Completed

Dapagliflozin and Clinical Pharmacist Support for Type 2 Diabetes Management

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What is being tested

Dapagliflozin 10mg

+ Clinical Pharmacist-led Intervention

+ Standard therapy group

DrugOther
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 40 to 70 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2024
See protocol details

Summary

Principal SponsorUniversity of Sulaimani
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2024

Actual date on which the first participant was enrolled.

This study is designed to explore the effects of adding a medication called dapagliflozin and the role of a clinical pharmacist in managing Type 2 Diabetes Mellitus. Participants are adults with diabetes who are already using standard diabetes medications. The study aims to examine whether adding dapagliflozin to their current treatment or having a clinical pharmacist involved in their care can lead to better blood sugar control. This research is important because it may help in finding more effective ways to manage diabetes and improve the health of those affected by it. Participants in this study are divided into three groups. One group receives dapagliflozin along with their regular diabetes medications. Another group receives support from a clinical pharmacist, which includes medication adjustments, dietary advice, education on sticking to their treatment plan, and regular check-ups. The third group continues with their usual diabetes medications without any additional intervention. Over three months, researchers measure changes in blood sugar levels, body weight, and medication compliance. This helps determine how effective each approach is in managing diabetes and improving overall health.

Official TitleThe Impact of Clinical Pharmacist Intervention and Dapagliflozin as Add-On Therapy in the Management of Type 2 Diabetes Mellitus.
NCT06719661
Principal SponsorUniversity of Sulaimani
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

138 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

3 inclusion criteria required to participate
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.

5 exclusion criteria prevent from participating
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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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

Group III

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Endocrine and Diabetes Center

Sulaymaniyah, IraqOpen Endocrine and Diabetes Center in Google Maps
Suspended

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

Sulaymaniyah, Iraq
Completed2 Study Centers