A. Ratha, Ph.D. Clinical Pharmacy · University of Sulaimani, College of Pharmacy

  • Taha O. Asaad, Professor · College of Medicine - University of Sulaimani

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-05-05
Completion
2025-06-01

Countries

  • Iraq

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06719661 on ClinicalTrials.gov