A Non-Interventional, Multicenter, Prospective, Observational, Comparative Study to Understand Usage, Safety and Effect of TENeligliptin Vs. GLImepiride as an Add-on to METformin Treatment in Indian Type 2 Diabetes Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- 1. To assess the occurrence of hypoglycemic episodes between two groups
研究概览
简要总结
A Non-Interventional, Multicenter, Prospective,Observational Comparative, Study to Understand Usage, Safety and Effect ofTENeligliptin Vs. GLImepiride as an Add-on to METformin Treatment in IndianType 2 Diabetes Patients (TENGLIMET Study). A total 500 patients are plannedfrom 10 sites across India. The primary objectives of the study are to assessthe occurrence of hypoglycemic episodes, change in HbA1c and body weightbetween teneligliptin and glimepiride groups. The secondary objectives are toassess change in Fasting Blood Glucose (FBG), Postprandial Blood Glucose(PPBG) from baseline to week 24. Also, to understand the study drug usagepattern and occurrence of adverse events.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient willing to provide informed consent 2.Female or male patient aged 18 years or above 3.Adult patients who had inadequately controlled type 2 diabetes mellitus despite using diet plus exercise and metformin: –HbA1C: 7 to 9% –FBG: ≥140 mg/dL 4.Physician prescribes teneligliptin or glimepiride as an add-on to metformin therapy 5.Patients must provide written consent to use personal and/or health data prior to the entry into the study.
排除标准
- •1.Patients with Type 1 diabetes mellitus 2.Patient on antidiabetic therapy other than glimepiride, teneligliptin and metformin 3.Contraindications for teneligliptin and glimepiride as per respective approved prescribing information 4.Any reasons of medical and non-medical character, which in the opinion of the physician can prevent participant participation in the study 5.Pregnant and lactating woman and women of child bearing potential not ready to use an effective barrier contraceptive method during the study.
结局指标
主要结局
1. To assess the occurrence of hypoglycemic episodes between two groups
时间窗: Baseline, Week 12 and Week 24
2. To assess the change in HbA1c levels from baseline to week 24
时间窗: Baseline, Week 12 and Week 24
3. To assess the effect of both the treatments on body weight
时间窗: Baseline, Week 12 and Week 24
次要结局
- 1. To assess the change in FBG and PPBG levels from baseline to week 24(2. To understand the utilization pattern of teneligliptin)