NCT06862739

Glycemic Control With Triple Pathway Approach Through Empagliflozin, Linagliptin and Metformin Combination

Glycemic Control With Triple Pathway Approach Through Empagliflozin-Linagliptin-Metformin

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Nabiqasim Industries (Pvt) Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The efficacy and safety of a triple-pill combination therapy for advanced type 2 diabetes care. The study aims to assess the impact of 3 Oral Anti Diabetic (OAD) drugs on metabolic control, patient compliance, weight management, quality of life, diabetic treatment satisfaction and frequency of hypoglycemic events by combining them into a fixed-dose single pill.

Detailed description

This study aims to demonstrate that a poly-pill approach combining metformin, linagliptin, and empagliflozin will provide an effective and safe treatment option for managing type 2 diabetes mellitus (T2DM). By focusing on the reduction of HbA1c levels and enhancing patients' quality of life, this simplified approach is expected to streamline medication regimens, reduce pill burden, and improve treatment adherence. Furthermore, the study anticipates that this combination therapy will positively influence weight management and lower the incidence of hypoglycemic events, addressing common challenges in T2DM management. As T2DM prevalence continues to rise, especially in low- and middle-income countries, the poly-pill strategy may offer significant benefits, promoting better compliance, affordable low-in-cost treatment, and facilitating improved long-term health outcomes. Through this research, the study intends to provide strong evidence supporting the poly-pill regimen as a viable and impactful option for global T2DM management.

Conditions

• Diabetes Mellitus
• Type 2 DM

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Empagliflozin+Linagliptin+Metformin	Scarcity of local population data on triple drug combination's impact on compliance, efficacy and safety in diabetic patients

Timeline

• Start date: 2025-10-30
• Primary completion: 2026-04-30
• Completion: 2026-06-30
• First posted: 2025-03-06
• Last updated: 2026-04-17

Locations

2 sites across 1 country: Pakistan