The Impact of Clinical Pharmacist Intervention and Dapagliflozin as Add-On Therapy in the Management of Type 2 Diabetes Mellitus.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Dapagliflozin 10mg (Drug)
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
干预措施: Clinical Pharmacist-led Intervention (Other)
Standard therapy group
Patients with uncontrolled type 2 diabetes receiving their standard dual or triple therapy only
干预措施: Standard therapy group (Other)
结局指标
主要结局
HbA1c
时间窗: 3 months
This measures changes in HbA1c from baseline to the end of the study period.
Fasting Plasma Glucose Level
时间窗: 3 months
This measures changes in fasting plasma glucose level from baseline to the end of the study period.
Body mass index (BMI)
时间窗: 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.
Waist circumference
时间窗: 3 months
This measures changes in waist circumference in centimeters from baseline to the end of the study period.
Incidence of adverse events
时间窗: 3 months
This measures the reported incidence of adverse events, including urinary tract and genital infections and hypoglycemia.
次要结局
- Modified Hill-bone compliance scale(3 months)
- Lipid Profile(3 months)
- Blood pressure(3 months)
- Serum creatinine(3 months)
研究者
Mohammed Abdalaziz Hama amin
Principal Investigator
University of Sulaimani