Effectivity of Empagliflozin Addition to Insulin and Oral Antidiabetic Medication (OAD) Regimen in Poorly Controlled Type 2 Diabetes
Overview
- Phase
- Phase 4
- Intervention
- Empagliflozin 10 MG
- Conditions
- Glucose Metabolism Disorders
- Sponsor
- SINA Health Education and Welfare Trust
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Number of participants achieved HbA1c level i.e. <7%
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Empagliflozin 10mg
Group A: Empagliflozin 10 mg once daily with antidiabetic drugs
Intervention: Empagliflozin 10 MG
regimen of Insulin+Metformin+DPP4 inhibitor (DPP4I)
Group B: usual care group \[Insulin+Metformin+DPP4 inhibitor (DPP4I)\] but without Empagliflozin with adjustment of therapy as the standard of care.
Intervention: Insulin+Metformin+DPP4 inhibitor (DPP4I)
Outcomes
Primary Outcomes
Number of participants achieved HbA1c level i.e. <7%
Time Frame: 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 Outcomes
- BMI in kg/m2(12 weeks)
- systolic blood pressure and diastolic blood pressure(12 weeks)
- Weight in Kg(12 weeks)