Usage of Dapagliflozin - a Sodium Glucose Co-transporter Inhibitor, in the managEment of Type-2 Diabetes Mellitus: A Real World Evidence Study in Indian Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- To record the mean change in HbA1C from baseline
研究概览
简要总结
This study is a non-interventional, multicentre, prospective, observational study to be conducted at 50 sites in India. The study targets to enrol 2000 patients with 40 patients per site. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB) and written informed consent of the patient.
详细描述
This study is a non-interventional, multicentre, prospective, observational study to be conducted at 50 sites in India. The study targets to enrol 2000 patients with 40 patients per site. The study would enrol T2DM patients who are/were inadequately controlled (HbA1c >7%) with existing anti-diabetic medications and who have been prescribed dapagliflozin 3 months prior to study initiation. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice and prescribed dapagliflozin 3 months before will be screened for enrolment in study. Dosage of dapagliflozin and other medications should be as per the routine clinical practice and prescribing information. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with 18 years and above.
- •Patients who provide written informed consent.
- •Patients with previously diagnosed Type-2 diabetes mellitus
- •Patients with inadequately controlled diabetes (HbA1c >7%) with existing anti-diabetic medications, prior to initiation of dapagliflozin treatment.
- •Patients who are taking dapagliflozin within last 3 months.
排除标准
- •Patients with Type-1 diabetes mellitus
- •Patients with any medical condition which in the opinion of the investigator would interfere with safe completion of the study
- •Pregnant or lactating women
结局指标
主要结局
To record the mean change in HbA1C from baseline
时间窗: 6 months
form basline visit to 6 months visit
次要结局
- To record the change in blood pressure(6 months)
- To record the change in weight(6 months)