A Non-INterventional, Multicenter, Prospective, ObserVational Study to UndErstaNd the Effect of Teneligliptin on QT Interval in Indian Type 2 Diabetes Patients
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To assess the change in QTc interval in ECG from baseline to week 4 and 12
研究概览
简要总结
This Non-Interventional, Multicenter, Prospective, Observational Study to UNderstand the Effect of Teneligliptin on QT Interval in Indian Type 2 Diabetes Patients (INVENT Study). Total 200 patients are planned from 20 sites are planned. The primary objective is to assess the change in QTc interval in ECG of type 2 diabetic patients (age > 60yrs) treated in routine clinical practice with Teneligliptin 40 mg from baseline to week 4 and 12 treated with Teneligiptin. The secondary objectives of study are (i) to understand usage pattern of teneligliptin (ii) changes in HB1Ac, FBG and PPBG levels from baseline to week 12 and (iii) to assess adverse event during study medication
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 60.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient willing to provide informed consent Female or male patient aged 60 years or above Treatment naïve patients or patients who had inadequately controlled type 2 diabetes mellitus despite using diet plus exercise and/or OADs: a.
- •HbA1C greater than 6.5% b.
- •FBS more than or equal to 140 mg per dL Patient is prescribed teneligliptin 40mg as a monotherapy or add on therapy Patients must provide written consent to use personal and/or health data prior to the entry into the study.
排除标准
- •Patients with Type 1 diabetes mellitus Patient on DPP-4 inhibitor other than teneligliptin and GLP-1 analogue therapy Contraindications for teneliglitpin as per approved prescribing information Patients taking any other drug prolonging QT interval.
- •Any reasons of medical and non-medical character, which in the opinion of the physician can prevent participation of subject in the study.
结局指标
主要结局
To assess the change in QTc interval in ECG from baseline to week 4 and 12
时间窗: At baseline, week 4 and week 12
次要结局
- To assess the change in HbA1c, FBG and PPBG levels from baseline to week 12