Evaluating the Efficacy and Safety of Empagliflozin Addition to Insulin and Oral Antidiabetic Medication (OAD) Regimen in Poorly Controlled Type 2 Diabetes and Obese Patient

• Status: Completed
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SINA Health Education and Welfare Trust
• Collaborator: Horizon Pharmaceutical Pvt Ltd
• Treatments: Dipeptidyl-Peptidase IV Inhibitors; Empagliflozin; Metformin

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.