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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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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

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Diabetes Mellitus Type 2 DM

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

1

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glem-Lin MXR Single pill combination study

Empagliflozin (25 mg) Linagliptin (5 mg) Metformin XR (1000 mg)

once daily combination therapy

Group Type OTHER

Empagliflozin+Linagliptin+Metformin

Intervention Type COMBINATION_PRODUCT

Scarcity of local population data on triple drug combination's impact on compliance, efficacy and safety in diabetic patients

Interventions

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Empagliflozin+Linagliptin+Metformin

Scarcity of local population data on triple drug combination's impact on compliance, efficacy and safety in diabetic patients

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No