CTRI/2018/02/012158尚未招募不适用
A 12–month prospective observational study assessing the real-world clinical effectiveness, safety and health-economic benefits of Toujeo® initiation after oral antidiabetic drug failure in insulin-naïve patients with type 2 diabetes mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 4,525
- 试验地点
- 18
- 主要终点
- Percentage of patients achieving the predefined individualized HbA1c goal at 6th month
研究概览
简要总结
Anobservational study to assess effectiveness, safety and health-economicbenefits of Toujeo Initiation in type 2 diabetes mellitus patients, which willbe conducted for 12 months in 1250 patients across 125 centers in India.Primary outcome is percentage of patients achieving the predefinedindividualized HbA1c goal at Month 6(If the goal is not defined at baseline,general HbA1c goal of <7.0% will be used).
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
- •Signed patient informed consent;
- •Type 2 diabetes mellitus;
- •Treated with at least 1 OAD for at least 6 months;
- •Legal age of adulthood, but at least ≥18 years;
- •HbA1c >7.0 % and ≤11% within 3 months of study baseline;
- •Physicians’ decision in accordance with the current local guidelines to add basal insulin glargine U300 to an existing OAD regimen.
排除标准
- •Diabetes mellitus other than type 2;
- •Existing or previous treatment with insulin or other injectable antidiabetic drugs. The following is allowed:.
- •Previous short-term insulin treatment due to an intercurrent medical condition, with treatment duration not exceeding 10 concurrent days in the past year;.
- •Previous insulin treatment of gestational diabetes, if the patient has discontinued insulin treatment more than a year ago.
- •Contraindication to insulin glargine U300 according to local product labelling;
- •Pregnancy, breastfeeding or pregnancy planned during the course of the study;
- •Drug or alcohol abuse within the past year;
- •Concomitant disease with life expectancy of less than 1 year;
- •Concomitant participation in a clinical trial.
结局指标
主要结局
Percentage of patients achieving the predefined individualized HbA1c goal at 6th month
时间窗: 6th Month
次要结局
- Efficacy endpoints:(1.Percentage of patients achieving the predefined individualized HbA1c goal at Months 3 and 12;)
研究者
研究点 (18)
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