NCT03703869已完成不适用
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 4,589
- 试验地点
- 388
- 主要终点
- Change in HbA1c at month 6
研究概览
简要总结
Primary Objective:
Assess effectiveness of insulin glargine (U300) in achieving glycemic goal measured by hemoglobin A1c (HbA1c).
Secondary Objectives:
- Assess effectiveness in achieving glycemic goal measured by HbA1c;
- Assess effectiveness on change in HbA1c, fasting plasma glucose (FPG) and self-monitored plasma glucose (SMPG) ;
- Assess requirement for intensification of therapy by additional antidiabetics.
- Assess incidence of hypoglycemia;
- Assess other safety endpoints: adverse events (AEs), serious adverse events (SAEs);
- Assess change in body weight.
详细描述
Patients will be observed for one year
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Insulin glargine (U300)
Insulin glargine (U300) dosage and dosing time as per local product labeling
干预措施: Insulin glargine (U300) (Drug)
结局指标
主要结局
Change in HbA1c at month 6
时间窗: Baseline, month 6
Percentage of patients achieving Hemoglobin A1c \<7.0%.
次要结局
- Change in HbA1c(Baseline, months 3, 6, 12)
- Change in Self-Monitored Plasma Glucose(Baseline, months 3, 6, 12)
- Hypoglycemia(Baseline to month 12)
- Adverse events(Baseline to month 12)
- Serious adverse events(Baseline to month 12)
- Change in fasting plasma glucose(Baseline, months 3, 6, 12)
- Body weight(Baseline to month 12)
研究者
研究点 (388)
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