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临床试验/NCT02588859
NCT02588859已完成不适用

A Non-Interventional, Multicentre, Prospective, Observational Study to Understand Usage and Effect of Saxagliptin as First Add-On After Metformin in Indian Type 2 Diabetes Patients. (ONTARGET-India)

AstraZeneca1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2015年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
1,200
试验地点
1
主要终点
Medication usage in enrolled subjects

研究概览

简要总结

This is a multicentre, non-interventional, prospective, observational study which would be conducted in India to understand the usage and effect of saxagliptin as first add-on therapy after metformin. The study will enroll Type 2 Diabetes Mellitus (T2DM) patients who were inadequately controlled with metformin alone and have been recently prescribed saxagliptin as an add-on to metformin.

详细描述

This is a multicentre, non-interventional, prospective, observational study which would be conducted in India to understand the usage and effect of saxagliptin as first add-on therapy after metformin. The study will enroll Type 2 Diabetes Mellitus (T2DM) patients who were inadequately controlled with metformin alone and have been recently (i.e. within past 15 days) prescribed saxagliptin as an add-on to metformin.

The Investigator/designee would get signed informed consent from potential subjects of the study. The patients who meet all inclusion and none of the exclusion criteria will be enrolled in the study. These patients will then be assigned a patient identification number for the study. The Investigator/designee will collect the information as per the study schedule. This will be considered as Visit 1 of the patients. The patients will be managed as per the routine clinical practice of the physician for their condition and this study will neither interfere/advise the Investigators/designee for any drug/medication to be prescribed to the patients nor prescribe any intervention to them.The enrolled patients would then be asked to visit their respective study sites after 3 months ( +7 days) for the Visit-2 of study.

Around 50 study centers throughout India will be selected with a goal of enrolling up to 1500 patients (approximately 30 subjects each per site). The study will be initiated after obtaining written approval of Independent/Institutional Ethics Committee and written Informed consent of the patient.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients willing to provide informed consent.
  • Female or male patients aged 18 years or above.
  • Patients with known case of Type 2 diabetes mellitus.
  • Patients with inadequate glycaemic control taking metformin monotherapy (minimum dose of 500 mg OD) for at least 3 months.
  • Patients who have recently (last 15 days) been prescribed saxagliptin in addition to metformin.

排除标准

  • Patients with Type 1 diabetes mellitus.
  • Patients taking glucose lowering drugs apart from metformin or saxagliptin.
  • Any medical condition of the patient which in the opinion of Investigator would interfere with safe completion of the study.
  • Pregnant or lactating women.
  • Women of childbearing potential not ready to use an effective barrier contraceptive method during the study.

结局指标

主要结局

Medication usage in enrolled subjects

时间窗: at 3 months

By Frequency of subjects taking different doses of saxagliptin and metformin

次要结局

  • Reduction in HbA1C(baseline and at 3 months)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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