Diabetes Mellitus, Type 2 DM
Conditions
Keywords
Combination, empagliflozin, metformin, linagliptin, compliance, Hypoglycemic events, weight management, quality of life, treatment satisfaction, glycemic control, Type 2 DM
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.
Interventions
COMBINATION_PRODUCTEmpagliflozin+Linagliptin+Metformin
Scarcity of local population data on triple drug combination's impact on compliance, efficacy and safety in diabetic patients
Sponsors
Nabiqasim Industries (Pvt) Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in HbA1c levels | 03 months, 06 months | Metabolic control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in scores of Quality of Life-Short Form "SF-36" questionnaire | 06 months | Improvement in quality of life (before and after treatment) |
| Changes in Diabetic Treatment Satisfaction Questionnaire "DTSQ" | 06 months | Diabetic treatment satisfaction level (before and after treatment) |
| Hypoglycemic events | 06 months | Hypoglycemic events frequency and severity of hypoglycemic events |
| Changes in body weight | 03 and 06 months | Increase or decrease in body weight |
Countries
Pakistan
Outcome results
None listed