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

Phase 4

Not yet recruiting

• Conditions: Diabetes Mellitus; Type 2 DM

• Registration Number: NCT06862739
• Lead Sponsor: Nabiqasim Industries (Pvt) Ltd

Brief 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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-03-01
• Last Update Submitted: 2025-03-01
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Study Start: 2025-04
• Primary Completion: 2026-03
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in HbA1c levels	03 months, 06 months	Metabolic control

Secondary Outcome Measures

Name	Time	Method
Change in scores of Quality of Life-Short Form "SF-36" questionnaire	06 months	Improvement in quality of life (before and after treatment)
Changes in Diabetic Treatment Satisfaction Questionnaire "DTSQ"	06 months	Diabetic treatment satisfaction level (before and after treatment)
Hypoglycemic events	06 months	Hypoglycemic events frequency and severity of hypoglycemic events
Changes in body weight	03 and 06 months	Increase or decrease in body weight