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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glem-Lin MXR Single pill combination study | Other | Empagliflozin (25 mg) Linagliptin (5 mg) Metformin XR (1000 mg) once daily combination therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin+Linagliptin+Metformin | Combination Product | Scarcity of local population data on triple drug combination's impact on compliance, efficacy and safety in diabetic patients |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in HbA1c levels | Metabolic control | 03 months, 06 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in scores of Quality of Life-Short Form "SF-36" questionnaire | Improvement in quality of life (before and after treatment) | 06 months |
| Changes in Diabetic Treatment Satisfaction Questionnaire "DTSQ" |
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Inclusion criteria
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faisalabad clinics | Recruiting | Faisalabad | Punjab Province | Pakistan |
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| Label | URL |
|---|---|
| Screening for Diabetes in Adults | View source |
| IDF diabetes atlas 2021 Pakistan's ranking | View source |
| Health system performance for people with diabetes in LMICs |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Diabetic treatment satisfaction level (before and after treatment)
| 06 months |
| Hypoglycemic events | Hypoglycemic events frequency and severity of hypoglycemic events | 06 months |
| Changes in body weight | Increase or decrease in body weight | 03 and 06 months |
| Aap ka Clinic | Recruiting | Lahore | Punjab Province | Pakistan |
|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |