NCT06145360

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

Effectivity of Empagliflozin Addition to Insulin and Oral Antidiabetic Medication (OAD) Regimen in Poorly Controlled Type 2 Diabetes

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: SINA Health Education and Welfare Trust · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glucose Metabolism Disorders
• Diabetes Mellitus, Type 2
• Hypoglycemic Agents
• Empagliflozin

Interventions

Type	Name	Description
DRUG	Empagliflozin 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
DRUG	Insulin+Metformin+DPP4 inhibitor (DPP4I)	Group B: usual care group but without Empagliflozin with adjustment of therapy as the standard of care

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2023-11-24
• Last updated: 2024-04-08

Locations

1 site across 1 country: Pakistan