Effect of Trelagliptin on vascular stiffness in comparison to Teneligliptin in type 2 diabetes mellitus: a pilot randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To evaluate the effect of Trelagliptin vs Teneligliptin on
研究概览
简要总结
DPP4 Inhibitors have shown mixed results in improving vascular outcomes. Trelagliptin, is a newer DPP4 inhibitor, recently been launched in India. Till now , a single pilot study has been done on Trelagliptin effect on Flow mediated dilatation (FMD) and it failed to show any significant changes on FMD. However, its effect on Pulse wave Velocity (PWV), which is a marker of vascular stiffness, is still lacking in clinical trial. This pilot trial aims to investigate whether Trelagliptin has any effect on PWV as well as vascular stiffness in Type 2 Diabetes mellitus patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult subjects ( more than 40 yrs to less than65 of age),of any gender Established diagnosis of type 2 diabetes mellitus Inadequate glycaemic control with existing glycated haemoglobin (HbA1c) value ranging between 7.0-9.0 Willing to providing written informed consent.
排除标准
- •History of serious hypersensitivity reaction to any DPP-4 in past Pregnancy or breastfeeding Patients having estimated GFR less than 50 ml/min/1.73m2 Patients having established cardiac rhythm disorder like atrial fibrillation or atrial flutter, implanted permanent pacemaker, sick sinus syndrome or atrio-ventricular block of more than second degree Patients suffered from Acute Myocardial Infarction, Unstable angina , Cerebrovascular accident within last 6 months Patients known Heart failure (Stage III or IV) Severe liver dysfunction(Child Pugh C) Baseline AST, ALT more than 3 times of upper limit History of chronic pancreatitis Patients with Bullous Pemphigoid Patients with BMI more than 40 Patients taking any other concomitant medication which is known to effect arterial stiffness (GLP1 agonist/SGLT2 inhibitors) Tobacco abusers, Alcoholic and any kind of substance abusers Patients with malignancy and/or on chemotherapy Patients with infectious disease like HIV, HepB, HepC.
结局指标
主要结局
To evaluate the effect of Trelagliptin vs Teneligliptin on
时间窗: 6 months
arterial stiffness as an add-on therapy to pre- existing oral antidiabetic
时间窗: 6 months
drugs (as per standard of care) in patients of T2DM
时间窗: 6 months
with impaired glycaemic status (HbA1c more than 7 but less than9) from baseline to week 24
时间窗: 6 months
次要结局
- To compare changes from baseline to week 24 in(1. HbA1C,FBS,PPBS, bodyweight)
研究者
Dr Arindam Naskar
School of Tropical Medicine