Glycemic Control with Triple Pathway Approach Through Empagliflozin, Linagliptin and Metformin Combination (GLYCO-3P)

Nabiqasim Industries

Status and phase: Not yet enrolling; Phase 4

Conditions: Type 2 DM; Diabetes Mellitus

Treatments: Combination Product: Empagliflozin+Linagliptin+Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06862739

NQ/DY/GLX/CT-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Patients of any gender
2. Patients aged between 18-80 years
3. Patients having HbA1c 8 % or above
4. Patients diagnosed with type II diabetes (more than at least 06 months)
5. Patients already on at least 02 or more anti-diabetic agents
6. Patients not allergic to empagliflozin, linagliptin, or metformin

Exclusion criteria

1. Patients with age less than 18
2. Patients with Type-I diabetes
3. Patients having diabetes for less than 06 months
4. Patients on GLP-1 and GIP
5. Patients who are pregnant or lactating females
6. Patients with decompensated chronic liver disease (DCLD)
7. Patients with eGFR less than 30 ml
8. Patients with end-stage heart failure (NYHA Class 4)
9. Patients who are allergic to empagliflozin, linagliptin, or metformin
10. Patients who are not willing to consent
11. Patients who are unable to give medical history

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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800 participants in 1 patient group

Glem-Lin MXR Single pill combination study

Other group

Description:

Empagliflozin (25 mg) Linagliptin (5 mg) Metformin XR (1000 mg) once daily combination therapy

Treatment:

Combination Product: Empagliflozin+Linagliptin+Metformin