Clinical trial NCT06862739: Glycemic Control with Triple Pathway Approach Through Empagliflozin, Linagliptin and Metformin Combination
Official title: Glycemic Control with Triple Pathway Approach Through Empagliflozin-Linagliptin-Metformin
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Diabetes Mellitus
Type 2 DM
Keywords: Combination
empagliflozin
metformin
linagliptin
compliance
Hypoglycemic events
weight management
quality of life
treatment satisfaction
glycemic control
Type 2 DM
Lead sponsor: Nabiqasim Industries (Pvt) Ltd
Sponsor class: INDUSTRY
First posted: 2025-03-06
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 1
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Changes in HbA1c levels
timeFrame: 03 months, 06 months
Secondary outcomes:
measure: Change in scores of Quality of Life-Short Form "SF-36" questionnaire
timeFrame: 06 months
measure: Changes in Diabetic Treatment Satisfaction Questionnaire "DTSQ"
timeFrame: 06 months
measure: Hypoglycemic events
timeFrame: 06 months
measure: Changes in body weight
timeFrame: 03 and 06 months
Other outcomes:
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