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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin as add on therapy group | 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. |
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| Clinical pharmacist-led intervention group | 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 |
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| Standard therapy group | Other | Patients with uncontrolled type 2 diabetes receiving their standard dual or triple therapy only |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | This measures changes in HbA1c from baseline to the end of the study period. | 3 months |
| Fasting Plasma Glucose Level | This measures changes in fasting plasma glucose level from baseline to the end of the study period. | 3 months |
| Body mass index (BMI) | 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. | 3 months |
| Waist circumference | This measures changes in waist circumference in centimeters from baseline to the end of the study period. | 3 months |
| Incidence of adverse events | This measures the reported incidence of adverse events, including urinary tract and genital infections and hypoglycemia. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Hill-bone compliance scale | 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:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammed A. Hama amin, BSc. Pharmacy | University of Sulaimani, College of Pharmacy | Principal Investigator |
| Rawa A. Ratha, Ph.D. Clinical Pharmacy | University of Sulaimani, College of Pharmacy | Principal Investigator |
| Taha O. Asaad, Professor | College of Medicine - University of Sulaimani | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endocrine and Diabetes Center | Sulaymaniyah | Kurdistan Region | 46001 | Iraq | ||
| Ministry of Higher Education and Scientific research, University of Sulaimani, College of Pharmacy |
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| 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. |
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| Standard therapy group | Other | Patients are receiving their standard dual or triple oral hypoglycemic therapy only. |
|
| 3 months |
| Lipid Profile | This measures changes in lipid profile (Total cholesterol, LDL, HDL and Triglyceride) from baseline to the end of the study period | 3 months |
| Blood pressure | This measures changes in blood pressure from baseline to the end of the study period | 3 months |
| Serum creatinine | This measures changes in serum creatinine from baseline to the end of the study period | 3 months |
| Sulaymaniyah |
| Kurdistan Region |
| 46001 |
| Iraq |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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