An observational study in PRIMARY Care settings in India to assess clinical outcomes, initiation patterns, and treatment-satisfaction in type 2 Diabetes Mellitus patients initiated on Insulin glargine (PRIMARY-India study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 450
- 试验地点
- 47
- 主要终点
- Mean change in HbA1c from baseline to 6 months
研究概览
简要总结
This is a national prospective, multicenter, observational study. This Indian study will mirror real life management of patients who have been initiated on insulin glargine (lantus® and toujeo®). The data will be collected from urban (megacities with population >10 million) and semi urban population (cities with population between 1 – 10 million) (9). This strategy will enhance the significance of the results and allow analyses on an urban/semi urban basis because management patterns vary between these two settings.
This study in a primary care setting will help us to understand:
Initiation patterns
Clinical outcomes
Physician satisfaction
Patient treatment-satisfaction
in T2DM patients initiated on insulin glargine (Lantus® and Toujeo®. The study will also attempt to understand the outcomes and initiation patterns in urban and semi-urban Indian sub-populations
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female aged ≥ 18 years
- •Insulin-naïve type 2 diabetes patients, uncontrolled (HbA1c > 7%), on at least 1 oral antidiabetic drug (OAD) for a minimum period of 6 months, initiated on insulin glargine (Lantus® / Toujeo®) in out-patient primary care settings
- •Signed informed consent form.
- •Note: Insulin glargine should be administered up to 7 days prior to informed consent or within 2 days after informed consent independent of this study.
排除标准
- •Known cases of type 1 diabetes mellitus and secondary diabetes.
- •Clinically significant acute major organ or systemic disease or other condition judged by the investigator that would create difficulty for the 6-month follow-up.
- •Current or planned pregnancy or lactating women
- •Patients on an investigational drug or have participated in a clinical trial in the previous 3 months
- •Contraindication to Lantus® and Toujeo® according to local product labelling
- •Patents requiring short-term insulin therapy.
结局指标
主要结局
Mean change in HbA1c from baseline to 6 months
时间窗: Mean change in HbA1c from baseline to 6 months
次要结局
- 1. Number of adverse events and serious adverse events and hypoglycemic events in overall population(2. Change in insulin dose in overall population.)