Clinical trial NCT06719661: The Impact of Clinical Pharmacist Intervention and Dapagliflozin as Add-On Therapy in the Management of Type 2 Diabetes Mellitus.
Official title: The Impact of Clinical Pharmacist Intervention and Dapagliflozin as Add-On Therapy in the Management of Type 2 Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Sulaimani
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 138
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c
timeFrame: 3 months
measure: Fasting Plasma Glucose Level
timeFrame: 3 months
measure: Body mass index (BMI)
timeFrame: 3 months
measure: Waist circumference
timeFrame: 3 months
measure: Incidence of adverse events
timeFrame: 3 months
Secondary outcomes:
measure: Modified Hill-bone compliance scale
timeFrame: 3 months
measure: Lipid Profile
timeFrame: 3 months
measure: Blood pressure
timeFrame: 3 months
measure: Serum creatinine
timeFrame: 3 months
Other outcomes:
Locations:
city: Sulaymaniyah
country: Iraq
facility: Endocrine and Diabetes Center
state: Kurdistan Region
city: Sulaymaniyah
country: Iraq
facility: Ministry of Higher Education and Scientific research, University of Sulaimani, College of Pharmacy
state: Kurdistan Region
Study officials:
affiliation: University of Sulaimani, College of Pharmacy
name: Mohammed A. Hama amin, BSc. Pharmacy
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sulaimani, College of Pharmacy
name: Rawa A. Ratha, Ph.D. Clinical Pharmacy
role: PRINCIPAL_INVESTIGATOR
affiliation: College of Medicine - University of Sulaimani
name: Taha O. Asaad, Professor
role: PRINCIPAL_INVESTIGATOR
References: