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

Sponsor
University of Sulaimani
Study ID
NCT06719661
Status
Completed

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

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
  • 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.
  • Standard therapy group — OTHER
    Patients are receiving their standard dual or triple oral hypoglycemic therapy only.

Study Details

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.

Key Dates

Start date
Dec 1, 2024
Status verified
Jun 2025
Primary completion
May 5, 2025
Completion
Jun 1, 2025

Study Design

Enrollment
138 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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
  • Other: Standard therapy group
    Patients with uncontrolled type 2 diabetes receiving their standard dual or triple therapy only

Primary Outcome Measure

HbA1c [ Time Frame: 3 months ]

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