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临床试验/NCT06862739
NCT06862739招募中4 期

Glycemic Control With Triple Pathway Approach Through Empagliflozin-Linagliptin-Metformin

Nabiqasim Industries (Pvt) Ltd2 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2025年10月30日最近更新:
适应症
干预措施

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

Other

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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