Diabetes Mellitus, Type 2, Empagliflozin, Glucose Metabolism Disorders, Hypoglycemic Agents
Conditions
Keywords
Insulin Resistance, Type 2 Diabetes, Overweight, Add-on therapy, Glycemic control
Brief summary
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.
Interventions
DRUGEmpagliflozin 10 MG
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
DRUGInsulin+Metformin+DPP4 inhibitor (DPP4I)
Group B: usual care group but without Empagliflozin with adjustment of therapy as the standard of care
Sponsors
Horizon Pharmaceutical Pvt Ltd
SINA Health Education and Welfare Trust
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 35 years or older, diagnosed with Type 2 Diabetes Mellitus, * Specifically, individuals with a documented HbA1c level equal to or exceeding 8.5% over the course of the last six months or more are considered eligible candidates. * these patients should currently be undergoing treatment involving a combination of Insulin and either Metformin or Sitagliptin.
Exclusion criteria
* Patients with a history of recurrent urinary tract infections * those who are currently pregnant are excluded from participation in the study. * patients with an estimated Glomerular Filtration Rate (eGFR) exceeding 40 ml/min/1.73m², * Furthermore, individuals with other concurrent medical conditions, and those who are unable to provide informed consent for the study, have also been excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants achieved HbA1c level i.e. <7% | 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight in Kg | 12 weeks | Number of participants reduces weight in Kg during the therapy or mean reduction in weight overtime |
| BMI in kg/m2 | 12 weeks | Number of participants reduces BMI kg/m2 or mean reduction in BMI overtime |
| systolic blood pressure and diastolic blood pressure | 12 weeks | systolic blood pressure and diastolic blood pressure measure in mmHg during the therapy |
Countries
Pakistan
Outcome results
None listed