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NCT Number: NCT06719661

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endocrine and Diabetes Center, Sulaymaniyah, Kurdistan Region, Iraq

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. HbA1c

    Time frame: 3 months

    This measures changes in HbA1c from baseline to the end of the study period.

  2. Fasting Plasma Glucose Level

    Time frame: 3 months

    This measures changes in fasting plasma glucose level from baseline to the end of the study period.

  3. Body mass index (BMI)

    Time frame: 3 months

    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.

  4. Waist circumference

    Time frame: 3 months

    This measures changes in waist circumference in centimeters from baseline to the end of the study period.

  5. Incidence of adverse events

    Time frame: 3 months

    This measures the reported incidence of adverse events, including urinary tract and genital infections and hypoglycemia.

Secondary outcomes

  1. Modified Hill-bone compliance scale

    Time frame: 3 months

    This measures the difference in adherence of patients to their medicines between baseline and the end of the study period. The questionnaire is composed of 14 item questions: appointment-keeping questions (3-items), diet (2-items), and medication adherence (9-items). The response to each question is one of the following:

    • All of the Time (Four marks)
    • Most of the Time (Three marks)
    • Some of the Time (Two Marks)
    • None of the Time (One Mark) The interpretation of the scale is done based on the following: Patients with mark scores of 14-28 will be considered as having good or high compliance, and those with mark scores of 29-42 will be considered as having average or medium compliance, while those having mark scores of 43-56 will be considered as having poor or low compliance.

  2. Lipid Profile

    Time frame: 3 months

    This measures changes in lipid profile (Total cholesterol, LDL, HDL and Triglyceride) from baseline to the end of the study period

  3. Blood pressure

    Time frame: 3 months

    This measures changes in blood pressure from baseline to the end of the study period

  4. Serum creatinine

    Time frame: 3 months

    This measures changes in serum creatinine from baseline to the end of the study period

Sponsors and collaborators

Lead sponsor

University of Sulaimani

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2024
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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