Glycemic Control With Triple Pathway Approach Through Empagliflozin-Linagliptin-Metformin
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Changes in HbA1c levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of any gender
- •Patients aged between 18-80 years
- •Patients having HbA1c 8 % or above
- •Patients diagnosed with type II diabetes (more than at least 06 months)
- •Patients already on at least 02 or more anti-diabetic agents
- •Patients not allergic to empagliflozin, linagliptin, or metformin
排除标准
- •Patients with age less than 18
- •Patients with Type-I diabetes
- •Patients having diabetes for less than 06 months
- •Patients on GLP-1 and GIP
- •Patients who are pregnant or lactating females
- •Patients with decompensated chronic liver disease (DCLD)
- •Patients with eGFR less than 30 ml
- •Patients with end-stage heart failure (NYHA Class 4)
- •Patients who are allergic to empagliflozin, linagliptin, or metformin
- •Patients who are not willing to consent
- •Patients who are unable to give medical history
研究组 & 干预措施
Glem-Lin MXR Single pill combination study
Empagliflozin (25 mg) Linagliptin (5 mg) Metformin XR (1000 mg)
once daily combination therapy
干预措施: Empagliflozin+Linagliptin+Metformin (Combination Product)
结局指标
主要结局
Changes in HbA1c levels
时间窗: 03 months, 06 months
Metabolic control
次要结局
- Change in scores of Quality of Life-Short Form "SF-36" questionnaire(06 months)
- Changes in Diabetic Treatment Satisfaction Questionnaire "DTSQ"(06 months)
- Hypoglycemic events(06 months)
- Changes in body weight(03 and 06 months)
