A Phase 4 interventional study of Empagliflozin 10 MG and Insulin+Metformin+DPP4 inhibitor (DPP4I) in Glucose Metabolism Disorders, Diabetes Mellitus, Type 2 and Hypoglycemic Agents, sponsored by SINA Health Education and Welfare Trust. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-04-08.
Sponsored by SINA Health Education and Welfare Trust · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
Group A: Empagliflozin 10 mg once daily with antidiabetic drugs
Drug: Empagliflozin 10 MG
Group B: usual care group \[Insulin+Metformin+DPP4 inhibitor (DPP4I)\] but without Empagliflozin with adjustment of therapy as the standard of care.
Drug: Insulin+Metformin+DPP4 inhibitor (DPP4I)
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
Also known as: EMPAA
Group B: usual care group but without Empagliflozin with adjustment of therapy as the standard of care
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
Time frame: 12 weeks
Weight in Kg
Number of participants reduces weight in Kg during the therapy or mean reduction in weight overtime
Time frame: 12 weeks
BMI in kg/m2
Number of participants reduces BMI kg/m2 or mean reduction in BMI overtime
Time frame: 12 weeks
systolic blood pressure and diastolic blood pressure
systolic blood pressure and diastolic blood pressure measure in mmHg during the therapy
Time frame: 12 weeks
Plan to share: No
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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SINA Health Education and Welfare Trust