Effectivity of Empagliflozin Addition to Insulin and Oral Antidiabetic Medication (OAD) Regimen in Poorly Controlled Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of participants achieved HbA1c level i.e. <7%
研究概览
简要总结
The primary aim of this study is to assess the impact of incorporating Empagliflozin, an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor, into the existing therapeutic regimen of Insulin+Metformin+Dipeptidyl peptidase 4 (DPP-4) inhibitors in poorly controlled type 2 diabetes mellitus (T2DM) patients. The study seeks to evaluate its effect on achieving glycemic goals in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 35 years or older, diagnosed with Type 2 Diabetes Mellitus,
- •Specifically, individuals with a documented HbA1c level equal to or exceeding 8.5% over the course of the last six months or more are considered eligible candidates.
- •these patients should currently be undergoing treatment involving a combination of Insulin and either Metformin or Sitagliptin.
排除标准
- •Patients with a history of recurrent urinary tract infections
- •those who are currently pregnant are excluded from participation in the study.
- •patients with an estimated Glomerular Filtration Rate (eGFR) exceeding 40 ml/min/1.73m²,
- •Furthermore, individuals with other concurrent medical conditions, and those who are unable to provide informed consent for the study, have also been excluded.
研究组 & 干预措施
Empagliflozin 10mg
Group A: Empagliflozin 10 mg once daily with antidiabetic drugs
干预措施: Empagliflozin 10 MG (Drug)
regimen of Insulin+Metformin+DPP4 inhibitor (DPP4I)
Group B: usual care group [Insulin+Metformin+DPP4 inhibitor (DPP4I)] but without Empagliflozin with adjustment of therapy as the standard of care.
干预措施: Insulin+Metformin+DPP4 inhibitor (DPP4I) (Drug)
结局指标
主要结局
Number of participants achieved HbA1c level i.e. <7%
时间窗: 12 weeks
The foremost objective is to determine whether the addition of Empagliflozin to the current treatment regimen leads to a significant improvement in glycemic control i.e. glycated haemoglobin less than 7% among poorly controlled T2DM patients in three months of treatment
次要结局
- BMI in kg/m2(12 weeks)
- systolic blood pressure and diastolic blood pressure(12 weeks)
- Weight in Kg(12 weeks)