A Phase 4 interventional study of Empagliflozin+Linagliptin+Metformin in Diabetes Mellitus and Type 2 DM, sponsored by Nabiqasim Industries (Pvt) Ltd. Recruiting at 2 sites in Pakistan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Nabiqasim Industries (Pvt) Ltd · Phase 4, Interventional, and Treatment
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.
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.
Exclusion criteria
Empagliflozin (25 mg) Linagliptin (5 mg) Metformin XR (1000 mg) once daily combination therapy
Combination Product: Empagliflozin+Linagliptin+Metformin
Scarcity of local population data on triple drug combination's impact on compliance, efficacy and safety in diabetic patients
Changes in HbA1c levels
Metabolic control
Time frame: 03 months, 06 months
Change in scores of Quality of Life-Short Form "SF-36" questionnaire
Improvement in quality of life (before and after treatment)
Time frame: 06 months
Changes in Diabetic Treatment Satisfaction Questionnaire "DTSQ"
Diabetic treatment satisfaction level (before and after treatment)
Time frame: 06 months
Hypoglycemic events
Hypoglycemic events frequency and severity of hypoglycemic events
Time frame: 06 months
Changes in body weight
Increase or decrease in body weight
Time frame: 03 and 06 months
Plan to share: No
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Nabiqasim Industries (Pvt) Ltd