Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Horizon Pharmaceutical Pvt Ltd | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
The primary aim of this study is to assess the impact of incorporating Empagliflozin, an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor, into the existing therapeutic regimen of Insulin+Metformin+Dipeptidyl peptidase 4 (DPP-4) inhibitors in poorly controlled type 2 diabetes mellitus (T2DM) patients. The study seeks to evaluate its effect on achieving glycemic goals in this patient population.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin 10mg | Experimental | Group A: Empagliflozin 10 mg once daily with antidiabetic drugs |
|
| regimen of Insulin+Metformin+DPP4 inhibitor (DPP4I) | Active Comparator | Group B: usual care group [Insulin+Metformin+DPP4 inhibitor (DPP4I)] but without Empagliflozin with adjustment of therapy as the standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 10 MG | Drug | the impact of incorporating Empagliflozin, an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor, into the existing therapeutic regimen of Insulin+Metformin+DPP4 inhibitor (DPP4I) in poorly controlled type 2 diabetes mellitus (T2DM |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants achieved HbA1c level i.e. <7% | The foremost objective is to determine whether the addition of Empagliflozin to the current treatment regimen leads to a significant improvement in glycemic control i.e. glycated haemoglobin less than 7% among poorly controlled T2DM patients in three months of treatment | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weight in Kg | Number of participants reduces weight in Kg during the therapy or mean reduction in weight overtime | 12 weeks |
| BMI in kg/m2 | Number of participants reduces BMI kg/m2 or mean reduction in BMI overtime |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hina Sharif, Pharm-D,MSPH | SINA Health Education & Welfare Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SINA Shireen Jinnah colony | Karachi | Pakistan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
An adaptive research design was judiciously employed to navigate the complexities of this research. Leveraging a secondary dataset, the study engaged data from registered diabetic patients who had been consistently monitored by SINA over the past six months. These existing datasets formed the foundation for analysis, enabling informed decision-making. Based on rigorous analytical evaluations, a standardized treatment protocol was established, with patients prescribed Empagliflozin 10mg for a duration of three months
Not provided
Not provided
Not provided
|
| Insulin+Metformin+DPP4 inhibitor (DPP4I) | Drug | Group B: usual care group but without Empagliflozin with adjustment of therapy as the standard of care |
|
| 12 weeks |
| systolic blood pressure and diastolic blood pressure | systolic blood pressure and diastolic blood pressure measure in mmHg during the therapy | 12 weeks |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C570240 | empagliflozin |
Not provided
Not provided
Not provided