A Non-Interventional, Multicenter, Prospective, Observational Study to Understand Usage and EFFect of Teneligliptin as Monotherapy OR Add On Treatment in Indian Type 2 Diabetes Patients on other Antidiabetic Drugs (AFFORD Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 7
- 主要终点
- To assess the change in HbA1c levels from baseline to week 12 in Indian Type 2 diabetes mellitus patients
研究概览
简要总结
A Non-Interventional, Multicenter, Prospective, Observational Study to Understand Usage and EFFect of Teneligliptin as Monotherapy OR Add On Treatment in Indian Type 2 Diabetes Patients on other Antidiabetic Drugs (AFFORD Study) to be conducted across India. A total of 1500 patients are planned from 15 sites across India. The primary objective of the study is to assess the change in HbA1c levels from baseline to week 12 in Indian type 2 diabetes mellitus patients.
The secondary end point includes assessment of change in FBG, PPBG levels and body weight from baseline to week 12. Also to understand usage pattern of teneligliptin as monotherapy or add-on with other oral antidiabetic drugs. It also includes assessment of rate 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 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient willing to provide informed consent
- •Female or male patient aged 18 years or above
- •Treatment naïve adult patients or adult patients who had inadequately controlled type 2 diabetes mellitus despite using diet plus exercise and/or OADs: a.
- •HbA1C greater than 6.5% b.
- •FBG greter than or equal to 140 mg/dL
- •Requirement for teneligliptin as a monotherapy or add-on
- •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
- •Any medical condition of the patient which in opinion of Investigator would interfere with safe completion of the study
- •Pregnant and lactating woman
- •Women of child bearing potential not ready to use an effective barrier contraceptive method during the study
- •Patients participating in any other clinical trials.
结局指标
主要结局
To assess the change in HbA1c levels from baseline to week 12 in Indian Type 2 diabetes mellitus patients
时间窗: Visit 1 at baseline | Visit 2 at week 12
次要结局
- 1. To assess the change in FBG and PPBG levels from baseline to week 12(2. To understand usage pattern of teneligliptin as monotherapy or add-on with other OADs)